Onward Med Nv

Good day and thank you for standing by. Welcome to the Onward Medical half year 2025 results webcast and conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Alternatively, you may submit your questions via the webcast. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Sebastian Cross, VP of Communications. Please go ahead.

Thank you, Sharon. Good morning, good afternoon, everyone, and welcome to UNWA's webcast following the publication of our results of the first half of the year. Before we get started, please take a moment to read this page. Today's presentation includes forward-looking statements, which should be considered with the appropriate level of caution as outlined in the disclaimer. The slides and the recording of this session will be available on our investor website after the call. Today's speakers, Dave Marver, CEO, Amory Fraser, our Senior Finance Director, and Gretchen Nelson, Senior Director of Clinical Operations. We provide an update on our progress. including the RTX launch and commercial momentum, the employer BPP was also designed and further before opening for questions. You may submit your questions verbally or via the Q&A module on the platform. With that, I'll hand over to Dave.

Thank you, Seb, and thanks, everyone, for joining us today. As is our tradition, I'm just going to start with a brief company overview. Onward is pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. We do that via three purpose-built neuromodulation platforms, ARC-EX, which delivers ARC therapy externally through the skin, ARC-IM, which delivers ARC therapy via a fully implanted system, and ARC-BCI, which pairs ARC-IM with an implanted brain-computer interface, or BCI, to restore thought-driven movement via our wireless onward digital bridge. We're here to solve a huge unmet need, in fact. There are 9 million people worldwide living with spinal cord injury. This is an expensive injury. The average lifetime cost of care exceeds $5 million. This is a large TAM, $17 billion or more with future indications. We are attacking that with a lot of innovation. We have 10 FDA breakthrough device designation awards, which is, I believe, unprecedented, and over 150 issued patents, over 300, actually, if you count country nationalizations. We are now a commercial stage company. The Archaic system is available in the U.S., and we're seeing strong initial demand and market uptake. And we have a robust pipeline for the future. that includes implantable and brain-computer interface technologies, including for Parkinson's disease and stroke. Despite having that robust pipeline, we are focusing first on near-term indications and a pathway to profitability. Later, at our option, we can unlock multiple additional indications and populations. So we're really thinking about this in two phases. Phase one is focusing on the immediate opportunities commercializing ArchIEX to address hand sensation and strength, and then getting ArchIEM through the EmpowerBP pivotal study, get that on the market, generating revenue. And then we can advance the pipeline with the benefit of grant funding, which is kind of a unique asset that the company has. Phase two is label, platform, and population expansion. So we can drive commercial update for ArchIEX and ArchIEM, We can pursue cost-effective label expansion leveraging Archiex and ArchIM technology, highly leverageable, including in Parkinson's and stroke, and we can advance BCI-enabled therapies. So a company with a lot of opportunity, but also a great deal of near-term focus and capital efficiency. All right, now I'm going to proceed to year-to-date highlights, which are as follows. All right. So, the highlights are that we met our commercial objectives, we received IDE approval from FDA to commence our Arc IM pivotal study, and we advanced science and technology leadership, including with our brain-computer interface platform. In terms of commercial traction, we met all of our objectives for this initial phase of our U.S. launch of ArcDX, including selling 30 units in the first half, which was precisely our target and expectation. From a regulatory perspective, for ARC-EX, we announced submission of our 510K application to the FDA to obtain regulatory clearance to expand the indication for home use. And also, we submitted our CE-MARC application to enable commercialization of ARC-EX in the EU and other countries that recognize CE-MARC. For ARC-IM, we received IDE approval for our pivotal study to address blood pressure instability after STI. That's called EmpowerVP, and we'll Go into more detail about Empower VP later in this session. In terms of advancing our scientific and technology leadership, we published the Pathfinder 2 study results showing sustained access to RTX therapy can continue to drive improvements even beyond one year. We advanced the clinical feasibility study on thought-driven movement with our fourth and fifth successful BCI implants, and we implanted the first human with our Arc IM lumbar lead, which is designed to help restore mobility. We now have an Arc IM thoracic and an Arc IM lumbar lead, and we have additional leads in development. From a financial perspective, we ended the first half with revenues, cash balance, and financial profile in general in line with expectations. Let's now talk about what's foremost on most of your minds, which is the Arc EX launch and commercial tractions. starting