Onward Medical N.V. (ONWD) Earnings Call Transcript & Summary

Welcome to Onward's Q3 2024 Business Update. I am Dave Marver, CEO. A reminder that today's event will contain forward-looking statements, which often differ from actual results. Any forward-looking statements communicated today reflect the company's current views and are subject to risks and uncertainties. Today, I have the privilege to be joined by Amori Fraser, our Finance Director; as well as Dr. Jocelyne Bloch, Neurosurgeon, Co-Founder and Onward Medical Adviser; as well as G Courtine, Neuroscientist, Co-Founder and Scientific Adviser. We will start with a presentation and prepared remarks, and then we would be pleased to take your questions. As we normally do, for those of you who are new to the story, we're going to start out with an overview of the company. So this is an at-a-glance slide or a summary. You can see we were founded in 2015 by Professor Courtine and Dr. Bloch. We now have about 100 team members headquartered in the Netherlands, but we have a science and engineering center in Switzerland, where we're currently broadcasting. And we have a growing U.S. presence in anticipation of our forthcoming launch of the ARC-EX system. We listed on Euronext Brussels and Amsterdam in late 2021, and we recently added a Euronext Paris listing, and we currently enjoy research coverage from 5 equity research analysts, most recently from Stifel, also Bryan Garnier, KBC, Degroof Petercam and Kepler Cheuvreux. Onward has 3 purpose-built neuromodulation platforms, all of which stimulate the spinal cord to restore critical movement and function after spinal cord injury. ARC-EX delivers our ARC therapy externally through the skin. ARC-IM is a fully implanted system, and we also have ARC-BCI, which pairs ARC-IM with an implanted Brain-Computer Interface to restore thought-driven movement via our wireless digital bridge. We're a very innovative company. We have 10 FDA breakthrough device designation awards and over 270 issued patents worldwide. In terms of clinical progress, we've already demonstrated the safety and effectiveness of ARC-EX therapy for upper limb function, that was demonstrated in our uplift pivotal study that was -- the results of which were published in Nature Medicine in May 2024. We also have positive interim results for ARC-IM and its initial indication that is addressing blood pressure disregulation after spinal cord injury, those were released in December 2022. We are launching into a large total available market, EUR 20 billion plus -- or dollars plus, I should say, with limited competition, and we expect FDA authorization and U.S. launch really imminently in the coming weeks. Our vision is that empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them. And we have developed or are developing 3 technology platforms that are very flexible and can indeed address many or all of the recovery targets that are prioritized by those with spinal cord injury. Here, they are pictured, ARC-EX, ARC-IM and then ARC-BCI. Even though we have a lot of recovery targets and a lot of activities here, we're very focused as a company and good stewards of capital. So in the short term, our focus is commercializing ARC-EX. We then want to start the global pivotal study for ARC-IM and then get that commercialized in the 2026, 2027 timeframe that would put us in the traditional NASDAQ IPO or M&A window, and then thereafter, we can easily expand indications, expand into adjacent populations as well as expand the platform to include the Brain-Computer Interface technology. This is a list of all of the recovery targets for which we've already achieved human proof of concept. Indeed, there's -- the last one here, bladder, we expect to do first in human in 2025. We, as a company, are very focused on the top 2, those in gray, and we're advancing the others in our pipeline with the benefit of brand funding. The company has received grants from DARPA, the U.S. Department of Defense, the Michael J. Fox Foundation, the Christopher Re Foundation, the European Innovation Council to name just a few. All right. Now to the update. This was quite an eventful quarter for us. Q3 and starting left to right. So in July, we announced publication in the journal Neuromodulation that contained programming suggestions for ARC-EX therapy. It will be very helpful to clinicians and physical therapists once this device is authorized by the FDA and we get it -- make the therapy available in clinics. In July, we announced the publication of our annual sustainability summary for the full year 2023. Many of you as individuals, this is important to you or if you represent institutional investors or funds, you have an ESG mandate. We certainly qualified. In September, we were awarded a grant from the Christopher and Dana Reeve Foundation to further use our Brain-Computer Interface system to study upper extremity function. We also, in September, announced the third implant of the ARC-BCI system or therapy to restore movement after spinal cord injury, movement driven by thought. In September, we expanded and not only do we have a listing on Euronext Brussels in Amsterdam, but we now have a listing on Euronext Paris. The company has deep ties to France. One of our founders, G Courtine, is son of [indiscernible]. And we have an important relationship now with CEA, the developer of the WIMAGINE BCI. So we wanted to expand the availability of our shares and drive more liquidity and investor participation in France. In October, we secured exclusive rights to the CEA WIMAGINE BCI technology, more to come on that. Also in October, we welcomed a new incoming board chair, that's Rob ten Hoedt, who's a former Medtronic President, more to come on that. Also in October, we announced that we had successfully raised EUR 50 million in an upsized fundraising initiative, and we added Ottobock as our largest investor, more to come on that. And in October, just kind of a nice thing, the ARC-EX system in a nod to its innovation was named one of Time Magazine's Best Inventions of 2024. In November, we announced that we were awarded another grant this from the European Innovation Council to address upper limb movement challenges after stroke. So reinforcing that even though SCI is our North Star, our same hardware platforms and therapies can potentially be used to help people enlarge adjacent populations such as Parkinson's disease and stroke. All right. So let's go into more detail regarding those highlights that were bracketed in red. Starting with our exclusive license of the CEA WIMAGINE BCI technology. We forge an exclusive license agreement to bring that technology in-house. This was my quote from the press release, CEA, Clinatec is a world renowned by a Medical Research Institute and its BCI is ideal for our applications. We can now develop a truly integrated system that is well suited for the type of study required to gain regulatory approval and bring a BCI-enabled system to market. And then from my counterpart at CEA, Guillaume Charvet, who heads the Neurotechnology biomedical research unit there. The early clinical feasibility research demonstrates the remarkable potential of the ARC-BCI system to restore thought-driven movement and function after paralysis. We are pleased to partner with Onward Medical. So now I'm privileged to invite 2 of my colleagues, co-founders of Onward Medical, who have pioneered this BCI research G Courtine, neuroscientist and Dr. Jocelyne Bloch neurosurgeon. So come join me here on the camera. Thank you very much. So I thought we'd just keep things informal today and do just a bit of an interview or discussion. Jocelyne, maybe you can explain how the WIMAGINE BCI is implanted?

