Onward Medical Aktie

Good day, and thank you for standing by. Welcome to the Onward Medical First Half 2026 Results webcast. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sebastien Cros, Head of Communications. Please go ahead.

Thank you, Mel. Good morning, good afternoon, everyone, and welcome to Onward's webcast following our results for the first half of 2026. Before we get started, please take a moment to read the usual disclaimer.

This deck includes forward-looking statements, which should be considered with the appropriate level of caution as outlined on this page. The deck and a recording of the webcast will be available on our investor platform after the call. Today for the call, I'm joined with 4 members of Onward's leadership team, Dave, our CEO; Ali, CFO; Shari, our Chief Clinical, Regulatory and Quality Officer; and Sean, our Chief Commercial Officer.

We'll start by covering the results and key highlights from the first half of the year before opening the floor for questions. You may submit your questions via the Q&A module on the platform. With that, I hand over to Dave.

Thank you, Seb. I have an easy job today because I've got my leadership team carrying most of the weight. Thank you, everyone, for joining.

Let me start with the highlights very strong quarter again. 159 ARC-EX systems were sold or supplied via paid evaluation in the first half of 2026. That's more than a 5x increase year-over-year. ARC-EX systems were available in over 130 U.S. clinics and 150 clinics worldwide in the first half. We also achieved implant in the ARC-IM pivotal trial called EMPOWER-BP to address blood pressure instability after spinal cord injury. 22 participants are enrolled in the study and 14 clinical sites are now active to date. So that's all the sites in the U.S. and Canada and Europe is next.

We initiated the EIGER feasibility study for ARC-IM mobility. This is an important study. It's a precursor to an eventual pivotal study for this indication. We successfully implanted an additional patient in the Parkinson's disease blood pressure trial, something called [indiscernible], and we announced 2 additional ARC-BCI implants, extending our global leadership in this realm. We reported EUR 4.2 million in revenue. That's a 250% year-over-year increase, and we ended the first half with a cash balance of EUR 81.5 million.

We raised over EUR 40 million in new equity capital, including a EUR 25 million investment from EQT Life Sciences, and we replaced our existing loan with an up to EUR 50 million debt facility from BlackRock.

With that, I'd like to turn it over to Sean. our Chief Commercial Officer. Take away, Sean.

Yes, absolutely. Thanks, Dave. That's a great intro to follow. And I'm excited to be here today to talk to everyone about ARC-EX, a product that is really starting to transform what is possible in rehabilitation for people living with spinal cord injury. Q2 saw continued strong execution and uptake of the product. So it continues the momentum that started with our commercial launch last year and has continued each quarter since. As Dave mentioned, in the first half of 2026, we had 159 systems either sold or sold as part of a paid evaluation in the U.S. Veteran Affairs Health care system and 89 of those sales happened in the second quarter. So we delivered nearly as many ARC-EX units in the second quarter of this year as we did in all of 2025.

And I think that fact speaks to 2 things really. The first is the value of the system that health care providers and people living with spinal cord injury see in the technology. And second, it also speaks to Onward's ability to aggressively ramp the commercial capabilities required to execute and scale. And that's across all the functional areas, whether it's sales and marketing and customer service or operations and finance and quality. So in parallel with this product launch, we're also building a sustainable commercial engine. for the company moving forward. At the end of Q2, as Dave mentioned, ARC-EX is present in over 150 clinics around the globe. Over 130 of those are in the United States.

So after 6 quarters of selling in the U.S., we estimate our footprint to be 35% to 40% of the facilities that manage people living with spinal cord injury. This is tremendous progress, I think, for a brand-new therapy in such a short period of time. Our commercial efforts in the VA have really started to accelerate. We started our selling into the VA in earnest with the availability of the home use version of ARC-EX earlier this year. And in 2 focused quarters of selling in the VA, we're now in half of the hub facilities that focus on spinal cord injury therapy and treatments for veterans. We're also pleased to see that the VA National Program Office issued guidelines in July for transcutaneous spinal cord stimulation. These guidelines are a positive sign of adoption for the new therapy.

And while they're not a requirement, their guidelines not a requirement for the facilities, enough VA clinics were starting to use the device that the VA clearly saw the need to issue some guidance. And overall, that guidance is fairly favorable for transcutaneous spinal cord stimulation. So we see that as a nice vote of confidence for a young therapy in the VA. In Europe, we had our first sales into Europe at the end of 2025. And since then through the first half of 2026, we've seen sales into 7 different countries and a growing clinic footprint that we are achieving and supporting through a combination of direct sales and distribution partners.

So while we're still really early in the commercialization of this therapy, the base of real-world use is starting to become quite large and growing quickly every day. And we're really excited about what we're seeing in that real-world usage. So at this point, there have been tens of thousands of ARC-EX sessions performed across more than 100 centers in multiple countries with hundreds of different operators and therapists and that we're starting to see that the results can be replicated across all those different environments. The treatment is also starting to move towards the mainstream, especially in the United States, where it's been on the market a little bit longer.

And what we're starting to see in that real-world use also gives us confidence in how the product performs, but also gives us confidence that the results that we're seeing in clinical trials can also be seen in real-world use. So ARC-EX, it's not unfair to say that the ARC-EX is truly having a profound impact on spinal cord injury rehabilitation. We expect that to continue to grow as the time in the market grows and as more people have the opportunity to experience it. And to underscore that, I thought we could share a short video here today from one of the key rehabilitation centers in the United States. So in this video, you'll hear from Dr. David Putrino. Dr. Putrino is the Director of Rehabilitation Innovation for the Mount Sinai Healthcare System in New York. So Seb, if we could play that video and hear from Dr. Putrino.

[Presentation]

With that, maybe, Shari, let's cover ARC-IM.

Okay. Excellent. Thanks. So today, I'm excited to share an update on the progress that we've made on advancing our clinical work on the ARC-IM platform. And I'll start with giving you some insights on our progress on the EMPOWER-BP global pivotal study. And this is a study that's designed to address blood pressure and stability after spinal cord injury, and there's a significant unmet clinical need for this therapy because over 90% of people with spinal cord injury who are treated with conventional therapies continue to experience symptoms. And we announced earlier this year that we successfully implanted the first participant in EMPOWER-BP.

Now there are over 22 participants enrolled in this study. and 14 additional -- or 14 additional clinical sites have been activated, and we expect additional sites in Europe to be activated in the next couple of months. And some sites in the study have already enrolled multiple participants. And some of the things that we're hearing from our sites and participants in the study is that ARC-IM provides hope for people who've been told that blood pressure instability is of an expected consequence of their injury. And many of the participants in the study say that they want to be in this study because of the impact that blood pressure and stability has on their daily lives.

And what that looks like is that they must sit in a reclined position when moving in their wheelchair. They may pass out just transferring from their bed to their chair in the morning. and others who can't sit upright through an entire meal with their family and friends. And these are just a few of the examples of why it's so important to us to find a treatment for this unmet clinical need. And with that strong momentum that's building in EMPOWER BP, we expect that by the end of this year, we'll enroll the sample size that's needed for our interim analysis that will be conducted early next year.

We're also on track for regulatory approval by the end of 2028 with a commercial launch planned early 2029. And we're also continuing to advance our pipeline. We completed the first successful implant in the EIGER feasibility clinical study, and that study is designed to demonstrate the ability for the ARC-IM to restore mobility in both subacute and chronic spinal cord injury population. And this is a major step towards a pivotal study for this indication. And this study will enroll up to 12 participants, and we're advancing this study with grant funding that's being conducted at prominent institutions in Switzerland. And we've also successfully implanted an additional patient in Parkinson's disease for blood pressure and 2 additional patients in the ARC-BCI implant study for mobility.

And this clinical progress demonstrates our ability to continue to expand indications for use for ARC-IM and advance all 3 ARC platforms towards solutions for these unmet clinical needs. So with that, I'll turn it back over to Dave.

Thank you, Shari. We also strengthened the balance sheet in the first half, successfully raising over EUR 40 million in new equity capital to fuel our growth. The financing included EUR 25 million from EQT Life Sciences. There was strong demand from existing and new high-quality long-only and sector specialist investors, and our cash runway now extends into Q1 2028. We also replaced our existing loan with an up to EUR 50 million debt facility from BlackRock. So BlackRock has replaced Runway Growth Capital as the company's lender. EUR 20 million was drawn at closing, and we have access to additional tranches as we grow RTX revenue and we advance toward commercialization of our investigational ARC IM system. So additional tranches are tied to business milestones. And I just want to be clear that our existing loan facility with runway growth has been fully repaid and retired using the EUR 20 million tranche that we drew from BlackRock at closing. So only the BlackRock facility remains. All right. So now I'd like to turn it over to Ali to review our first half financial results in more detail.

Thank you, Dave.

Half year revenues for 2026 was EUR 4.2 million, EUR 3.4 million of that was product revenues. Gross profit for the first half of the year was EUR 2.9 million or roughly 70%. You will recall this is due to the mix between first half of this year versus first half of last year. First half of last year, we were only selling professional units. First half of this year, we are selling both professional and the home units. Total operating expenses is EUR 26.3 million, which is up from EUR 21 million last year.

This is the continued investment we have in both our marketing and market access as well as clinical and regulatory expenses over the course of this year as we commercialize RTX and as we continue to execute on Empower BP implants and the sign-up of the sites. Overall, our operating losses for the first half is EUR 23.3 million, which is in line with our expectations. Net loss for the period is EUR 24.7 million. Our cash position at the end of June 2026 is EUR 81.5 million. That is up from EUR 68.1 million at the start of the year. As Dave has mentioned, this is because we raised EUR 40.6 million in April.

If we go to the next page, -- you will see that our cash burn for the first half was EUR 26 million as we've executed on our plan. We have EUR 81.5 million in cash as of the end of June 2026, which allows us to continue to execute on our priorities as a company. I'll turn this over back to Dave to take us through 2026.

Thank you, Ali. So we're going to keep pushing here, and our priorities are scaling the commercialization of ARC-EX and continuing to execute well on the conduct of the Empower BP pivotal study. But as usual, we expect continued and compelling news flow. And so this slide shows you the completed and upcoming milestones. Some of the things that we expect you can look forward to our first-in-human use of the ARC-IM system to address urinary incontinence. This is underactive bladder, which occurs after spinal cord injury. Also a very important moment that would be the top line interim readout from the Empower-BP pivotal study. As Shari mentioned, we expect that next spring. And we expect to make continued progress in the realm of brain computer interface, both addressing movement deficits after spinal cord injury and stroke.

Stroke is something that we're going to continue to explore. It's a large adjacent population, and we can leverage the R&D investments that we've already made. So with that, thank you for your attention.

And let's go to the questions in queue, starting with Ed Hall, please.

[Operator instructions]

And our first question comes from the line of Ed Hall from Stifel.

I have a couple. Just the first one would be on the VA. I think you mentioned you're in 50% of the hubs and it looks like you're penetrating quite nicely. I wonder if you could talk about the Spoke penetration as well, if this is as relevant as the penetration into the hubs and sort of your expectations for the rest of the year for the VA. That would be my first question. And then secondly, just on the potential for subacute patients. I'd be curious to sort of understand the rationale here. Is this to get a higher patient population overall? Or is there expectation of greater efficacy with the subacute patient population? And then just finally, just a bit of a housekeeping for me on the R&D spend in H1. I mean how much did you spend on Empower BP so far in the year?

All right. Thanks, Ed. So Sean, will you take the VA question first, the relative importance of spokes and perhaps explain why we're in certain spokes and not solely in the hubs at this point.

Yes, absolutely. Thanks, Dave, and thanks, Ed. The -- so as we mentioned there on the -- in the prepared remarks, there are 25 SCI hubs in the VA. We're in half of them. We're also in 4 of the spokes. The spoke strategy is one that's highly dependent on whether or not the spoke actually does SCI care or whether or not they refer their SCI patients to the hub as well as the relationship between the hub and the spoke with respect to where the prescribing and decision-making is done. So in a lot of regions around the country, all of that is centralized within the hub, the patients come there or the hub makes the decision and it is just administered at the spoke. So the strategy really as it relates to spokes is making sure we are clear on which ones are large enough and are doing their own spinal cord injury care and whether or not they are the decision-makers with respect to prescribing or whether or not that is done in the hub.

