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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Sébastien Cros, Vice President of Communications. Please go ahead.
Thank you, Michelle. 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 three 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'll 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 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. I'm 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(k), we earned an IDE, and we earned CE mark. We had a quite rare occurrence. We had simultaneous like publications in Nature and Nature Medicine, detailing the clinical feasibility results for our first indication for ARC-IM, blood pressure instability. A fantastic year overall.
Now let me run through the achievements in more detail. Three 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 continued 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 de-risking that indication. We published the Pathfinder2 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. 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 EUR 50 million in equity capital anchored by Ottobock, Invus, and ASR. We established a U.S. 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.
We filed an F-1 registration statement with the SEC for a potential Nasdaq IPO in the next 12-18 months. That doesn't mean we're gonna do the IPO in the next 12-18 months, but we wanted to demonstrate that we're making tangible progress toward preparing for such a listing. 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 2026 and 2027. The entries here that are shaded, I'll be going into more detail in the next slides. Okay, let's talk about ARC-EX and 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. 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. We increased the field organization, and we broadened the launch. 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 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. 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. There are 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 healthcare specialist investor Invus, 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 Sciara, whom you met during our most recent call, and then Ali Kiboro and Shari 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. Shari 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 has also strengthened significantly. We recruited Tim Denison, 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. 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 gonna 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 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 State 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 four areas of investment. First, the build-out of the U.S. commercial and operations supply chain organization. Second, the external spend regulatory approval activities, the CE approval for ARC-EX in September, 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 three 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. 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. Welcome.
Thank you.
All right. Now onto some commercial trends. This is a 2025 full year call, but we're coming to you on 31 March 2026. We thought we would share at least some of the trends so far from the first two months of the quarter. We didn't wanna spoil the next call by giving you all the information for the first quarter, so it's a bit of a tease. Let's take a look at how we did first within the VA clinics. 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, what they call VA hubs. Already we've penetrated nearly half of those 25 hubs.
In fact, we're in 11 of the 25. 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 DOD and some other dynamics. Now that they are active and engaged, they're really coming on quickly. 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. 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. 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. 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. Doing what we can to support and broaden access to this really important therapy. 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.
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. 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 Neurorecovery 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 Affan 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. For them, transfers are hard, being able to get dressed. 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. We started using ARC-EX 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. Then we put it on and do the same type of therapy.
Definitely able to move my hands more. 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, been 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. 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. It just goes to show that, like, if you try new things and, are willing to keep an open mind, then you don't know what's gonna 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. 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 independence, helping him get dressed in the morning, feed himself, and so forth. That really is the value proposition here. That's why at the clinics where we're seeing ARC-EX 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, that's ARC-EX where it 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 mask 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. 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. 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 autonomic signals, such as a full bladder or even an itch. These data are really compelling to me. 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. This is a very worthy pursuit for our first indication for ARC-IM. 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. It's 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. 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. 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 this 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. Okay. 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's Miller School of Medicine, located in Miami, Florida. Dr. Morse's site was recently activated, and she's gonna share with us the significant impact on the daily lives of patients who are living with blood pressure instability. With that.
Dr. Morse, thank you for your time.
Thank you. It's a pleasure to be speaking with you today.
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. It often goes unrecognized both by the patient and the clinical team as well. 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.
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?
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. 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 this study would demonstrate that neuromodulation can target autonomic dysfunction after spinal cord injury, not just motor or sensory systems. 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-IM can mean for the SCI community. Following the enrollment and the successful implant in Empower 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 Empower BP moving forward. Also in 2026, we expect to enroll all the participants that are needed to conduct the interim analysis in early 2027. This is in line with our roadmap for ARC-IM commercialization as early as the second half of 2028. With that, Dave will share the outlook.
Thank you, Shari. All right, 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. In last year, we were focused almost solely on launch to U.S. clinics. 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. 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. EU and rest-of-the-world opportunities, both clinic and home use.
These four 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. 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 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 ARC-IM, four 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 three of those are, in fact, grant funded. Then we expect to continue to extend our leadership in the brain computer interface realm to address movement disabilities. We expect additional implants for SCI upper limb and as well, first implant of the ARC-BCI therapy for stroke, also grant funded. A lot of news flow upcoming.
There may be some things that we don't even have on this slide. 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. I think Damien is filling in for him. Damien, take it away.
Hello. Can you hear me?
Yes.
