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.