Pulse Biosciences, Inc. Aktie

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences Q2 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. To ask a question, simply press star 1 on your telephone keypad. To withdraw your question, press star 1 again. We do ask that you limit questions to one and one follow-up.

It is now my pleasure to turn the call over to Tripp Taylor, Investor Relations. Please go ahead.

Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, August 6, 2026 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures, disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable gap measures, can be found in the press release.

Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com in the news and events section on our investor relations page. With that, I would now like to turn the call over to co-chair of the board and chief executive officer, Paul LaViolette.

Thank you, Tripp, and good afternoon, and thank you everyone for joining us today to discuss the results of our very active second quarter of 2026. I would like to begin with a discussion of the amazing and novel technology that sits at the core of everything we do at Pulse Biosciences, our proprietary nanotech second pulse field ablation or NSPFA technology. By delivering electric pulses in only billionths of a second durations paired with high energy, we are able to treat tissue non-thermally and with exceptional effectiveness. This translates into tangible and measurable advantages across a range of different diseases and tissues in the human body. NSPFA produces targeted energy, non-thermal ablations, durable lesions, quicker ablation times, and faster procedure times, all complementing the natural body function of regulated cell death. This mechanism is uniquely stimulated by NSPFA and is unmatched by existing ablation energies, including all prior art and the broad category of microsecond PFA alternatives. Underpinning the platform are a uniquely experienced technology development team, which has Thank you. our long-term leadership in this field.

Last quarter, we announced a strategic alignment to prioritize, accelerate, and broaden the development of our end-pulse cardiac catheter ablation system. focus remains concentrated on the treatment of atrial fibrillation and the development of our end-pulse cardiac catheter systems while we continue to advance our surgical clamp and thyroid programs with discipline and optimism. As part of our strategic alignment, we focused on two key pillars in our program, generating compelling clinical data and executing rapid trial enrollment across a growing base of studies. During the second quarter, with this shift in focus, we have delivered positive, and important achievements in our cardiac catheter program. We enrolled the first patient in our pivotal catheter IDE study, including seven cases on day one. We activated multiple sites, presented outstanding feasibility data at the Heart Rhythm Society meeting in April, and further strengthened our leadership team with the additions of Leanne Toplitsky as Chief Operator operating officer and Dr. David Kenigsberg as full-time chief medical officer. These two leaders have strengthened our ability to execute a successful pivotal IDE study and advance toward regulatory approvals.

We also meaningfully bolstered our balance sheet now with over $100 million on hand, expanding our runway to fund development and clinical milestones ahead. Our financing progress was an important marker of external confidence in Pulse Biosciences. Through our At the Market, or ATM, program, we raised a total of $57.5 million in net proceeds to date, initiated with continued insider support of approximately $13 million, and the remaining portion coming from outside institutions. investors. This strengthened our balance sheet during the quarter and reflects growing and expanding conviction in the NSPFA platform and the growth opportunities in front of us. This is a complex environment for raising capital, and we are proud that investors who took a close look at our technical and clinical progress, we're able to appreciate the value creation story we are building at Pulse Biosciences. Additionally, we recently announced that we have surpassed the halfway point of enrollment in our U.S. Pivotal Capitor Study. ahead of our original schedule, and on the strength of that pace, we are confident in completing enrollment on our accelerated timeline of early Q4.

Reaching this point so quickly in a pivotal AFib study is extraordinary, and and we attribute it partly to a straightforward dynamic. Physicians are thrilled by their personal NSPFA clinical experience when using this catheter and are highly enthusiastic to both expand their use and share their positive experiences with their peers. This response is universal across operators. Today I will focus most of my remarks on the catheter and then we'll provide updates on our two other NSPFA devices. We will then turn the call over to our Chief Financial Officer, John Skinner, to review the second quarter financial results in detail. We will then conclude with a question and answer session joined by Bob Duggan, co-chair of the Board. I will now discuss the end-pulse cardiac catheter system for AF ablation.

Earlier in July, we shared that the nanopulse AF study crossed its enrollment midpoint with more than 82 evaluable patients, net of roll-ins, treated in the IDE since the study began enrolling in the study. April. The pace exceeds all expectations and reflects investigational site enthusiasm for what NSPFA technology offers. Durable pulmonary vein isolation, familiar and rapid workflow, intuitive user experience, an efficient procedure, and consistently positive outcomes for patients in need of AFib resolution. We are proud of current results and, rest assured, we are persistent in striving to do even better. Given our enrollment cadence thus far and expectations for site performance in the second half of the study, we are are confirming our target completion date of early October three months earlier than our original timeline. This enrollment velocity reflects the quality of our investigational sites, along with their lab and clinical research staffs, and the compelling clinical attributes of our catheter and energy system. Physicians comment that the system is extremely intuitive, with a straightforward learning curve, as well as seamless workflow integration. integration, translating directly to rapid, efficient procedure and ablation times.

We have seen multiple sites perform five and up to seven cases in a day, and multiple physicians have completed their initial cases with seven to eight minutes or faster ablation times. Other ablation catheters currently available, EP labs generally do not schedule more than two to three cases per day. This early on meaningful expansion of daily case capacity is the best evidence of the workflow and procedure speed advantages as well as potential hospital economies that will follow as they utilize the NPulse system. catheters that change practice patterns for the better and dramatically so in our view will become a compelling and welcomed option for electrophysiologists and hospitals Upon the basis of workflow efficiencies, patient outcomes, and more, our NSPFA console and catheters continue to demonstrate unprecedented potential to transform the treatment landscape for atrial fibrillation. We chose to amend our nanopulse AF pivotal study protocol to increase the total enrollment target by 19 patients. Thank you. target of 145 to a new target of 164. This is being done in concert with reducing prior enrollment restrictions on the types of antiarrhythmic drugs, or AADs, a patient must fail in order to qualify for inclusion. Now, patients that have failed any one of the four classes of AADs qualify for the study.

We believe this protocol modification better reflects contemporary clinical practice and real-world patient management. This protocol change also expands the pool of qualifying patients. We are pleased to confirm that full study enrollment is still expected to be completed by our revised date of early October, even with the increase in study size. Site activation continues to proceed well, and the most Momentum across our investigational network is being maintained as we expanded the base of active study sites to 12, and this number is expanding in real time. While the study protocol allows for enrollment at up to 30 sites, we do not anticipate activating all 30 due to the physician enthusiasm and enrollment velocity we have already experienced in the current base as sites and investigators are activated. Diving further into our study protocol, our efficacy endpoint, freedom from treatment failure through 12 months, incorporates a mix of both 12-month and 6-month patient follow-up data. The Blended endpoint optimizes overall follow-up time for the study while supporting statistical rigor.

As a reminder of our data presented at Heart Rhythm Society, or HRS, Dr. Vivek Reddy, the National Principal Investigator for our pivotal study, shared expanded results from our European NPulse cardiac catheter feasibility study, including 6-month follow-up on 95 patients and 12 month follow-up on 53 patients within the five-second ablation cohort. These data were outstanding. 100% freedom from AF measured by 24-hour Holter monitor at six months and 96% as measured by 24-hour Holter monitor at one year, along with 90% Kaplan-Meier estimated freedom from recurrent AF, flutter, or tachycardia at one year, alongside a serious adverse event rate of just 1.7% across 177 patients. Those numbers compare quite favorably to the meaningfully lower success rates typically seen with other ablation technologies. and were achieved without antiarrhythmic drugs and with consistent performance across operators and sites. The EU feasibility data continue to support our path toward a CE mark submission in the second half of this year, and we see a potential CE approval around the middle of 2027, roughly six months post-submission. Supporting our go-to-market strategy with the EP Catheter, we are continuing to pursue a partnership strategy. dialogue with prospective partners is ongoing, centered around the established players in electrophysiology with available mapping technologies. Those conversations are underway and we'll provide details when appropriate.

Let's now move to our surgical clamp program, where treatments in our pivotal IDE clinical study continue to perform well. Concomitant ablation for pre-existing AF is, in our view, significantly underpenetrated, and we believe nanosecond PFA can support increased surgeon adoption. and drive meaningful market penetration over time. Currently, available tools provide inconsistent results with involved and time-consuming procedure protocols. Our clamp was designed to address these needs efficiently and to deliver the speed and effectiveness of NSPFA technology, which is the most important part of the process. capable of delivering reproducible transmural lesions nearly instantaneously, producing a more reliable and trusted ablation procedure, all for the purpose of improved patient outcomes. In addition to our IDE enrollment, our EU feasibility study has now treated more than 70 patients across six sites. Three-month post-procedure electroanatomical mapping results were presented at the European Heart Rhythm Association 2026 meeting and demonstrated excellent lesion durability and procedural efficacy on 34 patients. Total ablation time averaged just 4. 41 seconds per patient.

And pulmonary vein isolation success held steady at an extremely high rate of 94% at the three-month follow-up. unchanged from the initial readout we provided in October of 2025. Just as telling is the qualitative feedback. Surgeons consistently praised the speed, lesion quality, and ease of use provided by the Pulse NFPFA clamp. Given this encouraging progress, we remain on schedule to file for CE Mark before the end of 2026. In the U.S., our pivotal study, NanoClamp AF, continues to enroll. As a reminder, it remains the only trial of a PFA surgical device to have secured FDA IDE approval. The IDE is a prospective single-arm study spanning 20 centers. three of them international, with a target of 136 patients designed to establish the safety and effectiveness of the end-pulse cardiac catheter system in treating AF during concomitant cardiac surgery.

Enrollment and site activation is progressing. and we expect to complete enrollment by the end of the first half of 2027. Turning to our NPulse Vibrance percutaneous electrode system, the NPulse Vibrance system uses our nanosecond PFA technology to ablate soft tissue percutaneously. Vibrants can be used to ablate symptomatic benign thyroid nodules as an alternative to full thyroid ectomy surgery. Rather than removing tissue unnecessarily, Vibrance treats the thyroid through a minimally invasive approach in the outpatient setting. The procedure shrinks the nodule and relieves symptoms while sparing the surrounding anatomy and preserving thyroid function, a highly desirable outcome that is... is not possible with traditional surgical excision of the thyroid. In the second quarter, Vibrant's disposable sales were $434,000, a sequential increase from $400,000 in the first quarter. We remain focused on core market development goals, including generating clinical data for both expanding reimbursement coverage and achieving achieving specific regulatory label claims.

We are proud to announce a new partnership with the Klayman Thyroid Center in Tampa, Florida, the largest thyroid surgery center in the United States. This unique partnership is focused on supporting our core strategy of demonstrating the viability of the Vibrant System therapy for patients with symptomatic benign thyroid nodules. Key elements of this partnership will include registry data generation and unique study protocols for interventional therapy in thyroid disease. Bringing on a center of this caliber is an important step toward our goal of establishing NSPFA as a minimally invasive standard of care for benign thyroid nodules. Over the past several weeks, the Clayman Center has onboarded the Vibrant system and performed its first cases, and we look forward to seeing you next time. to reporting on progress toward our partnership objectives in future quarters. Additionally, our precise BTN, benign thyroid nodule study, continues to proceed quickly, and we expect the study to be fully enrolled this month. We broadened the study from its original 50-patient design to 100 patients to deepen the data set in support of adoption and long-term market expansion.

Scientific recognition of this work continues to grow. Data from Dr. Stefano Spiazia in Naples, Italy, was recently presented in a podium session at the North American Society of Interventional Thyroidology, or NASIT. The data showed durable results out to 15 to 20%. months, a 74% reduction in treated nodule volume as per our expectations, a alongside overwhelming patient satisfaction, featuring very rapid symptoms relief post-treatment. volume reduction continued to improve from one month all the way through 22 months with no nodule regrowth observed in the 15 to 22-month time frame. Beyond Precise BTN, we are also widening the clinical scope of our Vibrance platform. Through our research collaboration with the University of Texas MD Anderson Cancer Center, researchers at two study centers are conducting a multi-center, first-in-human feasibility study of MDAs. NSPFA for papillary thyroid microcarcinoma, or PTMC. This study is designed to enroll up to 30 patients across two sites.

I'm pleased to announce that this study is approximately half enrolled, and we expect to complete enrollment by year-end 2026. And looking ahead, we've begun planning additional clinical trials with the aim of extending the Vibrance platform into new thyroid indications as we support the our plans to bring this revolutionary therapy to a broader patient population. With that, I'll turn the call over to John to walk through our second quarter financial results.

Thank you, Paul. Now, I will highlight our GAAP and non-GAAP financial results. encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the second quarter, we generated revenue of $434,000 and cost of product revenue was $273,000 for the quarter. We remain in a disciplined launch focused on clinical and market development. Based on strong clinical results, we remain focused on growing procedural utilization within a limited customer base. Total gap costs and expenses for the quarter increased by $5.4 million to $25.7 million, compared to $20.3 million in the prior year period. The increase in gap costs and expenses was primarily driven by increased investment in our clinical programs and compensation and employee-related spend supporting our growth in clinical and product development. Compensation and employee-related expenses, including stock-based compensation, increased approximately $2.7 million versus the prior year period.

To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization, as well as non-recurring costs. Total non-GAAP costs and expenses in the second quarter of 2026 increased by $5.7 million to $20.5 million. compared to $14.8 million in the prior year period. The expected increase was driven by increasing clinical trial expenses and $2.9 million of compensation and employee-related expenses. Looking ahead, we expect quarterly operating expenses to remain in this range on a non-GAAP basis as we continue to invest in our clinical programs. Gap net loss in the second quarter of 2026 was $24.7 million compared to $19.2 million in the prior year period. Non-GAAP net loss in the second quarter of 2026 was $19.4 million compared to $13.7 million in the prior year period. March 30, 2026 cash and cash equivalents totaled $101.6 million compared to $68.3 million as of March 31, 2026. representing an increase of $33.3 million versus the prior quarter.

Cash used in operating activities during the second quarter of 2026 was $18.7 million compared to $12.8 million used in the prior year period and $14.6 million in Q1 of 2026. Through our ATM program, $57.5 million in net proceeds was raised since May. Bob Duggan and the Pulse team partnered with a sales agent to manage daily participation and run a successful program, raising approximately $44.5 million from outside investors. During Q2, insiders announced intent to purchase shares through the ATM program three trading days prior to the insider transaction, and management provided this update during our Q1 earnings call. This continued insider support contributed approximately $13 million through the ATM. Of the $57.5 million in net proceeds, $46.8 million was raised during the second quarter, with an additional $10.7 million raised subsequent to the close of Q2 and thus not included in our reported cash balances. As a result, we strengthened our balance sheet, ending with a strong longer cash position than we began and extending our runway to the key clinical and regulatory milestones ahead.

Additionally, we put a new $75 million ATM facility in place to preserve our financing flexibility going forward, along with our shelf that was put in place in February. We also received gross proceeds of $1.8 million related to exercises of the second tranche of 2024 rights offering warrants in July. Following this redemption, there are no remaining warrants outstanding. We remain disciplined on expense growth while continuing to fund our clinical programs, prioritizing financing through key milestones ahead. With that, I will now turn it back to Paul for closing remarks. Thank you, John.

Our strategic focus remains the treatment of atrial fibrillation, and with each new data readout, each new site activation, and each new investigator experience, the clinical strength and disruptive market potential of NSPFA becomes clearer to all. Enrollment in our pivotal IDE study is progressing ahead of our original timeline, driven by strong physician demand and site motivation. Looking ahead, our priorities remain clear. Continuing enrollment of our IDEs, progressing towards CE-MARC approvals for our cardiology devices, advancing our catheter partnership discussions, and new this quarter, developing Vibrance Market Value through our partnership with claimant center, all while maintaining the operating discipline required to effectively execute and complete these critical milestones that will define Pulse Bioscience's future. NSPFA technology continues to demonstrate remarkable clinical differentiation, and our work going forward is to transform that platform potential into durable, scaled businesses capable of generating multiple billion dollars of recurring revenue. Thank you for your continued support. and we look forward to updating you again next quarter. Now, joining us for the question and answer session is Bob Duggan, co-chairman of the board.

Operator, please open the call for questions. As a reminder, to ask a question, simply press star 1 on your telephone keypad. Please limit questions to one and one follow-up. Our first question comes from the line of Bill Plavancic with Canaccord Genuity. Please go ahead.

Yes, great. Thanks for taking my questions. Congratulations on successfully the enrollment rates. My first question pertains to that. You know, you've talked about the combination of the six and 12-month data and the final module submission. Given that this enrollment is so fast, I don't think I've seen anything quite this fast, does it even benefit you to have it be a combination of six and 12-month data, or is this something where you might end up waiting? you know, till you have full 12-month data for the final module submission of the PMA for the nanopulse AF.

Thank you, Bill. Good question, and you're right. So just to be, let's say, level setting, the six and 12-month combination presumes that patients early in enrollment will be followed 12 months, and patients later in enrollment will be followed six. Then the question becomes, what's the long pole, right? And if you enroll the second half of the study and follow those patients for six, they might reach their six-month endpoint before the earlier patients reach 12. So I think the real way to focus, I'll call it on the absolute timeline, is to think about 12-month follow-up on the patient cohort. And frankly, at that point, if enrollment continues to go so swiftly, whether you set that bar and say, let's do 12-month follow-up on the the 80th patient or the 100th patient or the 130th patient, the absolute time differential between those is relatively short. So we're focused less on that than we are on quality and expedited enrollment where very pleased by how enrollment is going. I would say we're very pleased by the uptake of second and third wave sites. and the fact that there's really no distinction between how a new user establishes clinical comfort with our catheter today versus how that was established a few months ago when the IDE commenced or last year when our first in human experience was commenced.

So, very good question. Twelve months from the earlier patient group is the long pole in the tent. And despite that, we'll certainly, we're going to be using all tools available to us to manage timelines effectively, including enrollment, including follow-up, and then, of course, submitting very clean data to provide FDA the opportunity.

to minimize their review time once submitted. And then just a follow-up on that, Paul, thank you, is, you know, given that, I mean, 80 patients out of, you know, you probably had only six or seven accounts that did all of those, I would imagine it's gone so quickly. Do any of these accounts stop out just because they've had too many, you don't want them to get to be too many patients or too big a piece of the study? And so that's maybe why the pacing that you're providing kind of maintaining, even though you expand number, but maintaining the timeline on this is because some of those earlier sites are going to.

pop out. That also is a great observation. And the typical of all FDA-approved protocols, the FDA is worried about and focused on generating a representative patient pool of data. And in a multi-center study, they want to assure that there is not excessive skew toward one or two centers. And so we do have a cap that represents 15% of patient enrollment at a given site, no more. And I I will say in response specifically to your observation, yes, several sites already have met their cap. Now, of course, the next sites being opened are equally interested in enrolling as many patients as they can. But as is always the case with clinical trial management, one, the sponsor, in this case, Pulse Biosciences, can't specifically predict which next site will be the next. site to enroll very rapidly and to reach its cap.

So, our job is to continue to activate sites, which we're doing. We have more in the queue, and we'll activate more sites over the next one and two months, and we'll continue to do that up to the point where we are nearing final enrollment. Yes, some of the measured momentum throughout now and the next several months toward our expected completion date is regulated, if you will, by the turnover of high-performing sites as we cap out on some and as new ones emerge to become the next high-volume sites.

volume enrollers. And then last one I promise is just, you know, you expanded the study. So my question was any major learnings, you know, you've enrolled 80 patients, but any major learnings from those 80 patients, and it sounds like one of them is just, hey, let's make sure we have all the AADs and, you know, get a real, true, real, real work. world patient population, but I don't want to put words in your mouth. And thanks for taking my question.

Thank you, Bill. Well, I won't comment on any form of results, but as we've indicated in our message about both the rapidity of enrollment and all the way back to our first announcement of first patient in. This is an exciting trial. Physicians are extremely enthusiastic about this technology. As you know, I've been doing clinical trials for 40 years, cardiovascular breakthrough clinical trials for probably 35 years. I've never seen trial enthusiasm any stronger. than what we have here. And so we're just amazed by, and I actually had this conversation with several members of our team, that as we focus on the extraordinary data, the outcomes, the data set that we announced at HRS, unprecedented data, it's important for us not to take for granted the acute experience in the lab. If we think about the AFib market, if we think about the dynamic change, the disruptive change that new technologies have brought in the last year, the shifts in market share, how those shifts in market share have translated to really fundamental shifts in market leadership positions, that has all been principally driven without outcomes data differences and mostly based on acute experience in the lab. And so the acute experience in the lab we have been clear about, we have been transparent about.

That acute experience is unbelievable. Rapid learning curve. Almost no required time to become facile with our catheter. Extremely rapid procedure times based principally on a limited number of ablations required because of the clarity and power of our lesions, and extremely short lesion delivery times of five seconds. So when you piece those together, the physicians who are the crème de la crème are telling us that this is an experience they've never had before. And I think while it's not data, it's observation and it's anecdotal, but I think the biggest learning is the validation of the fact that the pulse biosciences catheter experience in the lab is something unlike they've ever experienced before. that is a telling marker for how this technology is likely to be adopted when it becomes available.

Paul, this is Bob. If I just might add something to Bill here. Please, Bob. The faster enrollment – thank you – the faster enrollment is really a very positive product function feature as it's easy to use. as we found out. The quantity of patients treated is a very positive product economic feature for the OR. It is O-R-R-O-I that is significant. So we're really pleased about both of them, which ultimately are the adjudicator of hospital take-up if in fact the product is giving you superior results on the patient side. We look forward to the patient side, we're very confident, but we're very pleased about the quantity of patients being treated, and it wasn't something that we pushed or promoted. It was just the doctors want to look.

You know, I've got more time here. I'm done with the three in a few hours, and I did stack up some patients, and we'll just bring them all through. So it's a double positive. We're really pleased with that. Yes.

Great. Thank you for taking my question. Thank you, Bill. Your next question comes from the line of Anthony Patron with Mizuho Group. Please go ahead.

Thanks and good afternoon everyone. I hope everyone's doing well and congrats here on the progress on the IDE study. Maybe Paul and or Bob, just one on just mapping integration in a last at HRS we talked about M-Pulse magnet being compatible with Abbott's Nsight. I think the messaging there was that Carto was going to be brought into the study So in the IDE, are we still only using N-side? Have you brought in CARDO at this point? And maybe can you recap, what do you think continuous mapping can do, you know, ultimately for results when you compare it just to the IDE or the EFS study where we just used fluoro? And I'll have one quick follow-up.

Thanks. Thank you, Anthony. Yes, so the study has been enrolled to date with NSITE. We've been clear about that. You're commenting on physician commentary coming out of, I think, HRS where in some of those panel discussions, physicians, I would say, speculated about the potential for results to potentially even improve with higher quality integration of how our catheter is represented on the mapping system. And so I would say we expect to see that manifested. And I will say, if you think about more sites picking up the technology for the first time, treating patients, and you measure, I think, your question by the efficiency of the procedure. How many ablations were needed? And you can't compare specifically the IDE to feasibility because the feasibility study contained a little bit more patient heterogeneity, some additional ablation factors. strategies were deployed. But if you look at the IDE, the number of ablations per case is quite limited, quite efficient. And that's a measure of physician confidence in their specific placement of the catheter in the anatomy.

And of course, they deliver that limited lesion set, and then they do a post anatomical map, and they pick out record specifically the effectiveness in the lab of that lesion set. And so the ability to have tight integration translates to limited lesion numbers while achieving acute isolation, and that's the goal. So I do think we see a clear result of tighter integration. integration. And we won't comment further on any changes in the mapping systems being used, but I will confirm that through today, And while we have the ability to use other mapping systems, all of the cases have been done with the NSITE system.

No, it's helpful. And the follow-up here would be on capitalization. You brought some more capital in. The cost of the trials here is going higher. We are getting to a point it isn't rolling faster. You're looking into 2027. Almost presumably you could be on a footing for a launch. today as well you announced on track for CE Mark submission So does the capital also contemplate building up the infrastructure, you know, perhaps even on the direct sales side, where does the capital bring you? Is it just through clinical trial development, or will you actually start market development as well? Congrats again. Thank you. Thank you, Anthony.

Go ahead, Bob. Yes. Yes. I've had my finger on the pulse of that. Away from the pre-announcement that Paul and I made and gave other investors three days to jump in front of us if they desired to, the balance of the money was raised in the 27-28 area, which is about where we closed out the quarter. So we were pleased with our patients and how that went. the valuation has now gone up. So taking a measured pace on this was the right thing to do. We think it will continue to be the right thing to do. We will comfortably stay out there with at least five quarters of cash on hand relative to our forward spend. And as you get a label or close to a label, that spend will accelerate.

