Onward Med Nv

Ladies and gentlemen, thank you for standing by. Welcome to the Onward Medical Full Year 2025 Financial Results and Business Update. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Sebastian Cross, Vice President of Communications. Please go ahead.

Thank you, Michelle. Good morning, good afternoon, everyone, and welcome to Onward 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 three members of Onward's leadership team, Dave Marber, CEO, Ali Kiboro, our CFO, and Sherry 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 already or via the Q&A module of the platform. With that, I'll hand over to Dave.

Thank you, Seb, and thank you all all of you who have joined us today. 2025 was a really good year for Onward. I've been doing this for three decades now as a med tech 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 three. We earned a 510 , we earned an IDE, and we earned CE mark. And we also had also 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 and stability. So a fantastic year overall. Now let me run through the achievements in more detail. So three buckets here. First on the commercial side of things, we sold 117 Archaic systems to more than 80 US clinics in just our first year on the market. We recorded 5.4 million euros in revenue, which for our US listeners is over $6 million. We received CE mark and sold our first Archaic systems to European clinics. We received FDA 510K clearance and sold our first Archaic 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 Archaic system as well. We continue to advance our future pipelines. receiving FDA IDE approval to start the EmpowerBP pivotal study for Arc IM. We published Arc IM blood pressure instability clinical data in both nature and nature medicine, significantly de-risking that indication. We published the Pathfinder 2 study results showing that sustained access to Arc EX therapy can drive improvements without plateau at one year We advanced our brain computer interface or BCI leadership, studying thought driven movement restoration in four additional people, bringing our total to seven. And we implanted our first human with the Arc IM lumbar lead, which is designed to help restore mobility. From an enterprise perspective or corporate perspective, we raised over 50 million euros in equity capital anchored by Ottobock, Invis 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, two of whom you'll be meeting today. And we filed an F1 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, ArcheX has been a resounding success and PowerBP 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 ArcheX and our rapid commercial traction. For those of you who haven't seen ArcheX, 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 US 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 one ARC-EX system. One quarter of the U.S. specialized rehabilitation clinics are already penetrated. And one-tenth of the clinics have already purchased multiple ARC-EX systems. 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, UK, 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 510K for home use in the U.S. Also in October of last year, we executed another high-quality funding round. We raised over 50 million euros 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 healthcare specialist investor Invis, and a first-time investor, 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 three new C-level executives, Sean Chiara, whom you met during our most recent call, and then Ali Kibaro and Sherry O'Quinn, who'll 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 Sherry has experience at big and small med tech companies and a very strong track record at securing access to global markets for breakthrough medical technologies such as ours. Our board of directors is also strengthened significantly. We recruited Tim Dennison, who's 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 make 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 5.4 million euros, comprising product revenues of 3.7 million euros and grants and other income of 1.7 million euros. In 2024, total revenues were 1.7 million euros, of which product revenue was 77,000. The 3.7 million euros in product revenue in 2025 came from ArcheX 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 percent penetration of the U.S. rehab clinic market. Grants and other income was 1.7 million euros, consistent with the prior year, reflecting ongoing research funding from partners including the Swiss Secretariat for Education, Research, and Innovation, SARE, the U.S. Department of Defense, and the Michael J. Fox Foundation. Gross profit was 4.4 million euros, Excluding grants, product gross profit was 2.7 million euros and product gross margins was approximately 72%. Total operating expenses were 45.3 million euros compared to 36.6 million euros in 2024. The increase reflects four areas of investment. First, the build out of the U.S. Commercial and Operations Supply Chain Organization FDA clearance for home use in November and submissions for the Empowered BP Pivotal Study. Third, professional fees associated with capital markets activities and additional legal and tax advisory work. Fourth, recruitment costs for three senior leadership hires completed during the year. The net loss for 2025 was 41.8 million euros compared to 35.7 million euros in 2024. The interest bearing loan balance was 13.1 million euros at year end compared to 14 million euros in 2024 with the movement driven primarily by foreign exchange translation. We ended the year with a cash balance of 68.1 million euros compared to 60.0 million at the end of 2024. As you will recall, we raised 50.9 million euros in the fourth quarter of 2025. Total cash outflows in 2025 were 42.8 million euros. 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 two months of the quarter. We didn't want to spoil the next call by giving you all the information for the first quarter. That'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 US is critically important because they care for almost 15% of the paralyzed population in the US. The VA cares for the paralyzed population through 25 specialized clinics, which they call VA hubs. So already we've penetrated nearly half of those 25 hubs, We're at 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 and 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 510K for home use in the US. 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, six 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 6th. Starting in Q2, we're gonna 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 US Navy veteran. He's an ArcheX 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.