Now let's transition over to your question about subacute. So I think let me provide some context for your question, Ed. Give me a little leeway here because I'm going to make an assumption. So you're asking in the context of the EIGER study that we announced, the first patient enrollment. EIGER is a mobility study, clinical feasibility study for mobility using our ARC-IM system. This is actually a more important study than you may think because the company was founded to help people with spinal cord injury stand and walk again. And a lot of the early research was in this area, but it used highly repurposed pain stimulators and they just couldn't deliver the therapy that was envisioned.

And so the founders of Onward Medical said, let's build a company that can develop purpose-built technology for this mobility indication. All right. Fast forward now, we're first seeking to commercialize the blood pressure indication for ARC-IM. And now we're ready to move on to the path of commercialization for the mobility indication, starting with EIGER. EIGER is a clinical feasibility study.

The purpose of it is to identify the sort of the best patient population and to inform the design of the eventual pivotal study. So it's a precursor to the pivotal study that will, we hope, result in regulatory approval for the mobility indication for ARC-IM. Okay. Thank you for that. Now EIGER includes 12 patients. Some are chronic, so they've been injured for 1 year or more, and some are subacute. They've been injured for 6 weeks or less. So Ed's question is, why subacute? Is it because the population enlarges -- or is it because of efficacy? And certainly, the population will increase somewhat, but it's mainly because of efficacy, Ed. After a person has spinal cord injury, they lose muscle mass, they lose coordination and proprioception. And the thesis here is that if we intervene early, within 6 weeks of the injury before that muscle atrophy occurs, then in fact, the mobility therapy will be that much more effective. All right. That's about the longest answer you're ever going to get for me, but I hope it's helpful.

Now on Empower BP, I'm going to turn it over to Ali, and I don't know if we're going to give you the specific costs, but we can give you the overall cost for Empower BP and give you some sense for how far along we are. Would that be okay?

So housekeeping for you, Ed, what I would say is I think it's fair for you to assume that the majority of this increase year-over-year has been driven by Empower BP. We have also spent in terms of registrations into new geographies, but I think it's fair for you to assume that the majority of this increase you are seeing is coming from Empower BP.

And our next question comes from the line of Mathijs Geerts Danau from KBC Securities.

Congrats on the results. I had a question on the amount of patients in the clinic to home use devices. So how many patients decide to buy home use after they first encountered a clinic device -- and then also, I was wondering about the ex U.S. ex Europe expansion. Do you already have some plans to enter some markets outside of Europe? And what are major hurdles that you need to overcome to reach them?

Thank you. So I'm going to take the first part, and then Sean, I'm going to give you the second part. And so let's start that way. So we're not really breaking down the clinic versus home sales at this point. What we do know is there's a lot of demand for home use. That's been validated by some third-party research. And we are selling more units for home use than clinic units, and that's a trend that started in the first quarter, continued in the second quarter, and we expect it to continue actually for the foreseeable future. And that's really what helps this therapy to scale, and it's going to impact our top line. So with that, let me hand it over to Sean to talk about what we're doing outside the U.S. in terms of our field organization and our progress to date.

Absolutely. Thanks, Dave. So the question about expansion outside of the U.S., we are starting to grow and to do that. So I've been in the United States for about 6 quarters. The next geography that we have expanded into has been Europe. And as we recall -- as we kind of spoke to there, we started commercialization in Europe late last year and are now in 7 countries. And the -- in addition to that expansion, the first part of this year has been building commercial capabilities to allow us to continue to expand, but also to support the therapy once it's been introduced. So our sales organization there has grown.

It's a combination of direct selling resources and then distribution partners, distributors as we work across both Western and look to Eastern Europe. Beyond that, we are looking at expansion into other geographies. We've launched into one country outside of the United States and Europe and are evaluating others. To trade off the work required to enter versus the opportunity that is in there and are staging those out so that we can roll them out over time.

Part of your question was what were the challenges in doing that? The challenges in any market are twofold. A lot of these markets require us to find an appropriate distribution partner. So somebody that will work with us to commercialize a new therapy that we feel comfortable with and confident in. And then the second challenge is just the work required to do the associated regulatory filings and the operational pieces around getting a product into a new country. So the standard operational things that just come with commercializing medical technologies.

Thank you, Sean.

Next question from David.

Our next question comes from the line of David from Banque Degroof Petercam.

Okay. Perfect. Do you hear me?

Yes.

Okay. Excellent. Congrats on the update. A question on the home use conversion rate. So a bit related to an earlier one as well. So do you see meaningful differences between penetrated clinics in transitioning patients to home use? And if so, what separates these high converted clinics from the slower ones? I presume you see differences between VA clinics and more regional smaller ones, but would be interesting to hear if there's any other factors at play such as level of clinician training, patient demographics and so on?

And then maybe secondly, also more broadly in light of the early feasibility studies starting and already ongoing in adjacent indications when we can expect some more info on further program prioritization and more detailed time lines, therefore, which obviously depends on data, but would be pretty useful for modeling purposes and such.

Thank you, David. So Sean, how about you take the question about kind of the dynamics that might inform a clinic's proclivity to prescribe for home use. There's more of a general response there on what you're observing in the field.

Certainly. I would caveat the entire answer by saying it's still early in this process. So we're learning together with the clinics on how they want to establish kind of workflows for doing this type of activity. The uptake in clinic is -- I don't think you can generalize it between large or small or things of that nature. I think it comes down to something that's just more human nature and that some people are earlier adopters and lean into new things quicker and others want to see it become a little bit more established in the field first.

So certainly, we are partnering aggressively with kind of early adopters in that early majority and the pace with which we have established the footprint would certainly indicate that there are a lot of those and are building significant momentum. In the home use setting and the transition in prescribing for home use, there are very little barriers really from the clinicians in prescribing it for home use. The biggest are just ensuring that you have a patient that would benefit, a patient that could actually use it in a home use setting and a patient that has someone to help them. whether it's a family member or a caregiver or somebody that can do things as simple as just put the electrodes on. It tends -- it hasn't -- it can be a variable that needs to be considered in that. But the transition to home use is likely to continue to be much more dependent on just ability for access, either through insurance or ability to pay.

Thank you, Sean. The second question, David, was about our pipeline really, our early feasibility studies.

And indeed, we have them ongoing in Parkinson's disease, stroke. We're looking at new indications such as urinary incontinence, for example. And I think it's important to note that the company is largely deploying its capital on new and existing and near-term indications, so driving revenue uptake for RTX and then getting ARC-IM through the Empower-BP study. And we're advancing these pipeline indications with -- largely with the benefit of grant funding. And a lot of this work is being driven by our science and research partners in Switzerland and around the world.

So the pace of this is, for the most part, dictated by the pace at which these studies can be enrolled. So we don't, at this time, have what I would say, solid dates for you for these indications. And you've got a conservative management team here. So I think what we would prefer to do is let these early feasibility studies run their course, make sure that they are -- the indications indeed show the promise that we expect and then we can run the proper pivotal studies at scale and get these things approved the right way.

So we're excited about them certainly, and we're glad that we have them. But I think we're not at this time prepared to communicate time lines.

Thank you. A few questions came in via the web platform. Maybe we can take those.

All right. Sure. So first question is, what percentage of the units that are "supplied to VA patients were actually purchased. So just a little bit of nuance here is that the way the VA purchases devices like ours for home use is that first, they're prescribed for a 3-month paid evaluation. So the VA pays for use of the device during those 3 months.

At the completion of that period, -- the device is then purchased and the -- what was paid during the evaluation is netted out of the purchase price. So that's how the economics work. What we're observing thus far is that 90% plus of those patients who are -- who have the paid evaluation are converting to actual purchases. So very high rate of conversion there.

Okay. Next question. Revenue for RTX appears to have increased significantly in Q2. what are expectations for RTX sales in the second half. So we don't issue guidance here because the commercialization is still fairly early. For the most part, we ramped up home use starting at the beginning of this year, same with Europe, and we're still learning as a company. It's a brand-new market, brand-new technology. We're pioneering this and again, conservative management team. So I would not assume that the growth rate is going to continue at this pace, but we don't know. And we also expect that there'll be some seasonality because this is capital equipment, normally in capital equipment, things are fairly flat mid-year and then you see an increase in the fourth quarter. So those are general trends that are observed in capital equipment, but we're not issuing guidance, and I don't want to set expectations. I just know that we're going to continue pushing very hard to expand this therapy globally.

Okay. Next, when do we expect the first decision on codes from U.S. insurance to cover costs for RTX? Maybe, Sean, just if you could give an overview of the reimbursement milieu for RTX in the U.S.

Absolutely. So veterans in the U.S. Veterans Administration Health care system can have access to it in the home use today without waiting for broader insurance decisions. And then outside of that, we have completed our submission to the group within CMS that assigns coding to devices, and we expect to hear back from them in Q4. That would be the first big step forward to engaging payers.

In parallel, in the interim, we have established a program that we run and partner with clinics to help them -- to help their patients engage their insurance companies to start to get some level of reimbursement on a case-by-case basis. So this wouldn't be a -- this isn't a service that will lead to broad coverage, but this is a service that we will provide to clinics and patients to help them engage insurance providers on a case-by-case basis, and that was just launched in July.

Yes. Excellent. Thank you, Sean. Again, just to reiterate that, we can sell to the VA now. We can sell for self-pay. We're establishing this capability to assist patients who want to buy the device themselves to get reimbursement through their insurers on a case-by-case basis. So taking a lot of action here to expand access to this important breakthrough technology.

I can see we have a follow-up question from Ed Hall from Stifel. Mel, could you open please?

Ed Hall from Stifel.

Just a follow-up on -- I think you talked about sort of the -- your capital spend on near-term RTX and Empower BP. But I was just curious about sort of the amount of committed capital you would need for indication expansion in and around RTX. I think we've seen from some evidence that there is off-label interest in this device -- so how would this evolve in the midterm? Is this something that clinics would commit to do investigator-led studies?

Or is this something you would have to do sort of what are the steps that you would need to take to get ARC EX sort of penetrating other aspects of the spine?

Yes. Thanks, Ed. And the survey work you did indicate that there is some off-label use. Obviously, we can't promote it, but there's a great deal of interest in using this breakthrough technology to address a lot of recovery targets. Thus far, we have a number of investigation -- sorry, investigator-initiated research projects that we're in part supporting. And we're going to have to just wait and see where the evidence leads and also have discussions with FDA on what quantum of evidence is required to get regulatory approval for these new indications. This is a Class II device, which makes it a bit easier. It's also a breakthrough device, which allows us to have frequent conversations with VA.

So in some cases, it may be that the investigator-initiated research data is enough. In other cases, we may have to bring together 2 or 3 sites to aggregate and offer multisite data. I think it's TBD. But big picture, it should be a relatively efficient and low-cost pathway, certainly nothing like EmpowerBP with a Class III PMA device like you're seeing with ARC-IM.

Additional questions came in via the platform.

Okay. So the question is just how quickly are we enrolling for EmpowerBP. Shari, do you want to just comment on our goals and what we need to get to the spring interim readout?

Sure, Dave. I can take that. So our goal is to get to the enrollment number that we need to do the interim analysis. We will hit that number by the end of this year. And then we expect to do the interim analysis early next year by the end of Q1, early Q2.

Thank you, Shari. Also a question here on, are we still considering a NASDAQ listing? Good question. We did announce in the past several months that we had filed an F1 an S-1 equivalent. with the SEC. And so I would describe us as poised and ready, but the market conditions right now are not conducive to a listing. One of the important considerations is how large-cap med tech is doing. Many of the large-cap med tech companies are in a bit of a rocky period, and that affects investor appetite in the U.S. for new listings. So we're going to -- as we said when we announced the filing, we want to be poised, but we also want to add the NASDAQ listing when market conditions are supportive and positive and buoyant so that we can have a really well-supported listing and the stock will trade well in the aftermarket. Thank you very much. Another question is, when will ONWARD achieve cash flow breakeven? So I'm going to turn that over to Ali.

Thanks, Dave.

So as you know, it's early days. We've just started to commercialize our first product last year into this year. We've not guided as to when we will get there. It is going to essentially be a function of the growth of the company and the future indications and the investments that we are making, but we have not guided to when our company goes breakeven.

Yes. And let me just reassure everybody, we are in investment mode here. We're commercializing our first technology. We're spending money on the pivotal study for our second technology, but we also realize it's important to be disciplined in our use and allocation of capital. So -- as I said earlier in the call, we are deploying the vast majority of our capital toward those 2 pursuits and associated activities. And we're advancing our pipeline with the benefit of grant funding. So we want to be cash flow positive as soon as everyone else, we get diluted to when additional equity capital is needed.