I will say we already have calls from some of the best of sales and the best of marketing say, as and if you get a label, don't lose my number and here it is for the first time. That's the easiest area to add to and to complement what you have because you're getting calls from people that are competing with you now that well know how you stand. So that would be very difficult to go out and find a batch of engineers that could match or beat what we do. That's nigh near impossible. There's other administrative duties, regulatory, et cetera, that are... are difficult to come by. So we will be prepared for that. And whatever that case may be, we do recognize this is a business that has entrenched sales and marketing, but we do note that Boston Scientific from out of nowhere took market share like they were the Goliath, and until it was viewed as a commodity, I mean, they had like a $40 billion market cap jump when it looked like a monopoly. So valuation will not be a problem, if you look at that, and attracting the right people will not be a problem.

Time is on our side. for the continuation of the trial and the very popular trial status will in a sense provide some early benchmark. You get physicians that are doing seven a day, that's like 35 a week. there will be a classic number of EPs that go after this. And we have dealt with all the KOLs, so, to really get to the number, you can check in with them as to what they see, how competitive this will be. But we're pretty optimistic and we're very aware. In my final thoughts, Pharmacyclics Company, remember, we've not been in the drug business priorly, and McKee, my team, other people that are on board here, we did a billion dollars of revenue in the second year from out of nowhere. So we're not unfamiliar with what it takes to do that. I hope that helps to respond to the question.

Thank you.

and our preparedness for it. Absolutely. Thank you so much.

Thank you, Anthony. Your next question comes from Suraj Kahlia with Oppenheimer. Please go ahead. Hi Paul, Bob, can you hear me all right?.

Yes, go ahead, Jorge. Congrats on all the progress. So, Paul, Bob, two questions. The first is a multi-part question, and just trying to get my arms around this. called the fourth AAD added. I presume it's a calcium channel blocker. And maybe you could help us understand average age of the patients now, is it going to be end up being similar to the EFS and maybe if you could just kind of help us on the math of 19 additional patients.

Sure. So, yes. So, let's just level set for everybody. There are four classes of AADs. Two two of which are calcium channel blockers, one sodium and then one beta blocker. And the history of the field has generally driven patients to be non-responders at least in the class one and class three. Current practice though, if you think about what's going on in the marketplace today is that patients are in higher demand for earlier ablation. And that earlier ablation implies, yes, that patient still needs to be a non-responder to an AAD, but they don't want to go through the escalation of more severe drugs with greater toxicity and adverse effect profiles. So in order to keep the profile protocol, contemporary with current clinical practice, we felt it was important to add the other two AAD classes so that they could fail any one of the classes.

Now, first question on patient age. I don't believe this will alter patient age. What this will potentially do, and the way we thought about the stats, the change in the enrollment, enrollment number was to basically accept a question from FDA regarding the possibility that if you skewed more patients to being non-responders to a lower efficacy drug, it's possible that their AF burden could be slightly lower. So that leads to a potential question about performance goals, statistical rigor, and in order to bring equilibrium to all of those moving parts, we added patience. I think the important part of our thought process there was that there's very little price for us to pay by adding 19 patients. because our enrollment velocity is so high, that in order to keep all the stats balanced with the slight theoretical change in the number call it background risk of the phenotype of the enrollee, we'll add a few patients and it won't cost us anything because the time to enrollment would be essentially the same. So that's how we thought about it. I don't believe it will change the age.

And when you consider that we're not... not implementing this change until midway through the study. You then have the first half already having gone through the class one and class three non-response. The second potentially being a mix of one through four, the larger patient population is going to be quite comparable. And we just bolstered our statistical.

assurance, if you will, by adding those 19 patients. Perfect. I'll pull one quick question and I'll hop back in queue. the rest of the patients to be enrolled in nanopulse Maybe I missed your commentary. I know everything has been done on Insight so far. Should we glean from that that the rest of the patients also will be on Insight just for statistical analysis? purity here, and maybe if you could also give us an idea of the 80-plus patients and drawers, what percent would be on the AADs and what are now on for AADs? Gentlemen, thank you for taking my questions.

Thank you, Suraj. You may have missed it. I did make the comment that all All the patients so far have been enrolled using our system. mapped with NSITE. We are not going to comment on any expected change in that. So I think staying the course, the safest assumption should be that the remaining patients also will be enrolled on NSITE. That would not, by the way, change anything in the statistics to your question, our IDE actually allows us to use any available commercial mapping system. So there There is no anticipated outcome difference. It really comes down to the really the quality of the feel and the representation of our catheter on those systems in the lab.

So that's point number one. And then point number two, we, we are not going to comment on the specific AED I'd say, regimen of the first half of the population, the second half of the population. I would say physicians generally feel they can enroll. with greater ease by using a more liberal definition of AAD class non-responder. But we don't expect it to translate through to any difference in the first half and second half of the study population, given that, again, our principal goal here is to really make it easier for the clinical community to address who are now in the real world moving faster from diagnosis to ablation than they would have prior to the availability of PFA in the marketplace.

Thank you, Suraj. And your next question comes from the line of Josh Jennings with Katie Cohen. Please go ahead.

Hi, good afternoon. Thanks, Paul, Bob, and John. I wanted to just ask about the procedural efficiency you're seeing in the IDE study. The protocol, I think, is just general anesthesia for each patient. So it sounds like from your download, and I would imagine that physicians are having aha moments as they're doing six, seven cases in one day. And have any of them kind of forecast how many procedures using impulse, AFib ablation procedures they could do In an ASC, when like conscious sedation, I imagine some may be thinking about double-digit days, but I wanted to ask that, and I've got a follow-up.

Thanks, Josh. You're right. The protocol does call for general anesthesia. So One of the, I think, key observations that we have is that the relative time efficiency that we can deliver is... technically impaired, right, by the protocol and by the way we're treating these patients. And that in the real world, that you would have higher throughput when a lab is thinking purely commercial cases, morning midday and afternoon, multiple rooms, and patient throughput and efficiency. When you enter a patient in a protocol, you're more focused on grid great results capturing data, and if it takes 10, 20 more minutes, you don't really think about that on a given day. Now, one of the dynamics we've emphasized, and this is key to Bob's point, and I'm sure he'd be interested in commenting as well, This is about the translation of efficiency through to hospital economics. And we are actually asking our sites to try, if it's within their management approach, to stack some cases. Let's try to do back-to-back cases.

That does a couple of things. It's more efficient for the completion of the IDE, but it really forces them to experience what a day in the life would be like in the real world when this technology is available and when you can do three and four or five or seven cases back-to-back. and experience what that is like, you get both the acute benefit in that case, hey, my ablation time was only six or eight minutes in total. But then you also get the sense when that patient has turned over to the next, to the next, to the next, and now you've done four or five cases and it's only one o'clock, this is what is creating such a positive enthusiasm and expectation for this technology going forward. You could then take that, yes, into the ASC. And we have done patients, of course, not in an ASC in the U.S., but we have done patients with sedation protocols in Europe. And so we believe that's going to going to be quite feasible. And of course, that is an unlock for ASC conversion in the future. multiple cases per day will be feasible.

We do think labs will be thinking about how to make the downtime, right? It's less about now the time that pulse consumes. It's about the non-ablative time in the case, and then it's about the movement of patients in and out of the lab and the turnover of that time. that lab because the physician is not strained by these cases. And as a result, the physician can do multiple cases, and then it becomes more about, to use the analogy, the pit crew and the ability to turn over the room. And labs will be thinking about that because they know if they that low value time more efficiently, they can bring higher throughput and do more cases, and that will translate directly to the ASC. And Bob, do you want to make any further comments about hospital economics?.

Yes, just the number of procedures that I've been fortunate enough to be in that the doctors walk away at And I've seen two of them at the seven level just fresh ready to do more We're going to come back the next morning the This is huge for not only the doctor and their sanity, but for the hospital and its return. You really look at seven cases exceeds the revenue, the cost of capital of the generator. So the economics are superb here. And we want a label, we want the this done efficiently and we want smiles on everybody's faces, including the patient. Patients, by and large, if they have something less than full anesthesia, would rather do it if they knew for sure the outcome was the match and nothing less than full anesthesia. So I believe that is Chapter 2. Some have been done. They look good, but we won't be doing that in the trial.

Let's get through the trial, get the approval, and that's an uplift to be looked at as we get through regulatory approval and commercialization. But it's very practical and very doable. And yes, so I think you're, Josh, you're looking at it the right way. And it's really another differentiator. I think it's very, very difficult to pull that off with any pulse other than a pulse that stimulates regulated cell death, which other pulses have a very difficult time. if they can do it at all, we do it consistently. Remember, the NS pulse is a thousand fold faster than the micropulse. You penetrate into the cell at a pace that the cell does not inter-berate the inner cell working, so. It's a powerful technology. We'll take it one step at a time, but it looks really, really good.

Highly, highly differentiated. All in the direction of better for the physician, better for the OR owner, and better for the patient.

Thanks for sharing those answers and just one follow-up on I mean, just looking at the first in human data and APHIS symposium at the HRS, you know, and Paul seems to have... has the potential to deliver a differentiated efficacy profile, maybe even a record kind of freedom from atrial arrhythmia rate in the IDE study, but in a scenario where, you you know, it comes closer or even in line to the efficacy rates of competing a-fib ablation technologies or post-fib ablation technologies and what you're talking about in terms of the economic value proposition that's coming into play, I mean that would potentially still be a home run for post-biosciences and the platform just in terms of the adoption trajectory. Have you had discussions like that with any investigators or any KOL as well as in terms of where they're thinking about the efficacy bar needs to be. And clearly I'm not suggesting that it will be lower.

very strong preliminary signals in play already thank you thanks you're the good you're the best you're the best one to answer that but just on the top of this Josh an NS pulse delivered as we deliver it killed the cells a dead cell unless they are cousin of Lazarus does not come back a stunned cell which which can be otherwise the appearance of a dead cell can come back. So I look at it that the reason that you report and you're on the OR table is AF, you know, tachycardia, bradycardia. There are many ways to accrue brady and tachycardia. But the way that you came into that OR, that means in that mechanism, you're not coming back when you're treated with NSPFA. Now, you may marry someone else or lose money in the stock market or do whatever you do and have your heart go wild on it, and you could be back. We can't prevent other forms. But the reason that you report it in, that one's handled correctly. irreversibly handled. Dead cells don't come back, and we maintain that any other form of ablation can kill and can stun and have the appearance of dead cells, but somehow they seem to have recurrences.

We're not going to be in that class. So that puts us in a good position, but it doesn't mean that you will never have another, you know, you may have tachycardia today and two years later have bradycardia. That's just, that's the human physiology.

And yes, I agree with Bob 100%. I think the way I would add further to that, Josh, is that Let's assume that our data are exactly replicated from Europe. and that we post a 90% Kaplan-Meier outcome across all atrial arrhythmias. That... That's going to be questioned, right? Competition in the marketplace will say, well, that was a single study, it's not head-to-head. And they will say that that was still a relatively small data set, we've done 100,000 cases. So I think the market will accept that if we post that feasibility data, and by the the feasibility cohort will be double, right, in terms of one year follow up by then. Then we have the IDE data followed a year. That will be compelling. You put those two data sets together.

It's going to be, I think, very impressive. But I yield to the scientific community to say until we we've seen 10,000 patients, until we've seen this or that, we're not entirely convinced. But at that point they say, you know, actually, the acute performance is so good, and I'm predisposed to believe in better outcomes, even if it's not definitive head to head across a 5,000 patient study. The market is going to switch. The market has switched heretofore, based on acute performance, where there's been zero differentiation across outcomes. And so to add another leap in acute performance and complement that with a likely superior outcome still to be added to with more and more studies and more real-world studies, evidence. I think that physicians are looking at that saying, you know what, I don't need any more than that to switch.

Appreciate it. And exciting times for both of you. Thank you. Thank you, Josh.

Yes, you're welcome, John. And with no further questions in queue, I'll now return the call back to Paul for closing remarks.

Thank you, Operator, and thank you for those questions. Thank you all for your interest in Pulse Biosciences. We look forward to providing further updates on our progress, and I just want to wish everyone a good day, and thank you all for joining.

Thank you again for joining us today. This does conclude today's conference call. You may now disconnect.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]

We'll go ahead and get started with our next presentation. Very pleased to have management team from Pulse Biosciences, Paul LaViolette, President, CEO and Chairman here today to talk about the business. I make this offer in every session. This is interactive. Happy to take questions from people in the audience. If you do have a question, just wave me and we'll get you a mic. So it's available to those participating via webcast.

Maybe we just kind of start higher level. You've been at Pulse maybe 1.5 years or so. And give us a little bit of background, like what attracted you to the role? What did you see in the company? And how does this compare to kind of the bevy of other opportunities that you've seen across the?

Yes. Well, thank you, David. It's great to be here. I think it compares really favorably to use your phrase to the bevy of opportunities. If I think about what attracted me -- it's not surprising, right, with what's going on in the field of PFA in the last couple of years that PFA by definition, draws interest. But there are a lot of PFA companies. PFA is actually a relatively standard technology today. What drew me to this was the uniqueness of the form of energy, and we can talk about it in more detail, but it is a nanosecond. It's a highly differentiated form of PFA. PFA has the potential to treat so many maladies because of its unique nonthermal ablation form. And I saw in this company a fantastic team, great backers, tremendous innovation, 250 patents, the potential to own a new form of therapeutic energy that not only could be widely applied to multiple diseases, but in particular, it could be highly concentrated on some of the most important markets in med tech, most notably atrial fibrillation. So this was a unique lineup that aligned a technology that could be alone, not only best and first-in-class but alone in class in one of the most important med tech markets.

I think there's a lot of attention that gets drawn to the company on the AF opportunity. But it also sounds like you're describing this as a platform technology. Maybe help us think about just kind of the identity of the company and ultimately, longer term, what you're trying to build?

Yes, it's a great point. And platform companies are hard sometimes to understand to comprehend. So this is a platform technology. It started off a handful of years ago with its first and has had subsequent, I think, half a dozen FDA clearances and can be widely used. I'm really attracted to that. I -- frankly, in my 45-year history in med tech, I've worked in cardiovascular. I've worked in a lot of general surgery and endosurgery applications. There are benign and malignant applications here. So it's a portfolio approach in how we can define diseases. But we also really wanted to be focused on what was most important. And so over the last couple of years, we have advanced a number of programs. We have 2 others in either the market or in the clinic. But we focused in the last year based on, I would say, this positive data on AFib. And so we've really concentrated our resources now, and we'll spend more time, I'm sure, on the EP opportunity while continuing to advance other applications. And I do like to say, especially when I'm speaking to electrophysiologist, -- the data, as an example, that we're generating in the thyroid application is as impressive in that market as EP. But the combination of EP differentiated clinical outcomes, market size, market growth and early adoption of PFA, that combination is too compelling to not make it our principal focus.

And I obviously want to spend the majority of our time on EP here, but maybe just one more strategy question because the platform company, it resonates in that you can obviously have multiple growth vectors associated with it. But each of those different platforms does require different R&D, different go-to-market, specialized sales force. So how do you think about just longer-term resource allocation as you build out a multi-therapeutic platform company?

Well, we address the resource allocation by making the decision to focus on AFib, but not to leave the others entirely behind. And so we start with a single energy, right, which gives us a lot of concentration of resources. We have a single console that -- but for minor modifications in software can really be used across the board. Then it becomes an application-specific strategy. Do you want to generate a clinical study and an application in one area or another. We also have defined ourselves as having a partnership strategy. We have capability of going in select markets that are, let's say, more addressable with direct resources. But in any of the larger markets, and EP is a great example, very large, very competitive, we'll approach that market with a partnering strategy, which allows us from a capital and resource management perspective as well as investors from the perspective of, well, how much capital would this company consume. We're not planning to build stand-alone businesses in every market. And we'll use capital-efficient ways to bring this technology as rapidly as possible to patients where we can approach a market that will have the greatest business and clinical impact.

Well, it's a good segue to jump into the EP opportunity. Maybe we could start just with the technology specifically. You brought it up in kind of your intro around the NanoPulse energy source. And I think we talk about PFA or irreversible electroporation or however you want to define it, it is the next in a wave of energy sources that have been applied to EP. So maybe help us understand the NanoPulse technology and how it fits in the landscape of just that broader EP evolution from RF to cryo to the non...

Yes. So PFA, of course, is the manifestation, pulse field ablation of delivering pulse electric fields. So we're all delivering pulse electric fields for the purpose of treating tissue, not by destroying it with excess heat or excess temperature, hot or cold, but by obviously introducing IRE electroporation, causing cells to break down with membrane permeability. We do that very differently than all other PFA energies. And I think it's really important to understand that we're joining a group of technologies that has the potential to deliver nonthermal tissue therapy, but really with a different combination. People talk about algorithms that we're going to change this or change that. We're changing really the form of energy and the mechanism of action that we introduce. Nanosecond PFA shortens the pulse duration from millions of a second to billions. They're both short, but bear in mind, that's a 1,000-fold difference, right, on the time continuum. And then in order to make up for that extreme brevity of energy delivery, we dose with a much higher amplitude of energy measured in amplitude of bolts. That combination creates a different and much more efficient way of treating cells. It also creates a different set of technology requirements around which we have innovated, which creates a richness of patent and innovation protection that we think allows us to be considered really the only likely competitor or deliverer of nanosecond PFA.

Look, I think this is a super important conversation because as you look at the evolution of treating AFib by endovascular solutions, like you have an RF and we have contact force RF, and it was all about going deep, getting deep durable lesions. And then we had cryo, which kind of opened up the paroxysmal market and got to the younger patient population. But even with then a PFA, which is basically like kind of taking a Bazuka the left [ treatment ], delivering a lot of energy in a way that's nonthermal, so it's safe. And stunning the tissue. But all of this has led us to what's been deemed acceptable efficacy rates have been like still in the 70s Foristal patients and still in like the 50s and 60s for persistent patients. So maybe help us think about some of the sort of the disease treatment differences between NanoPulse and some of the other technologies and how you can address this still seeming shortcoming from an efficacy standpoint.

I think it's a great question, and it really highlights the state of the market, right, which is -- it is safer. We've expanded the patient population that we can treat. And of course, that's driving double-digit, even 20% organic growth in procedures. That's fantastic. This is the #1 arrhythmia. There's a lot of patients to be treated. We have so many patients who are struggling with throughput, even as procedures have gone from 2.5 hours to 2 to 1 to maybe just shy of 1 hour, we can't treat patients fast enough. So can we find an energy that can treat patients with less time, more energy efficiency, not compromising safety at all, maybe improving upon it and improving efficacy because to your point, that continuum of energy evolution from RF to cryo to first-generation PFA, all of those results are basically locked in that upper 70%. And so if you look at the feasibility data that we've published, 96% efficacy as it relates to AFib freedom at 12 months, 90% at 12 months freedom from flutter, fibrillation or tachycardia. How does that 90% compare? Well, Sphere-9 is doing really well in the market. Sphere 9 registered around 78%. [ VARIPULSE ], a big new story, 78%; FARAPULSE, the biggest story in the last 4 years, 74%. How do you go from 74% to 90%, which is -- if you look at it from 100% down, it's like we're reducing failure by 2/3. That's never been done by a single form of energy iteration in the past -- in the history of electrophysiology. So I think that puts in perspective what we think we have here.

And as you think about -- maybe jump into the clinical data a little bit further. You have the initial data. Maybe talk us through the U.S. IDE strategy and how to think about just timing and key regulatory milestones.

Well, let me correct the -- we have initial data, and I think that's fair. But we also have a tremendous volume of initial data. And if you think about most companies do a feasibility study, they might treat 20 or 25 patients and then they think, okay, now we know generally what we have. We have treated over 175 patients, and we have about half of those patients followed out a year now. So we have as much feasibility data as companies will generally produce in their pivotal study. So we feel really good about that. Then we go to the pivotal study and say, what are we trying to prove there? In many ways, we're really just trying to replicate the compelling nature of the feasibility data that we've already generated. So it's a relatively conventional pivotal study, single-arm, paroxysmal focus as the first sort of foray to enter that market, relatively modest scale, around 150 patients followed roughly a year and showing against an objective performance criteria ablation success. And so that's what we're doing. We received approval at the very end of '25, started enrolling in April and are off to a very good start. As we've mentioned publicly, we did our first cases the first week of April. And importantly, that first anecdotal moment, right, that first lab, a first time a team is touching this catheter for ever and on their very first day performed 7 cases, that's unprecedented.

And maybe just if we kind of fast forward, you kind of think about it, I don't know, 6 months to enroll, a year of follow-up, get the filing together, a year to approval, that would put you at 28.

Yes, early '28. So I look at it in 3 tranches of time and effort, enrollment, follow-up and then obviously, review time. Enrollment, we started off by saying we'll finish enrollment by the end of '26. We subsequently updated our enrollment schedule and said, we're ahead of schedule. We're going to move that now to October on a beat and raise kind of mindset. And of course, we're working as a team to try to beat and raise again. We haven't determined any changes subsequent to early October, but we're working hard to try to do that. So that's enrollment. Then you have follow-up. We're using a Bayesian analysis with a blended endpoint following some patients 12 months with the remaining patients 6. So we don't have -- we -- in our statistical plan, we do not need to follow the last patient in for 12 months. And we'll provide more detail on that over time. And then, of course, FDA review time is a function of -- they have a statutory 180-day to review that. But give them clean data, give them outstanding safety and review times can be compressed. And I think if we optimize our execution of those 3 tranches of time, we'll get very close to the end of 2027.

And there's -- and I think there's been some discussion -- this came up at HRS, conversations with the FDA around shortening the length of follow-up needed to get approval for an AF indication. I think there's been discussion about being 6 months data, 12 main and perhaps that's what you're reflecting in your statistical plan. Any update you can provide on that?

Well, only that, that is -- we agree with that, number one. Number two, it's based upon a lot of data, a lot of studies that are deriving from the efficacy. If PFA addresses cells and those cells are turned off, then what are you going to see from month 4 to month 7 to month 9? And at some point, there is diminishing value in following longer term, and you can use the power of some patients followed a year to inform how other patients followed for a shorter period of time will do over a year. That's what the statistical plan calls for, and that's how you can blend and optimize aggregate follow-up time with a combination of 6 and 12.

And between now and that launch time, maybe talk to us about Obviously, the things happening on the clinical and regulatory side, but talk about the other piece of it. What are the things you're doing over the next kind of 18 months to get launch ready? Is it upstream marketing, supply chain, starting to think about who are going to be your key sites. Maybe help us think about all the kind of priming the pump activities that you're going to be doing ahead of that approval.

Well, the first thing you think about is what is our go-to-market strategy, and we've defined that as a partner strategy in EP. So some of the elements that you described, we would not be doing entirely on our own. Preparing for launch, you mentioned supply chain. And yes, that's not something that you can turn on overnight. I will say our catheter and our team has done a magnificent job engineering from a not only a design perspective, but a design for manufacturability perspective. So we feel very good about our margin profile, and we feel very good about the scalability of this technology. We've already commenced manufacturing, and we're sourcing today for our clinical work devices from 2 contract manufacturers. So we don't have to build a plant ourselves. This is the kind of thing the medical device industry is extremely well suited to do for us. We do make the capital equipment ourselves. We have -- we will have no problem scaling to supply a significant launch in year 1 and year 2. And you think about that as 2028, 2029, that's a fair amount of time to scale up. When I think about segmentation, -- this is -- I don't want to dismiss the question, but this is a catheter built for every set of hands and for every left atrium. And by that, I mean, extremely low learning curve, follow the workflow of other catheters, much easier device to manipulate in the left atrium. We put this in the hands of physicians and time after time after time on their first case. And I will say anecdotally, we opened a site yesterday in the United States, very experienced, very prominent KOL using our catheter for the first time. He's probably tried every catheter on earth, and he turns to our team and says, this is amazing. That's the kind of feedback that we get. And that parlays into 5 to 10-minute ablation times. So how is that segmented? Well, it's for all paroxysmal patients. That's the #1 patient indication flowing through the EP lab. High-volume labs want it because it dramatically improves their throughput. Medium-volume labs want it because it reduces the variability of operator performance. It's really suited for every procedure. Now in the United States, we're obviously focused on paroxysmal as our first indication. We'll advance a persistent study later this year. But we treated a number of patients with both PVI and posterior wall ablation in our European study, and we have data on that. The data are outstanding. And so if you think about going to market, being able to treat pulmonary veins, being able to treat the posterior wall, that's 95% of the EP population.

