Hello, and welcome to Virtual Investor Conferences. On behalf of OTC Markets, we're very pleased you joined us for the Life Sciences Investor Forum. The first presentation today is from Onward Medical. Please note you may submit questions for the presenter in the box to the left of the slides, and you can view a company's availability for one-on-one meetings by clicking "Book a Meeting" in the top toolbar. At this point, I'm very pleased to welcome Dave Marver. He's the Chief Executive Officer of Onward Medical, which trades in the OTCQX Best Market under the symbol ONWRY, and on Euronext under the symbol ONWD. Welcome, Dave. Thank you, John. It's a pleasure to be with all of you today. Nice to be first. Hopefully, we'll get things started in a really productive and interesting way. All right, the requisite forward-looking statements slide, and then let's get rolling here. So Onward exists because it's truly an unmet need. There is no cure, nor are there really any effective therapies for spinal cord injury. Most people associate spinal cord injuries with paralysis or loss of sensation, but it comes with many other challenges: blood pressure, instability, incontinence, frequent infections, things of that nature, things that really affect activities of daily life. So outside assistance is often needed, and the quality of life can frequently be quite poor. In the middle of the slide here, you see the prevalence and incidence figures. This impacts 9 million people worldwide, about 650,000 just in the U.S. and Europe. As you can imagine, it's an expensive condition. So the average lifetime cost to support somebody with tetraplegia, meaning they've broken their neck essentially and their arms and legs are paralyzed, exceeds $5 million. So definitely a worthy pursuit. Indeed, that's our vision. We want to do something about this. Our vision is that empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them. Some want to use their hands again. Others want to stand and walk again. Others want to go to the bathroom without having to insert a catheter each time. And fortunately, our therapies, our technologies have the potential to help in every one of these areas. This is an overview of Onward Medical's technologies. We have three purpose designed technologies, each of which stimulates the spinal cord, and they're all at different phases or stages. The first is called ARC-EX. This is an external stimulator. This is now commercially available in the U.S., Europe, and other geographies. We also have our own implanted platform, an implanted IPG or pulse generator and family of spinal cord leads. This is now starting pivotal or phase three trials around the world. And then we have our own brain-computer interface platform. We call it ARC-BCI. This enables thought-driven movement restoration, and this is currently in the clinical feasibility study stage. Just some overall highlights about the company. We're headquartered in the Netherlands. Most of us are in Switzerland, and we have a growing group of people in the United States, a field sales and service organization, a clinical trial organization. Very unique company. So highly differentiated technologies. We have 10 FDA Breakthrough Device Designation Awards. I think that's more than any company on Earth. We have a very compelling body of clinical evidence, several publications in Nature, Nature Medicine, New England Journal of Medicine, so top-tier journals that help us understand our underlying mechanisms of action. We are leaders in brain-computer interface or BCI technologies, again, enabling thought-driven movement restoration. We've announced thus far five humans implanted with our system, and we're exploiting our first mover advantage. Already, we have more than 150 patents issued worldwide, over 300 if you count country nationalizations. Our go-to-market pathway is also favorable. So we have the regulatory authorizations for our first platform already in the U.S., Europe, and other geographies. We have a large TAM into which we're introducing our first couple of products. There's already a high level of awareness among clinicians and people with spinal cord injury who can benefit from our therapies. So we won't have to spend as much money and resources on marketing. And we have a highly concentrated customer base. We're not trying to target 10,000 or 20,000 physician specialists in the U.S. or around the world. There are about 500 clinics, specialized clinics, who have the expertise to treat people with spinal cord injury and advanced movement disabilities. This is where we're establishing our channel and our long-term relationships. From a company perspective, we have an experienced global management team and a very strong shareholder base. We have two strategic investors. One of them, Ottobock, which is the world leader in prosthetic limbs, and the other is the Christopher Reeve Foundation, which is the world's largest patient advocacy group in SCI. This is their first-ever investment in a for-profit company. So very pleased to have them on our cap table. Let's now go through our technology platforms in more detail. So this is ARC-EX. This is the first platform that's