But we need to grow our way into that, and we need to grow the top line so we can start to generate cash from operations, and that is absolutely our intent. Kind of a related question is whether -- if and when capital is needed, do we intend to issue more shares or tap the BlackRock facility.

Again, we're in a great place right now with our cash position at over EUR 81.5 million at the end of the first half. So we have cash into the first quarter of 2028. I would say that we're inclined to use equity capital going forward, and we're inclined to use the BlackRock facility if we need to bridge to a milestone that may help us raise equity capital at a higher valuation, it's less dilutive. But we're generally not inclined to take -- to draw more of that facility and incur interest expense and so on. So I don't want to answer that question definitively right now. I'm just going to say that we're more inclined to use equity capital than debt capital.

Okay. The next question, are we collaborating with Neuralink or similar companies to do research or to innovate? Really interesting question. So we have our own brain computer interface really safe and solid BCI has more than 8 years of human safety data, no degradation of signal. It was developed by a top and very innovative neurosurgeon in France. So it's a very simple, straightforward procedure for a neurosurgeon. It doesn't penetrate the brain or the lining of the brain.

And so the procedural risk is reduced. So we like our BCI that we have. However, we have -- in our ARC-IM spinal cord stimulator, it's also really innovative and flexible architecture. So it can communicate wirelessly with other BCI devices. So we have the option going forward to use our own BCI or to collaborate with other brain computer interfaces and the -- and those companies should it make sense to advance our therapies. And our therapies are focused on restoring movement of a person's own paralyzed lens. We are in discussions, some regular with many of the leading BCI companies around the world. A few, if any, are ready to do clinical research, so human studies like we can do today with our own BCI. So I'd say just like with the NASDAQ IPO, we're poised and ready, but we're waiting for these other companies to catch up with us. Any other questions?

No more questions.

All right. Thanks, everyone, for joining. I want to thank my team for their contributions. Enjoyed being with you today, and we appreciate everyone's support for our mission to help people with spinal cord injury enjoy better lives.

Thank you very much. Mel, back to you.

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

Good day, and thank you for standing by. Welcome to the ONWARD Medical Q1 2026 Results Webcast and Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Sebastien Cros, VP of Communications. Please go ahead.

Thank you, Sharon. Good morning, good afternoon, everyone, and welcome to ONWARD's webcast following the publication of our results for Q1 earlier today.

Before we get started, as usual, please take a moment to read our disclaimer. This presentation includes forward-looking statements, which should be considered with the appropriate level of caution as outlined on this page. This deck and a recording of the webcast will be made available after our call.

Today, I'm joined with 3 members of ONWARD's leadership team: Dave, our CEO; Sean Sciara, our Chief Commercial Officer; and Ali Kiboro, Chief Financial Officer. As always, we will present the results and key highlights from Q1 before opening the floor for questions. You may submit your questions orally or via the Q&A module of the platform.

With that, I'll hand over to Dave.

Thank you, Seb. We had another successful quarter and off to a very good start for the year. We continue to accelerate the launch of ARC-EX, achieving EUR 2 million in revenue in the first quarter. That was comprised of 70 ARC-EX systems supplied for use in clinics and homes. That means that ARC-EX systems are now available in over 100 clinics across the U.S. and Europe as of the end of the first quarter.

We also continued in our execution of the EMPOWER-BP pivotal trial for ARC-IM to address blood pressure instability. In fact, the first participant was enrolled and implanted in the first quarter. And as we sit here today, we've now activated 12 sites within that study. We also advanced our pipeline, successfully implanting one additional patient in the Parkinson's disease blood pressure trial. That's an early feasibility study.

And we initiated a new mobility feasibility study called IGR, in which we aim to enroll 12 subacute and chronic spinal cord injury patients. We also, last month, raised over EUR 40 million in new equity capital, supported by a EUR 25 million investment from EQT Life Sciences, extending our cash runway into Q1 of 2028.

So now let's talk a bit more about the commercial traction with ARC-EX. Those of you who are new to the company, this is ARC-EX pictured in the presentation. This is an external stimulator. It stimulates the spinal cord through the skin to restore strength and sensation lost after spinal cord injury.

Now I'd like to turn it over to Sean Sciara, our Chief Commercial Officer.

That's fantastic. Thank you, Dave. Well, in Q1, we crossed over 1 year of commercial availability in the United States. And you can see the run rate that we're on from a unit perspective. And in 1 year of real-world use, we've established, as you mentioned, presence in over 100 clinics -- and we've had many thousands of uses with the technology and with multiple health care providers in most of the clinics we're in, we have many hundreds of health care providers using ARC-Ex technology to care for their patients with spinal cord injury.

And in this first year, it's been exciting to see the product performing as well as it is, and it's been really exciting to see real-world use where the technology is living up to the expectations that were set in the clinical trials. At the end of this -- at the end of Q1, we estimate that we're in approximately 30% of the clinics in the United States that are caring for people with spinal cord injury. That's across your Tier 1 institutions as well as some of the smaller activity-based centers across the United States that care for patients.

And starting in Q1, we have technologies -- the ARC-EX technology available now not just in the clinic, but also in the home. One of our bigger focuses on the year is the United States Veteran Affairs Administration. And in the VA, we've exited Q1 in roughly 1/2 of the hubs that take care of spinal cord injury patients in the VA and have a number of them now actively prescribing for home use.

In Europe, our commercial journey is just beginning as the CE Mark came late in the year last year, but we've now launched clinics in over 5 countries across Europe. And our strategy, as can be seen on the slide, is a combination of both direct and indirect sales. This puts us in a position, I believe, to partner tightly with clinicians in the commercialization of this new therapy in Europe, leveraging a lot of the experiences that we've built in the United States.

In the United States, these relationships, like in the United States, these relationships in Europe will be important for commercial efforts, not just for ARC-EX, but they laid the foundation for ARC-IM and ARC-BCI to follow.

In Q1, in Europe, we hired and onboarded direct hires for our key markets. We've identified distribution partners for key markets and in early April, held a distributor workshop to begin the process of onboarding key distribution partners. So we're very excited about the speed of progress that we've had across the first quarter.

And back to you, Dave.

Thank you, Sean. Also wanted to update those of you on the call on our progress with Empower BP. Again, this is the global pivotal study to gather the evidence required to submit for regulatory approval for ARC-IM blood pressure instability indication.

We announced our first enrollment and first implant in the study in Q1. That was a Craig Hospital in Denver, Colorado, U.S.A. And as of this call, we have activated 12 U.S. sites in the study and more to come. We also initiated the IGR feasibility study, and this is for mobility. Many of you have asked, "Hey, when is the company going to get back to mobility, what's going to come after blood pressure instability."

We've done a lot of early feasibility work in mobility dating back to when the company was founded in 2015. Some of that work was done with highly modified pain stimulators, just as proof of concept. Here, we're going to use the purpose-built ARC-IM neurostimulator, and we're doing this study specifically to identify the most viable patient population and to inform the design of an eventual pivotal study that will occur globally. So again, it's called IGR. We're enrolling 12 patients, 6 of them with chronic SCI and 6 with subacute SCI.

So those that have been injured less than 6 weeks, the notion is that if we can implant these folks and help them with mobility before their muscles have atrophied a lot following their injury that they might have a better prognosis. This study is being done in collaboration with CHUV, the local hospital in Lausanne, with NeuroRestore, of course, and with the paraplegic center up in Zurich called Nottwil, which is a leading center globally.

And then lastly, we -- the big news. We had a very successful equity financing last month, raising EUR 40 million, supported by a EUR 25 million investment from EQT Life Sciences and a number of other very high-quality investors. There were 30 investors who participated, many of them high-quality, long-only sector specialists. In fact, our top 2 investors are now EQT and Ottobock. So that underscores the quality of our cap table and really validates the company and our future prospects.

Our cash runway now extends into Q1 2028. So very strong. I think that's as much runway as we've ever had here, at least since I've joined in 2020, and it allows us to very much focus on now executing the business, not having so many investor meetings. So that's one of our operating philosophies is making sure that we raise money before we get too tight keep a very high-quality cap table and focus on running the business.

Now I'd like to turn it over to Ali to tell us more about the results.

Thanks, Dave. Next slide. Revenue for the quarter was EUR 2 million, of which EUR 1.3 million of that was product revenue sales. As you've heard from Dave, we strengthened our balance sheet right after the end of the quarter. So at the end of Q1, our cash available was EUR 53.4 million. Post the raise of capital in early April, our cash balance at the end of April was EUR 89.8 million, which allows us to execute on our near-term plan and have runway through the first quarter of 2028.

Back to you, Dave, for the milestones.

Thank you, Ali. Next slide. So as usual, we expect a lot of news flow here. We've completed a lot of major milestones, but many await. So with ARC-EX, we still expect to announce first commercial home use sale in Europe and the first commercial clinic sale in rest of world. With ARC-IM, we expect to announce additional implants in mobility, particularly around the IGR trial that I just described, also first-in-human use of ARC-IM to address bladder challenges following spinal cord injury.

And then next spring, we expect to announce the interim analysis, the top line results from the Empower BP pivotal study. Again, that's for blood pressure. And we're continuing to support implants with our brain computer interface enabled system called ARC-BCI, both for upper limb, and we also have a grant-funded study using ARC-BCI in stroke. So a lot going on as usual.

And thank you for those of you who support the company, and let's roll into the Q&A Seb and Sharon.

Into the Q&A. Maybe, Sharon, you want to remind people how to submit questions first?

[Operator Instructions].

Yes, Sharon, I think before we take any questions, we did get some questions that were submitted in writing from Ed Hall, the analyst at Stifel. First question was the split of units placed U.S. versus Europe and clinic versus home.

So as you would expect, the great majority of units were supplied in the U.S. We did penetrate 5 different European countries thus far. And so we're building out a nice foundation of clinics using the device in Europe, taking advantage of the direct and indirect field organization that we're currently putting in place.

We're not going to share the exact numbers around U.S. versus OUS or clinic versus home. But I will tell you that for the first time, as you might expect, we sold more personal or home units than clinic units, and that's certainly a trend we would expect to continue going forward.

Another question from Ed while we wait is just to describe the current VA clinic penetration. So Sean, could you take that one? How are we doing with the VA currently?

Sure, Dave. The progress in the VA has been really fantastic. The VA is a notoriously challenging institution with a lot of highly regional and kind of localized policies instead of kind of one set of governance that governs the entire country. There are 25 hubs. So the VA for spinal cord care works on a hub-and-spoke model. There are 25 hubs. We're in approximately half of those with many of those that we're now in, in the clinic beginning the process of prescriptions for home use. So off to a really good start, and our target goal is to be in all of the VA hubs by the end of the year.

Okay. Thank you, Sean. And we do now, Sharon, have some calls in the queue from our equity research analysts. And we start with Clément from BNP Paribas.

Of course.

Did you hear me?

Yes, go ahead, Clément.

Okay. So just a few questions. The first one about the top line. So you get EUR 2 million, that's only EUR 1.3 million from the sales of ARC-EX. Just wondering where it come from the EUR 0.7 million, maybe that and for which programs.

Also, you displayed the delivery in Q1, but not the units sold. So I guess this is probably less than 70 units.

And last question, could you please provide the order you received in Q1, not the sales, but just the order?

Yes. Thank you, Clément. So first, I wouldn't say it's only EUR 1.3 million. It's quite a few units. We continue to see accelerating demand. And -- but I think one of the things you're probably getting to is about 1/3 of the units were VA units. And those undergo a bit of a different process. So those veterans, military veterans first have a 2-month evaluation period, after which we expect a very high percentage to convert into sales.

We think that process, even though it's a 2-month evaluation, is probably going to take 3 months just in terms of the information gathering and generation of the IPO. So we have a lot of demand that we enjoyed in Q1, some of it in sales, the EUR 1.3 million. A lot of it is dry powder that you'll see result in sales next quarter, and we'll be reporting in this way going forward because of the importance of VA and the way that they are purchasing the device.

And then I'm going to turn it over to Ali to talk about the grants, the $700,000 in grants.

Yes, Clément. So the grant income that we had here in the first quarter, that's the EUR 0.7 million that you saw us report primarily from 2 grants. One is a grant around Parkinson's, which we essentially advanced that during the quarter. And the second one is a grant around stroke. And as you know, we use these to fund our development of our pipeline.