with the demand indications. So these are data as of August 31st, so very fresh. We continue to see strong demand since our FDA clearance with many inbound requests for information and engagement. This is just U.S. data at this point. We'll begin to publish European data when we get CE mark, but already over 2,600 inbound leads collected, including over 340 clinic leads. Let me just put that in perspective. We estimate there are 420 U.S. clinics, so already 80% of those clinics have proactively reached out to the company to learn more about ARC-EX. Sometimes when I've met with some of you, I've explained that we're not going to have the same SG&A costs that a lot of high-growth med tech have, and this really illustrates that. There's already a high level of awareness and interest in our product that we don't have to generate with sales and marketing costs. Our sales are expected to increase every quarter in line with analyst consensus, thanks to our broader U.S. clinic launch and emerging OUS opportunities. So in the first half, we met all of our objectives for this phased launch. We wanted to sell 10 units in Q1 and 30 units in the first half, and now we're broadening things. We have a full complement of 12 field staff in the U.S., all of whom are trained physical and occupational therapists. We expect our sales to accelerate significantly in the second half. Here we're pointing to a minimum of 60 units sold through Q3, so another at least 30 units in Q3, hopefully more, and then we expect to achieve in line with analyst consensus of over 150 units sold. Importantly, not only are we selling units, we're also penetrating a lot of clinics. So in the first half, these 30 units sold represent approximately 25 clinics penetrated. We expect to have penetrated over 50 clinics by the end of Q3 and over 100 clinics by the end of Q4. So you can see the footprint and the adoption is proceeding extremely well. And and we're really advancing this launch. I don't know of a lot of other new technologies that reach this many clinics in year one. The reason that we have confidence in our projections for the full year is that we keep detailed data on our engagements with clinics. And this is what you see here is a probability-weighted pipeline, starting with process initiation when our reps or our insides salespeople first make contact with accounts. Here the probability of sale is relatively low. And then as we advance through product demonstrations, provisions of quotes for budgeting purposes, and then finally a verbal commitment, you see that the probability of sale increases dramatically. So you can take in aggregate the row at the bottom, expected unit sales, and you can see that already at this point in time, we have more than 110 units that we believe on a probability-weighted basis we can expect to sell this year. We still have, obviously, a lot of the year to go. So this is why we have confidence that our sales will indeed accelerate significantly through the end of the year. We also, though, in addition to U.S. sales, have some upside opportunities. On the basis of regulatory applications we filed in June and announced, for authorizations, regulatory authorizations. One of them being U.S. home use, which would be label expansion. We filed our 510K application with FDA in June, and the average time for such an application is about 150 days, which is why we continue to expect that in Q4. And then we also filed our CE mark application to enable commercialization for RKX in the EU and other countries. that respect EU. Again, that was filed in June, and we continue to expect that to be received in Q4. So, these are upcoming milestones that will further accelerate our commercial launch globally. All right. Now, I want to transition into the Empower BP pivotal study. We announced within the last two weeks that FDA had given us IDE approval to commence that study, and some of you have asked in the previous month, why blood pressure? Why is blood pressure important? This is not something that's commonly known in the general public. It's certainly acknowledged as important within the spinal cord injury community. And yesterday I had an opportunity to have this brief video interview with Dr. Nuno Abreu from Portugal, who was one of the first-ever recipients of the Arc IM device to address blood pressure instability. So, Sharon, could you start the video, please, and let's hear from Nuno. Nuno, it's great to see you again. Thank you for joining me today. How have you been?

Thank you, Doug. It's nice to see you, too. I'm doing fine. Just finished my holiday. Thank you.

Excellent. Excellent. Could you briefly introduce yourself and explain what you did and what your life was like before your spinal cord injury?

Okay. So, my name is Nuno. I am a medical doctor from Lisbon, Portugal. I was a general surgeon until And then I had a surfing accident, you can call it. And I broke my C7 vertebra and I am quadriplegic since then. And while I was in hospital, I was looking for solutions to help me in my condition. And I found the trial, the HEMON trial for blood pressure instability. I applied and I was accepted. And so I am an implant carrier since 2022.

And many people may not know, Nuno, that blood pressure instability is a challenge. after a spinal cord injury. Could you share your experience with blood pressure instability and what limitations it imposed on you and your life?