approved for commercial sale in the U.S., Europe, and elsewhere. We have our own external stimulator here. It connects to leads that are placed on the skin near the area of the spinal cord that's responsible for a given movement or function. We're starting with hand function. That's controlled in the neck area. Here you see the large TAM, about $8 billion worldwide for this device, and the system is programmed by a clinician, a physical therapist, an occupational therapist using this tablet programmer that you see here. ARC-EX was one of Time magazine's best inventions of 2024, also a Fast Company world-changing idea. We conducted a pivotal study. Now to a new device. We conducted a pivotal study to get this device FDA approved and CE marked, and these were some of the outcomes. 90% of the participants improved strength or function. 87% reported improvement in quality of life. Interestingly, we saw response up to 34 years after an injury. Today, or prior to the introduction of this device, a person would have an injury, they'd have emergency surgery, they'd be in rehab for maybe two months or three months, and then they're sent home and told nothing else can be done. Here we've shown even 34 years after an injury, we can show really meaningful improvements. These data were published in Nature Medicine, one of the world's preeminent science journals. This video brings to life some of the impact this device has had and could have. It also illustrates the earned media that we're able to generate as still a relatively small scale-up company with about a $250 million market cap. Need the video, John. Now to a new device just cleared by the FDA and given a chance for the roughly 30,000 Americans with spinal cord injury. We'll talk with one of the first patients in spinal stimulation. We're hearing double, John. I don't know what we can do about that. Now to a new device just cleared by the FDA that could be a game changer for the roughly 300,000 Americans with spinal cord injuries. [Wil Reeve] sat down with one of the first patients to use this new spinal stimulation technology, and he's here with more, Wil, good morning to you. I know this story is near and dear to your heart, my friend. It is, Michael. Yeah, it means a lot to me personally as the son of a man with a spinal cord injury. And I know that being able to regain any movement is a massive development for a person with a spinal cord injury. And that's what this device showed it can do. It brings back certain mobility and with it, a new level of freedom and hope. And in one terrible moment, the woman you are about to meet lost her parents, her ability to move, and she thought her future. But now the future is here. This morning, a breakthrough for people living with spinal cord injuries. This is one of the most meaningful steps I can think of for the spinal cord injury community, and it works, and it gives us hope. Based on the results of a pivotal trial published in Nature Medicine, the FDA announcing it has cleared a spinal cord stimulation technology from Swiss company Onward. The device called ARC-EX helps paralyzed people regain some mobility in their arms, hands, and fingers, and freedom. Freedom to go from this to this. Oh yeah, that's crazy. So ARC-EX is simply electrodes attached to the skin on the back of the neck. It runs all the time, and it makes it easier for people to move. We found that the majority of participants improved strength, sensation, and hand function to a significant degree. Jessi Owen was paralyzed 12 years ago when a tree fell and crushed the car she was riding in with her parents. ARC-EX now offering her life-changing possibilities. What can you do now that you couldn't do prior to this? I can paint with my hands now. I can open a jar of peanut butter. I could feed my kids because the amount of function I had in my hands changed. It wasn't, you know, perfection, but it was enough to make meaning in my life. What hope does this device provide to you? The future of spinal cord injury treatment is being written right now. This is the moment, and this provides the hope and the stepping stone to start that journey. We're very pleased to get that technology out there. We started with a limited launch in the U.S. this calendar year, and then in the second half, we opened it up. We've already placed more than, or sold rather, more than 70 systems to over 60 U.S. clinics, and the momentum is continuing for sure. This is now an overview of our fully implanted system we call ARC-IM. We have our own implanted neurostimulator. It's implanted in the abdomen or flank that connects to one of a family of leads that's placed directly on the spinal cord. The system is recharged and programmed wirelessly through the skin using this hub. The clinician uses this tablet programmer, and the patient actually uses a smartwatch where they can turn the system on and off and control it. This is a very versatile system. We're first, though, using it to address blood pressure instability. And already, as with ARC-EX, we have major publications. We had concurrent publications in Nature and Nature Medicine in September detailing the clinical feasibility results for the