And so as we've discussed, these could be quite lumpy throughout the course of the year. But here in the first quarter, given where we were in our development, we were able to recognize about EUR 0.7 million across a variety of grants. Most of it coming from those 2 grants that I've mentioned.

And caution for those of you who build models, don't straight line that $700,000 because as Ali said, it's likely to be lumpy, and we do not expect grant income to be, what, $2.8 million to $3 million this year, significantly less than that.

Okay. Thank you, Clément. Let's move on to Mathijs from KBC.

Can you hear me?

Yes.

All right. Yes, a question on the -- also on the VA home use units. So how many do you expect to be converted to real sales next quarter? Or what I understood was that it happens normally after 2 months that there is like a sort of period where they are on a training?

And then secondly, also on the home use again, how many units did you already sell for self from the self-pay units or the workers' compensation? That would be my question.

Yes. Thank you very much. So yes, indeed, just to drill down a bit more on the VA process. So indeed, the veterans do go on a paid 2-month evaluation, but then I would build in another 30 days of buffer because the results of the evaluation need to be processed, the POs need to be generated. So we're counting on approximately 90-day sales cycle from the point at which the prescription for the veteran is written.

We also expect a very high percentage of those to convert into device purchases in the subsequent quarter, by the way. Again, we're still early in this, so I don't want to give you a precise number. We'd rather do that based on actuals once we get further into the year. But again, based on what we're hearing and the feedback we're getting from the VAs, we expect a very high percentage of those to indeed convert.

The last thing is, again, we're not going to provide during these quarterly updates granularity on numbers of units sold via the various -- in the various categories. But we will share that in the first quarter, the home or personal units, the number of units did exceed the number of units sold in the clinics, and that's a trend we expect to continue and indeed accelerate because the home use market opportunity is so much bigger.

Okay. What else do we have here? Let's go back to another of the questions that Ed Hall asked, which was to comment on future indications for ARC-EX and how we should think about that.

Indeed, we got ARC-EX approved with an indication of addressing hand strength and sensation in -- after spinal cord injury, but this is a virtual device. And we think that it can potentially help patients in a number of different ways. That is reflected. Ed, in fact, did a survey of 13 clinics that are using ARC-EX in the United States, and he did find that there was a high percentage of off-label use. This is not something that we promote or encourage, but it nonetheless is happening, and we can learn from this real-world usage of ARC-EX to help us inform the priorities for the next indications that we may pursue for regulatory approval and label expansion.

In addition to that, we have an active program where we support and encourage investigator-initiated studies using the ARC-EX device. There are a number of those studies that are ongoing or pending commencement. And those 2 will inform the most promising and the next indications that we might pursue for ARC-EX. So it's a very rich and fertile ground, and we just want to be careful and prioritize and really do what is of most need, what the patient population finds the most important. So that's all TBD at this point, but we're monitoring off-label usage, and we're monitoring the investigator-initiated studies.

Okay. We have another question here from David, our analyst from Degroof Petercam, commenting a bit more on IGR -- and okay, you're sort of saying why do IGR since we already have compelling clinical feasibility evidence from STIMO, for example, and we're also obtaining evidence through FoxSwitch. Those early trials were really proof-of-concept trials, David. They were really done. They were more scientific than commercial.

IGR is very much a commercial early feasibility study where we're trying to use our device not to see what's possible across the range of injury severities, but looking at the injury severities and the patient population that we think are most likely to be included in a pivotal study and labeling for our device when it's eventually commercialized.

So you're seeing us go from the realm of scientific exploration and discovery, which was the case in 2015 through 2020, very much to getting on to a commercial pathway that would go from this study to a pivotal study to commercialization of a mobility label for ARC-IM to follow the blood pressure and stability label. So those are the key differences, I would say.

We're not at this point going to share readout timing or anything else. We're just focused on enrolling and learning and more to come.

Follow-up from Clément.

Follow up from Clément from BNP Paribas. We sold -- did you sell more home use than clinic use? Indeed, we did sell more devices for home use than clinic use in the first quarter, and that's a trend that we would expect to continue.

We have another question from an investor named Nick. How do you interpret the share price performance over the past 6 months? Which milestones do we think might influence the share price for the remainder of the year?

Yes. Obviously, we're not happy that the share price is down over the last 6 months. But looking at the entire med tech sector, it's down across the board. In fact, med tech is trading at an historic low relative to the S&P 500. And ONWARD has held up very well relative to our peers despite the fact that our stock is down.

I think that means that is evidence of the fact that the investor community recognizes that we're executing at a high level. They see the commercial traction that we have been achieving with ARC-EX. They see the clinical traction getting the IDE approved and the early progress with Empower BP. They see the quality of the equity financings that we're executing with a cap table led by EQT, followed by Ottobock and with others like AXA and BNP Paribas. So this is the reason that our stock is holding up well.

Certainly, we want it to start appreciating, but we also think there may be some sector rotation once AI maybe is not such a bright shiny object, we'll see. We just have to be a bit patient. And thank you for your patience as well.

In terms of milestones and upcoming catalysts, I did describe -- discuss some of those earlier. We've got a big data readout, the interim data from Empower BP that will -- we expect will occur less than a year from now. We expect continued commercial traction also to drive stock price. That's the way currently med tech companies are being valued by top line and top line growth. And we also expect continued announcements in the area of brain computer interfaces, which is typically a catalyst for us and other companies.

Thank you, Nick, for that question. Any other questions?

No more questions on the call.

All right. Again, I want to just thank all of you for participating. And to summarize, we're very pleased with the quarter, another quarter of strong commercial traction, 70 units, more than 100 clinics across the U.S. and Europe now using ARC-EX.

And in the first quarter, let's not take for granted, we expanded the use of ARC-EX into the home, which is quite significant. That's a larger market segment than the clinic. And it also allows patients to be more independent, use the device in the privacy and convenience of their home. Also very pleased with the traction of Empower BP with first patient enrollment and implant occurring in 12 sites now activated, more to come.

We reported ARC-BCI and use of ARC-IM in Parkinson's, which is a huge adjacent population in the first quarter, and we're very pleased with the capital raise. In this geopolitical environment, it's a tough market for any company that's not in AI to raise money right now, and we raised EUR 40 million. We've got a very strong balance sheet into Q1 of 2028. So very happy with the quarter.

Thank you for your continued support, and thank you for the team here on the call and the team at ONWARD that is driving this execution. Talk to you in a quarter, everyone.

Thank you.

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.

Ladies and gentlemen, thank you for standing by. Welcome to the ONWARD Medical Full Year 2025 Financial Results and Business Update. [Operator Instructions] Please be advised that today's conference is being recorded.

I would like now to turn the conference over to Sebastien Cros, Vice President of Communications. Please go ahead.

Thank you, Michele. Good morning, good afternoon, everyone, and welcome to ONWARD's webcast following the publication of our full year results earlier today.

Before we get started, as usual, please take a moment to read our disclaimer. Today's presentation includes forward-looking statements, which should be considered with the appropriate level of caution as outlined on this page. This presentation and a recording of the webcast will be made available on our investor website after the call.

With us today are 3 members of ONWARD's leadership team; Dave Marver, CEO; Ali Kiboro, our CFO; and Shari O'Quinn, Chief Clinical, Regulatory and Quality Officer.

Today, we will present a comprehensive business update before opening the floor to questions. You may submit those orally or via the Q&A module of the platform.

With that, I'll hand over to Dave.

Thank you, Seb, and thank you all of you who have joined us today. 2025 was a really good year for ONWARD. I've been doing this for 3 decades now as a MedTech leader. And it's really rare and exceptional to introduce a new technology and penetrate 80 clinics in your first year on the market, really rare and exceptional, quite proud of the team for that achievement.

We also had some quite important regulatory milestones, not just one, but 3: we earned a 510(k), we earned an IDE and we earned CE Mark. And we also had -- also a quite a rare occurrence. We had simultaneous publications in Nature and Nature Medicine, detailing the clinical feasibility results for our first indication for ARC-IM blood pressure instability. So a fantastic year overall.

Now, let me run through the achievements in more detail. So 3 buckets here. First, on the commercial side of things. We sold 117 ARC-EX systems to more than 80 U.S. clinics in just our first year on the market. We recorded EUR 5.4 million in revenue, which for our U.S. listeners is over $6 million. We received CE Mark and sold our first ARC-EX systems to European clinics. We received FDA 510(k) clearance and sold our first ARC-EX systems for U.S. home use. We completed MHRA registration in the U.K. and Swissmedic registration in Switzerland, and we received UL Mark certification for the ARC-EX system as well.

We continue to advance our future pipeline, receiving FDA IDE approval to start the Empower BP pivotal study for ARC-IM. We published ARC-IM blood pressure instability clinical data in both Nature and Nature Medicine, significantly derisking that indication. We published the Pathfinder2 study results showing that sustained access to ARC-EX therapy can drive improvements without plateau at 1 year. We advanced our brain computer interface, or BCI, leadership studying thought-driven movement restoration in 4 additional people, bringing our total to 7, and we implanted our first human with the ARC-IM Lumbar Lead, which is designed to help restore mobility.

From an enterprise perspective or a corporate perspective, we raised over EUR 50 million in equity capital anchored by Ottobock, Invus and ASR. We established a US ADR program. We strengthened our leadership team with additions to our Board of Directors and appointment of new senior executives, 2 of whom you'll be meeting today, and we filed an F-1 registration statement with the SEC for a potential NASDAQ IPO in the next 12 to 18 months. That doesn't mean we're going to do the IPO in the next 12 to 18 months, but we wanted to demonstrate that we're making tangible progress for preparing for such a listing.

So big year, ARC-EX has been a resounding success, Empower BP pivotal study is now underway and we have significant growth drivers in place for '26 and '27. The entries here that are shaded, I'll be going into more detail in the next slides.

Okay. Let's talk about ARC-EX in our rapid commercial traction. For those of you who haven't seen ARC-EX, it's pictured here. This is a hero shot of the neurostimulator. And last year was a good year. If you've been following the company, you know that we started with a limited launch, quite intentionally, in a rather small sales organization. Then, we increased the field organization, and we brought in the launch. So in total, we sold 117 units. We penetrated more than 80 U.S. clinics, again, really rapid adoption for a new technology.

The adoption was also widespread. You can see on the map, very broad geographic dispersion and adoption across 30 U.S. states. Again, some of the statistics that I've mentioned already, more than 80 U.S. clinics have already purchased at least 1 ARC-EX system, 1/4 of the U.S. specialized rehabilitation clinics are already penetrated and 1/10 of the clinics have already purchased multiple ARC-EX system. So very good start. That traction was achieved by our U.S. field organization, which, by the way, is comprised solely of former trained physical and occupational therapists.

You can see that we have, what, 17 people in the field as of March 2026, and we'll be adding to that over the course of the year. We also made very rapid progress in Europe, where we received CE Mark certification late last year. We registered our first sale in Europe to a clinic in Q4, and we've already sold and delivered to clinics in the Netherlands, Italy, U.K., Germany and Switzerland. Two of them are pictured here.

As I mentioned at the onset, it was yet another strong year in terms of scientific evidence generation. They're rare, concurrent Nature and Nature Medicine publications detailing our blood pressure feasibility study results and the mechanism of action that underlies those results. We also published on the LIFT Home Study, and we used those data to help obtain the 510(k) for home use in the U.S.

Also, in October of last year, we executed another high-quality funding round. We raised over EUR 50 million in equity capital supported by demand from high-quality, long-only and sector specialist investors. The financing was anchored by Ottobock, our strategic partner as well as well-reputed health care specialist investor Invus and a first-time investor, a Dutch insurance company, ASR, who invested through their Global Impact Equity Fund.

I'm also very proud to have recruited a number of very strong and seasoned leaders to the company last year. On the left side, you see 3 new C-level executives: Sean Sciara, whom you met during our most recent call; and then, Ali Kiboro; and Shari O'Quinn, who 'will be joining you here momentarily.

Ali is a former CFO at AliveDx and Quest Diagnostics. He has NASDAQ company experience and very well trained from The Wharton School.

And Shari has experience at big and small MedTech companies and a very strong track record at securing access to global markets for breakthrough medical technologies, such as ours.

Our Board of Directors has also strengthened significantly. We recruited Tim Denison, who is currently Professor of Clinical Neurosciences at Oxford, and he was Medtronic's top research and engineering leader in their neuromodulation business.