So the WIMAGINE BCI is implanted in 2 parts. The first one is the ARC-IM that implant above the region of the spinal cord that is controlling leg movements. And then the second surgery is to put the BCI implant, as you said. It's a little bit like an electronic bone. It's not a very invasive surgery for me. I opened a skin, I remove a piece of bone and I replace it with this electronic bone that is then going to record the thoughts of the patient. Everything is closed, and that's it. The day after the surgery, the patient can go home.

So for a neurosurgeon like yourself, who is accustomed to working with devices, is this a difficult or easy implant procedure?

So the BCI, the brain implant for me is an easy procedure. You just have to know the anatomy and where the region of the brain that is controlling leg movement or hand movement is located. And then you center your [ craniotomy ] on this region, and you don't even have to open the envelope around the brain that is called the dura. So everything is outside of the -- from the brain. So the risk is very minimal, and it's just a bone work.

So versus other BCI technologies, would you say this is actively noninvasive?

Absolutely. So the other technology I know and I've worked with are more invasive. It means that you implant electrodes in the brain of the patients. And this is more invasive, of course.

Okay. So G, how does this BCI system, ARC-BCI really work? How does this technology that Jocelyne just described result in thought-driven restoration of movements.

So the overall idea is that with this BCI system, we are recording what is called local feed potential. Each [ electrodia 64 ] on this electronic bone record activity of about 1,000 neurons, and from these recordings, we have an artificial intelligence that decode the intention to move, that means the legs or the upper limbs and translate this intention to move into a stimulation at the correct location, current parameter, correct timing in order to elicit the desired movement. So digital bridge between the brain and spinal cord that turn the thought into actions.

And would you both, you can both respond here. Why is the WIMAGINE BCI are preferred BCI at this point?

Yes, we both have argument for being in love with this device.

For me, it's clearly the non-invasiveness and the fact that it's a very stable signal that we get all over the time. So for me, those are the main features why I liked...

You show us like to say, WIMAGINE the concept was conceived by neurosurgery, which is kind of unusual. Usually, it comes from someone who does a technology. That's why she loves it because it has been conceived with this idea that I need to implant this in thousands of people. So it's very resistant to even surgical mistake in a way.

This is the same neurosurgeon who invented DBS as well. It has a very good reputation. Now Jocelyne talked about the stability of signals. And is that because unlike other BCIs, that penetrate the brain and the brain sort of fights back to protect itself that can degrade signals that doesn't occur here?