And one of the things that really caught my attention when I was spending time in EP labs is how much stuff is used in an EP case. You have the mapping system, you have access catheters, you have diagnostic catheters, CS catheters. This is an incredible amount of ancillary products that surround the procedure. Can you maybe just talk about how you're thinking about compatibility and integration with some of the electromechanical products on the mapping side, but then also just some of the mechanical products.

So it's a great setup. The lab is complicated and the procedure has a lot of stuff. But the market has voted and it basically has said, only one thing really matters to us, the right ablation tool. And with that, everything else can follow. If I go into a complex lab now, they've got multiple mapping systems. They can use the ancillary tools. So they're really thinking about how does this ablation catheter change my procedure setup. And I think we're redefining how that will happen. And so mapping integration, we are currently -- we can be mapped and if you read our IDE, it says you can be mapped with any commercially available mapping system, which means really the barrier to entry is not around mapping. It's around, are you interested in a device that will likely deliver more efficient energy, higher ablation results and much improved workflow. When I think about data, we have great data. We talked about that. The thing that's most compelling to our physicians, though, is the ease with which they can put this catheter into the left atrium move from one vein to another, deliver only ablation at the ostial, one at the antral, 8 lesions, each lasting only 5 seconds, taking only 5 to 10 seconds to move from one to the other. We've had our best ablation time to date be 3 minutes of ablation time. And our average again, with very low operator-to-operator hands-on experience in terms of how many cases they've done, 5 to 8 minutes. So when you think about what's going to drive the system change, what's going to drive selection, it's not about what transseptal device you use. It's not -- you're talking here about single-catheter workflow where you can map and ablate with one device that can do in and outside the vein ablations. And each of those ablations taking 5 seconds, you can do a variety of ablation protocols, if you will, all within a limited number of minutes, do a post-ablation map with this device and get out. that opens up a realm of throughput efficiency of easing the pressure in the AFib market of moving to alternative sites of care that no other device holds the potential to deliver.

It would seem like you kind of made a reference to it there, but we're seeing this like proliferation or potential proliferation of AFib procedures in the ASC. This would seem like an optimal technology to be used in that setting. So maybe talk to how you think that both unlocks kind of market growth, but also how it helps sort of validate your product market fit.

I think this is an unlock. I think -- and it does validate the fit. I think the -- if you think about the ASC trend, however, it's really just beginning subsequent to legislative changes that went into effect at the beginning of 2026. So this is a trend that is only commencing. If you were to look today and say, well, what percentage of all AFib ablations are done at ASCs, it's a low single-digit percent. But it's much more about how it will play a role in the next couple of years, both for efficiency, but also just to provide capacity in the marketplace. And I'll pivot off of your comment earlier about the complexity of the cath lab. How can we deconstruct that complexity and put it into a lower intensity site of care that allows for incremental procedure flow in AFib therapy. That's really the goal. So you have to have a couple of things that enable that. Number one, you have to have an ablation procedure that's driven mostly by anatomical decision-making, go in the veins, ablate those. We know where they are. then ablate the posterior wall, if that's your next step. Those are mapped -- they have to be mapped, but they're not mapping intense, which allows you to reduce your mapping intensity at the ASC. You want to treat a patient with a low anesthesia burden because you don't want to have GA on site. You can't use GA if you have to paralyze the patient. You have to paralyze the patient if you have low or slow, I should say, pulse durations because that stimulates a lot of involuntary muscular movement. And so you have to have a technology that can be used with sedation protocol that is mapping-light that can allow for super high efficiency and patient throughput. And I think I just described our device.

It's very helpful. And I totally agree with you on the selection criteria leading with the ablation catheter. And I had this experience on the other side that no one buys a car for like the handle on the glove compartment, right? You buy a car for a lot of other reasons and you sort of assume the other stuff works. And I think EP is very similar that you buy -- you engage with the company because of the ablation catheter and the efficacy.

I think that's similar...

Efficient.

But that's only recent. I think you should bear in mind that, that trend inverted with the arrival of FARAPULSE as the first-generation PFA device. Prior to that, it was mapping led and followed by ablation.

And as you think about the commercial strategy, I mean, I think one of the challenges even with the ablation catheter being your core technology, this is still becoming a contract-heavy sale? I can imagine the larger companies that have more sort of broad portfolios or trying to leverage that as the market becomes more competitive. So maybe just give us a window into like what the partnership strategy looks like, like how you envision that coming to life and what you're looking for in a partner?

Well, our partnership strategy is driven by our performance, our execution. So we're very focused on ourselves, come up with that best product market fit, drive execution effectiveness, put up data that no one's ever produced. We've done that in Europe. And now as we go from center to center to center in the United States and every single physician that touches our catheter is one of the KOLs in the market, and every one of them has the exact same experience and response. That -- okay, you want a partnership strategy, that's it because the partner prospects can then not deny -- let's look at what drives market cap. How about growth in EP? What drives growth in EP, having every physician desperate to use your catheter and having that catheter solve the difficult problems of this marketplace today, including throughput, including enabling more and more -- not all electrophysiologists perform AF as an example. How do we democratize this? So we are focused on delivering that value proposition. Then you step back and say, what are partners experiencing today? Partners are experiencing the volatility of their own short-lived product life cycle. They launch a product, they get leaped over by another minor iteration, they lose market share. And unfortunately, a 5-point market share change in AFib translates to a $25 billion loss in market cap, right? And so if you think about what would be the #1 most desirable drop-in for a partner, it would be a next-generation technology that was deeply patent-protected for which competitors would not be likely to arrive on the scene for a very long rich innovation at its base so that even if someone aspired to copy it, it would take them 10 years to get there and that added extraordinary ease of use to the lab and brought along the prospect for superior outcomes, which, by the way, unlocks something else, which is a diminution in the use of drugs as first-line therapy and an acceleration of the use of highly safe and highly workflow-efficient ablation as frontline therapy for AFib. That, to me, is what is the underpinning of the partnership strategy. And partnership can have a pretty wide spectrum too. You can have everything from an exclusive distribution relationship to a revenue-sharing model to a shared sales force all the way to an acquisition. So just help us think about how you're prioritizing your time and kind of establishing the right partnership such that when you do get FDA approval, you're ready to bring this product to market.

So we're really focused on doing our job and not surprisingly, in the process of doing our job and doing it well, partner interest is organic after that. So we don't have to work on partnership in the sense of a conventional company hires a BD Vice President to go establish partnership interest. It's not that way. And it's in large part because of the intensity of focus on AFib. So partnership dynamics are natural partnership discussions are taking place. And I think it's the drive from where are we now? And I'd like to remind folks, we only disclosed our efficacy data for the first time in February. And here we are...

[Audio Gap]

In some ways, burst on the scenes. And that entire partnership population is really coming to understand us quite well and has been doing that now only over the last couple of months. And you work that forward, say, okay, additional de-risking additional data coming to fully grasp the disruptive power of nsPFA. And then -- then you go forward to the timeline we talked about. What are you going to do? You're going to launch around the end of '27, early '28, work backward from that, how much time do we have to prepare supply chain, integration, all those things say, okay, well, somewhere between you advancing your story and us contemplating how this might work with us in a partnership, we begin to converge upon a timeline that is between now and the next number of quarters for something like that to materialize.

And appreciating that partnership announcement, timing them is unpredictable. What are the other kind of milestones that you'll be able to update investors on over the next, call it, 6 to 12 months? Are you going to provide quarterly enrollment updates? Are we going to see other...

We won't provide quarterly enrollment updates because we won't be going quarter-to-quarter and still enrolling. So we will provide -- think about the flow of information. So number one, we have this large open-label patient population that we've treated in Europe that will continue to produce data for us essentially on a real-time basis. So that's a wonderful asset, again, of size equal to or greater than the IDE. So while you wait for a binary opening of the envelope in the IDE, the feasibility study marches on and becomes richer and richer in what it teaches us. And the more and more data you have followed longer and longer time becomes so consistent and concordant. -- it makes it almost inconceivable that then a U.S. population following a similar patient group would not reflect the same outcome, right? So that's job #1. Job #2, IDE enrollment. We announced last month that we would shorten the timeline. We'll continue to drive that, and we'll provide routine updates on that. From that point, once you get to a certain percentage enrolled, then you lock the last patient in for the 12-month follow-up that kind of puts a pin in the calendar. We'll certainly announce that. And -- but then you go only weeks after that before significant enrollment milestone completion. We've already commenced modular submission. So this thing is moving, and it's moving fast, and I think our team is doing a great job executing.

And do you think we can see the U.S. IDE study readout at HRS next year or that the right time?

I don't -- well, we haven't announced anything like that. I'd have to think that through, but that sounds tight. That sounds tight just based on the composite follow-up timelines for the first half and second half of our enrollment.

Okay. Excellent. Well, I know we're just about at time here, but maybe I'll turn it back to you to make any closing remarks. I mean you've obviously -- it's been a really dynamic first half of the year. You had AF Symposium, you had HRS -- you've been, I think, out meeting with investors. Maybe give people a feel for how you want them to walk out of this conference and presentation and as they kind of go reflect on the story from here.

Well, first of all, I'm excited about the story. I hope some of that excitement has come through. I've been in med tech for 45 years. I've been associated with some really big devices and markets. I've never been associated with anything as compelling as nsPFA, number one. Number two, the experience in the cath lab is wholly different with our technology. And yes, that's going to convert into definitively measured clinical outcomes. But the top physicians, when they're going into a procedure, they're not thinking about what was the readout for this study or that study. They're thinking, okay, I know this catheter works and I know it works incredibly well in my hands. And what -- actually, the way physicians articulated to us is why would I use anything else? And then the last thing I would say, just from a mechanical perspective as a company financing, we opened up a financing strategy. We've talked about this. We have an ATM that's open and active now. We have a shelf registration and then we have the prospect of capital raise from a strategic partnership. So we're well financed to execute our plan today. We're adding capital over time. And I will tell you, this is an exciting story in the most hot and tightly followed market. And I think we're going to be extremely disruptive, not only to the treatment of AFib, but to a number of diseases thereafter.

Well, I think that's a great place to wrap up here. Paul, I want to thank you. Thank you. It's always a privilege to sit down with you. You have had an incredible impact on the medical device industry and really shape a lot of the companies that we know and follow today and looking forward to see the direction of Pulse play out.

Thank you very much.

Thank you.

All right. Thank you, everybody, for joining Day 2 here at the Bank of America Healthcare Conference. I'm Dan Lundquist, the health care specialist, very pleased today to have the team from Pulse Biosciences, where I'm joined on stage here by CEO, Paul LaViolette. CFO, Jon Skinner, is in the audience as well. They have a presentation which they'll run through. We have time. I have a couple of questions. But over to you, Paul. Thank you.

Thank you very much, and great to be joined by Jon and everyone interested in the Pulse Biosciences story. I'll be making forward-looking statements today, and this is our disclosure.

And so let's get into the actual story of our mission. We are a company dedicated exclusively to the development and delivery of a novel energy form Nanosecond Pulsed Field Ablation, which also delivers a novel mechanism of action, which is the generation of the regulated cell death process. It's a very novel approach, and we'll address many ablation opportunities, which we'll talk about.

As a company, we're very focused on the rigor of data generation. We have multiple clinical trials underway. We'll talk about those momentarily. And from an opportunity perspective, we're going after a number of significant markets, very large patient populations and the potential to be very disruptive as a next-generation energy opportunity.

The team is extremely strong, anchored by Darrin Uecker. Darrin, our Chief Technology Officer and really a founder of the company, has led the vision for Nanosecond Pulsed Field Ablation since our inception. In the last quarter, we added both a Chief Operating Officer in Liane Teplitsky and a full-time Chief Medical Officer focused on the electrophysiology opportunity. So this is a group that is highly focused today on the development and execution of our clinical trial study and strategy. And we'll spend more time talking about that study plan in just a few minutes.

We're led by an exceptionally experienced and successful Board of Directors anchored by Bob Duggan, of course, a legendary investor and entrepreneur. Bob is exceptionally involved in the company, and we're pleased to have his leadership and guidance.

We most recently added Maria Sainz to that Board. Maria, most recently of the Board of Directors of Shockwave Medical, which she helped lead to its exit to Johnson & Johnson. So a great team leading a very strong story and strategy.

From a financing and balance sheet perspective, we ended Q1 with $68.3 million of cash. That is in support of a quarterly burn of approximately $15 million. We've indicated that we expect our burn to increase slightly as a function of our increased strategic activity driven by those IDEs that I mentioned, principally the focus on rapid enrollment of our pivotal study for paroxysmal atrial fibrillation ablation, which is underway now. We have a second study also underway.

And we announced, in response to fantastic clinical data at the AFib Symposium earlier this year, a slight shift in our focus and a concentration of our efforts on EP, and we'll spend a little bit of time describing that.

We have described previously and remain committed to a market entry strategy that will depend upon a partnership strategy, and we won't go into that in more detail, but it's a central part of the Pulse differentiation and our plans to be capital-efficient as we access a substantial market value.

From a description perspective on Nanosecond PFA, let me just spend a few minutes talking about how this energy functions and how it is differentiated. I think we're all aware of minimally invasive therapeutic markets based upon the delivery of energy to treat unwanted tissues. This is something that has been leading the conversion of surgical procedures over less-invasive alternatives for decades. It has resulted in procedural markets of millions and millions of procedures.

And in the last several years, we've seen the emergence of pulse field ablation from a first generation perspective, which is really the microsecond PFA realm. That's what we see in Boston Scientific, Medtronic, Abbott, J&J, PFA Energies today. It is a -- in PFA terms, it is a relatively slow microsecond PFA delivery. It is operating relatively close to the thermal side of tissue temperature change. And because of its relative inefficiency requires significant manipulation, multiple overlapping lesions, it nevertheless has driven substantial market conversion in the very recent past year.

nsPFA operates quite differently. It's a much shorter, dramatically shorter pulse duration measured in billions of a second. To offset that shorter duration, we add additional voltage and high amplitude. And so it's a more powerful shorter pulse that creates, as I mentioned, a unique mechanism of action of regulated cell death, operates entirely nonthermally. And as a result of the power of the ablation creation is much easier to deliver without the need for overlapping lesions and catheter manipulation.

If we think about the novelty of that energy, it is protected by, I think, an unprecedented moat of an intellectual property for an early-stage company. We have IP on the generator. We have IP on systems of delivering that energy down through catheters out through electrodes into tissue and ultimately on methods of delivering energy. And so if you look at that in aggregate, 250 patents protecting Nanosecond PFA as a novel energy form and novel mechanism of action delivery system. We're extremely enthusiastic about our leadership in this field with IP today that will protect us in a leadership position for years to come.

The first application of our focus is on the EP AFib opportunity. You know this today. Everyone in medtech knows this is one of the hottest markets. It's possessed of very rapid growth, double-digit compounded annually, a significant new population of diagnosed patients annually, close to 2 million, leading to hundreds of thousands of current ablation procedures and a multibillion dollar addressable U.S. market that is expected to double over the next 5 years and even grow more significantly outside the United States.

Our catheter system will drop into the existing workflow of current systems and allows us the opportunity to convert this market quite rapidly to a superior energy form. The energy manifests itself in EP with significant advantages. Lesion quality is far superior based on transmural lesions delivered in a single 5-second application and creating transmural full-thickness lesion isolation of electrical signals. That produces a speed opportunity for us with very rapid lesion formation, 5-second energy delivery, shortened procedure times overall, and again, significantly less catheter manipulation for the operator.

We have workflow advantages related to anesthesia that allow us over time to move this procedure to the ambulatory surgery center, and we are producing data now from our European feasibility study, which I'll highlight momentarily that are unprecedented based on current EP market performance.

Just to give you a sense of how the catheter functions, a single lesion is formed. If you look at the animation in the middle of the fluoroscopic image on the right is -- replicates the same workflow. A single lesion is created for 5 seconds, then the catheter is pulled back and placed antrally on the roof of the vein and the second lesion is performed. Those steps, those 2 ablation steps are repeated at the 4 veins.

And so really, the ability to produce a completed paroxysmal AF ablation with 2 lesions per vein and approximately 10 or 12 lesions for a full ablation sequence is what is so unique about this system and enables not only a very fast workflow, but the effectiveness of that lesion generation has produced this clinical data output, which, again, is significantly different than anything ever been produced.

So here, you see a data set looking down the column in the middle, representing our 5-second dose. And with 95 patients followed out 6 months, we have 95 out 95 or 100% clinical efficacy at that mid-year point. We have 96% clinical efficacy, 51 out of 53 at the 12-month endpoint. That is a clinical data that reflects the primary endpoint that we'll be using in the pivotal study and is, again, a data set that is unmatched by any precedent data from competitive microsecond ablation systems.

You also see on the right a Kaplan-Meier curve, reflecting an even broader endpoint of all atrial arrhythmias, a flutter atrial fibrillation, atrial tachycardia and measured more commonly, actually measured weekly with telemetry monitoring in addition to -- and Holter and you see 90% effectiveness over time. So these results have never been produced with an ablation system before.

From a company perspective, we're focused on accelerating enrollment. We're focused on expanding the evidence development and also investing significantly in pipeline technology expansion, and I'll comment on those now.

If you think about our acceleration of the pivotal study, we initiated enrollment in the United States just last month at St. Bernards in Jonesboro, Arkansas, 7 cases performed on the first day. That is extremely uncommon and really unprecedented for the AFib world and, I think, is exemplary of the ease and workflow benefits we have with our technology.

And as we have now expanded to several additional sites and seeing comparable uptake and driven by the physician enthusiasm that we're hearing, we have shortened the time line for enrollment from our original forecast of the end of Q4 now to just the beginning of Q4 and October time frame. So we're extremely enthusiastic about how this trial is shaping up and the prospect for accelerated enrollment.

On a technology basis, the catheter on the left reflects the current technology, which generates a regional footprint of ablation circumferentially around those bipolar electrodes. On our next generation, we intend to marry that with a second tool contained within the same device that would provide focal ablation. So focal or regional ablation in the same device that can do both ablation and mapping. We think this can produce a single catheter workflow for a comprehensive paroxysmal AFib ablation in not only the benefits -- with the benefits of our very rapid ablation time but without the demands for any form of catheter exchange to complete a case.

In addition to AFib, we're also working on several additional markets, one of which is currently enrolling an IDE for concomitant ablation of patients undergoing cardiac surgery with prediagnosed AFib. This is a relatively small market today served by radio frequency ablation. We believe this market has the potential to be opened and expanded if PFA can demonstrate significant workflow and outcomes advantages. And so we're looking forward to the IDE to demonstrate those outcomes.

We have a second developing market to treat thyroid nodules. This is a market of several hundred thousand thyroidectomies per year. We believe that has the potential to be developed into a less-invasive alternative using a percutaneous approach, ultrasound-guided using the unique benefits of Nanosecond Pulsed Field Ablation. So between cardiac surgery and thyroid intervention, we have 2 early-stage markets that we're developing data in and look forward to determining how those can be potential drivers of our business over time.

And let me just flip over to the last slide and conclude by saying that we think we have an exceptionally novel story here. We have nanosecond pulse field energy delivery, which is a -- both has the benefits of PFA, but has the -- I'm sorry, has the -- let me just, there we go -- has the uniqueness of nanosecond pulse durations and extremely high voltage. That combination delivers regulated cell death, a unique outcome for PFA, and we think one that can revolutionize multiple fields of current clinical therapy.

This technology is protected by 250 patents and that estate will continue to grow. We have mounting clinical evidence emanating from clinical studies in the U.S. and multiple IDEs. That first IDE is intending to replicate the durability data that we've seen from our European data set, which is a very large feasibility study producing unprecedented clinical outcomes. We have multiple markets of high interest. But without a doubt, the principal focus for our attention and investment is the EP ablation market for AFib, which, as you know, is a multibillion-dollar fast-growing, very hot space that has demonstrated significant switching potential for next-generation capabilities.

We have multiple IDEs underway. We intend to execute flawlessly on those and a balance sheet to deliver the performance of those studies throughout the course of 2026 and into 2027.

And with that, I'll end my comments and happily answer any questions.

Great. I think we're past on the 4:50 but appreciate the time. Thank you all for joining and thank you very much to Paul.

Thanks.

Hello, and thank you for standing by. My name is Mel, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Pulse Biosciences Quarter 1 2026 Earnings Call. [Operator Instructions] I would now like to turn the call over to Trip Taylor of Investor Relations. Please go ahead.

Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, May 7, 2026, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued on Monday and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website.

Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release.

Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the News and Events section on our Investor Relations page.

With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

Good afternoon, and thank you for joining us. For those of you that are new to the Pulse Biosciences story, let me start with a brief overview of the technology at the core of everything we do. Pulse Biosciences is the pioneer of Nanosecond Pulsed Field Ablation, or nsPFA, a fundamentally new category of energy that we believe will change the way soft tissues in the human body are treated across multiple disease states.

Conventional ablation modalities, whether radio frequency, cryoablation, microwave or even today's first-generation microsecond pulsed field systems share common limitations. They rely on relatively long-duration energy delivery windows. They deliver current or temperature changes through tissue inefficiently. They cover small treatment areas, create shallow lesions and often require repeated applications.

Our nsPFA platform creates an entirely different and proprietary approach and experience. We deliver pulses measured in billionths of a second. At that time scale, with each pulse, the duration of a few billionths of a second, the energy interacts with cells through a nonthermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves and other noncellular structures intact.

The practical effect of nsPFA delivery is meaningful. nsPFA creates deeper and more durable lesions delivered in dramatically less time while providing a margin of safety that has been a core challenge for legacy energy sources. Surrounding this core technology, we have built a substantial and growing intellectual property state that positions Pulse Biosciences as the clear first mover and the long-term leader in nanosecond PFA. We are developing this platform to treat atrial fibrillation, where the unmet need is enormous and where our differentiation seems to be pronounced. And we are advancing additional applications that leverage these remarkable underlying therapeutic advantages of nsPFA energy.

Against this backdrop, the first quarter of 2026 produced a true inflection point for Pulse. Three milestones defined the quarter and recent progress produced by our team. First, we presented landmark late-breaking data from our large European feasibility study at the AF Symposium, which set a new bar for what physicians and patients should expect from a pulsed field ablation therapy.

Second, leveraging this unprecedented clinical data set, we made the decision to strategically reshape Pulse Biosciences to focus on our highest value opportunity, our nPulse Cardiac Catheter for atrial fibrillation and have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program.

And third, in just the past several weeks, we commenced enrollment in our IDE U.S. pivotal study, NANOPULSE-AF, treating our first patients with the nsPFA catheter system in early April. We also released updated follow-up data from the European feasibility study, further validating strong positive outcomes.

Each one of these milestones represents a meaningful achievement. Together, they reflect a clinical development program of great importance moving at impressive speed. Today, I will provide updates on our nsPFA system in more detail, and we'll then turn the call over to our Chief Financial Officer, Jon Skinner, to review the first quarter financial results. We will then conclude with a question-and-answer session joined by Bob Duggan, Co-Chair of the Board; and Liane Teplitsky, Chief Operating Officer.

I will now begin with our nPulse Cardiac Catheter System for AF ablation. Our nPulse Cardiac Catheter System is purpose-built to address atrial fibrillation with a 360-degree circular design. The clinical goal of ablation in the treatment of paroxysmal AF is straightforward, electrically isolate the pulmonary veins from the left atrium to prevent abnormal electrical signals from triggering arrhythmias. Achieving that goal durably, efficiently and safely has been the ongoing challenge in the field. And the ability to advance improvements in AF care will set our catheter apart from existing technology in this rapidly growing market.

The nPulse nsPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggests a physician can now rapidly position the circular catheter, deliver a single 5-second application of nanosecond pulse energy per target location and achieve a complete circumferential and transmural ablation without repositioning, without rotating and without the need to stack multiple overlapping lesions. That workflow advantage stems directly from the underlying ultrashort duration and high energy pulse parameters unique to nsPFA energy and Pulse's unique catheter design, which is possible in part because of the unique properties of the energy.

Because the energy is delivered in billionth of a second, the total cumulative energy transferred to tissue is dramatically lower, which means no measurable temperature rise and minimal neuromuscular stimulation. The result is a system designed for speed, reproducibility and durability, qualities that make the procedure more streamlined and efficient for operators as we redefine the standard of care in electrophysiology.

Since our last call, we announced a meaningful strategic alignment to prioritize and accelerate the development and future commercialization of our nPulse cardiac catheter ablation system. The European feasibility study results from 177 patients send a powerful message. The nPulse Cardiac Catheter System has the potential to improve clinical practice for millions of patients living with atrial fibrillation. In response, we are increasingly prioritizing the program by allocating additional resources to our clinical and R&D teams to accelerate time to market for this catheter system. This investment in resources and focus will accelerate the pivotal IDE study, the introduction of additional clinical studies and the development of our next-generation catheters.