So, you feel faint very often. You, for example, in the shower or during a meal or simply during a conversation, switching positions from lying down to sitting. You feel faint, and it produces also a lot of fatigue. It completely conditions your life, and so it's a very hard experience to live with low blood pressure.

So you were one of the first people in the world to receive this investigation on the Park IM device. What did it feel like when you first received simulation? in this hemodynamic hotspot to address blood pressure instability?

I am a very proud user of that device. I was really happy to have it. I think it was very fortunate that at the same time that I had the injury, this trial was opening because it was My biggest problem, my biggest issue, health issue, was low blood pressure. It was completely limiting for me. It made me feel that I could live again. Until that time, and without answering too much of a cliche, I was feeling completely lost. I was feeling that I wasn't going to be able to do anything with my life. And from that moment on, perspectives opened. You are able. I can talk to people. I can write my emails. I can take care of my family, get back to work. And it makes all the difference. It makes all the difference. And I'm very grateful to everything and to the technology and to the investigators. And what can I say? I wish the best for everyone. And to fight paralysis. fight all the effects that we as patients live. We have to go step by step. We cannot walk before we have good blood pressure and it's the first step. Blood pressure and then we build from here. So, let's start this.

It's motivating to me and our entire team here. Nuno was a participant in the HEMON study, and one of the upcoming catalysts, in fact, is publication of those detailed results. So that's something that you can hopefully enjoy within the next 30 to 60 days. All right. So this is a big unmet need, not just for Nuno, but for many people. And systematic blood pressure instability remains underappreciated, after spinal cord injury, it manifests in two different ways. One is orthostatic hypotension, what we're going to call OH here, which is low blood pressure tied to posture or postural changes. For example, when moving from a reclined to a seated position or just when sitting upright. This impacts 78% of people with tetraplegia. 28%, or just over a quarter, are diagnosed and treated. But even when treated, 91% still experience symptoms, so it remains a big problem and big unmet need. The other way in which instability manifests is called autonomic dysreflexia, which is a sudden, often dangerous rise in blood pressure in response to a stimulus below the level of injury. The body just can't deal with these autonomic signals, commonly triggered by something like a full bladder or an itch. Here, 82% of individuals with tetraplegia are diagnosed with with AD or autonomic dysreflexia, 30% are treated, but 98% still experience symptoms despite being treated. So the current treatments are just inadequate, which is why we're really keen to get this study started. And to tell you more about the study is Gretchen Nelson, a very experienced neuromodulation clinical leader, who at Onward is going to be responsible for enrolling and successfully executing EmpowerVP. Gretchen, take it away.

Thank you, Dave. As Dave mentioned, we were proudly able to receive IDE approval within the last 10 days here, and that's a huge accomplishment for Onward and what we need to do moving forward. We are going to launch the Empower BP study this month, a study that is a prospective randomized sham control double-blinded study. We're looking at up to 22 sites with up to 112 subjects. The randomized design has a two-to-one randomization with two patients receiving therapy to one patient receiving a sham therapy. They will proceed in this realm for three months, and then the patients in the sham therapy will cross over to therapy. The primary effectiveness endpoints at that time will be measured, which is an elevation of greater than or equal to 10 millimeters of mercury in systolic blood pressure while patients are in a seated position with stimulation on, as well as a greater than or equal to four-point improvement in a patient-reported outcome called the ADS-SCI, which will look at the hypotension domain of that PRO. At the crossover mark, we will continue to follow all patients to six months for the primary safety endpoints. From there, we'll have a long-term follow-up that takes patients out to 24 months. For the next slide, you can see that we have our blood pressure roadmap here, which follows our IDE approval just received, enrollment to begin in the second half of this year. And then we will conduct an interim analysis Once 33 patients have reached their three-month primary endpoint so that we can understand how many patients we need to enroll in the clinical trial. So a very unique design that the FDA approved for us to be able to sneak peek at 33 patients and decide do we have enough to stop at the 60 lower bound or do we need to proceed up to 112 patients. If we're able to stop at the 60 at that time, then we will go into follow-up for the patients, and we will be able to stop that in mid-2027 and submit the data to the FDA for a commercial launch in the second half of 2028. For other clinical pipelines,

I think back to me, Gretchen.

Thank you.