Exactly. This is why I love this WIMAGINE system. I know you do. But the [ load activity ] for an engineer is the best. So of course, these like little wires that to penetrate and set into the brain that are amazing to recover, which is called single unit, meaning individual neurons, which for research is amazing. For clinical application, it would be amazing if this signal will be stable over time, they declined. So at the beginning, it's like the epiphany of the honeymoon looks amazing. You have seen the data from Neuralink, the person can control a computer, play a video game. And then over the month, it degrade, declines, it's frustration, patient express frustration. It's completely different than WIMAGINE, 7 years of clinical data with highly stable seniors.

Yes. I think that's important. So these BCIs that penetrate the brain, those signals can degrade that does not occurred so far with the WIMAGINE BCI, 7 years human safety data and solid signals. Very good. So how are we using the BCI today in your research? And how do you foresee we might use it in the future?

So currently, I mean, the first step for us, we are now with the restoration of walking. That has been the first application. As you probably have all seen, [indiscernible] took the first step, [indiscernible] implanted the second participant, woman with a complete spinal cord injuries, so the most extreme severity of spinal cord injury, no sensation, no movement below the injury. And in this case, both of them, they think about the movement, they stimulate themselves, and they can stand, take voluntary step, adjust the height of the steps to really accommodate the leg movement to the [ environmental ] constraints.

So 2 so far for leg mobility or locomotion and then...

There was one patient so far for upper extremity movement. It's exactly the same principle, except that in that case, you record the region that is controlling upper extremity movement and you stimulate the region of the spinal cord that is controlling also the upper extremity movement. And the link is exactly the same. So the principle is the same. So far, we've also implanted in one patient. Soon, we'll have a second one.

In January.

And it's very impressive to see how we can train them the same way and how independence they get different movements for daily activities.

And more implants are coming, right? We collectively are benefiting from a grant from the Christopher Reeve foundation, which will support several hand and arm function for BCI...

Up to 8, probably 4 per limb, probably 4 for the limb. And we also have a support from the European Union to test the same concept to improve the recovery of the stroke. It's a very exciting time for the brain-controlled spinal cord stimulation.

Well, very good. Well, I'm very grateful to you for founding Onward Medical. I enjoy working with you, and thank you for joining me today.

Thank you for driving me to success.