As part of the strategic realignment, we continue to expand our EP leadership team. Most notably, Dr. David Kenigsberg has transitioned to a full-time Chief Medical Officer. Dr. Kenigsberg will lead our clinical strategy, investigator engagement, medical affairs and study execution as we enroll the pivotal IDE study and expand our clinical data set. In addition, we welcomed Liane Teplitsky to the Pulse Biosciences executive team as Chief Operating Officer, a newly created role on our executive leadership team.

Liane is a seasoned med tech executive with 20 years of experience and an exceptional track record of building and scaling innovative med tech businesses, particularly in electrophysiology. She held senior marketing and commercial leadership roles at Abbott Laboratories and St. Jude Medical, contributing to the development, clinical validation and global commercialization of electrophysiology therapies. She will oversee our clinical, regulatory, quality and commercial functions and will be focused on accelerating our strategic priorities with emphasis on the cardiac catheter development program. Collectively, the additions of David and Liane strengthen our ability to execute a successful pivotal IDE study and advance toward regulatory approvals.

On the clinical data front, we had a landmark quarter. At the Heart Rhythm 2026 meeting or HRS, Dr. Vivek Reddy, the national principal investigator of our pivotal study, presented late-breaking updated data from our nPulse Cardiac Catheter System first-in-human feasibility study. Building upon the very positive data presented at the AF Symposium in February, this newly expanded data set included 6-month follow-up on 95 subjects and 12-month follow-up on 53 subjects within the 5-second ablation cohort. The results were simply outstanding and reinforce the differentiated clinical profile we have observed since the earliest cases.

Key findings included sustained 100% procedure success by 24-hour Holter of evaluable patients at 6 months with 95 of 95 patients meeting the endpoint. Sustained 96% procedural success by 24-hour Holter of evaluable patients at 1 year and sustained 90% Kaplan-Meier estimated freedom from recurrent AF, atrial flutter or atrial tachycardia also at 1 year. Procedural performance data at HRS improved from the already impressive readout at AS Symposium with lower atrial dwell time, lower average number of applications and lower procedure and fluoroscopy times.

The safety profile also remained excellent with a primary safety endpoint, serious adverse event rate of just 1.7% across 177 treated subjects. These outcomes are remarkable in a field where reported 20% to 25% AF recurrence rates are typical. It is particularly notable that our results were achieved without antiarrhythmic drugs and with a high degree of consistency across operators and sites, which is typically difficult to achieve at an early stage of clinical development.

As Dr. Reddy noted, the durability of pulmonary vein isolation plus the procedural efficiency we are observing is a positive combination not typically expected at this point in the clinical program. These results reflect the underlying advantages of nanosecond PFA and our innovative catheter design, deeper lesion formation with fewer applications, lower cumulative energy and durable pulmonary vein isolation in a fast reproducible workflow. We believe our system directly addresses the limitations of current generation microsecond ablation catheters by enabling complete durable isolation in a single energy delivery with the potential to reduce procedure time significantly.

This time-saving advantage represents a meaningful potential capacity expansion for EP procedures and would likely drive rapid adoption of nsPFA as the preferred next-generation energy in the market, especially in light of the potential benefits of the efficacy improvements observed to date. As we look ahead toward the migration of AF ablation procedures to ambulatory surgery centers or the ASCs, we expect all the benefits of the nPulse cardiac catheter to align directly with the needs of the ASC and the overall expansion of treating the growing population of patients with atrial fibrillation.

The compelling body of clinical evidence from our European feasibility study provided a strong foundation for the most important operational milestone of the quarter, the commencement of our U.S. IDE pivotal trial. In early April, we announced that the first patients had been enrolled in our NANOPULSE-AF study, a prospective multicenter IDE pivotal clinical investigation evaluating the nPulse Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation.

The first 7 patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas in just 1 day under the leadership of Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. Dr. Nair has not previously used the nPulse catheter. And the efficiency with which the procedures were completed speaks volumes about the short learning curve and usability benefits we can expect from our system.

Early feedback from physician investigators reinforces the user-friendly nature of the system and the efficient reproducible streamlined workflow it supports. This positive feedback has helped create significant enthusiasm for study participation. Site activation is accelerating, and we are encouraged by the current and planned enrollment momentum we are seeing. Based on the excitement and momentum coming out of HRS, along with the benefit of our strategic realignment, we are tightening our enrollment time line to reflect the likely faster pace of our study execution. We now anticipate enrollment to be completed in early Q4 2026 compared to prior guidance that planned enrollment completion by the end of 2026.

Regarding study follow-up, the final proportion of participants with primary effectiveness success or freedom from treatment failure through 12 months will be estimated using a Bayesian analysis that includes outcomes at 12 months for a subset of patients and at 6 months for the remainder. Using a blend of follow-up durations will shorten overall follow-up time for the study. This method allows determination of success earlier than traditional statistical methods used in other studies. Overall, we are accelerating both enrollment and follow-up time lines to optimize the planned filing date for the clinical PMA module.

On the regulatory front in Europe, we expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE Mark approval in mid-2027.

We are also continuing discussions with potential strategic partner candidates. Potential partners include the world-class mapping providers and EP market leaders. A key advantage of the nPulse cardiac catheter is its ability to be integrated with all mapping systems. This creates a compelling synergy in which our partner or partners may gain access to the most advanced nanosecond PFA energy solution available. These partnership conversations are active, and we will share details of partnership prospects when the time is appropriate.

Let's now discuss our surgical ablation clamp. Our nPulse cardiac clamp pivotal study, NANOCLAMP-AF, is the first and only clinical study of a surgical device delivering PFA to receive FDA IDE approval. The nPulse cardiac clamp applies nanosecond PFA energy to create durable transmural lesion sets during concomitant procedures where the surgeon has direct cardiac tissue access and atrial fibrillation is present. The clinical opportunity is substantial.

However, despite strong guideline support for concomitant AF treatment during cardiac surgery, adoption of currently available devices remains low. We believe the primary adoption barriers have been procedural complexity, unreliable outcomes and too much time added to the surgery, concerns that nanosecond PFA may directly address through a combination of rapid energy delivery, reproducible lesion formation and a straightforward surgical workflow.

We continue to believe that concomitant ablation for preoperative AF is significantly underutilized and that the speed and effectiveness of nsPFA energy can transform this therapy and market. Enrollment in NANOCLAMP-AF continued to progress during the first quarter. As a reminder, the trial is a prospective single-arm multicenter study designed to assess the primary safety and effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries.

We plan to enroll a target of 136 patients at approximately 20 sites, including 2 international locations. Reflecting our strategic prioritization of the EP catheter ablation program, including some resource shifts, we now expect to complete enrollment of this IDE study by the end of the first half of 2027. We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation and clinical site activations continue to expand during Q1.

In Europe, we continue to generate excellent results in our cardiac surgery feasibility study. To date, investigators have treated over 60 patients, and we have expanded the study to now include 6 clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately 3 months after their ablation procedures to assess the effectiveness and durability of the treatment. These data were presented at the European Heart Rhythm Association 2026 meeting and are very promising, with individual ablation times averaging a very rapid 41 seconds total per patient.

Notably, as patient numbers have increased, the PVI success rate of 94% at approximately 3 months has remained consistent with the clinical outcomes we reported in our initial data readout in October of 2025. Surgeons using the system have reported favorable procedural characteristics, rapid ablation delivery, consistent lesion quality and smooth integration into existing surgical workflows without meaningful time or complexity added to the underlying surgery.

Feedback from the surgical community emphasizes that workflow efficiency and predictability matter as much as efficacy in the operating room. And the early signal is that nanosecond PFA delivers very favorably on both. We remain on track to submit for CE Mark by the end of 2026 using the European clinical data set.

Turning to our nPulse Vybrance Percutaneous Electrode System. The nPulse Vybrance System applies nanosecond PFA technology to ablate soft tissue in surgical procedures through a percutaneous approach, offering, for example, an alternative to surgical removal for patients with symptomatic benign thyroid nodules. Vybrance is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviate symptoms and preserve surrounding anatomy and normal thyroid function, outcomes that cannot be achieved with traditional surgical excision.

In the first quarter, the team generated approximately $400,000 in revenue from nPulse Vybrance Systems and electrodes. Our approach continues to be extremely disciplined and remains focused on core market development objectives. We continue to operate at an intentionally limited scale to demonstrate how meaningful over the long term and how well we can service initial Vybrance customers in exploring along with them the potential of the nPulse Vybrance System. Our work is focused on ensuring we generate robust clinical data to support a treatment indication while formalizing patient reimbursement to expand patient access in partnership with key accounts at large hospital systems in select geographies.

On the clinical front, the PRECISE-BTN or Benign Thyroid Nodule study reached an important milestone with enrollment of the first 50 patients now completed. We have further expanded the study to 100 patients to broaden the data set supporting adoption and long-term market expansion. It is also notable that scientific recognition of this work continues to build. Data from Dr. Stefano Spiezia of Naples, Italy were presented in a podium session at the North American Society of Interventional Thyroidology, or NASIT, in March, which demonstrated remarkable results.

Data presented from durable 15- to 22-month results showed 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported. Continued volume reduction improvements were seen from 1 month through 22 months with no regrowth of nodules at 15 to 22 months.

In parallel with the PRECISE-BTN study, we are continuing to expand the clinical scope of the Vybrance platform through our research collaboration with the University of Texas MD Anderson Cancer Center. Under this collaboration, we are conducting a first-in-human feasibility study evaluating nsPFA for the treatment of papillary thyroid microcarcinoma, PTMC, on up to 30 patients at 2 sites, and we are happy to announce that first patient enrollments were completed in Q1. We continue to expect to complete enrollment by year-end 2026.

With that, I will turn the call over to Jon to speak about our first quarter financial results. Jon?

Thanks, Paul. Now I will highlight our GAAP and non-GAAP financial results. I encourage listeners to review Monday's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.

In the first quarter, we generated revenues comprised of both nPulse Catheter and Vybrance disposable sales. Total revenue was $401,000 and cost of product revenue was $370,000 for the quarter. Total GAAP costs and expenses for the quarter increased by $1.6 million to $19.6 million compared to $18 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs, partially offset by lower stock-based compensation expense.

To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization as well as nonrecurring costs. Total non-GAAP costs and expenses in the first quarter of 2026 increased by $4.7 million to $17.4 million compared to $12.7 million in the prior year period. The expected increase was driven by increasing clinical trial, product development and market development activity.

GAAP net loss in the first quarter of 2026 was $18.6 million compared to $16.8 million in the prior year period. Non-GAAP net loss in the first quarter of 2026 was $16.4 million compared to $11.4 million in the prior year period.

As of March 31, 2026, cash and cash equivalents totaled $68.3 million compared to $80.7 million as of December 31, 2025, representing a decrease of $12.4 million versus the prior quarter. Cash used in operating activities during the first quarter of 2026 was $14.6 million compared to $13.5 million used in the prior year period and $14.8 million in Q4 of 2025.

As we discussed last quarter, we completed important corporate housekeeping by filing a $200 million shelf registration, all of which is available. In addition, the company has an ATM program in effect with approximately $60 million of availability as of March 31, 2026. We have received Board of Directors' approval for interested executives and Board members to participate in our ATM program. Our Co-Chairman of the Board and our CEO and Co-Chairman have both indicated they are likely to purchase shares in the near term.

Cash usage aligns with investment expenditures in pivotal trials, device scaling and market development. Expense growth remains deliberate and focused on long-term value creation. We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026.

With that, I will now turn it back over to Paul for his closing remarks.

Thank you, Jon. This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology, delivered landmark clinical outcomes at Heart Rhythm 2026 and AF Symposium that reinforced the durability and efficiency of our technology and commenced enrollment in our U.S. IDE pivotal trial for our cardiac catheter program. Today, resulting from those efforts, we announced a tightened time line for anticipated completion of enrollment in our paroxysmal AF pivotal study.

We strengthened the team supporting this mission, and we continue to advance our surgical and percutaneous programs in a disciplined manner aligned with our priorities. Our path forward is clear, enroll and complete our pivotal trials, finalize our CE Mark submissions and continue to advance our partnership pipeline, all while maintaining the financial discipline to fund the company through the milestones that will define its future. This disruptive nsPFA technology we are advancing has the potential to change how ablation is performed across multiple disease states. And we believe that executing toward those near-term milestones will unlock that potential for patients, physicians and shareholders alike. Thank you for your continued support.

Now joining us for the question-and-answer session are Bob Duggan, Co-Chairman of the Board, and for her first earnings call with Pulse Biosciences, our Chief Operating Officer, Liane Teplitsky. Operator, please open the call for questions.

[Operator Instructions] We have the first question comes from the line of Suraj Kalia of Oppenheimer.

Gentlemen, congrats on all the progress and the excitement at HRS. Paul, many calls going on. So please forgive me, I'll ask all my questions together. First, did you highlight the number of sites that are as part of the clinical trial? The limits to each site because you don't want too much concentration. And finally, if these patients are consciously sedated or general anesthesia.

Thank you, Suraj. And yes, we are happy to take all your questions at once. Regarding the number of sites, we have approval for up to 30 sites, and that's important in part because it determines how many total rolling patients can be advanced in the study, and that affects the total number of patients that we can enroll, bringing that number up to 215. So total number of sites is 30. We do not anticipate reaching that many sites just based on the total size of the study enrollment, the likelihood that a number of sites entering early in the protocol will, as you allude to in your second question, enroll at or close to the limit of their total enrollee allocation. And as a result of that, we're likely to involve active sites less than the number that we were allowed in our protocol of 30.

As it relates to the limits per site, you're right. Every protocol limits the number of sites based on a percent of total so that there's not an unbalanced skew toward too few enrolling locations. And that number is typical in this study as it is with many others. Usually, it's around 15% to 20% of total enrollment is the cap for an individual site, and that is the case here, which limits our sites to between, let's just say, the low 20s of patients per site maximum.

And then as it relates to our anesthesia protocol, you raised a really good question because conscious sedation is a likely viable sedation protocol for these patients. We've seen that in Europe, and we're quite enthusiastic about the potential for lower sedation long term, particularly as we enter the U.S. market and migrate patient therapies to the ambulatory surgery setting. That being said, the protocol in the pivotal study calls for general anesthesia.

[Operator Instructions] We have the next question comes from the line of Anthony Petrone from Mizuho.

Congrats on a strong start to the year and the 2 good medical meetings, AF Symposium, HRS. Maybe taking it from HRS, the podium presentation, Dr. Reddy, maybe a little bit of noise that crept into the dialogue there at HRS relative to AF Symposium, sort of the idea that as we expand to more sites in the U.S., we potentially enroll a somewhat sicker patient population in the U.S., that we can see at least some degradation to the durability statistics that we saw out of the early feasibility study. So maybe just walk through the expectations for the capability to maintain durability, how continuous mapping can potentially help to improve that. And any risk that there may be just from the differences in patient populations. And I'll have one quick follow-up.

Thanks, Anthony. Very good question. We're very pleased with the data. The data set so far has been extremely strong. And obviously, just to remind folks, at 6 months, 100% efficacy against our primary endpoint of rhythm control as measured by Holter monitor at that 180-day point. Same thing at 12 months, 96%, and of course not a primary endpoint per se, but a broader measure of efficacy would be the data that we represented in our Kaplan-Meier curve of 90% success with respect to freedom from atrial fibrillation, a flutter and atrial tachycardia. So those are the numbers that we're starting with.

As it relates to the comparison of patient severity between the European feasibility study and the pivotal study, for the most part, there is no difference. These are both principally paroxysmal patients. A patient enrolled in the European feasibility study was by definition, per his or her medical record, a paroxysmal patient. The same severity measure will be applied in the United States.

As it relates to some changes, let's say, in the population background, you will see, just based on moving to the United States and enrolling the vast majority of patients in the U.S., you will see minor changes in factors such as BMI, right? The United States patient population is slightly heavier, and so we would expect the BMI which was 28 in Europe to go up in the U.S., but that's not a significant risk factor. The CHADS score, which is an important cardiovascular measure was relatively low. That will be consistent in the U.S. based on a paroxysmal population. And other factors in the medical history, whether it's hypertension or heart failure, we expect to have a relatively generic paroxysmal patient population, most notably with a relatively near-term onset of atrial fibrillation typically in the 1- to 2-year time frame.

So I think overall, the patient population, while representing the U.S. population and maybe a little bit less healthy is not representing, I'll call it, a higher risk factor than the U.S. And therefore, degradation is not to be expected. This is a pulmonary vein isolation strategy using a highly effective novel energy, which we've now seen evidence that produces a really impressive ablation and impressive electrical isolation. We've treated more patients in Europe actually than we'll enroll in the United States. The endpoints that we're using in this case of freedom from AF as measured by Holter are the same. So the same endpoints.

And I would also say the sites that we're moving to, while we will have more sites in the United States, we use multiple sites, multiple operators in Europe. And the sites that we're going to in the United States represent the best in the world. So we believe that -- and we've seen this, I think, early on in our enrollment experience. We believe that we are going to see outstanding clinical results. Physicians are, I'd say, rapidly assimilating our technology into their workflow, and it's performing the way we expected it to in the U.S., based on how we observe those cases performed in our European sites.

Lastly, I think you make a great point about mapping. Mapping is now tightly integrated, as we've mentioned, with the Abbott EnSite system. That mapping, I'll call it, refinement, that fidelity provides our U.S. pivotal trial operators with a very high degree of precision location of the catheter, enabling them to localize catheter placement and ablation placement very rapidly in our procedures and very accurately. And so we think the risk of experiencing a meaningfully different outcome in the U.S. is managed well by all of these consistencies between Europe and the U.S. and that we don't see the introduction of a meaningful new risk that would dilute expected clinical performance.

My last comment there would be success is not defined in our case explicitly by a specific number that is 96% or 95%. We have we have the potential here to redefine the way atrial fibrillation is treated, the workflow, the efficiency associated with this technology, which we see, of course, in an acute way, we don't need follow-up data for that. That is a dramatic change. This is a significant disruptive technology in the hands of physicians going against the #1 most common arrhythmia in medicine. And I do believe we have something that's very significant here. And it's going to be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the U.S. trial.

And just the follow-ups in here real quick would be just to confirm in the pivotal study here, IDE study, will EnSite be the only mapper, or will you bring in additional mapping technologies?

And then a quick one just on soft tissue ablation, papillary thyroid microcarcinoma, new collaboration with MD Anderson. Maybe just a high level on the underlying TAM opportunity on the carcinoma side of the equation for the thyroid. Congratulations again.

Thank you very much, Anthony. Yes, on EnSite, based on the speed of enrollment and the availability of EnSite, it would appear today that EnSite will be the most common, predominant and likely the only system used in our IDE. That is against the backdrop that our technology really will work with multiple mapping systems. We have used different mapping systems. In fact, the European feasibility data set is a compilation of patients treated using 3 different mapping systems, and we would integrate with not only different systems over time, but because of the number, we have 12 sensors built into our device, we have now a magnet for electroanatomical connectivity, if you will, to the mapping system. So our system is capable now of higher fidelity mapping and navigation than we saw in our European data set. But principally, we expect EnSite to be the system used.

As it relates to the PTMC opportunity or papillary thyroid microcarcinoma, that is the single most commonly diagnosed thyroid cancer. And so if we think about the TAM, to your question, the TAM for soft tissue ablation focused on benign thyroid nodules begins with the annual diagnosis of about 250,000 patients with benign nodules. So converting from that, approximately 150,000 thyroidectomies are performed. And we believe the benign indication goes after some combination of surgical conversion and treatment of patients avoiding surgery now and going into active surveillance.

So if you think about 250,000 as the annual diagnostic volume in benign nodules. If we flip over then to papillary microcarcinoma, that number is lower. That number is about 25,000. And if we then take -- because this is a slow-growing non-metastasizing cancer, which makes it very amenable to our therapy, we believe, there is also a very large prevalence pool of papillary microcarcinoma patients who are living with cancer and who would want that cancer treated if a minimally invasive approach proved effective. And so the way we think about the addressable market there is that you have those 25,000 new diagnoses, you have a large prevalence pool seeking treatment, you're likely to yield perhaps 50,000 incremental procedures.

So if we think about the TAM driven by the benign indications, that could be 100,000 to 200,000 based on annual incidents and conversion of patients from a watchful waiting pool, add a number that might be an incremental 25% to 35% of that population based on the addition of a papillary microcarcinoma indication in the future.

Thank you. That will conclude our question-and-answer session. I will now turn the call back over to Mr. Paul LaViolette, CEO and Co-Chairman, sir, for closing remarks.

Well, thank you, operator, and thank you all for joining us on our first quarter earnings call. We look forward to providing updates on our very active operating plans in upcoming financial conferences in Q2 and on our Q2 earnings call later this summer. Thank you all very much.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Good afternoon, everybody. I'm Paul LaViolette, Chief Executive Officer of Pulse Biosciences. Really proud to have this gathering at HRS. We've been trying to provide updates at every single critical meeting on the itinerary symposium. And today represents a really nice opportunity for us to see you again.

Before we dive in, I just want to introduce a few of the Pulse members who will not be presenting today. I'll be joined by Dr. Kenigsberg and Darrin Uecker, momentarily, our Chief Medical Officer, Chief Technology Officer, respectively. I want to introduce Bob Duggan. Bob is our Chairman, our principal investor and really the visionary for the last decade behind the establishment of nsPFA as a next-generation energy to ablate in EP and many other parts of the body, as you're aware.

And I'll defer to Darrin Uecker always.

Darrin is our Bob whisperer. I also want to introduce Liane Teplitsky. There she is, Liane. Liane has just joined us as Chief Operating Officer. Liane has a pronounced career in med tech, but emphatically 18 or so years in the EP space. Knows many of our clinicians, knows the AFib technology area intimately. We're super happy to have her join and to add some extra horsepower in the drive of our clinical, regulatory and commercial areas.

Also joining Jon Skinner, our Chief Financial Officer. The investor community gathered here, I think, know Jon well. Bill Knape is also here. Bill is the leader of our clinical and regulatory organization. And of course, as we enter this phase of driving the pivotal trial enrollment in the United States, Bill, who has a lengthy career both at Pulse and in industry, is a critical member of our team.

So thank you for joining. I'm going to turn the floor over to Dr. Kenigsberg. Most important message...

Right now, somebody is like presenting these.

Update on clinical results we announced from our feasibility study at the AF Symposium. Those data were very strong. Many felt they were unprecedented. And I think if there's a word that best describes the takeaway from today's presentation, it was that those results have been sustained. We've added additional patients out to 6- and 12-month endpoints. And you've seen reinforcement of the evidence and outcomes of strength that we demonstrated in February AFS.

So with that, I'm going to turn it over to Dr. Kenigsberg. He's going to walk through the data, give an additional perspective. Then Dr. Kenigsberg, Darrin and I will answer your questions for the remainder of the session. Thanks.

Thank you very much. I'm David Kenigsberg. I'm a clinical cardiac electrophysiologist, practicing in Fort Lauderdale, Florida, and proud to be the CMO of this amazing company. I'm here today in the next 15 minutes or so to tell you why our technology at Pulse Biosciences is novel, unique and a game changer in electrophysiology and why I'm so enthusiastic to share the data and information I'm going to be sharing over the next little bit.

I've been doing EP for 20 years, and I've seen every single energy source. We started out with point-by-point RF ablation. And at that time, I said, "Man, I sure wish there was a technology that you could just put in the vein, turn it on, isolate the vein safely, effectively and be done with it and have good long-term data and we're there." That's what we're here to discuss today, and that's what I'm going to show you. I want you to all keep in mind that when I share the data, this is a very large first-in-man data set. This is not a randomized trial. This is not even our IDE yet. This is first-in-man data. It's a heterogeneous grouping of patients that were mapped with different mapping technologies. We kind of learned as we went while we did this. And even still, the data is very robust and compelling.

So this slide depicts what we have. So we have a very streamlined and easy-to-use ablation catheter where the energy is given between this inner ring and this outer ring and forms a toroidal ablation lesion in the pulmonary veins. In addition, there are sensors akin to a pentaspline sensing catheter that can be used for mapping during the procedure as well as there was a magnet, which was recently introduced for magnet mapping procedures, which the end of our cohort, we're able to benefit from. And this is where the magic happens. That's our console, and that console provides greater than 10,000 volts of energy, which if you look at any competitor currently FDA approved on the market, that's at least 5x or more what they can provide at maximum.