Yes. It's Damien. Thank you for taking my questions and, as you said, it's for Ed Hall. Two questions actually. First one is on the split in ARC-EX device placement. Would you be able to provide some more granularity on the location of device placement, including home use versus clinic use, U.S. versus EU, and how many clinics have bought additional devices? This is the first question. The second one is on pricing for ARC-EX. Could you provide an update on pricing for the device? Has there been any significant development since launch and any price changes you envisage for 2026? Thank you.
Thank you, Damien. 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. There's that. In terms of pricing, yeah, there have indeed been developments. The clinic pricing remains $39,000 list price, and the home unit or the personal unit, as we call it, has a list price of $29,000 . 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 Bassat from BNP Paribas.
Okay. Clément, bienvenue. Welcome.
Hi. Hello there. Hi, everyone. Thanks for the presentation. I have basically two questions. The first that I see some major European country are excluded from your target, like France. Could we know why? Is it a price concern or regulatory concern or maybe an access concern among the French clinics? About Empower BP, I have in mind 60 participants and an interim results in 2027. How many patients are required to provide interim results? Would you be allowed by the FDA to file a submission based only on this interim results? Thank you.
Yeah. Thank you. Clément, 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. 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. Certain countries will go direct, certain countries will go through a distributor partner. 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. For the interim analysis, we need 33 patients at three months to do the interim analysis to determine if we can stop enrollment. 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 PMA submission. That's what's the driver for the PMA approval at the end of 2028, second half.
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. 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 Mathijs Geerts Danau from KBC Securities.
All right.
Mathijs?
Yeah. Hi. Can you hear me?
Yes.
Yes.
First of all, congratulations with the results, of course. I do think 80 clinics is indeed very good for a 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?
I think that's. We're still in learning mode, Matthijs, 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. We're monitoring the demand. 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 know, you saw that the pipeline had 92 people in it. That we think was quite strong. In fact, that surprised us to the positive. 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. I hope to see some developments there as well. 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? Am I looking a little bit too deep into that one?
Oh, 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. We greatly value them as a partner. We learn a lot from them. They have experience in many, many global markets with similar devices. We leverage that certainly. 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. 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, yeah, the 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 electric cars and alternative energy. They're also making a lot of progress in biotech. 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'll be exploring potential partnerships there. 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. That's our real strength. 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. We can pair our ARC-IM or spinal cord stimulator with anybody's BCI as long as we take the time to connect the software. 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. 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 thought-driven movement restoration solution.
Okay. Sounds good.
All right. Next.
Thank you. We have Christophe Dombu next from Kepler Cheuvreux. Christophe?
Yes. Hi. Can you hear me?
Yes, very well.
Okay, perfect. Thanks, Dave, and congrats for this publication. I just wanted to discuss a little bit more about the numbers in 2025, especially about in-market dynamics because when I look at the numbers, so you have sold 117 units and showing very strong sequential growth quarter-over 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.
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 it is just some, I mean, limitation due to your resources? If you can comment more about what happened in Q4. Also one second question is question is about 2026. I was wondering if at some point in the year you will be able to provide us 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, Christophe . 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. Moreover, we wanted to limit the launch because it was a new technology, and we wanted to see how it went. That was expressed largely in Q3. You saw an increase sequentially from Q3 to Q4. Nearly all of those sales were into clinics. As you know, there aren't that many clinics in the U.S., and we've already penetrated 25% of them. 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 gonna grow that fast going forward.
Indeed, the clinic business is most important for us because it provides the foundation for home use sales. It's home use sales, VA and non-VA, that are gonna 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. 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 units-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 wanna go back to Damien's question from Stifel because I told him that we weren't gonna split out the sales by geography, but Ali reminded me that it's actually in the annual report. We are indeed comfortable sharing that today. Maybe, Ali, you can share the geographic split as conveyed in the annual report.
Sure. Damien, if you go to the annual report at 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 would 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? Yeah, indeed. 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 gonna be very prudent. We're gonna 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. That answers question number one. Question number two is what are the remaining clinical catalysts, particularly for ARC-IM? 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. No shortage of news flow at ONWARD as per usual. Any other questions from the analysts, Seb?
No.
Okay. I think we talked about Ottobock. Any other questions in the Teams?
No.
No? All right. Ali, Shari, what did you think of your first call?
Fantastic first year for ONWARD. Really excited about 2025.
All right.
I had the pleasure of announcing the first implant in the Empower BP and am 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?
I really enjoyed my call.
All right. Well, thanks everyone for joining. Thank you, Michelle from Virginia for moderating.
Thank you.
Thank you. This does conclude today's conference call. Thank you for participating, and you may now disconnect.