Thanks so much. And Gretchen will be available at the end to take questions as well. All right. So, okay. So just reiterating what I said at the onset, we do have a very robust pipeline, and we're advancing that with the benefit of grant support in the form of investigator-initiated studies and grant-funded studies. So it really helps us. We have seven investigator-initiated studies active, and 10 are approved and pending for ARC-EX. And we have nine indications that we're currently evaluating for ARC-IM and ARC-BCI. This is a summary slide that describes all of the more compelling indications in our current pipeline. So we have the option to commercialize new indications and unlock additional value in the future as the business grows. These opportunities include label, population, and platform expansion. So, again, the company is primarily focused today on ArcheX commercialization and the Archive and Pivotal study that you just heard about. But all of these opportunities are, to use an idiom, icing on the cake, upside opportunities, advancing with the benefit of investigator-initiated research or grant funding. So let me just explain this slide. At far left, you have – they're broken down by platform, ArcheX. Arc IM and Arc PCI. Next, you have the indication starting with bladder, bowel, stroke, upper limb, et cetera. Then you have a column designating whether these indications are any of our 10 FDA breakthrough device designation awards. Four of them are, in fact. So, that gives us opportunities for more frequent interaction with FDA and potentially some reimbursement advantages. And then stage. So, the investigator-initiated studies are using FDA-approved commercial technology in the form of ARC-EX. ARC-IM, they're all investigational, but you see they're either clinical feasibility studies, so up to 15 human participants, or a human proof of concept, first in human, and then there's an expectation of that occurring either this year or next year. And then those of you who are analysts and build models, this is hopefully helpful. I know you've long been awaiting this information. We have scoped a probable or potential launch date here, as well as what we characterize as the eligible population, medically eligible population, just in the U.S. and Europe. Certainly, Middle East, North Africa, China, Japan offers upside beyond this, but let's just start with U.S. and Europe. And so, you smart analysts just have to determine penetration rate and pricing, and you can come up with your models. So, hopefully, this is helpful. Now, we have a series of additional slides that are more detailed on each of these, actually, indications A through I. And I'm not going to go through them now on the call. They'll take too long. But they will be part of an updated company deck, company presentation that you can find on our website in the investors section. And that will be available after the call when we upload a recording of the call itself. So look for that later this afternoon or this evening. And hopefully that's helpful. And again, those of you who are analysts, if you want to call and ask for clarification, we're happy to help you through that. Okay. Now let's go through those other slides quickly, Seb. and get to half-year results. And now I'd like to bring to the microphone Amori Fraser, our Senior Finance Director. Amori.

Thank you, Dave. In the first half of 2025, if we move on to the next slide. Yes, thanks. In the first half of 2025, we made subtle progress towards delivering on our strategy with a good positive early commercial traction for the RKX system following SDI clearance. and the successful limited launch late last year. This represents a very important step as we transition towards a commercial company and executing commercially. Our operating expenses increased slightly compared to last year, as expected, mostly driven by commercial investments to support the launch of RKX, while we remained focused on disciplined cost management as we scale. The net finance expense for the period reflects the interest related to our growth financing that we are using to support commercialization and pipeline development. And if we move on to the next slide, our cash position at the end of June was 40.9 million euros. This gives us confidence that we will execute our plans and advance our pipeline, including preparing for the Empowered BP Pivotal Study that will start shortly. We're excited about the traction that we're seeing in the market, and we remain focused on careful execution, disciplined financial management, and continued progress across our commercial and clinical priorities. Back to you, Dave.

Thank you, Lori. Now let's advance to the 2025 outlook. and the upcoming milestones and news flow. And we have a lot of news flow. What I like to see is the left side of the slide with a lot of completed. That makes me feel good. That's our job here. And you can see we've executed very well across each of our technology platforms already this year. To the right side of the slide, this is what we're working to get done. So with ArcheX, we still expect Home use authorization from FDA, we expect CE mark so we can commercialize in Europe, and we expect first commercial sale outside the U.S. All of these we have to look forward to in 2025. For Arc IM, we expect an interim results publication. That's the one I referred to earlier from the study that Nuno was involved in. That we expect to publish shortly in a top-tier journal. We also expect first participant enrollment in the EmpowerVP pivotal study that Gretchen told you about. And then first in human for assessing the use of ARC-IM technology to address bladder dysfunction after spinal cord injury. And that's funded actually by a grant from the Christopher and Dana Reeve Foundation. We also expect additional implants using our ARC-BCI program. therapy. And indeed, we're going to experiment for the first time with that after stroke. And this is funded by the European Innovation Council and some other contributors. So a lot still coming up in the next 12 months. Most of these, in fact, in the balance of 2025. So Sharon, let's go to questions. I think we've got some people in the queue. Let me just see who Seb has upcoming. David, I believe, from DeGroof Petercam, you're in the queue.