We also recruited Lucas Buchanan. We call him Luca over here. He's the former CFO and COO of Silk Road Medical. He led their NASDAQ IPO and was CFO during the acquisition by Boston Scientific. So a nice exit for Luca, and he currently sits on several Boards of Directors for growth companies at similar stage.

Now, I'd like to turn it over to Ali, who's going to tell you more about our financial results.

Thank you, Dave. Good afternoon, everyone. I joined ONWARD at the start of the year because I saw a company with strong underlying fundamentals, a differentiated technology and a clear opportunity to accelerate its transition into a commercial stage business. Just as important to me is the direct impact our work has on people living with spinal cord injury. Our vision to empower their lives guides how we operate and makes decisions. With disciplined capital allocation and operational focus, I believe we can translate that into durable, long-term shareholder value. I look forward to engaging further with the investor and analyst community in the coming months.

Turning now to the 2025 full year financials. Total revenues for the full year were EUR 5.4 million, comprising product revenues of EUR 3.7 million and grants and other income of EUR 1.7 million. In 2024, total revenues were EUR 1.7 million, of which product revenue was EUR 77,000. The EUR 3.7 million in product revenue in 2025 came from ARC-EX system sales, primarily into U.S. rehabilitation clinics. This was our first full year of commercial operation. By year-end, we had placed 117 units in more than 80 rehabilitation centers, representing approximately 25% penetration of the U.S. rehab clinic market.

Grants and other income was EUR 1.7 million, consistent with the prior year, reflecting ongoing research funding from partners, including the Swiss Secretariat for Education, Research and Innovation, SERI; the U.S. Department of Defense; and the Michael J. Fox Foundation.

Gross profit was EUR 4.4 million. Excluding grants, product gross profit was EUR 2.7 million. And product gross margins was approximately 72%.

Total operating expenses were EUR 45.3 million compared to EUR 36.6 million in 2024. The increase reflects 4 areas of investment. First, the buildout of the U.S. commercial and operations, supply chain organization. Second, external [Technical Difficulty] FDA clearance for home use in November and submissions for the Empower BP pivotal study. Third, professional fees associated with capital markets activities and additional legal and tax advisory work. Fourth, recruitment costs for 3 senior leadership hires completed during the year.

The net loss for 2025 was EUR 41.8 million compared to EUR 35.7 million in 2024. The interest-bearing loan balance was EUR 13.1 million at year-end compared to EUR 14 million in 2024, with the movement driven primarily by foreign exchange translation. We ended the year with a cash balance of EUR 68.1 million compared to EUR 60.0 million at the end of 2024. As you will recall, we raised EUR 50.9 million in the fourth quarter of 2025. Total cash outflows in 2025 were EUR 42.8 million.

And with that, I will turn the call back to Dave.

Thank you, Ali. I must say it's nice to have a CFO present so many financial and operating metrics. It reflects our graduation, let's say, our evolution into a commercial-stage business. So welcome.

Thank you.

All right. Now on to some commercial trends. This is a 2025 full year call, but we're coming to you on 31 March 2026. So we thought we would share at least some of the trends so far from the first 2 months of the quarter. We didn't want to spoil the next call by giving you all the information for the first quarter. So it's a bit of a tease.

So let's take a look at how we did. First, within the VA clinics. And as you know, the VA, the military hospital system in the U.S., is critically important because they care for almost 15% of the paralyzed population in the U.S. The VA cares for the paralyzed population through 25 specialized clinics, which they call VA hubs. So already, we penetrated nearly half of those 25 hubs. We're in 11 of the 25. And we have 15 total active clinics within the VA hubs and spokes.

The VA was a bit slow early in the year last year. It was spooked a bit by DOGE and some other dynamics. But now that they are active and engaged, they're really coming on quickly. So we're very pleased at the quality of the partnership and the velocity of things within the VA now.

Also, things are strong outside the VA in terms of home use. And, as you know, we recently got 510(k) for home use in the U.S. We are initially targeting the VA for home use, but also self-pay. And so within self-pay, very strong early trends. We have 18 self-pay home units sold and purchase orders already received. And we have 92 additional self-pay opportunities in the sales pipeline. So a bit more robust even than we expected.

Within the VA home use, 6 of the hubs are already prescribing home-use demos, and we've already received 15 orders for home-use demos quarter-to-date or at least through March 6. Starting in Q2, we're going to be deploying a patient access support program to facilitate and support case-by-case reimbursement pursuits via workers' comp and private pay. So doing what we can to support and broaden access to this really important therapy.

And speaking of this therapy, it is having a big impact out there. We wanted to show you this video. This is AJ. He's a U.S. Navy veteran. He's an ARC-EX user. And he embodies the reason that we're all here on this call, the reason we're all working so hard in pursuit of this mission to bring breakthrough technologies like ARC-EX into the clinic.

[Presentation]

Excellent. And that video really typifies what we're seeing all over social media, where patients and clinicians at these 80 U.S. clinics, where ARC-EX therapy is currently being offered, are posting their stories. We're very gratified to hear stories like AJ's where the device is bringing him independent, helping him get dressed in the morning, feed himself and so forth. That really is the value proposition here. And that's why at the clinics where we're seeing ARC-EX therapy being adopted, there are frequently, if not all the time, waitlists, and these clinics are considering buying more devices or transitioning patients into the home.

Okay. So that's ARC-EX, where, again, the launch has been a resounding success. Now, let's transition to our next priority this year, which is executing well on the Empower BP pivotal study. Empower BP is intended to amass the data we need to get regulatory approval around the world for ARC-IM, which you see pictured here. This is an implanted neurostimulator and spinal cord lead, and the first indication we're pursuing here is blood pressure instability. It's not the first indication many of you may think of after a spinal cord injury, but it's really important. Here's why. This is a big unmet need after SCI. More than 90% of patients treated for blood pressure instability continue to experience symptoms. So this group of people badly needs a new and effective therapy.

Blood pressure instability manifests in 2 ways. One of them is orthostatic hypotension, which is very low blood pressure tied to posture or changes in posture, tends to manifest when people are sitting upright at a meal, while riding in a car. It can impede their ability to get out of bed in the morning. The other way it manifests is what's called autonomic dysreflexia, which are sudden dangerous spikes in blood pressure because the body has a difficult time processing autonomic signals, such as the full bladder or even an itch.

These data are really compelling to me. So 8 out of 10 tetraplegics are diagnosed with orthostatic hypotension, or OH. Of those, only 1/3 are treated and 91% continue to experience symptoms even when treated. It's even worse for autonomic dysreflexia. Again, 8 out of 10 are diagnosed, 1/3 are treated, but 98% continue to experience symptoms. So this is a very worthy pursuit for our first indication for ARC-IM.

So Shari O'Quinn, our new Chief Clinical, Regulatory and Quality Officer, tell us more about Empower BP.

Yes. Thank you, Dave. I'll start by sharing why I joined ONWARD. This is because I was inspired by its purpose. And I wanted to be part of this unique opportunity to bring truly transformative technologies and therapies to patients with significant unmet needs such as blood pressure instability. And today, I have the pleasure of sharing with you that the first ARC-IM implant was successfully completed at Craig Hospital in Denver, Colorado. This marks an important milestone for both the program and for patients.

And on the left is a picture of the ONWARD clinical team, along with Dr. Matthew Meehan, the neurosurgeon, who performed the case. We're now seeing really strong momentum building in the study with 10 active sites in the U.S., and we expect the remaining sites in the U.S. and Canada to be activated by the end of April with the remaining sites in Europe to follow shortly after. This positions us really well to accelerate enrollment in the study.

Now, I would like to share a short video of an interview with Dave and Dr. Leslie Morse, who's the Chair of the Physical Medicine and Rehabilitation Department at the University of Miami Miller School of Medicine located in Miami, Florida, and Dr. Morse's site was recently activated, and she's going to share with us the significant impact on the daily lives of patients who are living with blood pressure instability. And with that...

Dr. Morse, thank you for your time.

Thank you. It's a pleasure to be speaking with you today.

So we're primarily speaking with investors today. Can you please help them understand why it's important to address blood pressure instability after spinal cord injury?

Sure. Blood pressure regulation is one of the most pervasive, I would say, and potentially impactful symptoms after a spinal cord injury. And it often goes unrecognized both by the patient and the clinical team as well. So it manifests as -- there can be a lot of symptoms ranging from dizziness, difficulty sitting upright, fainting, but it can also lead to impaired cognition, brain fog and change in cognitive function.

So your site has only been active for a few weeks, but what has been the reaction so far among patients and clinicians now that you're up and going?

So even though we've only been active for a short period of time, I would say that the response from both patients and clinicians has been really encouraging. And one of the advantages, again, that we have at the University of Miami is the strength of our spinal cord injury ecosystem because we're so closely connected with the SCI community that partnership between patients, clinicians and researchers has really made early engagement very, very strong and very exciting.

Good. It's good to hear that there is some enthusiasm for the study. What do you think a successful study and subsequent FDA approval would mean for the SCI community?

Well, first, I would say it would significantly improve day-to-day function. More stable blood pressure means fewer episodes of dizziness, better tolerance for sitting and upright activity and greater ability to participate in rehabilitation in daily life. Second, improved cardiovascular stability could support better long-term health outcomes, including improved cerebral perfusion and potentially better cognitive and overall physiologic well-being.

There's also a broader implication for the field. Success in the study would demonstrate that neuromodulation can target autonomic dysfunction after spinal cord injury, not just motor or sensory systems, and that opens the door to addressing a range of physiologic challenges that follows spinal cord injury and represent a really important step toward restoring multiple dimensions of neurological function after trauma.

That's good. We hope it makes a big difference for people. Thank you so much for your time, Dr. Morse.

Okay. Thank you.

We really appreciate Dr. Morse sharing her perspective on what a successful pivotal study and subsequent approval of ARC-IM can mean for the SCI community. And following the enrollment and the successful implant in Empower BP that we just announced, we can share that there are now 4 patients fully enrolled and many more scheduled. With the 10 sites that are already active and additional sites to follow, we expect enrollment to accelerate the Empower BP moving forward.

And also, in 2026, we expect to enroll all the participants that are needed to conduct the interim analysis in early 2027. And this is in line with our roadmap for ARC-IM commercialization as early as the second half of 2028.

And with that, Dave will share the outlook.

Thank you, Shari. All right. So we're almost a quarter into 2026, and we're eager. We think there's a lot we can get done here. We have a couple of new demand drivers in 2026 and 2027. So last year, we were focused almost solely on launch to U.S. clinics. And we had the initial sales to European clinics as well. In 2026 and 2027, we have 4 growth drivers that we believe will contribute to very rapid growth.

First, our additional U.S. clinic sales. So ARC-EX sales to both new and existing clinics. Also, VA home use sales. Also, U.S. home use sales outside the VA, starting with self-pay and case-by-case coverage pursuit via workers' comp and private payers. And then, also EU and rest of the world opportunities, both clinic and home use. So these 4 buckets offer a lot of opportunity for us to grow the top line this year and next.

2028 promises an additional indication, a second indication for ARC-EX, and we also, as Shari just alluded, expect FDA approval of ARC-IM in the second half of 2028. So that should be a big year for us as well.

As you've come to expect with ONWARD, we should have a lot of news flow. Some of these are already completed, but let's just take them by platform. With ARC-EX, we expect going forward 2 news flow items: one being first commercial home use sale in Europe, second being first commercial clinic sale in rest of world, so outside U.S. and Europe.

For ARC-IM, 4 more news flow items, one being the interim analysis from Empower BP, which, as Shari said, we expect early next year. Next would be first-in-human use of ARC-IM to address bladder function. This is underactive bladder. We're trying to eliminate the need to insert catheters each time a person with paralysis has to urinate. Also, additional implants for ARC-IM in Parkinson's disease mobility and additional implants for SCI mobility. The last 3 of those are, in fact, grant-funded.

And then, we expect to continue to extend our leadership in the brain computer interface realm to address movement disabilities. So we expect additional implants for SCI upper limb and as well first implant of the ARC-BCI -- of ARC-BCI therapy for stroke, also grant-funded. So a lot of news flow upcoming, and there may be some things that we don't even have on this slide.

So with that, the prepared portion of the webcast is over, and we'd be very pleased to take questions.

I think we already have a question from Damien Choplain from Stifel. Our usual analyst, Ed Hall, is on vacation. We don't know where. But I think Damien is filling in for him. Damien, take it away.

Can you hear me?

Yes.