So we have a very streamlined workflow. There's no need to rotate the catheter. The catheter goes into the vein. We provide an application in the vein. If you could look at the top, there's like this mushroom type appearance to the catheter, and that provides our osteal application. You could see it in this cartoon and in fluoroscopy. And then we pull the catheter back and position it at the antrum. Each application is 5 seconds long and each vein gets 2 applications. There may be some additional applications, and I'll tell you about the average number as well as some early experience we have with the IDE.

So the first-in-human trial included 177 patients, 141 of which got a 5-second lesion and 36 got a 2.5-second lesion. We have landed at 5-second lesions because that's where our best effectiveness has been so far. And the study that we looked at was to try to assess the safety and efficacy of our catheter in a patient population that has atrial fibrillation. The study design was prospective. It was nonrandomized, single-arm feasibility study at 3 centers in Europe, the one in Homolce that's very well known, a center in Belgium and Andrea Natale's lab in Rome. Total number of operators were 7 operators. And this is the patient population. It's a 60-year-old on average patient population. The demographics are there. It's a fairly standard demographic for a first-in-man trial, if you look at any of the trials that are done in the AFib space.

And if you look at the procedure time and the success in this slide, it's extremely unique in the sense that for the first time, if you give this catheter to an operator, they're able to off the bat, perform an effective procedure with amazing success. And that speaks to the form factor of the catheter and the streamlined workflow that we have by easily moving the catheter in the left atrium. It's very, very easy. This catheter does not require a lot of skill to position in, let's say, the right inferior pulmonary vein.

So in the 5-second cohort, 141 patients, procedure time about an hour, LA dwell time about 18 minutes, fluoroscopy 9 minutes, although it could be done easily just with 3D mapping, especially now with our very integrated mapping with EnSite. 12 on average PV applications -- 12 applications to isolate all 4 pulmonary veins. So 2 per vein and then 1 on the carina, maybe 1 or 2 anterior to the right. That lands us at 12 applications on average to perform the entire procedure. And again, each application, 5 seconds. The acute PV success, 100%. But if you look at the 6-month Holter data, 100%; 95 out of 95 patients which -- with success. And at 12 months, 96.2%, 51 out of 53 patients. That's amazing.

Now if you look at the adverse events, we had a cardiac perforation/tamponade, really unrelated, in my opinion, to the procedure itself, but nonetheless happened to one of our patients during the first in-man data. And then we had some hemolysis resulting in some kidney injury. However, that patient's renal function fully resolved.

If you look here at our 2.5- and our 5-second patient cohorts, and again, we landed at the 5 seconds, so I would focus on that. The freedom from any atrial arrhythmia at 1 year is 90%. So for first-in-man data, early experience with a catheter. This is an amazing Kaplan-Meier curve showing the excellent freedom from atrial arrhythmias at 1 year.

Now if you look at -- this is very recent, our 5-second cohort followed out 12 months, 96.2% success rate by Holter and at 12 months, like I said, 90% freedom from any atrial arrhythmia.

Now the difference between nanosecond PFA and microsecond PFA really needs to be elucidated and highlighted here. We're talking about 2 completely different things. We're talking about a catheter that can provide greater than 10,000 volts in a few nanoseconds versus a catheter that needs a lot more time and a lot less voltage. And the difference between nanosecond and microsecond at the cellular level is extremely important to point out. The difference is what we're trying to create with nanosecond PFA or what we're trying to create with ablation in general is clean apoptosis. We want to get into the cell and destroy the cell and not have any collateral damage. We want to have the absence of char or any other problems. With this technology, our nanosecond PFA gets into the cell and it kills the organelles, kills the cell, kills the nucleus in a very clean and efficient manner, which differentiates from microsecond PFA, not only at the cellular level, but also as you can see with our data for safety and efficacy as well as efficiency of the procedure.

So this technology is unique. It's safe, it's durable and as I demonstrated, has excellent clinical outcomes. We should definitely consider following these patients more closely. And I would mention that I predict in our IDE, it's likely because we have integrated mapping now that our data could get even better. And from -- again, my recollection from 20 years ago doing RF ablation where our maximal ceiling for efficacy was in the 60s. We're talking about 90% with early experience that could get better, that's spectacular.

I just want to show you an example of 3D electroanatomical mapping during the ablation with the catheter. This is with the EnSite system. And as you can see, as we're applying in the vein, you can see where the electrical activity is on the bottom of the screen, and then you could see that after a 5-second application, that electrical activity goes away and the vein is isolated. And then you move on from the osteal to the antral position, do the same thing and do that for all 4 veins.

So -- did I skip a slide? No. So we just embarked on our IDE trial, and this trial is looking to enroll about 215 patients and up to 30 sites. The first patients were recently enrolled, and we're looking for some really excellent results to come now that we have integrated mapping, and we're bringing this trial to IDE.

And the last thing I'll mention is Pulse Biosciences' nanosecond PFA is not a one-trick pony. This is a platform. This is an energy source that's novel and unique. And we have in the works focal catheter, Epicenter Plus. Other things that we're working on that will add to our armamentarium to treat atrial fibrillation, not only the pulmonary veins, but other things like mitral annulus or CTI and so forth.

Thank you very much for your time and attention.

Thank you, David. And I just want to mention that we are passing a microphone around the room and because we are webcasting this, if everyone could ask their question with the microphone, when the question is asked and as we're answering it, we'll move the microphone around to the next participant. And Darrin, if I could ask you to come on up and join. David, Darrin and I will now entertain your questions.

Anthony?

You mentioned 3D electroanatomical that I assume, fluoroscopy maybe done. So what happens this time for procedural 3D mapping? And then several times at AF Symposium seem to indicate that there could be an efficacy benefit. So we're looking to the equation. If you had one, how do you think that's going to benefit durability?

Great. So -- sorry, fluoroscopy is definitely a mechanism to see the catheter and make sure that your catheter is in position with the vein either osteal or antrally. You could see the catheter conform to the osteal or antral position with fluoroscopy.

And with PFA, as we all know, it's a contact sport. You need contact, but you don't need force, right? So it could be done with fluoroscopy. But in the United States, the majority of operators like myself are fluoroless, and we heavily rely on intracardiac echocardiography and 3D electroanatomical mapping. Early on in our experience, the 3D mapping that we were using was pretty crude. And now we have very advanced integration with the 3D map. So I -- that's why I feel that with the IDE with integrated mapping, we could see better results.

The time of the procedure is definitely going to go down. And I think you have to keep in mind in this trial, we did pre-maps, we did the procedure, we did complete post maps. Some of these patients received extra pulmonary vein applications. So I think the time will go down. I actually think in clinical practice, if you took this catheter today, again, this is a prediction. But if you took this catheter today to clinical practice, you'd probably see about a 30-minute procedure time around that.

It's Josh Jennings from TD Cowen. Congrats on the updated data. I wanted to stick on procedural efficiency. I think Paul had earlier told that has started just to benefit first center that enrolled patients in the IDE setting. One day new operator chose the new technology. Maybe just you can give us more details, some of the details you shared prior to the...

Yes. So we did 7 procedures that day before 5:30 p.m. in 2 labs with 2 teams and 1 operator. Procedure times were around 30 minutes. All procedures were done fluorolessly with integrated EnSite as well as ICE and very efficient, and this operator never touched the catheter before. So I think one of the main differentiators about this catheter versus some of the other ones on the market currently is that this is very easy to use. You can hand it to someone and they'll figure it out. There's really no learning curve. I remember with cryo, we had to do 30 cases to kind of figure out how to work it. It's not like this anymore.

Paul, can you just update, have you integrated nPulse into EnSite system? I think there's plans to collaborate with other players -- patients. Is there any updates on the progress or just the overall road map in terms of how many partners you have in terms of nPulse in the EnSite system?

Yes. So our system, if you read the IDE, the IDE allows for any commercially approved EAM system to be paired with ours for the generation of data. That, of course, will lead to a commercial label that will allow for the same. So the way to think about this, of course, individual mapping systems can be open or closed, but the pairing with our system would be -- we would be considered open architecture to be used with any other system.

As we stand here today, the EnSite system is likely to be the primary system to be used in the IDE enrollment. We don't have another custom integration available, but other systems could be used in a commercial setting in a lab in the next week or 2. We're emphasizing the EnSite integration because we think that will deliver the best outcomes.

David from Goldman Sachs. If you look at the enrollment time lines here and just kind of take typical enrollment and follow-up time lines, assuming the FDA does not cut its requirement at 6 months for a follow-up on AF cases, you're coming to the market in the middle of 2028. So if you fast forward today and you think about the unmet needs in the market at that point in time, what does this technology solve and maybe you can talk about that from a clinical standpoint and maybe a site of care standpoint as well?

Yes. So the -- we can obviously massage the time lines, right, as a function of really the 3 phases. You've got the phase of enrollment, which we're working hard to accelerate and do as quickly as possible. You alluded, David, to the 6- and 12-month endpoints. We do have both a 6- and a 12-month endpoint and we'll use a blend of those 2, and we can provide more details on that over time.

And then, of course, the cleanliness of the data determine how rapidly you'll be reviewed at FDA toward the low end of that line at likely a 180-day review for PMA. So that lands us right at the beginning of 2028. Of course, it can go up or down from there. I think the beauty of the Class III medical device world is you can see what's coming. So we can predict with, I think, very high clarity, the likely lineup of products in 2027 and 2028. Of course, we know that things like Sphere-360 will be forthcoming, something in the form of an OmniPulse, not that much else. I would call it minor modifications to waveforms, perhaps a FARAWAVE, Ulthera or something like that.

But I think the lineup of fundamental systems will be the same that we see today. Those that are in later-stage clinical development will be available in 2028. I would posit that everything Dr. Kenigsberg described will be needed in 2028. We will need improved workflow. If you think about the demand to drive AFib patients through the lab, if you think about the desire and the economic value of doing 7 or 8 cases a day versus 3 or 4, those will be increasingly important pressure points in the delivery of health care in 2028.

So if you take what we are seeing today in our European real world, yes, it's a feasibility study, but they're really doing it in a real-world setting with 5- to 7-minute ablation times, 30-minute skin-to-skin procedure times. The potential has been alluded to by Dr. Reddy in his presentation for a sedation protocol in lieu of GA, Dr. Kenigsberg being a leader in the ASC movement in the United States. All of those trends are going to accelerate and the pressure will intensify based on the need to pull more patients in and their desire to be treated frontline therapy with ablation instead of a drug.

So what I think you'll see between now and then is a market that has procedure volume that's probably 40% greater only 2 years from now than today with emphasis on workflow efficiency greater than today. And if you think about what's the greatest inefficiency in health care delivery overall, it's the treatment of that same patient the second time around.

And so as our European feasibility data roll forward, we increase the n, we increase the follow-up. It becomes clear that our -- the possibility for superior outcomes exists. The reduction in second treatments on a per patient basis, that's a boon for the health care system and for everyone trying to deliver efficient care.

Darrin, you said there has been [indiscernible]. You saw smartest in early VT data. These results were recent, but 112 applications [indiscernible] 2.5 hours that where efficiency can be more impactful. So can you speak a little bit about the characteristics of nanosecond PFA and how it is applicable in the VT setting? And then also, there are dual energy transport [ P1G ] obviously available. Darrin, maybe can you speak about how this architecture can facilitate that, or do you need complete redesign of the Pulse platform?

Yes. Those are really good questions. So on the nanosecond side, the thing we do -- I think we know is nanosecond is very different than microsecond. One of the ways it's very different is that these nanosecond pulses penetrate tissue deeper and more homogeneously, right? So we operate below the charge time constant of cells, which allows us to pass through the cells.

By passing through the cells, we get deeper and we're more homogeneous. This is important in the atrium for sure. It will definitely be important in the ventricle where you're treating more tissue and you're working through scar and other things like that. In the HRS meeting this week, we had a poster that was presented by Mount Sinai on a focal catheter, kind of an early-stage focal catheter that we developed. That data looks very promising. It's ablation depths in the 10 millimeters even at sort of modest energy levels.

So we think this technology is going to be able to deliver very deep lesions all over the heart and very efficiently. So we can definitely move very quickly. David showed you a second-generation design, which combines a focal catheter with the current epicenter catheter, allowing you to do sort of circumferential ablations, but also lines and spots and those kinds of things. That also really drives efficiency of procedures, especially when you're doing things outside of the pulmonary veins. So in those cases, you're doing veins, posterior wall plus spots and lines and whatever else you need.

And so we haven't participated in the ventricle as of yet, except for in preclinical work. But I think the opportunity is there, and I think this is a technology that's going to work quite well in that chamber of the heart. Yes, sorry. So the dual energy side, as an engineer, I'm going to walk out on the limb and say, "I'm not convinced that, that's necessary." I think it depends largely on the application. There's some data that suggests PF before RF or RF before PF in the same lesion can be a little bit bigger. We haven't seen that in our hands. And I think maybe that is more an indication of microsecond PFA needing to get deeper as opposed to nanosecond, but we'll see.

I mean if other energies can be brought to bear and create a more efficient workflow, we can certainly do that. It's not a -- these are, I think, engineering activities that are doable and not a long time horizon. But I think the first step is, do we really need that? That adds a lot of complexity, obviously. I think a single energy with devices that are designed for that energy source that can deliver the kind of lesions you need is really the optimal solution. And I think we'll drive for that before anything else.

I'm from Canaccord. Congratulations on the data presented today. And my question is really about efficacy and some of the commentary in the follow-up that was provided was this was -- and I'm curious how you think about these variables. The patients weren't sick. And now we're talking about the pivotal trial, like we're doing them faster. We have the capabilities, but they're not. How do you think about this as you run through a trial, if they're doing it faster, they may not get higher efficacy versus what's more important? Is it speed? Is it efficacy? And I'm just trying to kind of think about as you went through the feasibility study, how much did the product change? How many iterations? And what did you see that gives you the confidence that we could see kind of better outcomes...

Yes, great question. So as I said, we kind of learned as we went during the first-in-man. And some things we learned were how many -- how long should the lesion be, 2.5 seconds or 5-second applications. We settled on 5 seconds. So that right there, we showed that, that data of the cohort is better.

Mapping integration. We went from really crude mapping integration to fully integrated. As far as the post-presentation commentary by Prague, I think it's great. I think it arms us and invigorates us to show everyone that we're going to provide the best possible data through our IDE now that we have figured out the time, integration. And as far as patient population, this is all comers. These are patients that we had. I guarantee the U.S. data, the U.S. population is different. Usually in Europe, we have healthier patients that are studied. In the U.S., unfortunately, we have sicker patients, and that will show through probably. We're not cherry-picking the patients. These are patients that are enrolled in the IDE. They're all comers.

Yes. I would just make one comment also. I think we can't overemphasize the benefit of a really tight integrated mapping system. You saw it in the videos that we showed and maybe didn't pick up all the nuances. But as they ablate, you see the color change, you see this kind of blue area, like that's where they've ablated. So they know now that they can move on. They know that they're filling in all of the areas. And that was sort of available in different iterations of it through feasibility, but largely maybe only over the last several months. Has it really been at that level with the magnetic sensor in the catheter? So that speeds up the procedure for sure.

I mean, anecdotally, I mean, a lot of procedures these days, they're in the 30-minute range almost all the time. And it will improve outcomes because they can see better where they're at and they can treat things. I mean it's a little bit -- honestly, if you were driving a car at night and you were holding a flashlight out of your window to try to see where you're going, that's how it was before we had good integrated mapping. Now we have headlights. So it's phenomenally better. I think we don't even -- we don't see it in the data because it hasn't been in there long enough for us to see it. So that's, I think, why we're so optimistic. And you can see it. When you watch these cases, it's obvious. If you talk to EPs, I mean, if you talk to anybody, they'll be able to articulate it like David.

Pulse, in your commentary, just really has the technology fit very well in the ASC setting. Curious what you hear from the doctors who use this and your general thesis in the ASC setting.

Yes. So I've done about 40 ablations in an ASC setting. And the most important thing about an ASC setting is the doctor who's doing the procedure is basically on an island. And there are no other doctors that can bail you out. There's no CT surgery. You need a procedure that's safe, that's effective and that's efficient. This fits all 3 of those criteria. This would be an ideal tool for an ASC setting. Unfortunately, for me, it's not available yet.

Whether any changes in procedural strategy that you think are really going to show up in terms of safety or anything beyond that in terms of workflows for the larger arm setting?

Yes. I mean as you do a procedure, there are many things that you kind of think about. I'll give you an example. And I probably won't be able to list all of them off the top of my head, but I'll give you a quick and easy example, the sheath. So at the beginning, we were using one sheath. And at the end, we've landed on a sheath that we feel is just generally safe. It really has nothing to do with our catheter, but we feel that, that adds to the safety of the procedure.

One thing to think about, I mean, I know it may be obvious to all of us in the room, but there are many things outside of the catheter that's being studied that can go wrong in a procedure. And we need to control for those things, patient selection, are you irrigating through the sheath? Are you getting the right ACTs, anesthesia-related things, groin-related things, pericardial effusions that aren't totally unrelated to the procedure. So yes, as you go through a first-in-man, you kind of think about all these things. But yes, I think that those are the reasons why we do IDEs and other trials.

Follow-up. Just on mapping, I think EnSite is going to be map for NEI either. So it has to be CARTO and at some point, is there a marker to mesh, nPulse with CARTO and I guess [indiscernible]. Just how many will come in and how long does it take to get up to speed?

I can answer in a slightly different way as a clinician. We're only going to allow mapping in that's tightly integrated to the point that it's right now with EnSite. So we actually do have an iteration with CARTO, but I don't like it enough to say that it's as tightly integrated as our EnSite is. If they can get there, we're happy to use it. It's up to them.

In this study, general anesthesia was used. How important to making PV ablation really feasible in the ASC at scale is moving a conscious sedation and nanosecond PFA help with just musculoskeletal interaction, other things to worry about?

So anecdotally, I happen to be in some of these cases in Prague, and I know of a handful of cases where the patient was pretty much awake and there was really no extra cardiac stimulation. So yes, it could be done. And yes, it could be done under conscious sedation/deep sedation, which is basically Versed and fentanyl plus a little propofol at convenient times during the procedure to keep the patient comfortable, which is what we currently do in an ASC. So I think as far as anesthesia goes, this catheter and technology lends itself to an ASC setting for that reason as well.

Paul, you talked about a formal partnership with one of the strategics. Has anything changed in integration with EnSite? Is that the partnership? Help us think about kind of the strategy going forward, please?

Yes. Great question. Number one, the strategy has not changed. And number two, the short-term integration steps that you see, they're not indicative of a larger partnership. And maybe Bob Duggan can answer as well.

It may or may not. Senior to that have invested in a number of very successful companies. One of the keys to that success, are you investing in source? Are you investing in an in-licensor that when they need to make change, they have to go back to the source. They can't locate the source. Our team is a source at Pulse. Our competitors are using microsecond PFA, none of them are the source of microsecond PFA. So in terms of -- doing something different. They've got to go back to the book they read for a better creator. We don't have that view. We go straight to the procedure, straight to the physics, straight to the DKs and the source of creating nPulse, which we know A&P for the last 10 years.

So that's why we have rapid particle focus and we'll do what's necessary. So we're now presenting procedures for less than 200 patients compared to 10,000 and 50,000 procedures to our competitors. Someone once asked me robotics. Bob, you've been in robotics for 5 years and you're no better than human hand. I said how long a human hand here, 400,000 years, give me 5 more years. No one would like to do a procedure with the human.

We have over half the procedures of robotics. Nano Pulse is the sweet spot for energy in this area. And we're the source of it, gives some great confidence that we're going to be able to push ahead here and the future is incredibly bright, but we're going to take it one step at a time. You get too far out front and you make inadvertent iatrogenic instances that never should have happened, but it did happen and it makes the headlines. So we're in a really nice space. One thing I'd like to have Liane to step up. She's our Chief Operating Officer. She's here with the mic. Some of you may know her. I didn't know her too well, but I want to give the floor to her. I got to know her better. But just a few minutes on why you're here and your background.

Sure. I -- not that long ago, but I've been in the space for a really long time. I was at St. Jude Medical and then went through the acquisition. So I was there for about 20 years, a bunch of engineering and physiology under biomedical engineering. So a lot of engineering background. Moved over to the clinical and business side of things for kind of the back half of my time there, running a large portion of the division on the marketing and sales, bringing all these products to market that's sort of been the peak of my career and just really work with these folks. This technology is extremely exciting and very differentiated, and that's kind of what brought me over to really want to work with this fantastic team.

You talked a little bit about some post [indiscernible] data and how it translates to clamp. It's a little [indiscernible] plays into the...

Yes. I mean, I think it reads directly on it. This is an energy that can be used to ablate cardiac tissue very effectively. And I think our clamp is a really exciting implementation of a device that utilizes nanosecond PFA similarly in that it is very, very efficient and effective at ablating cardiac tissue. So cardiac surgeons use the clamp in concomitant procedures. They do a handful of ablations. It typically takes several minutes, and they can fully complete the ablations that they need to do to treat that AF and then they move on to replacing the valve or whatever. But it's -- certainly on the cardiac side, you can infer from this data that you're getting very good ablations that will translate directly to our clamp.

Any last questions?

Okay. Thank you so much for joining. Bob, do you want to...

[indiscernible].

Great. Thank you all. It's a pleasure to have you here.

Ladies and gentlemen, thank you for standing by. My name is Colby, and I will be your conference operator today. At this time, I would like to welcome you to the Pulse Biosciences Q4 and Full Year 2025 Earnings Call. [Operator Instructions]

I will now turn the call over to Trip Taylor. You may begin.

Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today, February 19, 2026, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements.

We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the News and Events section on our Investor Relations page.

With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

Thank you, Trip. Good afternoon. Thank you, everyone, for joining us today. At Pulse Biosciences, we aren't just making a better medical device, we are creating a pulsed field ablation platform to completely shift how physicians treat disease. We intend to transition the entire medical field away from using energies that apply extreme heat or cold to destroy tissue and toward our much more precise method, nanosecond pulsed field ablation or nsPFA.

Our technology has potential to completely disrupt multiple soft tissue ablation markets. And here are the reasons why. First, it offers incredible precision. Our system directs ultra-short duration bursts of energy, lasting only a few billionths of a second to only the precise locations where therapy is needed. Second, nsPFA creates a human body compatible healing advantage by initiating regulated cell death. Third, it operates with blisteringly fast speeds measured in billionths of a second. Precisely because of the speed and efficiency in ablating cells, we deliver less cumulative energy due to significantly shorter treatment cycles delivered in record fast procedure times. And finally, we have built an imposing legal fortress of intellectual property. We added 67 issued and 77 pending patents in 2025 alone, equivalent to adding a new piece of intellectual property every 2.5 days throughout the year to protect our novel developments. In total, 250 patents have been granted to Pulse Biosciences and an additional 180 patents are pending approval.

Overall, we made progress in calendar year 2025. Today, I will walk through those updates and our plans for 2026. After that, I'll turn the call over to our CFO, Jon Skinner, to review the financial results, and we will conclude with a question-and-answer session joined by Bob Duggan, Co-Chair of the Board.

At the start of 2025, we defined a focused set of objectives for the year. Our highest objective was and remains to advance our nanosecond PFA platform into late-stage clinical development to treat atrial fibrillation in both electrophysiology and cardiac surgery. In addition, we plan to explore launch feasibility of our soft tissue ablation system prior to gaining a specific therapeutic claim using Category II reimbursement. We are pleased to report we made progress across each of those goals in 2025, and that noteworthy progress continues into early 2026.

On the clinical front, we secured IDE approvals for both our electrophysiology catheter and our cardiac surgical clamp programs, positioning both to move into pivotal trial enrollment. In parallel, we significantly expanded treatment of patients in our European feasibility studies across both cardiac platforms, generating increasingly robust data sets to show superior workflow and procedural consistency. We also started publishing those data sets and through today have produced clinical performance of interest in each of our 3 clinical programs.

On the commercial front, we continued the highly controlled launch of the Vybrance platform for soft tissue ablation in a targeted disciplined manner. We did so by focusing on supporting a few select institutions dedicated to procedural excellence in order to validate the clinical and economic model. We fully appreciate the essential value of FDA indication clearance as well as reimbursement certainty. We anticipate this to be a worthwhile work in progress over the next 4 to 8 quarters.

Operationally and financially, we executed well and maintained disciplined expense management, exiting the year with a strong balance sheet that will enable us to execute on our clinical priorities in 2026. As we look ahead to 2026, our focus is clinical and market development execution. In electrophysiology, we intend to commence and complete enrollment in the nPulse cardiac catheter IDE study while continuing to treat patients in Europe in support of expansive clinical data essential to our successful CE Mark submission.