Thanks very much. All right. That was a treat. Moving on, just a bit more detail on the why. You heard about the clinical and scientific rationale behind our decision to license this WIMAGINE BCI exclusively and make it an Onward technology. But for us, as a business, this enables us to be first to market with a BCI-enabled system to restore thought-driven movement after paralysis or movement disabilities, you heard about the potential applicability for stroke, for example. It also gives us full control over a technology that really is the best fit for onward indications, and it gives us an opportunity to develop a truly integrated system under one quality system, single interface. So this also provides advantage to us as we prepare to initiate a global clinical trial for this technology at some point in the future. And you heard that this is -- it's a very fertile area. A lot of people have interest in it. And as a result, we can indeed attract grant funding to support the research. You heard 2 such examples from G Courtine from the European Innovation Council and the refoundation, so we can advance this technology, learn, move it forward in the pipeline with the benefit of grant funding. So certainly, that's an advantage. Also, in this quarter, as I mentioned, we have continued to strengthen and evolve our board. So I'm very pleased that Rob ten Hoedt is joining us as incoming chairman. Rob is former Medtronic President and Executive Committee member. He has 30 years of experience in MedTech, successful track record in technology development, commercialization and business model innovation. Also, he's an industry leader. He was a long-time chairman of MedTech Europe, the association representing the medical technology industry here in Europe. I've known Rob for 25, 30 years. I'd lost touch with them. I saw him in the Geneva Airport about a year ago and started my pursuit, and I'm very pleased that he decided to join us. He's very much captivated by the mission and excited to reengage with the company at our stage it reminds him of Medtronic in the early days. Also, we've recruited Rahma Samow, who is a commercial expert community builder. She's certainly a sitting CEO of ClearChoice Dental Implant centers, which is a U.S.-based dental implant provider. She's a digital health and direct-to-consumer business leader and also an esteemed background, former member of the Executive Management Board of Straumann Group and also she spent 15 years with Siemens Healthineers. So 2 additions that are going to strengthen our Board as we transition from a development phase to a commercial stage company. Also, the capital raise, which was big news this year, we raised EUR 50 million in an upsized capital increase, part of that raise was a strategic investment from Ottobock, they're a global leader in prosthetics, orthotics and exoskeleton technology. They're now the #1 shareholder of the company, around 10% of our shares. And this initiates a strategic relationship with the company. I'll get more into that in the next slide. This financing was important. It extends our runway for 2 years or more. And also in addition to bringing Ottobock onto the cap table, we recruited several new high-quality, long-only and sector specialist investors. So a very good, high-quality financing for the company. In terms of Ottobock, we are grateful for the investment, but we're also excited about the opportunities to collaborate with them. This is a company with over 100 years of experience serving people with movement disabilities. They are a global leader in prosthetics, orthotics, exoskeleton technologies serving the same people that we are working so hard to serve. And they have scale. They are private companies. So many of you maybe have not heard of them, but they operate in 60 countries, 9,000 employees, over 400 brick-and-mortar patient care centers, EUR 1.5 billion in annual turnover and nearly EUR 300 million in adjusted EBITDA. So a financially strong company and partner as well. As I mentioned before, they're now our largest shareholder with just around 10% of our outstanding shares, and we are going to take this opportunity now to explore commercial and development collaborations that will benefit both companies. On the right side of the slide, you see a from the Ottobock owner. This is a family-owned company, been in the family for 100 years. Professor Hans Georg Nader is their owner and chairman. What he said, Onward Medical has the potential to become a game changer in the therapy of spinal cord injuries with its innovative solutions. Our investment in Onward is an investment in the future of medical technology. So we're very pleased to be working with Ottobock and we appreciate the investment very much. Also recognizing that we could represent the future of medical technology is Time Magazine, which recently named the ARC-EX system, one of the best inventions of 2024. And we believe in this system very much as well. We're very keen to make it available to people with spinal cord injury, and we're hopeful that occurs just in the matter of the coming weeks. Now for a financial update. I'm pleased to welcome Amori Fraser. This is perhaps the last quarter where we restrict the financial update to just cash. Hopefully, we'll have a bit more to talk about going forward. Amori, take it away.

Thank you, Dave. We closed the third quarter end of September with a cash balance of EUR 23.2 million, representing a cash burn of EUR 8.9 million. The EUR 8.9 million of cash burn includes transaction costs that related to the debt financing we concluded in the second quarter. And net of these transaction costs, the cash burn is in line with historical averages from previous quarters. Following a successful capital raise in October, our cash balance for last week closed on EUR 65.8 million. And as Dave mentioned, we are confident that our cash position will fund our operations for 2 years or more. Back to you, Dave.

Thank you, Amori. And we won't always provide our most recent cash balance, but we thought that, that was particularly salient today given that we just had the financing, and we have a much stronger cash position than we did at the close of the third quarter. All right. Now moving on to the outlook. As usual, there's a lot of upcoming news flow and several important catalysts. They include FDA clearance of the ARC-EX system, first commercial sale of that system. And then we're keen to also make the technology available in Europe. So we look forward to announcing MDR submission. CE Mark certification and first commercial sale of ARC-EX in Europe. As mentioned before, our therapies and our systems that we've developed for SCI have the potential to also help people with Parkinson's disease. So we have an ongoing clinical feasibility study for Parkinson's disease mobility. We look forward to announcing that first patient enrollment in the near future. And also, we expect detailed results from for first 14 people who have received our ARC-IM therapy to address blood pressure disregulation. That should be published in a top-tier medical journal in the coming weeks or months. Now staying on the theme of ARC-IM, we're also keen to get that global pivotal study start. We call it Empower BP. So we look forward to announcing IDE submission, IDE approval and first patient enrollment in that study, which will be a global study with centers in the U.S., Canada and Europe. We also want to continue to use ARC-IM to explore future indications in clinical feasibility studies. As I mentioned before, we look forward to enrolling a patient in a bladder study. This is underactive bladder, another category in which we don't have competition because the incumbents are addressing overactive bladder. And then of course, we'll announce additional implants for ARC-BCI as they arise. So a lot going on here. We're going to stay busy. So that's the end of the prepared remarks, and I'd like to open it up for questions now. So you can either raise your hand, and we'll call on you or we're happy to also take questions through the chat function.