Yes, it's Damien. As you said, it's for Ed Hall. So 2 questions actually. So first one is on the split in ARC-EX device placement. So would you be able to provide some more granularity on the location of device placements, including home use versus clinic use, U.S. versus EU? And how many clinics have bought additional devices? So this is the first question.

And the second one is on pricing for ARC-EX. So could you provide an update on pricing for the device? And has there been any significant developments since launch? And any price changes you envisage for 2026?

Thank you, Damien. So we don't intend to discuss the unit sales in more granularity in terms of category or geography. We can, however, share that 10% of clinics have purchased more than 1 device. So there's that.

In terms of pricing, yes, there have indeed been developments. So the clinic pricing remains USD 39,000, list price. And the home unit or the personal unit, as we call it, has a list price of USD 29,000, and that is being applied consistently around the world, albeit with respect for differences in foreign exchange. Thank you, Damien.

Next is Clement Bassat from BNP Paribas.

Okay. Clement, [Foreign Language], welcome.

And I have basically 2 questions. The first that I see some major European countries are excluded from your target like France. So could we know why? Is it a price concern or regulatory concern or maybe an access concern among the French clinics? And about Empower BP, I have in mind 60 participants and an interim result in 2027. So how many patients are required to provide interim result? And would you be allowed by the FDA to fill a submission, but only on this interim result?

Yes. Thank you. So, Clement, we certainly do not intend to exclude France. It's a very important country for many of us. The fact that France is not represented as one of the first countries is only a function of the fact that we have not yet established a channel there. So our approach in Europe differs from the one that we have in the U.S. In the U.S., we have a dedicated company channel with physical and occupational therapists.

In Europe, we're going to take a hybrid approach. So certain countries will go direct, certain countries will go through a distributor partner. And we haven't finalized that yet for France. I imagine once that is finalized, you'll see a clinic sale shortly thereafter.

Okay. In terms of the enrollment numbers for Empower BP, Shari, would you like to take that? Or would you like me to take it, as you prefer?

Sure. I can answer that question. So for the interim analysis, we need 33 patients at 3 months to do the interim analysis to determine if we can stop enrollment. But by that point, as I shared earlier, we will have approximately 60 patients enrolled. And we'll need to follow them out to 6 months in order to file the PMA submission. And that's what's the driver for the PMA approval at the end of 2028 second half.

And then the other question is, would we submit a PMA application based solely on the interim data? Is that a possibility?

That's something we can discuss with the FDA, but at this point, we're planning on 60, but we can evaluate after the interim analysis.

Is there another question from the panel?

Yes. The next one is Mathijs Geerts Danau from KBC Securities.

Can you hear me?

Yes.

First of all, congratulations with the results, of course. I do think 80 clinics is indeed very good for the first year. But I did have some questions on the home use uptake in non-VA clinics. What kind of percentage do you think that patients would buy the home use device that are now on clinic devices?

Yes. I think that we're still in learning mode, Mathijs, for these demand drivers. We only recently got 510(k) for home use in the U.S. and only recently obtained CE Mark for clinic use in Europe. And so we're monitoring the demand. So it's hard to really give you a percentage for how many people outside the VA will be willing to self-pay for the device.

I will say that you saw that the pipeline had 92 people in it. So that we think was quite strong. In fact, that surprised us to the positive. But we'll know more as the year progresses. We think that most of our home use sales will come out of the VA system this year because they do have the mechanism to pay for it even today. Self-pay is an unknown. But again, we've been surprised toward the positive, at least in the first couple of months in the year.

Okay. Interesting. Interesting. I hope to see some developments there as well. And then, I also had a second question, more on your collaboration with Ottobock. I saw in your annual report that you maybe plan to leverage the collaboration there and potentially go to other geographies outside of Europe? Or am I looking a little bit too deep into that one?

It's a very good question. We -- first of all, Ottobock did their own IPO within the past few months. And so a lot more investors are aware of the company, and they're aware of what a high-quality partner they are. I mean, nearly 10,000 employees, very profitable. They've been in this sort of mobility, movement disability space for over 100 years. So we greatly value them as a partner. We learn a lot from them. They have experience in many, many global markets with similar devices. And so we leverage that certainly. And there are a couple of areas where we're exploring collaboration, nothing that I would point to yet as sufficiently mature to announce, but we're looking at R&D collaboration. And indeed, we're looking at commercial collaboration, where we would leverage their distribution infrastructure in certain countries in the world. So more to come.

All right. Sounds good. And maybe one last question. It's more on China and how you look at Chinese competition. I believe that there is a BCI approved there. And also one that really resembles your ARC-BCI device. How do you look at that -- yes, the dynamic there?

Yes. Thank you. China is very interesting. BCI is one of their strategic priorities in their recently published 5-year plan. As you know, they've made a lot of strides in certain strategic industries such as electronic cars and alternative energy. They're also making a lot of progress in biotech. So Chinese companies have not been successful in the U.S. and Europe in MedTech thus far, but I don't discount that they could be.

We do not have our head in the sand here. In fact, later this month, I'll be traveling to Shanghai. I'm giving the keynote address at a major neurotechnology and BCI conference hosted by Fudan University. We will be exploring potential partnerships there.

And I think it's important to note that in the area of BCI, ONWARD is quite well positioned. We have a lot of strategic optionality. We have a real expertise in understanding how to stimulate the spinal cord to restore movement. We have a huge IP portfolio in that area. We're aligned with the group at EPFL here, who are the global thought leaders in the area. So that's our real strength. And we have our own BCI, which we've in-licensed from a biomedical research institute in France that has 8-year human safety data and is functioning very well in the 7 humans whom we've implanted.

However, if another BCI presents as suitable or superior to ours, our ARC-IM device is agnostic. So we can pair our ARC-IM, our spinal cord stimulator with anybody's BCI as long as we take the time to connect the software. So we're really in a good position. We can partner with companies in China if it makes sense. We can partner with American companies if it makes sense. We can partner with European companies if it makes sense. But for now, we have our own system with -- that's been developed the right way with a MedTech quality system and rigorous engineering, and it's performing well, and it allows us to sustain our leadership and be potentially first to market with thought-driven movement restoration solution.

We have Christophe Dombu next from Kepler Cheuvreux.

Yes. Can you hear me?

Yes. Very well.

Okay. Perfect. Congrats for this publication. I just wanted to discuss a little bit more about the numbers in 2025, especially about the in-market dynamics because when I look at the numbers, so you have sold 117 units and showing a very strong sequential growth one quarter from the -- I mean, the quarter-over-quarter growth was actually very strong. But it looks like in Q4, the -- I mean, of course, the sequential growth was above what -- I mean, it was better than Q3, but at the same time, the top line growth was also slightly below what you have achieved during the first 3 quarters of the year. So I just wanted to better understand if you -- what happened in Q4, if you can provide us some granularity? Can we already talk about some seasonality here? Or is it just some limitation due to your resources, if you can comment more about what happened in Q4?

And also, one second question is about 2026. I was wondering if at some point in the year, we'll be able to provide some guidance or some direction about how many units you plan to sell in 2026? And more specifically, how you see it in terms of split between the clinics and the in-home use? That's it for me.

Okay, Christophe. So what you observed in 2026 was we had a limited launch, and then, there was some latent demand that we didn't satisfy in Q1 and Q2 because we didn't have a field organization in place, and moreover, we wanted to limit the launch because it was a new technology, and we wanted to see how it went. And so that was expressed largely in Q3. And then, you saw an increase sequentially from Q3 to Q4, nearly all of those sales were into clinics.

And as you know, there aren't that many clinics in the U.S., and we've already penetrated 25% of them. And sure, we can penetrate more, and we can sell more than 1 unit to some of these. But we don't believe that the clinic business in the U.S. is going to grow that fast going forward. And indeed, the clinic business is most important for us because it provides the foundation for home-use sales. And it's home-use sale, VA and non-VA, they're going to fuel top-line growth going forward for ARC-EX.

The reason that those 80 clinics are so important for us is because this is where the patients experience ARC-EX therapy have their programming parameters set. They learn how to use the device. Their caregiver learns how to use the device. And so it becomes an easy transition to home use. So we're very, very happy actually with the home-use penetration. You should not expect us to sell that many clinic units on a go-forward basis. We don't know really what the steady state is. It might be 20 to 30 units per quarter. 47 is a lot of units. Not all of them are clinic, but most of the growth will come from the home going forward, no question.

Okay. Also, I want to go back to Damien's question from Stifel because I told him that we weren't going to split out the sales by geography, but Ali reminded me that it's actually in the annual report. So we are indeed comfortable sharing that today. So maybe, Ali, you can share the geographic split as conveyed in the annual report.

Sure. Damien, so if you go to the annual report in the back, we are splitting out the revenues by region. There's EUR 3.7 million of product sales in 2025, EUR 3.2 million of that or 86% roughly was in the U.S., EUR 330,000 was in Europe, and then, there's another EUR 175,000 in the rest of the world. If you use that to estimate where the 117 were approximately, I think you'll be in the right place as to where the units were for that EUR 3.7 million of product revenues.

All right. Thank you. Damien's mic is not live, but I'm sure he's thanking you, Ali.

Okay. So we also got some questions before the call from David, the analyst at Degroof Petercam, who couldn't join us today. The first question is macro factors aside, can you elaborate on any commercial and/or clinical milestones that you deem essential to be able to execute a NASDAQ listing?

Yes, indeed, so at the beginning, I told you that we did file with the SEC. It's called an F-1 filing for a foreign issuer. And this is among the preparations that we're making for a NASDAQ IPO. We've talked about that possibility since we first did our Euronext IPO in 2021. We are going to be very prudent. We're going to look at market conditions and so forth, which do change. When there are wars, market conditions are not favorable. When there are no wars, market conditions are more favorable.

Some of the factors that are important would be revenue scale, revenue growth and revenue predictability because, particularly in the U.S., it's important to meet and beat analyst expectations. So that answers question number one.

Question number two is what are the remaining clinical catalysts, particularly for ARC-IM, and we have a lot of them. I detailed some of these in the news flow slide, but there's the urinary incontinence first in human for ARC-IM. There's ARC-BCI's use in stroke and SCI mobility. There's some additional work that we intend to do in mobility that I expect we'll announce over the course of the next year.

Also, within Empower BP, we might announce some enrollment milestones, and also, the primary outcome completion when we have a sufficient number of enrollees and sufficient time for those follow-ups. So no shortage of news flow at ONWARD as per usual.

Any other questions from the analysts, Seb?

No.

Okay. And I think we talked about Ottobock. Any other questions in the Teams?

No.

No. All right. Ali, Shari, what you think of your first call?

I just did the first year product awards. I am really excited about 2025.

Alright.

And I have the pleasure of announcing the first implant in the Empower BP, and I'm excited over the coming year to share more news about the study.

Yes, having 10 sites activated really gives us the machinery to enroll more quickly going forward, doesn't it?

Exactly. That lays the foundation, and the magnitude of screening that we can do will drive that enrollment.

Excellent. Seb?

Everything is done.

All right. Well, thanks, everyone, for joining. And thank you, Michele, from Virginia for moderating.

Thank you. This does conclude today's conference call. Thank you for participating, and you may now disconnect.

Good morning, good afternoon, everyone, and welcome to our ONWARD's webcast following the publication of our results earlier today. As usual, before we get started, please take a moment to read our disclaimer. Today's presentation includes forward-looking statements, which should be considered with the appropriate level of caution as outlined on this page. The slides and this recording will be available on our investor website after the call. Today's speakers include Dave, our CEO; Sean Sciara, our Chief Commercial Officer; and Amori Fraser, our Senior Finance Director. As usual, we'll go through a comprehensive update before opening for questions. You may submit your questions verbally or via the Q&A module on the platform.

With that, I'll hand over to Dave.

Thank you, Seb. So it was an eventful quarter for ONWARD. Since our last update, we exceeded EUR 1.5 million in quarterly revenue. We received CE Mark and U.S. home use clearance from FDA for the ARC-EX system, and we raised EUR 50 million in new equity capital. So let me just run through these in a bit more detail, and then I'll also go into further detail during the presentation that follows.