In cardiac surgery, we intend to expand and accelerate IDE site activation and complete patient enrollment in 2026, while continuing European feasibility activity and preparing for an additional CE Mark submission by the end of the year. In soft tissue ablation, we are completing enrollment of the PRECISE benign thyroid nodule study, deepening commercial utilization in key accounts, driving the business model to our goal of financial viability and continuing to demonstrate the clinical advantages of the Vybrance nsPFA treatment. Each of these milestones advances our position as the disruptor in PFA therapies and first mover in nanosecond pulsed field ablation, a position that is reinforced by our significant intellectual property estate.

Pulse Biosciences is advancing a platform that integrates advanced biophysics and precision engineering that will be changing for the better the standard of care for multiple disease states affecting patients worldwide.

I will now start with our nPulse cardiac catheter system for AF ablation. While our nsPFA technology is a versatile platform designed for multiple clinical applications across the body, our primary focus is transforming heart care for AFib patients. We have developed the world's first one-shot ablation solution for atrial fibrillation. Our nPulse cardiac catheter can treat a targeted area of the heart with a 5-second single-shot burst, delivering circumferential pulmonary vein isolation or PVI.

The nPulse cardiac catheter minimizes the need for the physician to reposition the catheter or overlap lesions. The nPulse cardiac catheter incorporates several differentiated design and performance features that set it apart from existing ablation technologies. We have previously presented data on acute procedural measures that validate workflow advantages and our recently presented outcomes data provide the first long-term clinical evidence of procedural success and are available on our website at pulsebiosciences.com. Because nanosecond pulsed energy is delivered so rapidly, the system delivers minimal cumulative energy to tissue. This results in no measurable tissue temperature elevation and low neuromuscular stimulation, which contributes to shorter procedure times and may reduce required anesthesia levels.

In addition, the catheter incorporates a patented proprietary flexible electrode design that enhances maneuverability and conformability within the left atrium, allowing physicians to deliberately move the catheter within the left atrium and rapidly achieve stable positioning, enabling seamless procedural efficiency.

In comparison to the current standard of care, the clinical benefits we reported in February 2026 have been nothing short of outstanding. In our European studies presented at the AF Symposium on February 5, the lead investigator of our feasibility study provided comprehensive as well as compelling data on procedural speed, workflow, safety and outcomes durability. Key study findings were outstanding and highlighted 100% procedural success or freedom from AFib at 6 months and 96% procedural success at 1 year for evaluable patients.

Overall, freedom from atrial arrhythmia was 90% at 12 months as shown on a Kaplan-Meier curve and the data are available on our website. All 3 of these endpoints represent new standards of therapy effectiveness for nsPFA treatment of paroxysmal AF. Procedural efficiency remains remarkable. While still early on, we are routinely seeing physicians finish these ablations in just 6 to 8 minutes or faster, which could cut total procedure times by over 50%. These results reflect the underlying advantages of nanosecond PFA, deeper lesion formation with fewer applications and lower cumulative energy to deliver durable isolation.

Physicians continue to highlight the simplicity of a single-shot approach and the reduction in catheter manipulation and lesion stacking compared with legacy technologies. The nonthermal nature of nsPFA continues to show a favorable profile, allowing physicians to treat efficiently and proceed to additional targets without delays between dose deliveries, unlike microsecond PFA, which requires prolonged recharging times. The Pulse Biosciences system directly addresses limitations of current generation catheters, microsecond PFA or thermal modalities by enabling complete durable isolation in a single energy delivery with the potential to cut procedure times in half.

We expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE Mark approval in 2027. We are focused on accelerating our market entry strategy through strategic mapping partnerships. To bring this revolutionary nsPFA technology to the global market as swiftly as possible, we are actively pursuing strategic partnerships with world-class mapping providers and EP market leaders. Such a partnership should produce a tremendous win-win. By integrating our best-in-class nanosecond PFA solution with an existing best-in-class mapping ecosystem, our potential partner or partners can capture and solidify their market share with the most advanced energy solution available, while Pulse would benefit from nanosecond PFA worldwide commercial launch acceleration.

These synergies should ensure that physicians and patients gain rapid access to the fastest, most precise and durable nanosecond PFA solution in present time.

Let's now discuss our surgical ablation clamp. Our nPulse cardiac clamp is the first in the world FDA-approved IDE pivotal study, NANOCLAMP AF for a surgical device that delivers PFA. This represents a significant landmark in cardiac surgical innovation. Our system is designed to deliver fast, contiguous transmural ablation lines during open heart procedures for patients with atrial fibrillation. We believe the current treatment of preoperative AF with concomitant ablation is significantly underutilized and the speed and effectiveness of ablation delivered with nsPFA can transform this therapy and market.

Our IDE program is progressing and enrollment activity is underway and expected to conclude during 2026. As a reminder, NANOCLAMP AF is a prospective single-arm multicenter study designed to assess the primary safety and effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. We intend to enroll 136 patients in approximately 20 sites, including 2 international locations.

In Europe, we continue to generate excellent results. Data presented previously at EX highlighted what we consistently see with this system, very fast total ablation times, clean lesion sets and reproducible workflow in the surgical environment. Surgeons continue to emphasize the importance of speed and predictability in this setting, which aligns well with the intuitive workflow and short energy delivery times observed with our system. These initial treatments keep us on track to file for CE Mark by the end of 2026.

Beyond the significant clinical progress of our cardiac programs, the nPulse Vybrance percutaneous electrode system is validating in real-world use our technology in non-cardiac soft tissue applications. The nPulse Vybrance system is initially being used by physicians to treat symptomatic benign thyroid nodules, eliminating the need for traditional surgery. This is a very common and disabling condition associated with 250,000 new annual U.S. diagnoses. This annual incidence converts into 150,000 total or partial thyroid removal surgeries each year. And this is precisely the clinical practice opportunity we are exploring with our minimally invasive application of nsPFA to reduce nodule size and eliminate patient symptoms.

Our current nPulse Vybrance technology has the potential to shrink nodules while sparing vital nerves, blood vessels and sensitive structures in the neck. In the fourth quarter, the team generated $264,000 in revenue from Vybrance systems and electrodes, an increase in revenue versus the third quarter. We are taking an extremely disciplined approach as we closely monitor individual account procedural volumes, site-by-site patient outcomes, all local procedure reimbursement results, procedural efficiency and overall clinical and business success factors routinely considered by each hospital when adopting a new procedure.

Our approach remains deliberate, evidence-based and focused, operating at an intentionally limited scale to demonstrate how meaningful this opportunity can be within key accounts at large hospital systems in selected geographies. From a clinical perspective, the PRECISE benign thyroid nodule study remains on track to complete enrollment of 50 patients in the next few months. We plan to further expand the study to 100 patients over the ensuing 2 quarters. Broad adoption and viable long-term market expansion is our goal. It is important to note that scientific recognition of this work is on the rise. Data from Dr. Stefano Spiezia in Naples, Italy, have been accepted for a podium presentation at NAFID, the North American Society for Interventional Thyroidology in March.

In parallel with the PRECISE-BTN study, we are expanding the clinical scope of the Vybrance platform. In the fourth quarter, we announced a research collaboration with the University of Texas MD Anderson Cancer Center, one of the world's leading oncology institutions to evaluate the use of nanosecond PFA for the treatment of both benign and malignant thyroid tumors. Under this collaboration, we are conducting an FDA-approved IDE study evaluating nsPFA for the treatment of papillary thyroid microarcinoma and expect to complete enrollment by year-end 2026.

In addition, preclinical work is underway exploring the potential application of nsPFA in anaplastic thyroid carcinoma, a highly aggressive cancer with limited treatment options. We view this collaboration as strategically important for several reasons. First, it meaningfully expands the potential indication set for the percutaneous electrode beyond benign disease and into cancer, while remaining within the same core workflow of endocrine surgeons targeting thyroid disease.

Second, it reflects external validation of the nonthermal mechanism of action of nanosecond PFA, particularly its ability to ablate cellular tissue and initiate regulated cell death while sparing surrounding critical structures, an attribute that is especially relevant in the neck because of the high density of critical nerves such as the recurrent laryngeal nerve, which controls the vocal cords, major blood vessels, the trachea and esophagus. And third, partnering with a world-class institution such as MD Anderson reinforces institutional and physician belief that the Vybrance nsPFA platform has broad applicability and will expand over time beyond its initial commercial use case in benign thyroid nodules.

While this work remains in the research and feasibility stage, it underscores the platform nature of nsPFA and its multi-decade potential to address a wide range of soft tissue applications as clinical evidence develops. Economically, the Vybrance system is driven by recurring disposable electrode utilization and minimal facility overhead. The opportunity and model align with the growing trend toward minimally invasive procedures performed in lower overhead settings. We look forward to continued adoption of the Vybrance system and additional data publication in the second half of 2026. It is clear to us that multiple therapeutic FDA clearances beyond the soft tissue ablation clearance, while not yet achieved, will be essential to building a significant revenue growth business. Our commitment to generating clinical evidence, which will be highlighted later this quarter, will be the next critical step toward achieving FDA therapeutic clearances.

With that, I will turn the call over to Jon to speak about our fourth quarter and full year financial updates. Jon?

Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use. I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter, we generated nominal revenues comprised of both nPulse Capital and Vybrance disposable sales. Total revenue was $264,000, up from $86,000 in Q3. This sequential growth was driven by both capital and disposable devices. Cost of product revenue was $260,000 for the quarter, slightly lower on a sequential basis as compared to Q3 2025.

Total GAAP costs and expenses decreased by $1.7 million to $18.5 million compared to $20.3 million in the prior year period. The decrease in GAAP costs and expenses was primarily driven by a decrease in nonrecurring expenses. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization as well as nonrecurring costs. Total non-GAAP costs and expenses in the fourth quarter of 2025 increased by $2 million to $13.3 million compared to $11.3 million in the prior year period. The expected increase was driven by increasing clinical trial and early commercial launch activity.

GAAP net loss in the fourth quarter of 2025 was $17.4 million compared to $19.4 million in the prior year period. Non-GAAP net loss in the fourth quarter of 2025 was $12.2 million compared to $10.4 million in the prior year period. As of December 31, 2025, cash and cash equivalents totaled $80.7 million compared to $118 million as of December 31, 2024, and representing a decrease of $14.5 million versus Q3 of 2025. Cash used in operating activities during the fourth quarter of 2025 was $14.8 million compared to $9.1 million used in the prior year period and $13 million in Q3 of 2025.

We have also recently completed important corporate housekeeping filing a $200 million shelf registration. This provides the company with flexibility to support the balance sheet in an expeditious manner to ensure we have the resources required to achieve upcoming clinical milestones. Cash usage aligns with investment expenditures in pivotal trials, device scaling and initial commercialization. Expense growth remains deliberate and focused on long-term value creation. We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026.

With that, I will now turn it back to Paul for closing remarks.

Thank you, Jon. We are standing at the forefront of a medical transformation, leveraging Nanosecond PFA energy. Our Nanosecond PFA platform is no longer just a concept. It is scientifically validated, clinically proven in early use and its vast potential is slowly but certainly emerging across the fields of electrophysiology. We are moving forward with speed and purpose to establish Nanosecond PFA as the new global therapeutic standard. Our mission is steadfast, delivering significantly better outcomes for patients and creating robust long-term value via an emerging new era of patient and physician-friendly therapy for our shareholders. We are enthusiastic about the promising journey ahead, and thank you for your continued support.

Now joining us for the question-and-answer session is Bob Duggan, Co-Chairman of the Board.

Operator, please open the call for questions.

[Operator Instructions] Your first question comes from Anthony Petrone with Mizuho Group.

Congrats to a strong start to the year in 2026 to the team. Maybe Paul, I'll start with Vybrance and then jump into nPulse for pulsed field ablation. Maybe looking at Vybrance here, we're 2 quarters into the launch. The team is expanding in a limited launch release phase here. Maybe just as we think about the next couple of quarters, when do we transition from limited release to a broader release for Vybrance? And then maybe just a recap on the enrollment time lines for the post-market surveillance study for thyroid, and then I'll have a follow-up on nPulse.

Yes. Thank you very much, Anthony. I appreciate your comments. Vybrance is exactly where we want it to be right now. It is in a market development mode. We are at a limited number of centers, and we are evaluating exactly how it works and exactly what we need to really scale it. I would say that phase is going really well. You alluded to the fact that the team is stable. We're focused on quality and as one would say, going deep rather than going broad. And we're very focused on data, and I'll talk about the benign -- the BTN study in a second. We're very focused on data. We're very focused on repeating quality outcomes for patients in multiple centers, and we're now at a number of centers. And we're very focused on accelerating the reimbursement process.

So data will drive all of that and ultimately, data will drive a further therapeutic indication from FDA. We think those are the things that are required in our line of sight before we push on an accelerator to expand commercialization broadly. I've done a lot of market development work in my career in med tech, and it's really important to get the foundation right. That's what we are really focused on. We are very pleased to report increasing revenues. But we're really focused on the qualitative build-out of the market development and market enabling factors that will underpin revenue growth going forward.

And so our focus is on building that rock-solid foundation for the long term because we know given the size of this market, given the lack of alternatives to these patients, given the quality of the outcomes we're seeing, given the, I'll call it, exclusivity of nsPFA and its ability to treat benign thyroid nodules in comparison to other minimally invasive alternatives or surgery, we know that we have that right formula. And so we're really focused on ensuring that we build that foundation because growth in patient treatments, growth in activation of patients both in converting them from surgery to less invasive nsPFA and in recruiting patients off the watchful waiting list. We know those things will happen once we build the fundamentals.

On the recap, if you will, of the enrollment, we had mentioned in our prepared remarks that we expect to finish enrollment in the next few months. We are right on track for that. We have already enrolled a majority of that patient target in the first few quarters, and we're on track to finish it over the next 1 to 2 months ahead. So we feel very good about completing that enrollment on time. And then as I said earlier, our plan is to expand the study. We think we have the likelihood for very favorable clinical outcomes. We think those clinical outcomes which are very focused on quality of life and qualitative performance of those patients symptom relief based on the ThyPRO-39 score. We think that data set in concert with the data set that we will present at the NAST conference, which will focus on long-term outcomes from our feasibility study in Europe. We think the combination of those two will really create a very strong data set for additional regulatory authorization.

So that's our focus with the current enrollment completed on time and the plan for expanded enrollment to increase the robustness of that data set.

Very helpful. And then I'll just squeeze one in on nPulse. So obviously, good showing at AF Symposium '26. 96 procedural success rate at 1 year, 22-minute dwell time in the left atrial wall and 90% freedom for arrhythmia. So a quick 2-part question. One is we move away from that medical meeting a few weeks ago. What has been the reception from the community? There seems to be quite a bit of buzz at the conference. And then what are the updated time lines for the IDE study in terms of enrollment? Can it actually be accelerated just coming off a strong feasibility study?

Yes. Thank you, Anthony. Receptivity to the data, I would say, has been exceptionally positive. The buzz in the meeting, which I appreciate your comment on, I think you read that accurately. The reason AFib is so exciting is because as a business, it treats the single most common arrhythmia in our population. And so it's a very large market. We all know that over time, the retreatment rates for ablation generally fall in the real world in that 20% to 25% or 25% plus range. And so technology after technology, system after system have come along. We've seen the progression from RF to PFA. Most physicians would still say, in the real world, regardless of the system use, the recurrence rate requiring retreatment is still about 1/4 of the patients.

So when we report a 96% 1-year procedural success rate or a 90% rate for left atrial freedom from arrhythmia, that is an exceptionally differentiated outcome. It needs to be validated in a pivotal study. But it is, I would just call it noteworthy, and it has garnered a lot of attention. So we feel very good about how folks in all constituencies, if you will, physicians, patient populations, the corporate entities in the cardiovascular space, I think the reception to the data has been very, very positive. The time lines are, as we discussed, previously. We're expecting to commence enrollment in our study in the next 1 to 2 months ahead. We would then expect to enroll relatively swiftly. Our plan is to complete -- to start enrollment and complete enrollment in 2026. And you asked about acceleration, and certainly, we're prioritizing this program, and we're looking at all ways feasible to accelerate.

I think in my experience, I've run dozens of pivotal studies. There are many factors that contribute to enrollment velocity, nothing more important than physician embrace of the technology. It's important to have a clean protocol, one that yields high patient flow through the screening process, one that fits well into the workflow of the clinical setting and physician interest in the technology because they believe it will treat their patients well and importantly, because it represents an improvement in workflow, in speed and ease of use. That is a very powerful combination. We've previously demonstrated with our data that our workflow is superior. We hadn't until the AF symposium put forth data that would imply an outcomes benefit. So those 2, we think, will accelerate physician interest and attention to the study. And when you look at that study hurdle of 155 patients in our protocol and look at the number of centers and the interest in participation in the study, we think it can move along quite swiftly.

Your next question comes from the line of Suraj Kalia with Oppenheimer.

Gentlemen, I'd like to echo congrats on the exceptional data for nPULSE at the AF Symposium. Paul, if I could, just piggybacking on Anthony's question, right? So we do expect or at least hope pace of enrollment would pick up. But one of the things that Dr. Reddy had said at the presentation, Paul, was the nPulse wasn't really integrated effectively with mapping. I'm paraphrasing, but you get the point. For the IDE Pulse, are any steps being made to make the nPulse more effectively integrated with, let's say, CARTO or EnSite? Just trying to analyze or assess if there could be some incremental benefit in the IDE from mapping integration.

Paul, next question, if you could give us any update on the next-gen nPulse. And are you seeing any spillover on the NANOCLAMP side of the equation, just given the EFS with nPulse? I know I threw in a lot in there, Paul. Hopefully, you got all my questions.

Thank you, Suraj. So I'll try to get them all. The question really -- the first question is about the potential benefit associated with a more completely or more effectively integrated catheter with mapping system. And so first of all, for those who may not have been at the AF Symposium, we did conduct a live case that morning from -- that Saturday morning from Prague, which put on display a more completely integrated system between catheter and the mapping software. That is a good example of, I'll call it, contemporary display of catheter rendering on a system. And it is precisely the quality of that rendering that had not been available for those first 150 cases. So that is what, Suraj, your point is alluding to.

And the answer to the question is yes, we do expect to have improved software integration in the IDE, number one. And it remains open to speculate -- and I think Dr. Reddy commented on this in a couple of ways. It remains open to speculate how much better the results can be, and he somewhat jokingly implied that you can't get much better than the results we've already achieved. On the other hand, he also said that through the dozens of cases that he had performed in the feasibility study, he couldn't really tell exactly where the catheter was. And now having performed cases with a more integrated system, he could. And he felt that, that would improve the accuracy of his lesion creation and potentially reduce the number of lesions he might make. Already at a record low for nPulse, but he could do even fewer lesions with high confidence that he was placing them precisely where he wanted. So I do think we could receive both acute procedural as well as outcomes benefits from improved integration, and we do expect to have improved integration available in the IDE.

The next-generation nPulse system is a device that is still in the development phase. So we're not providing time lines on that. Suffice it to say, it is intended to be a device that would integrate a regional footprint ablation system, which is what we have today with the current 360 as well as a, I'll call it, a focal or a large footprint focal device integrated in the same product. What that would allow, of course, is pulmonary vein isolation and then left atrial ablation points or lines without having to exchange the device. So that, we think, is a really breakthrough concept and will have significant procedural benefits, but is still in the development stage.

And then lastly, your question about spillover benefit from nCLAMP. And I think the answer to that question is yes. And of course, those benefits are nsPFA derived. We're now applying the same energy to cardiac tissue in different methods and for the same indication, but with different ablation line patterns. And as we previously reported, we've done comprehensive remapping of those open surgical cases, which builds our confidence in the, I'll call it, the potency, the power of our ablation energy. We now have seen that 96% procedural success rate, that further reinforces the potency of our ablation energy. We have outstanding safety being derived from both cohorts of data presented at ESC for surgery, at AFS for electrophysiology.

You can imagine that those data sets are being submitted to the FDA. We feel we had an excellent process for IDE approval with FDA. I'm certain that the TAP program status and the breakthrough designation of the clamp device provided some tailwind, if you will, for the approval that we ultimately receive for the IDE for the EP catheter. So those, of course, will both be going through their data collection and ultimately, submission processes around similar times. And really, what that provides the FDA with is just more safety data, more clarity that we can deliver great lesions in either lesion set, interventional or surgical. And I think it's difficult to specify the benefits, but we know that there are real synergies as we generate great data in each application and both of those data sets go into the FDA to essentially comparable review teams on nearly overlapping time lines.

Your next question comes from the line of Josh Jennings with TD Cowen.

It was great to see the stellar feasibility results for nPulse at AFib Symposium. During the data presentation, Dr. Reddy and others kind of discussed the clinical success rate that 90% freedom from atrial arrhythmia at 12 months, exceeding expectations and maybe even higher than what we expected just based on procedural success or lesion durability alone, suggesting the possibility of some other biologic impact or modulation beyond just the conduction block. You reviewed some of the hypotheses behind that at the Pulse event at the symposium. But maybe if you could just review those? And is there any way to confirm any of these hypotheses with either an animal model or anything on the preclinical side?

Yes. Thank you, Josh, and very good question, and thank you for paying such close attention to everything that was reported at AFS. It's great to see. I would echo exactly what you said. These are hypotheses. We don't know that any incremental mechanism is actually required in order to achieve the results that we've seen. I think the first thing I would say is that the reason a hypothesis for incremental benefit might be pursued is because the original data that we presented were so strong in comparison to a history of delivering lesions with PFA that clearly maxed out at lower levels.

It leaves one to question how it is that such a significant leap can be made. We have less wonder about why that leap can be made. We've been making lesions in preclinical models for years. We have tremendous understanding about the power of nsPFA and that it is a differentiated energy. Yes, it's a form of pulse electric field delivery, but we really do believe it is a different type of energy. It has a different mechanism of action already as we've defined than microsecond PFA and the consistency and depth and the transmurality of our lesion generation, we think is on its face, the explanation for superior results.

That being said, we certainly can conduct preclinical experiments to assess whether other nerve targets that might be extra atrial could be effective. But while we will work with our clinical advisers to do that, I would say we are less inclined to search for a novel mechanism because we believe we understand the clinical results and why they are a direct result of the energy that we are delivering. What's unique about nsPFA, and we see this in multiple indications, is that it is hard to imagine how effective it can be while being so fast, while being so nonthermal and fitting into workflow as exists already in existing clinical practice. But that is what we're seeing essentially time after time.

So we believe the most important thing to replicate is not a novel mechanism that is the result of speculation, if you will, but rather to replicate these clinical trial results. They've been derived on a large n. We're continuing to follow those patients. So I think the most important clinical discovery will be how does the next tranche of patients as you build up the full 150 now going to beyond that and follow those patients 6 and 12 months and continue to just reinforce the fantastic clinical results. To us, that's more important than looking at preclinical models for atrial ganglia ablation.

Understood. And then just to follow up on the tail end of your answer, just how should we be thinking about the timing of future updates to the feasibility study results and particularly the final results that will be submitted, it sounds like for CE Mark approval.

Thank you so much, Josh. Timing, really the next event will be at HRS. We plan to submit data for review at HRS. And that, of course, will be, I'll call it, on a rolling time line. So as many patients as meet the endpoints by the various presentation cutoff deadlines, that's what we'll present. We think that will provide us a very nice increment in total number of patients over time. And so that will be the next event in addition to an update when we commence enrollment in the study, which we expect, as mentioned in the next few months. So very nice updates coming between the announcement of first patient enrollment as well as HRS by just a few months down the road.

Your next question comes from the line of [ Jesse Crawford ] with Luxury Lifestyle Design and Development.

Thank you guys. Thanks for putting on these calls. These are actually really, really beneficial to everybody, especially all of the people who really believe in the technology. I'm one of those people. I evangelize for Pulse all the time. And when people ask me what it is, I kind of have to give them the dumbed down version of it, but I kind of equate it to the tricorder in Star Trek. People laugh at that analogy, but I really think this is the future of kind of the 2 holy grails of treatment for cancer and heart disease. So as an avid investor, I like to participate in the calls, but I also have AFib. So I would be very interested in participating in one of the clinical trials. I'm that big of a believer in it.

Well, thank you, Jesse. And I appreciate your transparency about AFib. The fact of the matter is it is so common. We can't go very far without finding a patient right in our midst. And AFib is so common. It's growing in incidence. And what we're faced with right now is, as you well know, a progression through early diagnosis and then most commonly drug therapy, which is often undesirable for the patient, some combination of anticoagulation therapy and antiarrhythmic medication. And I think the ultimate vision for a therapy is to pull forward the option that can be offered to a patient to allow for a very safe and highly effective intervention as first-line therapy so that a patient that is tolerating atrial fibrillation, which is obviously associated with higher risk factors that, that you would not have to tolerate AFib because the balancing act between first-time effectiveness and safety is so favorable that you can be offered the option of going straight to an intervention.