I already see one question coming in, which is at what stage are you in obtaining approval to introduce ARC-EX to the European market, are you first waiting for FDA approval? And if so, why aren't you doing both at the same time? Okay. Fair question. Yes, indeed, we want to get FDA approval first or FDA authorization, De Novo authorization for ARC-EX. We're also, though quite busy. Our regulatory group is quite busy in getting the IDE prepared, so we can initiate the global pivotal study for ARC-IM, called Empower BP. So we're doing 2 things at once already, 3 things would really be too much for a company of our size. We're trying to be, again, efficient stewards of capital and not take on too much or add too many resources. So once, both of those processes are well in hand, and we have FDA authorization to market ARC-EX in the U.S., then we will pursue CE Mark certification in Europe. So this is something that we're guiding will occur in the first half of next year so that we can have authorization to make ARC-EX available in CE Mark countries in the second half of next year. Okay. Got another question here that came in from David Pepper, who is a frequent guest of these calls. Will the ARC-EX initially deployed at clinics versus home? Indeed, that is our expectation. We want to get started in the clinics. Those are our anchors. That's where people with spinal cord injury will first experience the therapy, learn about it. Their stimulation parameters can be established in the clinic. So we're going to ramp up relatively slowly starting in a select number of clinics expanding from there and then making the device available for home use. So that's the current plan, David. Okay. Any other questions maybe from our traditional analysts, Okay, I see. All right. Let's start with Thomas, you first, Thomas from KBC.

Yes. First of all, congrats on another strong quarter. A couple of questions from my side. Maybe first one is indeed on the FDA approval there. Could you share some sentiment on your level of confidence that the approval would still come before year-end, which is pretty much 30 days from now. What makes you so confident that will arrive within that time frame? And then I'll have some follow-up questions later as well.

We remain confident that we'll receive the authorization this calendar year. That has been our guidance for several months now and we've learned nothing that would provoke a change in that guidance. This is one of our 10 Breakthrough Device designation awards. So we have frequent and high-quality interaction with the FDA. And again, I don't want to say anything more, but at this point, we continue to believe that FDA authorization is likely this calendar year.

Okay. And if I could make use of the fact that the KOLs are there as well, maybe a couple of questions for them as well. Perhaps for Dr. Bloch. Could you give a bit of an indication of how easily is this for a neurosurgeon to be trained to implant the full ARC-BCI system, including both the brain chip and the neurostimulator. And also from a patient perspective, how long do they require hospitalizations before and after the procedure and what the main risks could be. And then perhaps to Professor Courtine. I was wondering if you could share your views on where you currently see and the biggest potential actually for ARC-BCI from a clinical from an academic point of view, across the different indications, SCI, stroke, Parkinson's, maybe others and why?

So do you want Dr. Bloch to focus just on ARC-BCI, Thomas?

Well, it would be interesting to make the comparison as well, of course, to the other technologies if it's -- that's possible?

So I believe that it's an easy technology to teach to other neurosurgeons. If I compare it to DBS, for example, which requires much more years of training to be a good DBS surgeon. Here, it's -- this craniotomy is pretty easy to perform. As I said, probably for me, the most important thing is just to localize it well, and then to perform the surgery is an easy procedure that can be taught to everyone. And I would say that its again a teamwork. So the surgeon himself will not be able then to do all the decoding and to do all the work. But the work of the surgeon is an easy work. So then for the hospital stay, you asked me. So it's -- every procedure that is not in the brain, the hospital stay is pretty short. So in general, they spend one night after the surgery in the hospital. And we perform a CT scan the day after, just to make sure that we have no complication and the complication we could expect would be a little hematoma or an infection, the infection would come later on, but the hematoma can be detected the day after the surgery. And if we don't find anything, the person can go home.

And I think that's going to be market dependent, Thomas. Maybe in the U.S., it will be viewed as a 23-hour procedure, just the spinal implant because that's customary for pain.

All right. If I take on the second question. First, academically since you asked, I think that the concept of a digital bridge between the brain and spinal cord to restore movement is probably the only grade of neuroprosthetics. Everybody is dreaming to achieve that. I mean, Elon Musk announced he would do that for many, many years. He was the only one who actually did it so far, the proof of concept and we believe that Onward can take it to the commercial application as the first iteration, but in parallel, as academic we are continuously innovating and bringing this technology even more advanced. What does that mean? That means that we are already creating some chip to do old decoding directly on the device, we are bringing all the next-generation AI, so developing what we call brain GPT to use all the large language model to learn the language of the human brain and have the decoding even more robust. And we are already testing all these type of application in non-human primate models. So you need to anticipate that Onward will continuously innovate, iterate additional technology that will be more and more effective in this area of research.