Thank you, sir. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. If you wish to ask a question via the webcast, please type it into the box and click submit.

We will now go to our... Go ahead and start with David, Sharon.

Thank you, sir. David, your line is open.

Hey, good afternoon, Dave and team. Perhaps first on the clinic dynamics, right? So if I saw it correctly, now already about 80% of the 450 US call points have inquired about RTX. And I think you indicated about 150 devices at least that's the expectation, right, should be sold by year-end to about 100 of these 450 clinics. I guess some clinics will not have come to a decision yet on buying the device by year-end and then will likely come through in 2026. So just wondering what your expectation is in terms of the number of these 450 call points that will still end up dying eventually. And also the, you know, the current 2025 expectation implies that about two-thirds of clinics buy more than one device, assuming here that two is the max amount. So just curious if that is the expected rate going forward. And then maybe just quickly on a barbecue as well, if I recall, your strategy for RKM reimbursement strategy is currently still twofold, right? So either you use an existing code with an add-on payment or you would pursue a new code. So just curious if and what the potential impact could be of your clinical trials study strategy on this, considering this would consist either of fighting based on interim analysis using data from fewer patients versus running the full study. Thank you.

Thank you, David. You got your money's worth there. Okay. So, I'm just happy. So, for ArchIEx, I just want to be clear, we're not issuing guidance as a company. We refer to the analyst consensus, and we believe that we can achieve in alignment with that consensus. So, again, just want to be clear about that. And just based on current trends where in the first half we sold 30 units to approximately 25 clinics, I am confident that we will sell into at least 100 clinics by year end. And I'm hopeful we can also sell 150 units or more. But this is, again, we're only referring to consensus and aligning with consensus with our performance. Big picture is I want to set expectations that we expect things to greatly accelerate in the second half relative to the first half. The first half was a phased, controlled launch. We didn't want to burn a lot of capital. So we didn't deploy a sales organization. We didn't really even spool up manufacturing until we had FDA clearance. And so the first half of the year was about prudently scaling up, making sure that the introduction, the launch went well, went smoothly. We benefited from learning. And now we're really opening things up in the second half. With respect to Empower BP and reimbursement for Arc IM, you're absolutely correct, David. There are a couple of different paths. we can pursue one is to use existing codes for the implantation of an ipg and paddle lead and then get new technology add-on payments on top of those for which we qualify because we have breakthrough designation in the meantime this is two to three years away so we're eager to see how the reimbursement landscape evolves there are some other non-pain neuromodulation devices that are pursuing higher pain codes and we could step into those if appropriate at that time. So we still have some optionality. And this is just your last question is if things go extremely well and at the interim analysis we can enroll the minimum number of patients or a smaller number of patients than our than are approved in the IDE. I think that's great, obviously. And this is a very rigorous trial. It's double-blinded, it's sham-controlled, it's an RCT. So we're hopeful that the data will be compelling to payers regardless, whether we enrolled 60 or 112. All right, thank you. Can we go to Jacob from KBC, please, Sharon?

Thank you, sir. Your next question comes from Jacob.

Hi there, and thanks for taking my question, and congrats on the progress. I do have a question on the sense of demand that you're getting for home use from patients that are currently being treated in the clinic, and do you have an idea of the reimbursement profile of those patients? And I have a follow-up after that.