We know that with AFib, the earlier one intervenes, the likelihood is that the AFib is not advanced in its complexity. And if it resides still in the pulmonary veins, one is more likely to treat it definitively, which is to say an ablation can be a cure. And that's not really the way patients are provided therapy opportunities today. That requires more data, more changes in guidelines. But I think the trend as supported by the kind of early results that we've seen so far could be supported by this kind of a breakthrough technology. So we really appreciate your support and your evangelizing. And I would say from what I've seen, if I had AFib, I would want the therapy, too. So we are like-minded. So thank you, Jesse.

Thank you. I'm very -- actually a very pharmaceutical treatment at averse. So this is very exciting to me and a lot of my friends as well. And I guess a follow-on question to that would be for Bob on what his strategy is for partnerships?

Jesse, good to hear your question. You sound -- your viewpoint on the product and our efforts and the technology is really a duplicate of my own here and I'll get to the money question that you just asked. The challenges have really been it's a novel technology. This is not MicroPulse. It's a nanoPulse. It's different from, say, laparoscopy as robotic procedures where people recall robotic as it's an extended form of laparoscopy, but it was quite a bit different, had a real significance. That had to be proved out, and we've had fortunately, the benefit of working with the world's top-class surgeons, and we're comfortable now. So we go into this final study on the CA side. It won't be the final study, but it will be a study that we would expect we would go forward and get approval from. So we're very optimistic about that.

When it comes to reimbursement in this business industry, which I've been in for a couple of decades, you -- it's really a high priority to have a label. But to get a label, you've got to have the top quality professionals using your product and really signing off on its ease of use and the duration of outcomes that they achieve because some of these are the best of the best and they can get almost anything to work. So you really have to democratize it for a bit. So we're well into all of that now. On the -- but importantly, we do not have a label from anything other than soft tissue ablation, which we cannot directly pinpoint and tell people. Here's what you should do or train them for that and originate that.

And given the scarcity of people through a trial, we do not have reimbursement. Paul said on the call, and I think it's accurate, that will come over the next 4 to 8 quarters. And so those that are potentially frustrated on the Vybrance, it's just -- we just have to live with that. I've seen many companies rush in without that. They get stalled out and you become a company that your revenues are not able to even match your expenses. So we will not be doing that. And it will take a little bit of time on the Vybrance side. We're still working now to get a label on the CAF side and the clamp side, but we believe those are coming in 2027.

But we think the probability of that is extraordinarily high. We are more than pleased with the outcomes. And just one touch more back on the Vybrance side. We look forward to the readouts on that trial coming by midyear. So that news is all good. Now how do you turn around and fund that? That will require additional funding, but it could come in the nature of a partnership. It could come through distribution. There are any number of forms that, that could take place. We did a significant rights offering a year ago or so and you saw us participate in that. And we're still living off of that. We have about $80 million in the bank closing the year out. We have another $2 million in warrants as the stock would trade over $22 a share for another few weeks. So that's what we have in mind. We watch it carefully knowing that we've always got access to money. We haven't had to go and get 2 years' worth of equity dilution in order to have a couple of hundred million on account.

But we're very pleased with our following now. We're very pleased with the leadership. And I would say there's a touch of frustration on the Vybrance side where the singular importance of being able to achieve a label has been long coming. But we're now closing that gap, and we'll get on that. And as much as -- I wish I could say it was 2 to 4 months, but it's really going to be about 4 to 8 quarters out before we have that lined up. And then it's Katy bar the door. So I appreciate your enthusiasm. I think you called it correctly. I too have AFib. And as soon as this is labeled, I'll be getting it, if not sooner. It's -- I've been in the operations, seeing the procedures, some without full anesthesia. -- just really, it's just warm my heart to know that I've participated in this and the benefits that will be accruing from it. So I hope that addresses your questions, Jesse.

And with no further questions in queue, I'd like to turn the conference back over to Paul for any closing remarks.

Well, first of all, thank you, Bob, for those comments and really for the great questions we received. On behalf of the team here at Pulse Biosciences, thank you all for your interest. We look forward to providing you with updates throughout the very busy 2026 we have ahead. So thank you all for joining, and good afternoon.

This concludes today's conference call. You may now disconnect.

Good afternoon. Thank you all for joining us today. My name is [Henry Jiang]. I'm with the banking team here at JPMorgan. And today, I have the pleasure of introducing Pulse Biosciences presenting today will be the CEO, Paul LaViolette. And just a quick note, we'll have time for Q&A at the end of the session. So please wait until then, and we can get you a microphone.

But without further ado, I'll turn it over to you, Paul.

Thank you very much, Henry. It's a pleasure to be here presenting on behalf of Pulse and the team. And I am actually celebrating my 1-year anniversary. I joined the company in -- just before JPMorgan of 2025. So this is a perfect opportunity to reflect on the prior year, what we've been able to accomplish, where we stand today and what we have to look forward to as we go forward into 2026. And I'll be making forward-looking statements today. So this is our forward-looking statements disclosure.

Our mission is to really capitalize on something that we think we have exclusive control over, which is Nanosecond Pulsed Field Ablation. We have the benefit of participating and riding the tailwind of the PFA dynamic, which many investors are familiar with, while actually possessing and energy in pulsed electric fields that is truly unique, highly differentiated, and that differentiation translates both to technical and clinical advantages. And we'll spend some time talking about that.

Our mission is to build a viable and thriving company and to do that by participating in multiple large clinical markets. And we have many to address. We've selected 3 initially, and we'll talk about those 3 today. Our strategy really is to capitalize on that exclusive nsPFA energy and to deliver it into multiple markets on an optimized time line. We believe we are moving faster than predicate PFA companies. We'll describe that a little bit for you.

And we also, in an effort to be fast and to optimize capital efficiency, our goal is to select business models based on market entry criteria. And we'll talk about having a partnership or a direct business strategy as a function of how directly penetrable that market is with our resources as compared to the ability to expedite time to market and access of this technology by patients through partnership strategies.

The team that we have is outstanding. I had the privilege of joining this team a year ago, as I mentioned. I bring, I'm sorry to say 45 years of experience in the medical device industry. That is as an operator and investor, as a director. I've had a to be exposed to an innumerable list of highly disruptive technologies. I've never been associated with the technology in that 45-year period that has more clinical and financial potential than nsPFA. I'm joined by a management team that has a lot of experience, experience with innovation, experience launching technologies, experience with growth strategies, both in exciting markets like robotics, but also specific in energy delivery.

We are invested specifically in technology. And we -- I would say, one of our strengths is technology development. One of our other strengths is clinical development. We have a strong lineup of clinical leaders, key opinion leader, physician, medical officers and they participate directly in defining and leading our clinical strategy. We have a world-class Board. It's extremely unique Board. We'll talk about our inside ownership in a minute. Bob Duggan is here. Bob is a legendary investor, a serial entrepreneur, a visionary that has created markets and built spectacular shareholder value. That team brings in really a difficult to describe asset to Pulse Biosciences.

And I will say we were very pleased to announce a few weeks ago, Maria Sands joined us as an Independent Director. Maria also brings a lot of experience, a veteran executive in strategics in the med tech space, a multiple time Chief Executive, currently Chief Executive of Hyperfine, a serial director as well, including helping lead companies like ShockWave. So we really have a very strong team, one that I'm proud to be a part of.

If we look at our financial snapshot, we ended 2025 with $81 million, representing burn in Q3 of about $13 million, in Q4 of about $14 million. So a slight uptick in burn, representing our conviction to invest in our strategic priorities. We, as you may have seen, received IDE approval for the cardiac surgery initiative in the third quarter and in the fourth quarter for the PFA delivery in electrophysiology. And so as we scale up those IDE activities, of course, our burn will increase. But corresponding to that burn increase, we are moving those programs forward toward their commercialization dates. And we did initiate in -- for the very first time, recording revenues with the commercialization of our vibrant platform. That is a platform that treats benign thyroid nodules and we'll spend time specifically addressing that opportunity.

So initiating revenue, using cash wisely funded through our critical value inflection points, delivering IDE enrollment and critical clinical data throughout 2026.

So let's talk a little bit about the markets that we're pursuing. And we have 3 selected thus far. We will have a list of markets that we can pursue after that. The nsPFA is a bountiful platform. It has the ability to address multiple applications. And we calculate that the addressable markets for that initial list is $6 billion. And of course, that increases over time as we would expand our footprint internationally and expand markets in some ways, driven specifically by the availability of nsPFA to bring more patients in more rapidly.

You see on the left-hand side, an image of the console. What's important to understand is that, that is the generator for our Pulse and it is a universal generator. We can apply that same generator across the various applications, which creates tremendous capital efficiency. And we then have a software capability within that platform to vary all of the Pulse parameters to allow us to modify the therapy delivery from one indication to the next to the next. So it's really a remarkable piece of technology.

The thyroid application is the first, and that's a market that we intend to create. There really is no today interventional thyroid market to speak of. We think that market has real scale potential and is one that we can have a true proprietary foothold in, and we'll describe that in more detail.

Cardiac surgery is a market that we can enter and expand. That market exists today but it is not as large as it should be based on low frequency of utilization for ablation technology. And we'll describe how nsPFA will totally change that dynamic.

And then lastly, and the largest of all, of course, is the EP ablation market. We'll get into that with some specificity. It's a very significant opportunity and rounds out the market potential that we're going to be addressing in the years ahead, but starting with thyroid in the immediate term.

So a little bit about nsPFA. Everyone, I think, is by now familiar with pulsed field ablation. And it has really changed the dynamic of delivering energy to treat unwanted tissue versus what was available before. And we broadly describe that as thermal energy, which could have been radio frequency or high-intensity focused ultrasound or microwave, but generating heat to destroy tissue, which can be effective, but also has substantial side effects. So most fundamentally, this is a nonthermal and irreversible energy delivery. We use electricity delivered in billions of a second pulses at high amplitude to produce the same effect therapeutically that thermal energies would, but without all of the repercussions of using heat. That's point number one.

Point number two, you are familiar with PFA. PFA exists, and it's been doing very well. PFA in the first generation is delivered in microsecond pulses, which are pulses that are measured in millions of a second. Those pulses enter cells and fragment them. They destroy the cell membrane. They cause the spilling out, if you will, of the contents of that cell and stimulate an inflammatory response. So they can affect cells and cause cell death, but they are not benign.

Then we get to Nanosecond Pulsed Field Ablation, which is an entirely different really point on the spectrum of energy delivery, where we measure those pulses in billions of a second, we increase the amplitude of energy that we drive down that catheter or electrode system. And we totally introduce a novel mechanism of action. We actually induce regulated cell death. This is a means by which the cell effectively turns itself off. We don't fragment and destroy and distribute cell contents. And as a result, we have a very different cell elimination process. It's much more natural. And it fundamentally allows us to change the way we deliver that electricity, that pulsed electric field and allows us, I would say, both, as I mentioned earlier, technical and clinical advantages and we'll talk about how those convert into real outcomes and workflow differences for physicians in each of these markets.

Now how do you protect a technology like that so that nsPFA as it becomes commonly used in multiple markets, is used exclusively from Pulse Biosciences. And the answer to that, of course, is intellectual property. Over the past year, we have increased our IP portfolio by 144 issued and pending patents. That's an increase of 1 piece of intellectual property asset every 2.5 days across the course of the year. We have patent protection that covers every facet of the generation and delivery of nanosecond high-voltage pulses through 2 of the end application, the end electrode. And I would say it's going to be extremely difficult, if not inconceivable for a company to come along and try to replicate nsPFA. So our job is to build clinical value, build evidence, develop markets, and deliver technologies to convert existing markets, and we think we have an extraordinary array of opportunities, market by market, all under an umbrella of proprietary innovation.

So let's look at the first and this is the largest, and this is the electrophysiology market. Now we are familiar with several facts. Number one, atrial fibrillation is the #1 arrhythmia on earth. Number two, it is currently treated with ablation, but that utilization of ablation is actually very low in total penetration. It's actually in -- arguably in single-digit penetration. So this is a very large opportunity with tremendous growth ahead.

Number three, PFA has already been introduced in this category and has shown us that it can totally displace thermal energies and the rate at which physicians change from prior energy sources to PFA has been exceptionally fast. And really the vast majority of that market changed to a PFA opportunity in the first year. This is a very large market. This is hotly contested, and it's one that has demonstrated its willingness to change rapidly. So we think this represents an exceptional opportunity for Pulse Biosciences.

Now let's look at where we stand and what we're producing. As I mentioned, in the beginning of 2025, we were really just in possession of limited initial feasibility data. And if you look at where we stand today, we have treated over 150 patients we have follow-up on those patients that is reaching 12 months in duration, and we'll talk about that in a minute. So we are in possession of data sets now today that tell us we really have a valid statement of lesion quality, speed, workflow gains and soon to be described what we believe will be an efficacy advantage. So lesion quality. This is all about entering the left atrium, laying down lesion sets and isolating arrhythmias. We can do that because of our unique energy delivery capabilities. We can do that with a single circumferential lesion. This is the first time really in the field of EP catheter development that a single-shot technology has come to fruition. We deliver transmural lesions. We have lesion depth that is unmatched by any other PFA platform.

Speed. Speed is really what physicians are looking for, particularly in a market of this scale where the goal is to increase throughput to treat more patients over time. Our lesions are created in 5-second pulse deliveries. The total speed of all lesions delivered, therefore, can be measured in low to mid-single-digit minutes in a case. With that limited procedure time, we can drive patient throughput much higher, and we simplified the number of work steps that a physician has to take to complete an Afib ablation procedure.

Workflow. As I mentioned, speed, fewer number of ablations. We're lowering the number of ablations delivered with our catheter in comparison to the market leader by about 75%. We also can map follow-up outcomes, electrical activity outcomes with our catheter, which allows us, over time, to create a single catheter workflow where you ablate and map without having to exchange catheters, without having to add a high-density mapping catheter to the procedure. We think that is a breakthrough that in concert with our energy, which has lower neuromuscular stimulation effects and therefore, can treat patients with lower anesthesia levels. We believe lower anesthesia levels, higher speed and the ability to complete procedures with a single catheter workflow will enable the movement of these procedures from the cath lab in the hospital to the ambulatory surgery center. And that's going to be a defining dynamic in the treatment of millions of Afib patients in the market over the next number of years.

And then lastly, the one area that has really not been changed or upgraded in Afib ablation is efficacy. What is the rate of efficacy loss from 100% acute efficacy leaving the lab to 12-month efficacy? And what the Afib burden is following time? And unfortunately, with first-generation PFA, the efficacy loss of 25% to 30% is really no better than what had been delivered with prior thermal energy. So the procedure can be faster, it is safer because it's nonthermal, but it has never really been improved. And what's important to think about for our program is that we have received an IDE just in December. We're going to be commencing enrollment of that study starting in the first quarter. We expect to complete enrollment of that study in the calendar year 2026. And with the follow-up evidence we have from the European feasibility study we will be presenting for the first time, efficacy outcomes at 12 months, replicating the U.S. pivotal trial endpoint at the Boston AF symposium on February 5. And so we're very excited about unveiling that data set and beginning the discussion of the full value proposition of nsPFA in Afib, which is workflow gains, speed, safety and efficacy.

All right. Let's move on to the second market. This is in, I would say, comparable stage to that first market. It also treats atrial fibrillation. But in this case, it treats atrial fibrillation that has afflicted patients who are undergoing cardiac open surgery. So these are older patients, they have cardiac comorbidities. They're going in for open heart surgery to have a coronary bypass or have a valve repair or replace, and they already have Afib because of their complex cardiovascular history.

Now if they already have Afib and if they are undergoing surgery, it would be a good time to treat them for that Afib. And that is what the guidelines direct to be done. However, only about 30% of all patients have that therapy despite the guidelines. And there is a basic reason for that. The current approach uses radio frequency ablation. It is not as reliable as surgeons want. It is not as fast as surgeons want and these patients are frail and they are on cardiopulmonary bypass. So the goal is to move those patients to Afib free status, but the surgeons are saying, I'm not confident enough that the extra time and risk on bypass is worth the gain because I don't believe I'll get fast, efficient and effective ablation every time. That's an opportunity for nsPFA. And that's why we've addressed this as our second opportunity.

And so let's look at that. What is the status of that? Well, number one, we have treated about 40 patients in a European feasibility study. We have followed those patients with electroanatomical mapping follow-up. We have confirmed very high safety and efficacy for this therapy. We used that data to submit to the FDA. We received breakthrough designation on this technology and also received IDE approval. We received that in the third quarter of 2025 and have commenced enrollment of this patient population. And I will say anecdotally, as an example, we treated a patient today and that patient was treated with a total ablation time of 4 minutes. That is the kind of therapy that will fundamentally change the rate at which ablations are performed in surgery compared to today.

And our goal is to first convert that existing 30% of patients that are treated with RF. And then second, to increase the 30% to closer to 100% because the speed and efficacy and overall efficiency of that procedure becomes something that every surgeon wants to make available to their surgical patients. So we're enrolling our IDE. We'll continue to report on longer-term outcome of our European data, and we're very excited about the ability to add this technology to the cardiac surgery marketplace.

The third and final procedure for us to address today is the benign thyroid market opportunity. Now this is a very different opportunity. This is, first of all, non-cardiovascular. And second of all, it's a market that does not really exist today. There really is not a market of substance that one would define as, I would say, interventional thyroid management. And that's really what nsPFA has the potential to create. So let's think about it this way. Every year in the United States, 0.25 million patients are diagnosed with benign thyroid nodules. And 60% of them move to have their thyroid removed as the only viable therapy to treat those benign growths. So 150,000 patients a year are losing their thyroid. These patients tend to be young. And the cost of losing that thyroid is the elimination of hormones that control blood pressure and body temperature and heart rate and metabolism. That's an extraordinary cost in addition to placing that patient then on hormone replacement therapy and endocrinology follow-up for the rest of their lives. That, I think we can all agree, is suboptimal.

But there has been no energy that can treat the thyroid in that very confined space where it resides between the carotids immediately adjacent to the esophagus and trachea and precisely a zone that one would avoid introducing thermal energy to create tissue ablation. That's the opportunity that nsPFA has to address. To address those thyroidectomy procedures and all of the patients who are not getting thyroidectomies, even though they've been diagnosed and are symptomatic, but choose to endure and tolerate the symptoms rather than treat -- undergo treatment because the treatment today is removal of that organ.

So today, we are approved and under that clearance, commencing commercialization of a treatment, minimally invasive, introducing nanosecond pulse field ablation to address thyroid nodules in this otherwise surgical patient population. And what have we learned? First of all, this therapy works. We have now seen and treated hundreds of patients with follow-up that show that the mechanism of action that we described, that regulated cell death that we introduced in all tissues, all sell in all cells in the body that is working to clear that volume. We see a very rapid procedure. This is a 45-minute procedure done under conscious sedation with a total of about 7 or 8 minutes of treatment time with lesions that are created in 8 seconds piece. The workflow is spectacular. These patients leave the hospital with nothing more than a Steri-Strip or a band-aid on a small puncture that allowed that percutaneous electrode to treat that thyroid.

And the data that we're showing is compelling. We see significant volume reduction in the thyroid we now have data out long term that shows that reduction in volume is durable. And we also see validated reduction in thyroid symptoms. And those symptoms are relieved in about 2 weeks. So imagine, instead of having a life-altering surgery removing the thyroid and going on HRT. Instead, you have a 45-minute procedure, have symptoms amelioration in 14 days, and we can now say that, that procedure will produce durable outcomes for that patient, all of which preserves the thyroid and preserves natural thyroid function in those patients.

We are validating that further with additional data. We are enrolling a trial called the PRECISE BTN trial, Precise benign thyroid nodule trial which is a 50-patient study nearly completely enrolled. We'll complete that in this first quarter. That is generating additional data. We intend to add more feasibility and market expansion studies to this data set over the course of this year. We have commenced pilot commercialization. We initiated pilot sites with key opinion leaders in the United States to begin validating this commercial market and clinical practice and now we're starting to expand that. And all of those pilot sites converting to commercial by the end of January. And from that point forward, we'll begin to build this business.

We reported initial results financially in Q3. We'll report those updated in Q4. We're not giving guidance on this business. very focused on developing the market, build the quality, build the metrics, build all the evidence that this is a really sizable and repeatable and profitable business for hospitals, and then we will expand from there. We're extremely excited about this opportunity.

And so with that, let me just wrap up by saying two things. Number one, if you look at where we were a year ago, look at what we did in 2025, it was really a year fundamentally of building evidence, initiating trials and converting that evidence into initial regulatory processes. And we've seen that commence with 2 IDEs with multiple published data sets. And with data that will flow from those studies continuously throughout 2026. We have established and will now further make concrete in 2026 more evidence. We will enroll the cardiac surgery IDE. We will enroll the EP IDE. We will present outcomes data for efficacy results in EP for the first time in January. We will publish and present long-term efficacy data in thyroid performance in March at the thyroid conference.

And this will be a year of really advancing the clinical and regulatory processes as well as commercial for thyroid to a point where each of those businesses at the end of this year will be calculable. We'll have U.S. and European market launch timing based on CE Mark and PMA time lines. It's going to be a very productive and exciting year in 2026.

And with that, I'll conclude with this summary slide that tells us where we really are as a company. We are in possession of a revolutionary energy. We have extraordinary IP protection to keep that proprietary. We are taking advantage of a momentous drive of PFA into markets but nsPFA is truly uniquely differentiated, technically, clinically, and we're starting to see that now with outcomes. Clinical evidence is mounting and that evidence is quite impressive. We're going to add to that with 2 IDEs throughout the course of 2026. The markets that we're pursuing are very large, $6 billion in value near term. We have a list of markets that we can add to that including oncology-related applications that we'll begin to explore further, including those supported by our alliance with MD Anderson.

We've got initial commercialization underway to build the first thyroid intervention opportunity. We think that has very large business potential, and we have the cash on hand to run that set of plays in 2026 and produce significant value creation events.

And so with that, I'll conclude my comments and look forward to answering your questions.

Great. If you have a question, please raise your hand, and we can get you a microphone. If not, I have a few questions for you, Paul, and that we can kick off with. Are there current updates on the progression of the cardiac catheter ablation system ID?

Sure. So the current update is, as I mentioned, we received IDE approval in December. And with that, of course, you immediately begin to approach your sites and initiate their readiness to enroll patients. And so we are doing that. And so that's usually about a 30- to 60-day process that involves contracting and local IRB approval and our own site initiation activity with those investigators.

So we've assembled a clinical steering committee that is the most renowned physicians in the EP world. We have sites that are gearing up and will prepare to enroll in Q1. And as I mentioned, our expectation because of the size of the patient population with paroxysmal AF, because of the frequency with which those patients come into these major centers, because of the relatively, I'd say, common label that we're pursuing, right, which is almost an all-comers paroxysmal indication, we should have high patient flow. So there's some inertia to overcome to initiate sites, get them up and running. But once we do that, we're enrolling 150 patients. So if you think about a certain number of sites with high velocity enrollment, average enrollment 10 to 15 patients per site, per month. It does not take that much time to enroll a study like this. So a single-arm 150-patient protocol with a conventional end point.

So we're looking forward to running the trial. We have -- I would say, I've been associated with at least a dozen PMA studies. We have exceptional physician interest in this study, and I think there's going to be really strong support buy sites to enroll patients and to get this trial completed.

Got it. So given those numbers, when would you expect enrollment completion as well as like the first data readout?

Our target is to complete enrollment by the end of the year. And our second target is to accelerate that enrollment by every means possible. So I personally would like to see that trial enrolled closer to the end of the Q3, then by the end of Q4.

Got it. And how does the nanosecond PFA catheter differentiate from what's existing currently?

Too many ways for me to articulate in a short amount of time. But the catheter itself importantly, is designed to carry our energy. And we start with energy that is extremely different. This is hard, I think, to describe because PFA sounds like a catch-all category. We're delivering ultrafast pulse electric fields. But -- but there's a difference between a microsecond and a millisecond and that -- I'm sorry, a microsecond and a nanosecond. And that difference is 1,000-fold. It's hard to comprehend because when we think about gains in medtech development, we think about those gains on relatively minor increments, moving something from 3 French to 2.9 French in catheter size. This is a dramatic difference in physics and in energy capability.