And there's other question was, do you see applicability beyond SCI into other movement disabilities?

So we have no old the proof of concept in human for spinal cord injuries upper limb and lower limb. We also have for Parkinson's disease now recently, 2 weeks ago, 3 weeks ago, just implanted in a new participant with Parkinson's disease with the ARC-IM system. It was a great success so far. So it alleviates the gait disorder, reduced freezing of gait. And we already have the intention to be able to use the BCI in this concept, meaning with the electrode for deep brain stimulation that just input in the subthlamic nucleus, we can actually detect the intention to walk, the gait disorder and tune the stimulation in real time. And that's also at this step academic...

But don't give away too much. Thank you. All right. Let's see. I think we have Ed is next, Ed Hall from Stifel.

Thanks, Dave. I guess first question was similar to Thomas. I guess looking on the concept, maybe from the financial side, with the use of proceeds now with the recent transaction. And how do you view the pipeline now? Obviously, you've got 2 in gray, let's say, but a fair amount of white space. So what do you see as a priority to get into the clinic, I guess, beyond this blood pressure indication? I guess, with the backdrop of having in-licensed the BCI implant made progress in other areas like [indiscernible] and then adjacently in stroke and Parkinson's, from a financial perspective, I guess we've already asked a scientific. But from a financial perspective, what is the most interesting for you, Dave?

Yes. I mean first, I want to reiterate that we will -- we expect to spend our capital on the indications in gray. We need to successfully commercially launch ARC-EX globally. We need to successfully execute the pivotal study ARC -- for ARC-IM called Empower BP. In the meantime, we're very fortunate that we benefit from grant funding to advance the other recovery targets in the pipeline, many of which were just discussed, some involved BCI, some involve ARC-IM alone, some are ARC-EX alone. And as those mature and as our financial situation evolves and we begin to generate our own cash and so on, we can commercialize more and more of those. So that's the idea. In terms of what's compelling as I've said before, SCIs are our North Star, that's our reason for being our raise and that's why we're going to continue to serve that community. But there are really compelling business opportunities in these adjacent populations such as Stroke and Parkinson's. So if we can indeed pursue those as well without losing focus on SCI, then that's what we're going to do.

Perfect. And then maybe just on the WIMAGINE device. I mean you're not working along this with this BCI implant. But my understanding, it's not an exclusive agreement per se you can work with other implants. So let's say Synchron or Paradromic or Neuralink suddenly get more progressed. I mean how transferable is the ARC stimulation programs with other BCI implants. Maybe this is a question for Dr. Courtine.

Well, the ARC-IM here is agnostic. It can receive wireless data with low latency from any of those devices. As we've discussed, we believe at this point that WIMAGINE is without question the best device currently for our intended use. That doesn't mean that in the future, we might not do something a bit different. But I think for the foreseeable future, we want to make this digital bridge work with WIMAGINE. So I think we're in a very good situation. We now have brought in-house, really the only clinically viable BCI for our indication, it's ours now, and we can turn that into a product. And in the meantime, in the future, we stay abreast of developments. Keep in touch with all of the industry players, and we make the best possible decision at that point in time. Maria, I'm sorry, I had you wait. Maria from Bryan Garnier.

Yes, perfect. Congratulations again for another super productive quarter. Maybe I would like to touch on the fact that you added Ottobock as a strategic partner as an investor. You mentioned potential synergies on R&D and commercialization. I know maybe you haven't discussed or already with Ottobock, but as we are getting closer to ARC-EX clearance, maybe you can tell us a bit of what could look like the commercialization synergies with Ottobock for ARC-EX?