first 14 people to receive this therapy worldwide. And it had outstanding results, reducing the blood pressure instability in all 14, reducing fatigue, improving bowel management, increasing their tolerance of upright postures, improving quality of life, et cetera, et cetera. Just to say, I'll just pause for a second. What are we talking about here? This is not garden variety hypertension or high blood pressure. Rather, after a spinal cord injury and sometimes after Parkinson's as well, people have this blood pressure instability. It makes it difficult for them to sit upright, to stand, or to transition body position, let's say from a bed to chair in the morning. It can also become faint or lightheaded after meals, so it can be very debilitating, keeping people homebound or even bedbound, so definitely something that we want to help to address, and this is a video that will explain more of that to you or bring it to life for you. I was very homebound. I didn't leave my room very much. Couldn't do anything basically. Was in bed most of the time or in the couch or in my chair, but then with my legs up because otherwise I would just faint maybe 10 times a day, maybe 12 times a day. It was no life, to be honest, and when the researchers turned the stimulation on for the first time, I was still in the ICU, and I remember to feel the energy rushing through my body for the first time in nine months at the time. It was an amazing feeling, and I saw my blood pressure value on the screen next to me rising to a normal level. It was like a sort of rebirth to me, and that meant the start of my real recovery journey. Of course, I needed some time to adapt to the system and to, yeah, learn how to work with it, but I immediately saw the opportunities coming back. I could immerse myself into rehabilitation, build muscle mass, have a social life again, go out with friends and family, and it also allowed my brain to function again. Since November, I've restarted my PhD at FWO, which is just amazing. It was impossible before the surgery. It's indeed one of these challenges that arise after spinal cord injury that the public doesn't know a lot about, but is really meaningful and impactful. And so we're very keen to get that indication approved by the FDA and out there in the marketplace. And again, we have started our pivotal study already. This is the third platform overview. This is our BCI or brain-computer interface platform. And here we implant a recorder in the brain, the BCI, and then that records a person's movement intention, sends it wirelessly to this tablet, which interprets those signals and translates them using AI into instructions for our spinal cord stimulator, which then stimulates the spinal cord to enable thought-driven movement restoration. It's truly a digital bridge. Once again, I have a video here that explains the technology and also shows you the impact that it can potentially have on people with paralysis. So John and Janelle, I'm going to click here, and hopefully third time will be the charm. Now, thanks to Courtine and Bloch's latest technology, five other patients can move their paralyzed limbs using their own thoughts. It's called a digital bridge, and it wirelessly connects a patient's brain to their spinal cord stimulator. To do that, Dr. Bloch implants a small titanium device originally developed by a French research institute in the patient's skull directly over their motor cortex, the area of the brain responsible for controlling movement. You see, you have the 64 electrodes. And so each of these is what? It's electrodes that are recording populations of neurons underneath, and you can immediately see which ones are the best correlated to a certain movement. Like the hip is here, and then the knee is here, and then the ankle is here, et cetera. Yeah, yeah. yeah. Started. Increasing amplitude. Marta got the digital bridge implanted in September. She's worked with a team of engineers and physical therapists to figure out how much electrical stimulation is needed to move her legs. Nice. Yeah. And hop. So that's the stimulation, the electrical stimulation is making the leg move. Yeah, Marta is completely paralyzed. This is the magic clappy. But Marta has also had to teach herself to think about moving the exact same way every time. Right. So the AI can recognize her thoughts. She practiced at first with this avatar. Stop. You have to relearn or rethink how to walk. Exactly. How well the digital bridge works still needs to be studied in a lot more patients. Go. They hope to launch clinical trials in the U.S. in the next two to three years. The FDA has already designated it as a breakthrough device, which will prioritize the review process. And Courtine and Bloch have co-founded a company called Onward Medical to bring this technology out of the lab, making it faster, smaller, and widely available. Yeah, we really appreciated that coverage on 60 Minutes. There's also a 60 Minutes Overtime feature, and both of those are available on YouTube currently. And Anderson Cooper took his vacation time. He spent three days with us on this story. Okay, the company as well, just because of our mission and the unique