Then that translates to the catheter. And let me just say, as a point of comparison, the most commonly used catheter today is the FARAPULSE catheter from Boston Scientific, which has done exceptionally well. That catheter delivers 5 small points of ablation. That catheter delivers 5 small points of ablation over a 30-second dose delivery. And then it has to be rotated and delivers those 5 again and again and again and again, overlapping stacking lesion creation, all for the purpose of trying to create depth. Well, why can't you create depth the first time? Well, because your energy doesn't penetrate the tissue. Okay. Well, and why don't you increase the size of your electrodes so that you can cover more tissue geography? Well, because the energy density of delivering those microsecond pulses is too great and the catheters can't -- don't have the capacity to do that. Nanosecond PFA allows us to change everything about catheter engineering and catheter design.

We can cover larger geography ablation footprint. We generate deeper penetration lesions. And so we can create 1 or 2 lesions in the pulmonary vein and be finished in two 5-second energy deliveries plus 10 seconds to move the catheter. So you can literally create isolation in a vein in a minute, isolation in 4 veins in a handful of minutes and be done with PVI in 6 minutes of operative time. That is unmatchable by catheters that are designed to endure the rigors of microsecond PFA.

Okay. And then another question, what is your current partnership strategy for the EP market? And how does the IDE approval sort of affect those discussions?

So first of all, IDE approval is a big deal. I think anyone who's been through these processes understands that requires great rigor, great evidence development. In our case, I'd say, a very impressive balance of preclinical and clinical evidence. And we have the benefit of what I mentioned earlier, which was the history of developing the generator and prior FDA clearances of the generator. So this is not an entirely new system in that regard.

So the IDE is a big deal in the sense that it is a highly validating moment for the company. And in partnership terms, that means those partners can look at us and say, "You know what, this company really is producing tangible results. They have an IDE approved." They understand in their own work, how hard that was for them. And so I think there's enormous credibility cast upon Pulse Biosciences with the IDE. It also says that we're now moving into the market. We're now starting clinical. We're now starting to enroll patients. And everyone understands we're going to be mapping with a mapping system and that drives a partnership dynamic because there's competition in mapping systems.

I also think the data that we present at the AF Symposium in February will be another accelerant, if you will, in discussions because we'll start to really add illuminating evidence on further safety performance, the workflow has already been reported acutely, but for the first time, efficacy evidence. And so I think as someone who's been, I'll call it, a strategic in the past, from a strategic perspective, from a partnership perspective, everything we've done, everything that represents the status of our EP program today has made it more and more and more compelling and more attractive over the last year, that will only increase as we enroll. And at that point, then once you enroll -- and then you know your follow-up time line and you can predict your PMA approval time line, you can put a stake in the ground and say, this is going to be commercial at this time. And no partner wants to wait until point. So I think it increases the likelihood of partnership discussions in the near term.

Okay. Thank you.

I have a question, Paul. Can you explain the importance of mapping navigation, especially with FARAPULSE? And how our approach is similar or dissimilar to those? And then as an additional topic, the -- any advancements in ultra as you see into the future, how that might impact the benefits of the technology is the drug today?

Great questions. So when you think about mapping is, I would say, it's an essential part of the practice, right? We're trying to create electrical isolation, and we know that we either have or have not by virtue of mapping for that conduction. So it is really important to map. What has happened, though, I think, really importantly, in the last year, particularly with the launch of PFA is that we have seen that ablation energy has become more important, I think, than mapping. And I say that with all due respect to mapping systems which are elegant and critical.

The launch of FARAPULSE showed that physicians will drop a catheter that is integrated with a mapping system in order to get a better energy. And that, I think, came to the surprise and consternation of the large mapping companies that had held on to ablation market share because of mapping integration. So I think it's important for Pulse Biosciences to bring the best ablation energy forward. And I think we're going to do that. I think it's important for us to work with mapping systems so that we are rendering clear images to physicians and making their cases easier to do and more accurate. And I think better and better mapping can produce better and better ablation results because you really are able to direct that energy where you want. But I think my opinion, what has happened is that ablation has become the predominant and first choice a physician has to make and then mapping may be secondary to that. So that's my opinion on mapping.

On ultrasound, I'll give you an example. With the thyroid, we use ultrasound guidance to deliver that electrode into the thyroid and create needle tracks and ablation zones in 3 dimensions. That is somewhat tedious. And it's a skill. It's a skill that is predicated on the ultrasound capabilities of delivering and interpreting images in the hands of that physician. That's hard to do. I think ultrasound is going to be a transformative technology for guided therapies. We're doing more ablation. What does that allow? Less surgery, increase of image-guided therapies. How often is ultrasound used? Almost all the time. How can better, easier, faster, more intuitive ultrasound capabilities? How much can that enable and accelerate the adoption of elegant energy ablation technologies? I think they can almost go hand in hand.

So as ablation becomes better and better and more capable, if you can pair that with better and better imaging it's going to accelerate the speed with which markets convert.

[indiscernible]

That is correct. That is correct. FARAPULSE, of course, now is paired with its own mapping system. But that's really an option. The physician does not need to use the Boston Scientific mapping system to use the FARAPULSE ablation technology. So I think the best way to think about it is that the market for mapping has moved to open architecture. The ability to close that loop and mandate a single catheter with a single mapping system, I think for the most part, those days are behind us. And what is going forward is ultimate optionality where physicians can choose the ablation technology they prefer, they can map with the mapping system for which they have the greatest comfort level, and they shouldn't be forced to choose one because of the other.

[indiscernible].

Yes. So the question was the ability to reduce fluoro use or to lower anesthesia requirements. That also is key. Physicians -- no physician wants to be exposed to radiation. And so fluoro times, of course, are the enemy and the desire to lower and lower and lower fluoro time is very important to physicians. There is a concept now of fluoroless ablation where physicians are pairing mapping and ultrasound guidance, IC or intracardiac echo -- and by pairing those elegantly, rendering precision of catheter location, allowing the elimination of fluoroscopy. So that's a cutting-edge technique today, but because of its obvious desirability for operators, for physician operators, I think that's going to increase meaningfully.

Anesthesia levels, same thing. Patients are routinely under general anesthesia for Afib, and that is a limit in, I'll call it, location. that general anesthesia is typically delivered in an operating room capable, right, anesthesia capable in the cath lab. So you're pairing imaging and anesthesia. If you can break that anesthesia requirement and PFA at nanosecond times can do that by lowering the possibility of patient movement due to electrical stimulation of their muscles. If you don't have that, you can lower anesthesia from general anesthesia to some level of sedation, conscious sedation. That allows the movement of the patient outside of the hospital and more and more toward the ambulatory surgery center. And that, I think, is a real opportunity for a technology like this.

Sorry, that's all the time we have today. But thank you so much, everyone, for joining us.

Hello, and thank you for standing by. My name is Mark, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences' Q3 2025 Earnings Call.

[Operator Instructions] Now I would like to turn the call over to Trip Taylor, Investor Relations. Please go ahead.

Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today, November 5, 2025, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release.

Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the News and Events section on our Investor Relations page.

With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

Thank you, Trip. Good afternoon, and thank you for joining. I'm very pleased by the progress Pulse Biosciences has made in Q3 towards advancing our goals in each of our 3 market development programs. I'm pleased to share these updates with you today. I will then turn the call over to our CFO, Jon Skinner, who will review the third quarter 2025 financial results. And we will conclude with a question-and-answer session, joined by Bob Duggan, Co-Chair of the Board.

At our core, Pulse Biosciences creates, markets, and services a medical technology platform that delivers proprietary nanosecond pulse electric fields generated by our nPulse technology to ablate tissue in various parts of the anatomy. We are developing a portfolio of specialized devices for multiple clinical applications with the goal of creating great procedures.

Nanosecond PFA is clinically differentiated from thermal ablation energies and microsecond PFA as it delivers higher, shorter bursts and lower cumulative energy levels into tissue, preventing tissue temperature rise or the spread of thermal injury. Our extensive preclinical and clinical experiences suggest nanosecond PFA should advance the speed, safety, efficacy, and workflow efficiency of prior generation energy modalities in multiple clinical specialties and has already shown the potential to be a truly disruptive technology.

As a next-generation leader in pulse field ablation, Pulse Biosciences is committed to advancing transformative therapies in large and growing markets with significant unmet clinical needs, consistently improving patient outcomes, procedural efficiency and patient access to minimally invasive therapies. With this scientific foundation in place, we are now dedicated to executing our strategic priorities outlined at the start of the year. We are driving early targeted adoption of the nPulse Vybrance percutaneous electrode system for soft tissue ablation with benign thyroid nodule treatment as the first use case. This includes our pilot program, new commercialization accounts and the initiation of the PRECISE-BTN or PRECISE benign thyroid nodule clinical study, all of which contribute to growing procedural utilization.

We have received FDA investigational device exemption approval to study the nPulse cardiac surgery system for atrial fibrillation, or AF, including the start of patient enrollment. We continue to advance our IDE submission with -- for our nPulse 360 Catheter, for the treatment of atrial fibrillation. Simultaneously, we are advancing our European feasibility studies for both of our cardiac devices with additional patients being treated with the surgical clamp and the electrophysiology catheter. Early therapy outcomes suggest market disrupting potential. And we will continue to share new data as available in the quarters ahead.

We are proud of these recent accomplishments and pleased to see the excitement grow and a bright future emerge for Nanosecond PFA in the medical community. Our patient results speak volumes. Regulatory progress is essential. And we are pleased to be thoroughly engaged in that regulatory process.

I will now provide more detailed updates on each of our individual market programs. Starting with our soft tissue ablation device, the nPulse Vybrance percutaneous electrode system. We are excited to announce our new product and technology naming. Our proprietary nanosecond PFA platform is now called nPulse Technology. Our percutaneous electrode is now the Vybrance percutaneous electrode. This new naming was rolled out and well received by physicians at the recent American Thyroid Association Annual Meeting in Scottsdale, Arizona. Physicians are currently using the Vybrance device for the ablation of symptomatic benign thyroid nodules, along with toxic and cystic thyroid nodules.

Through our pilot launch, we are proving very strong product market fit for the application of nsPFA to these conditions. Over 200 patients have now been treated across the pilot program, the PRECISE-BTN study and our first commercial procedures. Procedure volumes in the quarter grew on a sequential basis as positive and consistent outcomes are being reported across a growing number of providers.

We are pleased to observe growing utilization with one physician completing double-digit procedures in 1 month, indicating scale potential for this procedure. Our commercial team's primary focus is on driving procedure count to the point of clear economic viability for our customers within a limited array of accounts and geographies. We are intensely focused during this early phase, ensuring we identify proper patients, develop and train physicians and staff on consistent techniques across multiple conditions, confirm market access for commercial reimbursement, and provide clinical support to generate consistently positive outcomes. The nPulse Vybrance system is a first-in-class treatment and we are very pleased with early results.

Given that physicians are already caring for many patients with symptomatic benign thyroid nodules, patient flow has been positive or accelerating at all pilot sites. Patients who do not want or are not candidates for surgery, the watchful waiters, including those patients under active surveillance and those who are newly diagnosed are all strong candidates for the Vybrance procedure. We continue to take steps to validate the potential of the nPulse Vybrance system to both convert current thyroidectomy volume and expand this overall interventional market by addressing the active surveillance pool of patients.

Doctors have reported the procedure being straightforward to learn. They are able to leverage the skill set used to perform other ultrasound-guided procedures, enabling them to gain proficiency after performing just a few cases. The perceived safety benefits of the inherently nonthermal energy delivery of the nPulse system are of high importance to physicians treating benign thyroid nodules with this minimally invasive alternative to thyroidectomy.

Dr. Richard Harding of the Thyroid Nodule Treatment Center recently said, "I have treated 15 symptomatic thyroid nodule patients. And it is the safest intervention I perform for my patients on a weekly basis. We are seeing early and significant symptomatic relief in all patients. And they are very excited and satisfied to feel like themselves again without requiring an invasive surgical procedure." We are hearing very similar feedback across our expanding group of new users.

We are encouraged to see a positive trend in insurance claims being processed and paid, which supports the clinical value of these procedures. There is a compelling economic reality to be presented for the minimally invasive organ-sparing Vybrance procedure versus the more expensive and invasive thyroidectomy that typically requires hormone replacement therapy and continual lifelong medical monitoring. We believe this economic argument will be a growing consideration for payers as we expand market access for patients and providers.

We are early in our launch and focused on quality therapy development and are proud to recognize initial revenues this quarter as we initiated our limited market release during the third quarter. We have launched new accounts outside of our pilot program and completed initial commercial procedures during Q3, and expect to see procedures grow in Q4.

As we progress through the rest of the year, we will maintain consistent commercial headcount in Q4, as we concentrate on expanding accounts in the existing large metropolitan geographies covered by our current commercial team. Once these initial accounts achieve the desired utilization levels, we will expand headcount and launch into new geographies.

As the pilot program continues to progress, we simultaneously initiated the PRECISE-BTN study with the first successful procedures of the study completed in multiple sites during the quarter. This prospective single-arm multicenter clinical study aims to generate robust clinical evidence to demonstrate the safety and effectiveness of this less invasive thyroid-preserving procedure.

Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients at up to 4 sites. Study endpoints evaluated during the follow-up time points will include safety, symptoms reduction, improvements in quality of life, targeted nodule volume reduction and cosmesis over various follow-up periods. The study is progressing according to plan with more than 40% enrollment to date, with multiple sites up and running. We expect to complete enrollment in Q1, and we will report on results at our next quarterly update.

Positive data from our pilot program showcasing the safety, effectiveness and workflow efficiency of the nPulse Vybrance percutaneous electrode system was recently presented by Dr. Ralph Tufano at the prestigious American Thyroid Association Annual Meeting in September. And we look forward to sharing continued updates as patient follow-ups progress along and long-term follow-up data are published in the future.

Long-term follow-up evaluations of patients in our recently published Italian feasibility study are underway to further demonstrate the durability of Vybrance thyroid treatments. Additional data and publications will play an important role in driving adoption and utilization of this novel procedure as our commercial efforts scale.

Let's now discuss our surgical ablation clamp. We are pleased to announce that the FDA has granted approval of our IDE pivotal study, allowing us to proceed with the initiation of the nPulse surgical ablation clamp study, NANOCLAMP AF, for the treatment of atrial fibrillation. This is the first PFA study approved by FDA for a surgical cardiac ablation device in concomitant surgical procedures. The first patient has successfully been enrolled and treated in the IDE study, marking an important step in clinically validating the nPulse cardiac surgical system. Based on active discussions and preparations, we intend to expand into additional sites by the end of the year, as well as into Q1. This prospective single-arm multicenter study is designed to assess the primary effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. Up to 136 patients will be enrolled across approximately 20 sites, including 2 international locations.

The nPulse cardiac clamp is engineered to deliver precise, continuous, and transmural linear lesions during concomitant cardiac surgeries. Due to its nonthermal mechanism, nsPFA significantly reduces the risk of unintentional damage to surrounding tissues. This bipolar system utilizes Pulse Biosciences' proprietary nanosecond pulse field ablation, nsPFA energy to achieve full thickness, contiguous durable lesions with reduced ablation times compared to traditional thermal ablation methods like radio frequency.

The nPulse cardiac surgical system was granted FDA breakthrough device designation in July 2024, and is currently part of the FDA's total Product Lifecycle Advisory or TAP program. The company's feasibility study continues to enroll patients in the EU and aims to evaluate the initial safety and effectiveness of the nPulse cardiac surgical system for the treatment of atrial fibrillation. To date, 44 patients have been treated by investigators in Europe, including Dr. Bart Van Put at San Antonio Hospital in New Egan, Dr. Bart Mason at Maastricht Medical Center and Dr. Antoine Dresen at Amsterdam Medical Center. Within this initial cohort, 27 patients have undergone electro-anatomical mapping approximately 3 months after their ablation procedures to assess the effectiveness and durability of the treatment. Initial data are incredibly promising with individual ablation times as low as 50 seconds total per patient.

Late-breaking clinical results from the feasibility study were recently presented at the renowned Annual European Association for Cardiothoracic Surgery Meeting, or EAC, held October 8 to 11 in Copenhagen, Denmark. As the first clinical use of an nsPFA cardiac surgical technology, the study demonstrated that the nPulse cardiac surgical clamp enables a fast, safe and efficient workflow, highlighting its potential to significantly broaden the adoption of surgical ablation in the treatment of atrial fibrillation. We are excited to advance the IDE study while we continue to generate and publish positive patient outcomes with our feasibility study in Europe.

Now moving on to our nPulse 360 Catheter for AF ablation. The nPulse 360 Catheter is designed to deliver a complete circumferential lesion in a single brief energy application, eliminating the need to stop, rotate and reposition the catheter. We believe the system offers key advantages, including lower cumulative energy delivery, potentially reduced neuromuscular stimulation as well as the valuable ability to create deeper, more uniform lesions. The nPulse 360 Catheter system's flexible design also enhances maneuverability within the left atrium, making it intuitive and user-friendly for physicians. Encouraging initial clinical outcomes from Europe confirm our belief that the benefits of Nanosecond PFA delivered by the 360 catheter will significantly advance the treatment of AF for patients worldwide. Regarding current status with our IDE submission with this device, we are making positive progress. We are engaged with the FDA on our proposed IDE study protocol and expect to resolve several remaining open items over the next couple of months and we will be in a position to commence the study in Q1.

In Europe, our ongoing feasibility study with the 360 catheter has now enrolled 150 patients by leading investigators and follow-up on early results continue to be collected. Importantly, in what we believe will be a significant development for the AF clinical community and positive catalyst for Pulse. We are anticipating sharing new safety and efficacy data, including 1-year follow-up data from the initial cohort of patients at an upcoming scientific meeting in Q1.

The EP ablation market presents a significant opportunity where a strategic partnership could accelerate Pulse's growth and quickly achieve significant market penetration. We continue to explore potential collaborations with established leaders in electrophysiology. And we'll share updates on any partnership progress as and when appropriate.

With that, I will turn the call over to Jon to speak about our third quarter financial updates. Jon?

Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use and revenue. I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.

In the third quarter, we generated our initial revenues comprised of both nPulse capital and Vybrance disposable sales as we initiated our limited market release. Total revenue was $86,000.

Total GAAP costs and expenses increased by $6.8 million to $20.5 million compared to $13.7 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in expenses related to the expanding organization to support advancement of our nsPFA device clinical trials and commercialization, along with noncash stock-based compensation, which was $5.6 million in the third quarter of 2025 compared to $3 million in the prior year period. Noncash stock-based compensation was 38% of the year-over-year increase in costs and expenses.

To remind everyone, non-GAAP costs and expenses exclude stock-based compensation as well as depreciation and amortization. Total non-GAAP costs and expenses in the third quarter of 2025 increased by $4.2 million to $14.6 million compared to $10.4 million in the prior year period.

GAAP net loss in the third quarter of 2025 was $19.4 million compared to $12.7 million in the prior year period. Non-GAAP net loss in the third quarter of 2025 was $13.5 million compared to $9.4 million in the prior year period.

As of September 30, 2025, cash and cash equivalents totaled $95.2 million compared to $79 million as of September 30, 2024, and representing a decrease of $11.1 million versus Q2 of 2025. Cash used in operating activities during the third quarter of 2025 was $13 million compared to $9 million used in the prior year period and $12.8 million in Q2 of 2025. Cash used this quarter was a result of continued expense management and deliberate resource expansion.

Looking ahead, we expect disposables and in full system sales will grow along with overall procedure acceptance. At this time, a large portion of procedures are being completed under our pilot program or as part of the PRECISE study, which are not included in revenue totals. Our principal focus is to build a viable organization for the long term, supporting commercialization activity focused on key accounts in a few chosen geographies as we execute our strategy to train consistent technique, confirm significant market access as well as high-volume potential, generate consistent positive outcomes and ultimately, drive account utilization prior to expanding headcount within our sales force.

On the expense front, as previously stated, we expect quarterly cash use to increase as we've commenced enrollment in our cardiac surgery pivotal trial and expect to commence our EP study in the next couple of months. These essential pre-commercial investments are directly aligned with our 2025 priorities and will support development and commercial adoption of our nPulse technology. This is a very exciting and focused time for Pulse Biosciences, as we drive adoption of our transformational technology in soft tissue ablation and advance development of our cardiac devices for patients in need all around the world.

Now joining us for the question-and-answer session is Bob Duggan, Co-Chairman of the Board.

Operator, please open the line for questions.

[Operator Instructions] Our first question comes from the line of Suraj Kalia with Oppenheimer & Co.

Paul, Jon, Bob can you hear me all right?

Yes, Suraj.

Perfect. Gentlemen, congrats on all the progress. Paul, really three questions on the clinical trials, if I may. NANOCLAMP, congrats on the first enrollment. Paul, how should we think about the pre-op lesion work set done? Is it like one size fits all? Is that the approach? And also, if I read the trial design on clinicaltrials.gov, it isn't obvious to me that left atrial appendage closure is also part of the trial, but measuring stroke is. So maybe if you could give us some clarification there.

Right. Good question. So the lesion set does vary as a function of the severity of the Afib burden. And so the veins can be isolated, a full box maze can be performed. The surgeon really does have discretion in determining that lesion set. On left atrial appendage occlusion, you're right.

Now we don't expect a large number of neurological events in this study. Left atrial appendage occlusion is occurring. And you see that now somewhat, I'll call it, a dual concomitant procedure, right, concomitant surgery and sometimes LAA exclusion. That's obviously not part of this protocol nor would it be expected to have essentially 2 therapies in 1. So we are only performing the ablation procedure. And we will adjudicate strokes per norm, and that's very typical, right, within the established precedent of concomitant surgical protocols.

Paul, in NS 360, the pivotal trial that is expected to begin in Q1. Is the thought process Pulse is going to fund this unilaterally? Or you still have expectations of bringing a strategic partner on?

Well, those are not mutually exclusive, first of all. So yes, our base case is that we are funding. Our budget is that we are funding. We are the sponsor of the study. And the outcome is measuring the effectiveness of the 360 catheter in treating AF. So it is our study, number one.

Number two, we remain committed over time to a partnership strategy. And that, of course, will manifest at commercialization and could become active before, including during the study. A study support a partner, let's say, a mapping partner would provide mapping support in the procedure as would normally happen in any current ablation procedure. But that would not be, let's say, core support of, let's say, the strategy. The strategy for us is still we drive the study. We get approval for our device and then our device would be supported by the mapping technology. So we would not necessarily expect funding of the study. Now we may or may not negotiate a fee structure in a partnership. That's all speculative and to be determined. But funding specifically for the study would be expected to come off of the Pulse income statement.

Paul, finally on my side, PRECISE-BTN, can you share some additional details on what the performance criteria? What is -- how should we compare it after the results are posted? Gentlemen, congrats on all the progress.

Thank you very much, Suraj. I think we have to back up and look at thyroid intervention and think about what we're introducing here as a really a novel therapy. And today, of course, a patient can have his or her thyroid removed. That becomes an effective treatment in the sense that it eliminates, let's say, the compressive symptoms for that patient. But at the same time, it also eliminates thyroid production. So measuring, let's say, the elimination of compressive symptoms is one measure for the study, but cannot be the sole measure because if that were the case, it wouldn't take into account the loss of the gland.

The second would be -- and this is more typical of, let's say, RF ablation -- a pure volume reduction. What was the size of the thyroid nodule and what percent of that size was eliminated through a volume rate reduction measurement. That also, in our view, is an insufficient measurement, although it's part of a base case, if you will, for intervention. It's insufficient because size alone may or may not eliminate symptoms. And so -- and I say that because if you ablate with RF, you can have a reduction in the raw size of the nodule. But you could introduce a fibrotic ball there, which itself would introduce symptoms. So what we're looking at are patient outcomes in terms of the quality of life against an established thyroid patient scale.

We're looking at volume reduction, total symptoms burden and really trying to establish, I'll call it, a composite endpoint for how these patients do so relatively well. As an example, it's our observation that patients treated with nsPFA have the bulk of their lesion reduced much faster than what we observed with RF. So speed of the elimination of symptoms burden would be a new measure. And as we said earlier, this whole notion of raw elimination of compressive symptoms in and of itself is no longer adequate because gland removal does that. But it also leaves the patient burdened without hormone production and all of the downstream consequences of that. So that's how we're thinking about this study to really establish a landmark of new data on that composite approach to treat these patients.

There's no further questions at this time. I will now turn the call back over to Paul LaViolette for closing remarks. Paul?

Thank you, operator. Well, on behalf of the entire team at Pulse Biosciences, thank you for joining. We look forward to having a very productive fourth quarter and to providing you with future updates on our progress. Thank you very much.

That concludes today's call. You may now disconnect.