So most importantly, for most of you is commercial traction. So we continue to see acceleration of ARC-EX in U.S. clinics. We sold 40 units in Q3, and we exceeded EUR 1.5 million in quarterly revenue for the first time. Actually, we hit EUR 1.7 million, which is nearly a $2 million run rate. It's $1.96 million at today's exchange rates. ARC-EX systems are now available at over 60 U.S. clinics. We also achieved several important regulatory milestones. We received CE Mark certification for ARC-EX for use in both clinics and homes. We completed U.K. MHRA registration for the ARC-EX system, meaning we can now promote the device in the United Kingdom. We received U.S. FDA investigational device exemption, or IDE, for the ARC-IM system so that we can start the Empower BP clinical study. We received UL Mark certification, which is an electronic safety certification for the ARC-EX system. And we received FDA 510(k) clearance for home use in the U.S., which greatly expands our market opportunity.

We continued our science and technology leadership, announcing simultaneous publications in Nature and Nature Medicine, and there was another publication on the LIFT Home study results in Neurology Clinical Practice. From a company perspective, we raised over EUR 50 million in new equity capital, anchored again by Ottobock and also anchored by Invus and a.s.r. And we strengthened our leadership team with the appointment of new senior executives.

Let's start with more information on our commercial traction. So you've seen this slide before. This is a demand indicator. We continue to observe very high inbound global interest about ARC-EX. And these numbers are unsolicited inbound requests for more information or for a product evaluation. So thus far, more than 5,000 global leads have been collected, more than 3,300 collected in the U.S. alone and 430 of them are collected from U.S. clinics. So nearly every U.S. clinic whom we consider a target has reached out to ONWARD to learn more about this device.

Unsurprisingly, our sales are also increasing, reflecting that demand. In the first half, it was a limited launch where we sold precisely the number of units we intended. And then we preannounced our Q3 results that we had sold 40 units in Q3, placing our year-to-date units sold at 70 and our penetration into over 60 U.S. clinics. We expect the demand in Q4 to remain strong to be sustained. And there are 2 important catalysts that may provide upside in Q4, but will largely be drivers for significant growth in 2026, that being the CE Mark approval that allows us to market the device in Europe and then the 510(k) that we recently received for home use in the U.S.

And I'd now like to turn things over to Sean Sciara, our new Chief Commercial Officer, to walk through a couple of slides on our commercialization.

Thank you, Dave. We're obviously pretty excited about the 2 big catalysts that we have in front of us to put us in a great position for accelerated growth in '26. The first of those, as you mentioned, is the European launch. So as everybody knows, we received our CE Mark in September. And since then, we've gone on to complete the additional regulatory work to secure clearance and registration in both Switzerland and as Dave mentioned, the United Kingdom. Our launch is underway. Our initial focus, as you see here on the slide, will be on the critical cluster of DACH, so Germany, Switzerland and Austria.

To that, in this initial launch phase, we will add the Netherlands and the United Kingdom. So 2 countries where we've had long-standing partnerships and clinical trial activity. As we look to expand across Europe, we're going to do that with a combination of direct sales where we think that's most critical as well as through distributor relationships where we think that is most appropriate. We have our leadership in place today. We have additional hiring underway. We commenced selling activity immediately upon the CE Mark clearance, and we look forward to first sales here in Q4 and launching some of these early European centers in the fourth quarter.

The second of the big growth catalysts is on the next slide, it is -- I would say, certainly equally, if not more important, and that is our recent home use clearance in the United States, which is all of a week old at this point. Initial response from the field has been fantastic. Our inbound leads are up threefold over our typical levels, and our clinic partners are telling us they have clients actively reaching out to them to talk to them about how to obtain a home use unit. Being able to extend this therapy into the home is obviously a very big deal for the community. For people with limited mobility, being able to extend the therapy into the home makes it more accessible. And we know from the LIFT Home trial that sustained engagement and use of the therapy is important not just for maintaining benefits, but potentially extending benefits as well.

The home use trial builds on the tremendous success we've had in the clinic. As Dave mentioned, we've got a footprint of over 60 clinics. As people with spinal cord injury will need to get exposure to the therapy in the clinic to integrate it into their rehab programs to establish the appropriate stimulation parameters that are optimized to them, all of that is done in the clinic. So having this really large base already in place gives us a really solid foundation in the United States to begin the extension of the therapy into the home.

As it relates to our readiness and getting moving, we've established home use pricing for veterans that are receiving their care through the United States Veterans Affairs system. We have the product on the federal supply schedule, so it is available today. For other home users, we have cash pay and third-party financing options. But we also know that ultimately, we'll need payer support here to make this therapy as broadly available as everybody in the community and we would like. So to help both patients and our clinic partners with that, we're going to be implementing patient access programs to support everything from prior authorizations to claim submissions to, if needed, appeals for claim denials. Development of those programs is currently underway, and we look forward to putting them in place in the first half of 2026.

On the logistical flows on how a person goes about getting a system, you can see that on the slide. ONWARD is going to partner with clinics to provide all of that setup and support. So as ARC-EX is only available by prescription only, it means that the start of the journey for a person that wants to get access to ARC-EX in the home is -- the start of the journey is for them to visit their clinic to assess whether or not the therapy is right for them to obtain a prescription.

Once there is a prescription, that prescription is sent to ONWARD. ONWARD works with its accredited third-party partner to complete the prescription verification and billing. And upon payment, the device is shipped directly to the person's home. The person then will take that device to their clinic for setup, for programming and for training. That training will be both for them and for any caregivers that they have that support them. And then ongoing support after that point is done in 2 ways. The primary piece of support will be done by the clinic itself, and ONWARD has a team of therapy consultants and clinical managers distributed around the United States to help support the clinics in caring for their clients.

Beyond that, we'll also have support through the ONWARD customer experience teams, helping with things like logistics and troubleshooting, and we'll have a bunch of training resources, whether video print and all of those types of things on the website to help with the most common questions and the challenges -- potential challenges in any of those early stages of use. So we're obviously very excited about these new growth catalysts. We've been working on readiness for many months. We're looking forward to being able to bring the new therapy to people living with SCI in Europe and then also bringing this therapy into the home, allowing people living with SCI to extend the benefits that they're seeing with ARC-EX in the clinic into the home setting. Enthusiasm is very high for the product.

All right. Thank you so much, Sean. Let me now move on to some of the other achievements this quarter. Starting with our capital raise. So we raised over EUR 50 million in new equity capital, extending our cash runway into Q1 2027. This was a very clean financing supported by demand from high-quality, long-only and sector specialist investors. Our anchor investors were Ottobock, Invus and a.s.r.'s Global Impact Equity Fund. So we had a strategic specialist investor and a well-respected generalist investor. This is the second time Ottobock has anchored an investment for us, and we really continue to value that partnership very highly.

Moving on, we also received UL Mark certification, reinforcing the engineering and process integrity underlying the ARC-EX system. The UL, for those of you who don't know, certifies that ONWARD meets rigorous standards required by UL Solutions across design documentation, certifications, component traceability and safety test reports. This opens the door to certain U.S. clinics and hospitals that have a strict requirement for a nationally recognized testing laboratory mark. So for example, the biomedical engineering departments in certain clinics or hospitals will not permit the purchase and deployment of a piece of medical hardware without this UL certification. So we're pleased to have this now in place.

We continued our legacy of outstanding scientific publications in the third quarter. There were concurrent Nature and Nature Medicine publications detailing the blood pressure feasibility study results and the underlying mechanism. So our thanks and congratulations to Professor Courtine and colleagues for those breakthroughs. There was also a publication on the LIFT Home study results published in Neurology Clinical Practice. So more on that. That was a study we did to -- as part of our data package for FDA to get the home use 510(k). There were 5 sites, 17 participants looking at the safety, usability and therapeutic benefits of at-home ARC-EX therapy as a continuation of in-clinic treatment. So 96% of the sessions that were attended were successfully completed. Compliance was high. We observed that the home use maintained or further enhanced the benefits following in-clinic use and 65%, so about 2/3 of participants showed clinically meaningful improvements in at least one primary strength or function assessment during the study. And as is always important, there were no serious device-related adverse events.

As far as Empower BP is concerned, and again, we did get IDE approval from FDA to start Empower BP. We have our first site activated, and that is Craig Hospital in Denver, Colorado. This is one of the world's preeminent rehabilitation clinics, and we expect additional site activations to follow this in rather short order, and we further expect to announce the first participant enrollment before the end of the year.

We continue to strengthen the leadership of the company. In fact, this is the next wave of leaders that we need to scale the company. I'm very pleased with the group of people who've chosen to work here and commit to our mission. You heard from Sean Sciara, a very impressive guy, very pleased to have him here. He initially joined us as VP Marketing, and we recently promoted him to Chief Commercial Officer. Sean is a long-time leader at Boston Scientific and Integer. He's launched scores of products. And again, we're very pleased that he's bringing his experience to bear at ONWARD.

We also have hired a new Chief Financial Officer, who will be starting in early January, Ali Kiboro. Ali was CFO at AliveDx and a senior finance leader at Quest Diagnostics. He has more than 25 years of finance leadership, including service as a NASDAQ CFO. He is very well educated. He has an MBA from the Wharton School at the University of Pennsylvania and very pleased to have him join us, and you'll be hearing a lot from Ali starting next year. And then starting December 1, we have another high-powered senior leader that being Sherry O'Quinn, who will be joining us as Chief Clinical, Regulatory and Quality Officer. She's been a long-time leader in those disciplines at W.L. Gore, C.R. Bard, TriVascular and Endologix, so therefore, start-up experience as well as big company experience. She has experience as well with both Class II and Class III devices, innovative therapies and health care economics, and we're confident she's going to add a lot to the company as well. And you'll be hearing from her as early as December, but more likely next year.

All right. So next to comment on our Q3 financial results is our Senior Finance Director, Amori Fraser. Amori?

Thank you, Dave. So as you have heard earlier on the call, we recorded EUR 1.7 million in revenue for this quarter, reflecting continued execution of our early commercial activities. Our cash burn for Q3 was EUR 8 million, driven by ongoing investments in commercialization, R&D and preparation for pivotal clinical milestones. We ended the quarter with EUR 32.9 million in net cash as of the end of September. And following the October capital raise, our net cash position increased to EUR 77.7 million at the end of October. This provides us with a strengthened balance sheet and supports our ongoing focus on disciplined capital management. Overall, with increased liquidity and ongoing operational focus, we are well positioned to execute on our near-term priorities. Back to you, Dave.

Thank you, Amori. Okay. Now on to our outlook. So putting up Slide 23 here on milestones and news flow. And you can see we've knocked out quite a few of these this year. There are some remaining and some may also occur in the first quarter of next year. But we continue to expect to announce first participant enrollment in the EMPOWER-BP pivotal study also first commercial sale in Europe for ARC-EX. Both of those are expected later this year. First-in-human use of ARC-IM for bladder could happen in first quarter. And then first implant of ARC-BCI for stroke is also something that we expect in the coming months. We're likely to refresh this slide as we go into next year, but it's satisfying to see all of these milestones completed, which is really a credit to the very committed and hard-working team here at ONWARD Medical.

So with that, Sharon, let's go ahead and open up the lines for questions, starting with the analysts. I think they have to press *11 if I'm not mistaken.

[Operator Instructions] I will hand back to you, Dave.

Thank you. So while we're waiting for that queue, there are a couple of questions that came in via the chat. One of them from Mr. English wanting to know about the pricing for ARC-EX in the U.S. and Europe, clinics and home. So the pricing is more or less the same for U.S. and Europe, allowing for differences in foreign exchange. We do intend, as Sean Sciara indicated earlier in the call, that we do intend to price the home use device about 25% lower than the clinic use device. A couple of reasons for that. One is we're a mission-driven company. Access is very important to us. So we want to make sure that this device and the therapy is available to as many people as possible. And also, it's a more limited device in terms of feature set than the clinic use device. All right. It looks like we've got a few questions, but I'm not seeing them, Sharon. So why don't you take them?

Your first question comes from the line of Ed Hall from Stifel.

A couple of questions from my side. I think, firstly, just on the backlog of leads. Could you talk about this from -- obviously, firstly from the clinic and the home use perspective? And if we think about looking to next year and collating leads into sales, how is this going to be -- how is this going to work? Are we going to see those already in the clinic prioritized? That would be my first question.

Second question would just be on your outlook based on the data you've seen from revenues this year as a percentage of sort of ARC-EX devices that are put on rental versus outright purchase. That would be great. And then I have a follow-up after that.