Things like paper and cards or something small like this, I would have to slide it to the end of the table and pick it up with two hands. But now I can get my thumb and my pinky and pick it straight up off the table.

I'm Ashley Clark. I've been a physical therapist for about 16 years. I started Revive Neuro Recovery Center three years ago, mostly because there wasn't a place for people to go after they graduated or got discharged from traditional therapy. And I felt like people just had so much more to gain.

My name's Afton Walker. I'm from Rock Hill, South Carolina originally. I joined the Navy shortly after I graduated high school. I just happened to dive into a pool and broke my neck. My C6 vertebrae was a burst fracture, so it just completely shattered. And then I actually pinched my spinal cord at the C5 level.

We have a lot of clients with spinal cord injuries, specifically quadriplegia. So their injuries are in their neck. They don't have a lot of arm strength or some of them just don't have any hand function. So for them, transfers are hard, being able to get dressed. So they learn compensation techniques to be able to do these things, but it just takes them a lot longer to be able to do or to get ready for the day. I've been working with AJ for about three years. I met him at a rugby practice. He came in, we were just doing traditional type of rehab stuff, picking up where he left off at the VA. And then we started using ARC in May. With ARC-EX, we run our program just like the study. We do three times a week, but only one hour sessions for 24 sessions. And then we put it on and do the same type of therapy.

Definitely able to move my hands more. But at home, for me, it is easier to pick things up with one hand or I'm able to hold whatever sodas or cups I have with one hand and drink it without worrying about dropping it.

Since using Arc, he has been able to start moving his left fingers, being able to pick up things. It's still a little challenging for him. His routine of getting ready in the morning is a lot faster. I think the changes from Arc EX have made AJ more independent and more confident to go out and do things on his own. And to be able to see progress in a population that usually it would take a long time to see progress, we're seeing it in a short amount of time. So it just goes to show that if you try new things and are willing to keep an open mind, then you don't know what's going to happen.

I would say just try it because it'll get you out doing things that you didn't think you could do again.

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 ArcheX Therapy is currently being offered or posting their stories. We're very gratified to hear stories like AJ's where the device is bringing him independence, 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 ArcheX therapy being adopted, there are frequently, if not all the time wait lists 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 EmpowerBP pivotal study. EmpowerBP 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 SEI. 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 two 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 the autonomic signals such as a full bladder or even an itch. These data are really compelling to me. So eight out of 10 tetraplegics are diagnosed with orthostatic hypotension or OH. Of those, only a third are treated and 91% continue to experience symptoms even when treated. It's even worse for autonomic dysreflexia. Again, eight out of 10 are diagnosed, one third are treated, but 98% continue to experience symptoms. So this is a very worthy pursuit for our first indication for Arc IM. So Sherry 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. And it's because I was inspired by its purpose and I wanted to be part of this unique opportunity. 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 position does really well to accelerate enrollment in the study. Now I would like to share a short video of an interview with Dave and Dr. Leston Morse, who's the chair of the Physical Medicine and Rehabilitation Department at the University of Miami's 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. So 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's 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 and 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 follow 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-IN can mean for the SCI community. And following the enrollment and the successful implant in Empowered BP that we just announced, we can share that there are now four 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 in the Empowered BP moving forward. And also in 2026, we expect to enroll all the participants that are needed to get up the interim analysis in early 2027. And this is in line with our roadmap for ArchIM commercialization as early as the second half of 2028. With that, Dave will share the output.