Yeah, thank you, Jacob. Very good question. We're not doing a lot of interacting with patients now with regard to demand for ArcheX because it's not approved and it wouldn't be appropriate. What I can tell you, though, is that with every ArcheX sale to clinics and clinic deployment, on average, those clinics can put about 15 patients on a device. So patients are coming in for therapy two to three times a week. So 15 patients times three is 45, divided by five working days is nine sessions per day. So each of these clinics is bringing forward 15 or actually filling the pipeline for potential home sales of 15 patients, and some even have waiting lists. So we're really filling the pipeline of demand for home use. So then how would that be filtered? So that's a good question that you answered. Our reimbursement for home use for RTX, our plan is as follows. We want to be careful and conservative with respect to CMS reimbursements, so Medicare and Medicaid, and not apply for a code until we have significant real-world data and real-world invoicing history. The risk if you don't do that, if you apply for a code too soon, is that you'll be what's called crosswalked to reimbursement levels for an existing technology, one that does not offer anything approaching the breakthrough nature of Archie X and its benefits. So it's important to wait and be prudent in that fashion. In the meantime, however, we have an opportunity to sell the device to multiple groups, multiple populations. one being the military hospital system or VA. They don't need a CMS code. The other being people who are covered by workers' compensation insurance schemes. They don't need a code. And we also think that there's a decent amount of demand that can come from self-pay, in particular in the U.S., where there's the potential for legal settlements after an injury or GoFundMe crowdsourcing sort of campaigns. We also expect to assist people in pursuing services reimbursement on a case-by-case basis with private payers and even CMS until such time as some sort of national or regional coverage decisions are made. So because we have such a large percentage covered by VA and these other groups, we have the benefit of waiting and ensuring or increasing the probability of excellent long-term reimbursement by virtue of this plan. Okay, follow-up questions?

Oh, thank you. That's very clear. I wanted to ask about the Empower BP trial. Maybe if you can just walk us through how the thresholds for the primary endpoints were selected, in particular for the rating scale that was included. And in your view, what would be the bar for success for this trial? I know meeting the endpoints, et cetera, but is there an internal sort of, you know, outcome that you'd like to see?

Well, we just want to see a successful trial, one that helps us bring this technology to this population that's in great need, as you heard from Nuno. Gretchen, maybe just a general comment about the endpoints, the seated blood pressure and the Adopski scale.

Yeah, we chose a composite primary endpoint to show both an objective and subjective measure using a PRO. So that's the reason behind the seated blood pressure, where we are able to physically show an increase in blood pressure with the stimulation, as well as something really important in that we discuss the unmet needs in the symptomatic feelings of the blood pressure and autonomic dysfunction. So the composite endpoint really shows that we can prove that both of them are important to patients and that we are successful in treating both of them.

Did that address your question? Okay, very good. Thank you. All right, Sharon, could you open up the mic for Ed Hall from Stiefel, please?

Thank you. Ed, your line is open.

Perfect. Thank you very much. Good afternoon, all. I have a number of questions. Maybe just start quickly on the commercial side. I think it's already been touched upon, but if we just talk about the incremental demand from current clients, Can you talk about their current feedback with the device? I mean, on my numbers, it appears like a lot of people are on waiting lists, even in current clinics, or these current clinics looking to purchase additional products. Maybe if we should just start with that first question, then we can move into some of the clinical questions.

Yeah, the feedback is very good, and the patient experiences that are being reported back to the company are excellent, and in many respects, beyond our hopes and dreams for the therapy. There is demand for additional devices. This is a capital equipment purchase for clinics, and so often they have to go through committees or wait until the next year's budget cycle in order to purchase a second device or rely on donor funds. So find somebody in the community who wants to support the clinic so they can purchase a second device. So I think you see that reflected in the numbers that were reported for the first half. Some clinics have the ability to buy two devices, but most of them are just buying one for now, and then they're budgeting for a second or third device next year.

That's right. That makes sense. And then maybe questions for both yourself but also Gretchen as well. I mean, it's largely on the Empower BP. I'm just going to list a couple off. I mean, in terms of sort of the timeline for recruitment, do you have a sort of timeline in mind for, let's say, the minimum, the 33 versus the full, let's say, data sets? And then just a couple on the current patients that are looking to go into this trial. Obviously, probably quite a lot of them on blood pressure meds. Are they going to maintain on this cohort or regimen, or how does that affect the trial readouts? And then another question just on sort of only 28% of patients that have been diagnosed with autostatic hypertension were treated. I mean, is this a characteristic that we would place in terms of if we were building a model in regards to R-CAM? I mean, maybe those are just the first couple of questions.

Yeah, the interim analysis we're projecting will be in a position to do that in the second half of 2026. Gretchen, will you talk about the inclusion criteria and the timing for discontinuing meds and so forth?