technology, and we really are pioneering some very impactful things. We've been able to attract some of the best and brightest in the industry. You see at left are two co-founders who were featured in that 60 Minutes piece, Professor Courtine and Dr. Bloch. The management team as well, very experienced med tech leaders with global experience. And then we've also really put together an impressive board of directors. Our board chair is the former president of Medtronic International and longtime chairman of MedTech Europe, the industry association. We recruited recently Dr. Tim Denison, who was for a long time Medtronic's preeminent neuroscience engineer and now is on faculty at University of Oxford. Lucas Buchanan comes to us from Silk Road Medical, where he was CFO. He's now on the board of several high-growth med tech companies in the United States. And Vivian Riefberg was the former McKinsey government and healthcare practice chair in the United States. So this is just an example of the caliber of people who've joined us in this important cause. We also work hard and we execute. So this slide shows you the many achievements that we can point to over the last 12 months. You can see them here. We received FDA authorization for the ARC-EX system in the United States. We recorded our first commercial sale. We met all of our sales objectives year to date. We received CE marks so we can commercialize in Europe. We got 510(k) clearance from FDA for home use, which is really where the ARC-EX System scales. Each person who can benefit from it can not only use it in the clinic, but be prescribed use of the device at home. We also advanced the pipeline. We received IDE approval from FDA to start the EmpowerBP pivotal study. We published the interim feasibility or the feasibility results in Nature and Nature Medicine. I reviewed those with you earlier. We secured exclusive rights to our BCI technology from a leading site in France. We also received several grants, and that's something that is rather unique to our company. We can advance our pipeline with non-dilutive funding. We have grants from the Michael J. Fox Foundation, the U.S. Department of Defense, the Christopher Reeve Foundation, the European Innovation Council, et cetera. We continue to broaden our IP portfolio. We implanted the first human with our lumbar lead, which is an important lead placement for standing and walking. From a corporate perspective, we've raised over EUR 100 million in equity over the past 12 to 15 months. I think that's around $125,000. We've secured two strategic investments from Ottobock. Ottobock is, I'll spend some time here. They are number one investor. This is the company that's the global leader in advanced prosthetic limbs. They've been in existence for over 100 years. They have 9,000 employees. They operate in over 50 countries. So a lot of expertise, same ethos, and a lot of history in the space. We did establish the ADR program as well last year so that those of you who wish can transact or trade share or share equivalents in US dollars. And we continue to strengthen our board as well. In terms of milestones, we put this up at the beginning of the year. You can see we've knocked out nearly all of them. There are a few milestones remaining. So some upcoming news flows that could be catalysts for the stock. First commercial sale of the ARC-EX system outside the U.S. First participant enrollment in the Empower BP pivotal study. First in human use of the ARC-IM device to address urinary incontinence, so underactive bladder after SCI, and then additional brain-computer interface implants. All of those could happen in December, January, February. Upcoming catalysts for those of you who may have interest. So that's the end of the prepared presentation. I'm very happy to answer questions. I see several of them have arisen. Let me see if I can scroll through here. I just see five through eight, by the way, Janelle. I don't know where to get to one through four, so let's just start with those. One question is, how many ARC-EX systems have been sold and deployed globally, so heretofore, we've announced that we've sold over, we've sold 70 systems to over 60 clinics. That was at the end of the third quarter, or at least when we did our third quarter update. Fourth quarter is going very well, meeting our expectations, so we look forward to announcing Q4 and full year results early next year, but we can guide that the commercial traction continues to meet expectations and be very strong, and I didn't have that slide in this particular deck, but we have received thousands of inbound indications of interest, unsolicited, from individuals with SCI, family members, as well as rehabilitation clinics, all wanting to learn more about or to trial the device. As a result of the fact that there's so much demand, our field organization is actually comprised solely of physical therapists and occupational therapists. So it's very much of a consultative sale for us, really putting the patients at the center, which is a nice segue into the next question is: how will you go to market? And indeed, because we have a limited number of these specialized rehabilitation