Thank you, Sherry. All right, so we're almost a quarter in to 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 in 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 four growth drivers that we believe will contribute to very rapid growth. First are additional U.S. clinic sales. So, pardon me, Archiex 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 four buckets uh 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 Sherry 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 archiex we expect going forward two 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 archim four more news flow items one being the interim analysis from empower bp which as sherry said we expect early next year next would be uh first in human use of archim 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 three 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 new slow up coming 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 Chaupin from CIFL. 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. Thank you for taking my questions. As you said, it's for Ed Hall. So two 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 placement, including home use versus clinic use, US versus EU, and how many clinics have both additional devices? So this is the first question. And the second one is on pricing for ArcheX. So could you provide an update on pricing for the device? And has there been any significant development since launch? And any price changes you envisage for 2026?

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

Next is Clément Bassa from Yenpi Paribas.

Okay, Clément, bienvenue, welcome.

Hi, hello there. Hi, everyone. Thanks for the presentation, and I have basically two questions. The first, that I see some major European countries 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 results? And would you be allowed by the FDA to fill a submission based only on this interim result? Thank you.

Yeah, thank you. So, Claymont, 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 gonna 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, Sherry, 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 three 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 six months in order to file the TMA submission. And that's what's the driver for the TMA approval. at the end of 2028, second half.

And 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.

Okay, thank you. Okay, thank you. Is there another question from an analyst?

Yes, I think the next one is from KBC Securities.

all right that's it yeah hi uh can you hear me yeah it's up uh first of all congratulations with the with the results of course uh i do think ad clinics is indeed very good for 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 would buy the home use device that are now on clinic devices

Yeah, I think that we're still in learning mode, Matisse, for these demand drivers. We only recently got 510K 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 um more on your collaboration with the auto with autobock uh i saw in your uh annual report that uh you maybe plan to um leverage the collaboration there and potentially go to other geographies outside of europe or am i um looking a little bit too deep into that one um

Oh, it's a very good question. We, first of all, Autobach 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 a hundred 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 stop 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 dynamic there?

Yeah, thank you. China is very interesting. BCI is one of their strategic priorities in their recently published five-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. Chinese companies have not been successful in the US 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'll 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. It has eight-year human safety data and it's functioning very well in the seven 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 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 a with thought-driven movement restoration solution okay sounds good all right next thank you we have christophe domus next from kepler yes hi can you yes can you hear me yes very well okay perfect

Thanks, Dave and Conrad, for this publication. I just wanted to discuss a little bit more about the numbers in 2025, especially about in-market dynamics. And when I look at the numbers, so you have sold 117 units and showing very strong sequential growth. one quarter from the previous. I mean, the quarter over quarter growth was actually very strong. But it looks like in Q4, 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 three quarters of the year. So I just wanted to better understand 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 you will 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. Thanks.

Okay, Christoph. 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 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 US and we've already penetrated 25% of them And sure, we can penetrate more and we can sell more than one 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 sales, VA and non-VA, that are 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 ArcheX 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 clinics, but most of the growth will come from the home going forward, no question.

Very clear, thank you.

Okay. Also, I want to go back to Damian'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.

So if you go to the report in the back, we are splitting out the revenues by region. There's 3.7 million of product sales in 2025. 3.2 million of that, or 86% roughly, was in the U.S. 330,000 within Europe, and then there's another 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 3.7 million of product revenues.

All right. Thank you. Damian'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? Yeah, indeed. So at the beginning, I told you that we did file with the SEC. It's called an F1 filing for a foreign company. 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, the market conditions are not favorable. When there are no wars, the 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 will announce over the course of the next year. Also within PowerBP, 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 new slow at Onward as per usual. Any other questions from the Analyst, Seb? No. Okay. And I think we talked about Ottobock. Any other questions in the teams? No. No. All right. Ali, Sherry, what did you think of your first call?

I thought it was the first year or onwards. I'm really excited about 2025.

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

Yeah, 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?

Hi, my name is Doug Michael.

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

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