Yeah, of course. Yeah, so as David mentioned, also I'll just go back to the interim analysis because at the time point we will do the interim analysis, we also expect that we would have enough patients enrolled. So we will expect somewhere between the 70 and 80 patients enrolled and just at that point awaiting either their implant or their three-month follow-up. So when we do the interim analysis, we will be able to say at that point we are done enrolling and we will stop and then let the patients that have been enrolled continue along the study. And then for your question about meds, it's a great question because we don't want to and we don't allow patients to make any adjustments to their medications. So we ask that they come into the trial on a stable dose of their blood pressure medications, and then for at least the first three months, that dose cannot be adjusted. It cannot be increased or decreased. After the three-month mark, we allow patients to decrease their medications so that we can see a difference and really be able to define if patients do, in fact, reduce their medications as we've seen in our early feasibility studies. Can you repeat your third question?

Yes. It was just on the – it was one of the slides. I think just orthostatic hypertension where I think it was 28% of those diagnosed are treated. So I was just curious as to why it seems like quite a low number of diagnosed patients actually getting a drug or a therapy. Is this a characteristic we would expect for RKM as well?

Yeah. So this – Ed, this is something where there's some work to do to build awareness for the importance of treating hypotension. And so stories like Nuno's are important. And we believe just the conduct of Empower BP will help dramatically because these 20 sites across the U.S., Canada, and Western Europe, all of these clinicians will be able to see the impact of this therapy and and those stories will spread. So we think that by the time we get PMA approval and we're in a position to commercialize this first therapy, there'll be a much greater recognition of the importance of addressing orthostatic hypotension and the potential to treat it effectively. In addition, though, we haven't talked a lot about it, but one of the secondary endpoints is autonomic dysreflexia. Gretchen can speak to that. That is much more widely acknowledged, by the way, as something that is important to treat. And so here again, we're hopeful that the dysreflexia, the amplitude of it can be moderated with the benefit of this therapy.

That's really clear. And then maybe just one final, I know I'm hogging the show, but just one final sort of bigger picture question on the number of indications you've given in the timeline. I mean, that's really great. And thanks for the clarification there. If we were to rank in terms of priority of these indications, if you could look at this, or is there a scenario where we could, in theory, see all of these indications come within the same timeframe of 2030 to 2032?

It's difficult to say. There's going to be more clarity on the other slides that will be available to you, Ed. Some of them have a say a streamlined or more efficient regulatory pathway, we believe. So, for example, for Parkinson's disease mobility, we could follow a pivotal study for SCI with maybe a PMA supplement extending the therapy to people with Parkinson's, with gait challenges in Parkinson's disease. Same thing with OH and blood pressure. This is also potentially applicable to the Parkinson's population. There again, we could actually do a PMA supplement. So, some of these have a more traditional approval path. Some of them we think have a truncated in a good way or accelerated path using a PMA supplement. And all of these for ArcIM will be easier once safety has been demonstrated for SCI.

That's great, Theo. Thank you very much, guys, and congrats on the print.

Oh, our pleasure. Any other live questions? No. Okay. Okay. Yeah, let's see. Just looking at the chat Q&A. There are some questions about cash, including from Nicola. I hope Paris is treating you well, Nicola. So we've not updated our cash guidance. The last time we did that was when we did an equity raise last October when we said we had cash through – or two years of cash. So that would have been October 2026. We still have the debt instrument that we entered into with Runway Growth, which is a U.S. growth debt firm. So if we take down additional tranches, we still have only taken down the first tranche of 16 million euros. If we take down additional tranches, then that previous guidance still stands. If we don't want to take down more debt, then we add our option. good to an equity rate. So it's really a matter of doing what's best for the company and our investors at this point. So everything remains at our option. All right. So I think that's it. Thanks so much for everyone's participation. We also have some U.S. equity research analysts on the line. So welcome to the Onward family here. And, you know, it's no secret that since our You're an ex-IPO. We've talked about a NASDAQ listing as a possibility. It remains a possibility. The MedTech window has really opened up on NASDAQ this year. So that's, as we have indicated for the last four years, we're evaluating that as a possibility as well. So anyway, more fun things to come at Onward Medical. Thanks again for joining. Thank you, Sharon.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.