Yes. I think the first thing I want to say is that Ottobock has shown to be a really excellent and respectful partner. I mean they're obviously quite a bit bigger than us, but they want to work with us to identify collaborations that are indeed win-wins that benefit both companies. One can envision on the go-to-market side of things. They have a global footprint. They operate in 50 countries. So maybe by leveraging their distribution network, we can more quickly enter and access some of these global markets that we otherwise would have to put off for several years, even just looking in the U.S., they already have an embedded presence in clinics -- leading clinics such as Shirley Ryan in Chicago. They have deep relationships with all of the VA, the military hospital hub systems. So there are opportunities to -- for them to make introductions for us to have joint programs where we talk about our technology, even seminars and education sessions for people who have injuries. Those are all kind of easy things to envision. On the technology side, they have an exoskeleton that could potentially be used as an adjunct to our therapy, maybe to get people who receive ARC-IM for mobility up on their feet and moving more quickly and easily. They are leaders in prosthetic limbs, maybe in the future. Those can be powered with a brain computer interface as well, leveraging our capabilities and know-how. There's a lot of things that we've discussed that are super interesting. I think that anyone could probably into it. I'm not giving anything away. That isn't to say we're going to do any of these things that I've mentioned, but I'm just explaining some possibilities.

Yes, that's helpful. And maybe if we're looking now only a few weeks ahead of the commercial launch, could you share any level of demand that you're already kind of estimating if this -- if you have already had contact with clinics that you run the pivotal study or the clinics outside of the study?

Yes. Thanks for your question, Marie. We're not allowed to promote the device at all until such time as we get FDA market authorization. So I really can't comment on demand other than it's natural to assume that clinics who are participants in our uplift pivotal study are likely to be sources of demand for the device. We also have received inbound inquiries from people with spine cord injury, their caregivers. So we have a long list of folks who we can notify once we have authorization to market device. So I think there's probably a lot of latent demand. Nothing I can quantify because we've not been out there discussing or promoting the device at this point.

All right. And then maybe just to wrap it up about the European preparations for submitting this in regulatory processes. You mentioned in the press release that you're expecting to submit for CE Mark in H1 and potentially receiving approval in H2, any commercial plans or strategies already designing for the European markets, considering we're talking about more difficult reimbursement schemes depending on countries.

Yes, sure. I think step 1 is to get regulatory approval to get CE marking, maybe follow that up with authorization to market it in the U.K. Now that they're no longer part of Europe. And in the meantime, we will put more structure around the go-to-market. Our current intent is to start in the large markets, chiefly, Germany, where reimbursement looks like it's really not bad. And then we'll go from there looking opportunistically at the market sizes, reimbursement regime, ease of access, things of that nature. We'll also look rest of the world. There are geographies that accept FDA organization that accept CE marking. And so we'll look to add distribution partners in those markets that might be sort of easy paths to revenue as long as it doesn't distract us from our geographies of primary focus, those being the U.S. and Western Europe. Okay. I think we have a question from David from Degroof Petercam. David, you are live.

Regarding Empower BP, perhaps how are you thinking about its -- what is primary endpoint in case you can already comment on that, of course, will this be more functional or still blood pressure related? And how long is surely expected to last more or less?

We're going to provide more information on Empower BP once we have IDE approved from FDA. I think to do so now, given there still might be some shaping and modification would be premature. I am confident however saying that blood pressure disregulations is the primary focus and will shape the primary endpoint, and I'll stop there. But more to come, David, don't we have enough to talk about?

You definitely do.

Okay. All right. But good try. Let me see if anything else came in that I want to address, yes, there's a question about manufacturing. I'll just generally state that we use CDMOs, so contract manufacturing partners who have a long history in the medical technology space. Most of them are based in Europe. One of them is a major contract manufacturers based in the U.S. all selected by our leadership who've been in the industry for a long time. So that's the philosophy there. Okay. Thomas has another question here about the 2-plus years of cash runway. Does that include any capital from runway growth capital? This is the debt financing instrument into which we entered in June that gives us access to up to EUR 52.5 million of capital. The first tranche we pulled down, it was EUR 16 million that was used to retire our previous debt, which was an innovation loan from the Dutch government, which we took out in 2016. Amori, does the 2-plus years of runaway include any of the runway tranches? If so, which ones? Tranche 2, Tranche 3?

So it includes Tranche 2, Tranche 3 and Tranche 4, which we expect to unlock in the next 2 years -- over the next 2 years.

Yes. Okay. So I think what time is it Team? I think that's probably it. Yes, thank you so much for joining. We appreciate it. And Hopefully, we'll have big and important news upcoming. Thanks for your support. Oh, I'm supposed to read this. We don't have a Didi today. She has the week off. It's American Thanksgiving. You don't get to hear her professional voice. You just get to your mine. I think I'm supposed to tell you for more information, visit the website, onwd.com or follow us on LinkedIn, ONWD empowered ONWD Empowered. That's our handle. See you in a quarter.