All right, Ed. I love your compound questions. I'll do my best to keep track here. So we are unlikely to pursue a lot of direct-to-patient sales, at least in the next several quarters because we think it's going to be more efficient and effective to go through clinics. And we want people with spinal cord injury to first experience the therapy in the clinic. That way, their programming parameters can be optimized. They can be trained on using the device. Their caregiver can be trained on using the device, and then they can be prescribed use of the device for use at home. And also, as Sean indicated earlier in the call, we -- part of our deployment case is that home use devices are paired with clinic devices and in a very efficient way with a QR code, the programming parameters can be ported over to the home use device. So for those reasons, the way we're viewing the queue or the lineup for home use sales is that we're expecting that most of the home use sales will come from those patients who have already or will experience use of the device in the clinic environment.

Secondly, as for next year, as you know, we don't issue guidance at this stage of the company. However, the consensus is that we'll do low to mid-teens in revenue from a euro perspective, which would be mid- to high teens from a dollar perspective. And that would constitute more than doubling and even perhaps tripling of revenue year-over-year. So we would consider that a big success, and that would be in line with year 2 of some of the more successful med tech companies that have emerged over the past decade or so. I think I might have forgotten your third question, Ed.

It was just on -- maybe just looking at this year as a percentage of rental cases versus outright purchase.

Yes. We haven't really broken that down, at least not at this time, but the vast majority of them are purchases.

Yes. Perfect. And then finally, just quickly on -- obviously, you talk about EMPOWER-BP and the enrollment there. We've seen the first site activated in Colorado. Can we just unpack how quickly do you expect enrollment, especially for this indication? You've talked about the broad interest in ARC-EX, and I don't know how you could potentially draw comparisons to the therapy for the clinical trial and how quickly we could see full enrollment?

Yes. We're hopeful that enrollment will go quickly. There's a lot of interest and excitement about the blood pressure instability therapy in the community and the centers with whom we've been having discussions about participation and start-up have been identifying potential study participants. So it could go relatively quickly. It's -- I don't want to necessarily, again, guide on when the thing is going to fully enroll, but we're hopeful that we can get to the point of interim analysis by late summer. So if you recall, again, one of the benefits of having 10 breakthrough device designations is we have frequent interaction with FDA. Such was the case with Empower BP.

We do have an interim analysis built into the study where we can pause at 33 participants and look at efficacy at that point. Should that go well, we can stop the study at 33 for efficacy, and I believe 60 for safety, and that would lead to a more favorable launch date. As far as full enrollment, again, I'd like to maybe defer comment on that until we get started on the study and I have more information.

Your next question comes from the line of Jacob Mekhael from KBC Securities.

I have one, maybe a follow-up on the home use purchases. From the patients that are currently being treated in the clinic, do you have an idea in terms of demand that those patients would have towards buying the device? And maybe can you quantify what proportion of those patients would be able to -- or would have the means to buy the device or would be able to get reimbursed for home use?

Yes. Thank you, Jacob. So demand is quite high. There -- we're getting a lot of inbound interest from patients about home use. The one caution I would have is that not everyone has reimbursement coverage from day 1. And here, we're talking about the United States. So -- at this point in time, we think the most likely purchasers, those that have potential reimbursement will come from the military hospital system, so the VA, also those covered by Workers' Compensation insurance. Those -- they can all purchase a device without a code. We also expect some demand in the near term from those who have the means to self-pay, so to buy it themselves. And then as Sean mentioned, we're going to stand up a patient access program to support the pursuit of reimbursement from private payers on a case-by-case basis.

So that's how we're going to drive growth over the next couple of years, the VA, Workers' Comp, self-pay and private pay on a case-by-case basis as well as any sales that come from the EU and other geographies, high-profile geographies that accept FDA approval or CE Mark. We're intentionally not pursuing a code, a Medicare code at the beginning because we want to, at the right time and with the right evidence, lock in a favorable code and favorable coverage. So we may not have that for 3 years. But in the meantime, we have ample growth opportunities in front of us and certainly enough of an opportunity to sustain the sort of growth that is expected by the consensus.

Okay. And maybe just a follow-up on the reimbursement by the VA. Could you perhaps walk us through how this process would work in practice? And what criteria do they need in order to reimburse the ARC-EX device? And maybe a follow-up on that. Would this also apply to ARC-IM further down the line?

Yes. So first, I'm going to clear off the ARC-IM question, and then I'm going to turn it over to Sean Sciara, who, by the way, is a fourth-generation military veteran, and he can comment on the VA. The -- as far as ARC-IM, that has more established reimbursement pathways, in fact, globally because there are codes that exist for the implantation of neurostimulators and spinal cord leads. And then we believe we'll be eligible for new technology add-on payments and pass-through payments that are in place to support novel technology such as this.

There's also an initiative underway in the U.S. where there's a group of neurotechnology companies that are not pursuing pain and they're pursuing a higher pain code, and that's something that we can get involved with at the appropriate time. We do have some time to sort that out given that we don't expect ARC-IM to be approved in the U.S. until 2028. Now as far as how the VA works, it's a bit more complex, and I usually wouldn't take it on a call like this, but I think Sean can explain it pretty simply for the group. Sean, do you want to just handle clinic and home purchase processes within the VA?

Absolutely, Dave. Thank you. The purchase process for a clinic unit would look very similar to the purchase process for any other clinic. So it's a piece of capital equipment that gets purchased under capital budgeting processes. Where the VA will be a little bit different is in the home use setting. So the VA unlike other reimbursement kind of services or programs kind of in the United States, either public or private where a service is performed and then it's reimbursed or the piece of equipment is reimbursed, the VA is a cost-based system, not a reimbursement-based system. So they have an appropriation and a budget that they get from the government, and they can spend that kind of as they see fit in different places.

So under those auspices with the product being approved, it is eligible now to be purchased for veterans for use in the home. So the work that we'll be doing here in the coming quarters is working with all of the local VAs to establish the appropriate workflows for veterans who are coming in as part of their annual -- veterans with SCI that come in as part of their annual check-ins to evaluate them for suitability of the ARC-EX product in the home. And at that point, they could be purchased for the veteran in home.

Thank you, Sean. Sharon, let's go to David, and then I think we can convert over to the chat.

David, your line is now open.

Congratulations on the commercial progress and leadership additions, very impressive profiles there. Can you maybe talk a little bit about the clinic mix and the device utilization rates in the U.S. centers you've sold to so far? Like are they fully occupied throughout the week? Or do you have a few centers with just one or more patients coming in per week as this will be obviously crucial to drive home use next year and going forward?

Sure, David. Sean, do you want to take that one as well?

And I'm sorry, I cut out just for a second there, David.

Yes. I think David was just asking about the utilization of the devices that are in clinics now. Are they being used all day? Are there waitlist? Is there demand for more than one device at certain clinics? He just wants to get a sense for that.

Yes, absolutely. Utilization is high. Devices are used typically 4 to 5 days a week, anywhere from 5 to 8 hours a day. So as the word gets out, and we saw some of the social media that we shared in that video where clinics are using ARC-EX to promote some of the additional capabilities and technologies that they have to offer to their clients, it's bringing more demand in. And we are seeing a dramatic increase here really over the last quarter of customers coming to us and wanting to talk about the addition of a second unit. And then as we get into a lot more of our kind of purchasing discussions, a lot of these initial discussions centered around multiple units right out of the gate as some of the enthusiasm and excitement about the product is getting out. So utilization is high. And the other thing that's probably worth stating in there is we do monitor it on an ongoing basis. And what we see is it remains high. So it's not something that starts with a big bang and then tails off. It starts high and stays high from a utilization perspective.

And just the first part, right, the clinic mix. I remember initially, you set out this Tier 1 list of, I think, 75 clinics in the U.S. I think last call, you mentioned as well that some community centers are buying the device. So just curious how many of these 75 Tier 1 clinics you have ticked off so far?

Yes. Why don't I take that one, Sean. So that's not a number that we've necessarily given. What I will say is this, David, there were 25 SCI hub centers within the VA system embedded in the 75. And as I've shared with you in the past, the VA uptake has been slow this year, owing to the uncertainty and some of the instability with U.S. government spending and staffing and so forth. We are now seeing that roar back and the VA is normalizing. So I think in the fourth quarter and in the first quarter of next year, we look forward to making some very positive announcements about VA penetration, which will put us in really excellent shape in terms of penetration of those first 75.

All right. Okay. So now let's go over to the chat and our newest equity research analyst, Clement from BNP. There are a couple of questions from you, Clement. Perhaps you don't know, but he initiated coverage last quarter, our first French language coverage for those of you who are more comfortable on français. He has 2 questions here. Okay. Sean, maybe this is for you. What are we viewing in terms of backlog for ARC-EX in clinics and about the opportunity to sell multiple devices to clinics? You spoke to this a bit earlier. But maybe you can tease fourth quarter and some of the maybe new things that folks can look forward to.

Yes. I would say our sales pipeline is incredibly robust. And what we're working through for the most part with our clinic customers is just working through their capital budgeting cycles kind of around time lines. So deep pipeline that I think has us feeling very bullish about our ability to continue to grow and penetrate clinics. And the variable piece that we're working with is just the capital budgeting cycles there.

And the question about multiple units, we're -- we have many in the pipeline that are multiple deal purchases. And as we're starting to get kind of deeper into the sales pipeline in some of these larger centers, as you were referring to, Dave, with the Tier 1 centers, a lot of those centers now that they're seeing some of the momentum that's out there about ARC-EX are the ones that are talking to us about more than one unit, just understanding that they've got larger patient pools. They have kind of more complicated patient flows in terms of how they do scheduling and moving people through and just acknowledging that they may need more than one unit.

Perfect. And Clement also asks, Sean, how the home device is paired with the clinic device and whether he should consider the clinic device a master that manages multiple home use ARC-EX devices or whether the home device just links to software that's hosted at the clinic. Just a bit more detail on that.

Yes. You can think of them in many ways as tethered. So the unit we call the professional unit, which is the one in the clinic is a system that's designed for a clinic to manage many patients with many different stimulation parameters and programs, all from one central unit. And then the home use unit is a little bit defeatured in that it just allows one stimulation program to be used for one very specific person. And the way that, that is transitioned is all of the work is done in the clinic to understand how to set up the device and set up these very specific stimulation parameters that are optimized to that patient and to the rehabilitation program that's been established for the goals that they're trying to reach. And then that program is the one that is transitioned into -- onto the personal unit. And then the personal unit at home has very limited ability to change parameters at all. So that's obviously a safety feature and it is designed to make sure that the home-based therapy stays aligned with the rehabilitation program that has been established by the health care professional in the clinic.

All right. Thank you, Sean. [ Nicola Nordon ] from Paris asks, hello team, congratulations on recent achievements. Can we get a quick reminder of the ARC-IM upcoming catalysts and calendar? So there are 2 primary catalysts upcoming, [ Nicola. ] One is first participant enrollment in the UPLIFT -- sorry, the Empower BP study. So that's our pivotal study for ARC-IM, where Craig is now activated as a site, and we hope to have first participant enrollment announced here before the end of the year. The other rather important milestone would be late next summer when we hope to unblind the data and conduct an interim analysis of the first 33 participants in the study. And if things go extremely well, we may have the option to stop the study early, which would lead to an earlier approval, first half of 2028 versus second half of 2028.

There may be some additional announcements of a clinical feasibility study in the area of mobility and also some additional announcements with ARC-IM paired with a brain-computer interface to enable thought-driven movement restoration. All of those can be reasonably expected in the coming months.

All right. See, we have a couple of other questions. One is just on OpEx. Why is OpEx increasing? So OpEx is pretty flat this year. As Amori said, it was a bit down in -- or at least the cash burn, let's just focus on cash burn. Cash burn was a bit down in Q3, but that can be attributed more to the timing of project and payables versus anything else. We think that the cash burn will be fairly steady this year at around EUR 9.5 million to EUR 10 million per quarter. We do also expect that to grow next year because we are both commercializing ARC-EX and spending on the conduct of the Empower BP clinical study. However, we are continuing to approach things with a lot of focus and capital discipline. And as mentioned, we have runway into Q1 of 2027, and that's without taking down any more of our debt facility with Runway Growth Partners. So we do have flexibility and optionality in our capital structure, but we're going to keep our heads down and keep doing a really cautious job of managing our capital as we've done in the past.

Okay. I don't think we have any other questions unless you flip over to the other screen, Seb, and something else has come in telephonically. No. Okay. Anyway, thanks, everyone, for joining. Really appreciate your time and attention. Thank you, Amori and Sean, for your support today, and we look forward to delivering another excellent quarter in the fourth quarter, and we'll talk to you soon.