clinics who care for people with spinal cord injury and stroke patients and others with movement disabilities, we can go to market ourselves. So we've already put together a U.S. sales organization, has 12 people today, likely to grow next year. And then in Europe, we're also putting together a field organization. In Europe, we'll have more of a hybrid approach. Certain countries will be direct, others will be indirect through distributors. Moving on here. Reimbursement pathway for ARC-EX in the U.S. and Europe. Very good and well-informed question. We'll talk. I'm going to focus more on the U.S. because it's simple and more straightforward, so this is the ARC-EX device, by the way. I'm holding it here. We are intentionally not pursuing Medicare coverage initially because we don't want to be crosswalked to a legacy device that doesn't have anywhere near this device's capabilities. This is really a pioneering device. We went through a De Novo pathway to get approval. There is no predicate for it. There's never been a device FDA approved shown to improve strength and sensation like this after spinal cord injury, so we're going to, again, intentionally not pursue CMS coverage for a couple of years so that we can amass real-world invoicing and usage history. In the meantime, we are confident we can grow the top line impressively because we can sell into the VA, the military hospital system without a Medicare code. Also, anyone covered by workers' comp can get this paid for. We expect healthy self-pay demand for this. And we intend to support private insurance on a case-by-case basis until they make policy decisions. So the way I would describe this is growing in the next couple of years, maybe three years with U.S. VA, U.S. workers' comp, U.S. self-pay, some private pay, also OUS sales into clinics as well, and some OUS home use sales. And then we expect Medicare approval, and that's where we'll really surge. Around that time, by the way, we also expect approval of the ARC-IM device. So we'll begin to layer in revenue, and that's where our growth will come from. All right, let's see. What are the key, let's say, more about the Empower BP trial, key endpoints, enrollment, timing? Again, another well-informed question. So with Empower BP, we're looking at whether the ARC-IM system can address blood pressure instability in people with chronic spinal cord injury. So this is a randomized control trial with a sham and a crossover. So two-thirds of the participants will be randomized to Stim On, one-third to sham. And then there'll be a crossover. And so everyone will eventually be on the therapy. There'll be an efficacy measure at a certain time, and then a safety measure as well. What's interesting is that we, because of Breakthrough, we have a lot of interaction with FDA, and we've built in an interim analysis. So after 33 patients, when we have efficacy data, we can unblind the data and potentially end the study early. If not, okay, fine, we'll continue to enroll. We can enroll up to 112 patients at up to 22 sites worldwide. In terms of outcomes measures, there's one objective measure, which is seated blood pressure. And there's one subjective measure, which is patient-reported outcomes. So the severity and frequency of blood pressure instability events. So that's Empower BP. We hope to, again, get to that interim analysis point by late next summer. We hope to fully enroll by maybe late next year or maybe a bit into 2027. And the target here is that we get this ARC-IM device approved and on the market sometime in 2028 in the U.S. Okay, are we fully funded for 2026 milestones? Yes, indeed. We completed a financing recently, a follow-on financing of EUR 50 million or $60 million. This was closed in late October. Very good round. It was anchored by three investors, Ottobock being one, our strategic investor, also Inkef, which is a very well-known and respected life science investor that operates globally, and a.s.r., which is a leading insurance company based in Amsterdam or in the Netherlands in any case. So we had a strategic, a specialist, and a generalist as anchors. And then we raised the additional funds from a number of other long-only and very good investors who are on board, also mission-driven investors as well. And we've indicated that we have runway into 2027. Okay, next question. Timing for revenue ramp. Yeah, so we haven't guided on revenue, just checking time. Oh, we're almost out of time. We haven't guided on revenue, but the consensus is that we'll do in year one, let's say, $6-$6.5 million in revenue. And then next year in the mid-teens, which is absolutely right down the middle if you look at other successful high-growth med tech companies over the last decade or so. So we're definitely on the right path, and we're highly focused on execution. So with that, thanks for all the excellent and well-informed questions. Thanks for your interest. If you want to learn more, you can send an email to investors@onwardmedical.com. That's onwardmedical.com. Or follow us on social media. All of our channels, all of our handles are onward empowered, ONWD empowered, all one word. Thank you very much, John and Janelle, back to you.