Earnings call transcript: ONWARD Medical’s Q1 2025 revenue surges

In the first quarter of 2025, ONWARD Medical reported a significant increase in revenue, driven by strategic innovations and market expansion. Despite posting a net loss, the company’s stock price showed resilience, reflecting investor confidence in its growth strategy. According to InvestingPro data, the company maintains a market capitalization of $20.42 million, with analysts maintaining a strong buy consensus.

Key Takeaways

• ONWARD Medical’s revenue increased to €1.7 million, a substantial rise from €500,000 in the previous year.
• The company completed its first commercial sales and expanded its product lineup with the ArcEX system receiving FDA de novo classification.
• Operating expenses slightly increased, but R&D costs decreased by 8%.
• The company’s cash position nearly doubled, supported by successful equity fundraising.

Company Performance

ONWARD Medical demonstrated strong performance in Q1 2025, with total revenue and other income rising to €1.7 million from €500,000 in 2023. This growth was bolstered by the company’s strategic focus on the spinal cord injury rehabilitation market and its unique neuromodulation technology. Despite a net loss of €35.7 million, slightly improved from the previous year’s €36.2 million, the company continues to invest in expanding its market presence and product offerings.

Financial Highlights

• Revenue: €1.7 million, up from €500,000 in 2023
• Operating expenses: €36.6 million, a slight increase from €36 million in 2023
• R&D expenses: €17.2 million, down 8% from the previous year
• Net loss: €35.7 million, compared to €36.2 million in 2023
• Cash position: €60 million, nearly doubled from €29.8 million in 2023

Market Reaction

ONWARD Medical’s stock price experienced a slight decline of 0.46%, closing at €4.32. InvestingPro analysis indicates the stock is currently trading near its 52-week low, with the RSI suggesting oversold territory. While the YTD return shows a decline of 9.82%, the company maintains a FAIR financial health score. Get access to 8 more exclusive ProTips and comprehensive valuation metrics with InvestingPro’s detailed research report, part of their coverage of 1,400+ top stocks.

Outlook & Guidance

Looking ahead, ONWARD Medical is targeting home use authorization from the FDA in 2025 and aims to secure the CE Mark for European commercialization. The company plans to expand its commercial sales outside the US and is preparing for the EmpowerBP global pivotal study. InvestingPro data reveals the company operates with moderate debt levels and maintains strong liquidity, with liquid assets exceeding short-term obligations - crucial factors for supporting its expansion plans. Unlock detailed financial analysis and growth projections with InvestingPro’s comprehensive research report. Additionally, ONWARD Medical is exploring new indications for its technology, including bladder function and mobility.

Executive Commentary

• "The impossible is now possible," stated the Chief Scientific Officer of the Christopher and Dana Reeve Foundation, highlighting the groundbreaking nature of ONWARD Medical’s technology.
• CEO Dave emphasized collaboration: "We are working with them to explore opportunities for development related and commercial collaboration."
• Mary Jones, a physical therapist, described the technology as "groundbreaking revolutionary."

Risks and Challenges

• The company faces potential challenges in obtaining regulatory approvals for new markets.
• Market competition in neuromodulation, though limited, could intensify.
• Supply chain disruptions could impact production capabilities.
• Economic conditions and reimbursement strategies may affect market penetration.

ONWARD Medical’s focus on innovation and strategic expansion positions it well for future growth, despite current financial challenges. The company’s ongoing efforts to enhance its product offerings and expand its market presence reflect its commitment to revolutionizing spinal cord injury rehabilitation.

Full transcript - ONWARD Medical BV (ONWD) Q4 2024:

Dave, CEO/Presenter, Onward Medical: With that, let me get started. As usual, some of you are new to the new to the company, new to the story. So I just have a few slides to serve as introduction to tell you a bit about the company. So we were founded about ten years ago. We have a hundred people or so.

We’re headquartered in The Netherlands. We have a science and engineering center in Switzerland, and we have a growing field sales and service organization based in The United States. We are a listed company. We’re listed on three exchanges, Euronext, Brussels, Amsterdam, and Paris, and we enjoy research coverage from five banks currently, all of whom maintain a buy rating. As a company, we have three neuromodulation platforms, all of which stimulate the spinal cord to restore movement and other critical functions after spinal cord injury.

We’re a very innovative company. In fact, we have 10 FDA breakthrough device designation awards and over 150 issued patents. That’s a lower number than you’re used to hearing from me because we have taken out the country validations. With country validations, we now are approaching 300. We have also exhibited a lot of clinical tracks in, so we’ve already established the safety and effectiveness of ARC therapy using the ARC EX system for hand strength and sensation that was highlighted in our Uplift pivotal study that was published in Nature Medicine last year.

And we’ve also published positive interim results for Arc I’m therapy. We’re launching into a large total available market and limited competition. And indeed, we’re here to talk about the fact that we finally have a commercial product out there helping people. The ArcGeX system received FDA de novo classification and U. S.

Market authorization in December. We’re in the middle of a limited launch, which we concluded really in the first quarter. And now that we’re in the second quarter, we’re expanding the the launch, and we’re increasing production and field presence and everything else. So more to come on that. Our vision is that empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them.

And we are pursuing that vision with these three technology platforms that I briefly referenced a few moments ago. First is the ArcEX system. This is an external stimulator. The first approved indication is hand strength and sensation after spinal cord injury. The results were published in Nature Medicine last year, and we’re currently exploring additional indications via investigator initiated research projects in both spinal cord injury and stroke.

We also have an implanted device called ARC I’m Here, the first indication we’re pursuing is blood pressure instability after SCI. We are expecting IDE approval from FDA so we can start that global pivotal study sometime in the first half of this year. And in the meantime, we’re using this technology to conduct clinical feasibility studies for mobility and blood pressure in SEI and Parkinson’s disease, and we expect to start a study using the Arc I’m system to address urinary incontinence this year after spinal cord injury, which is a big issue. We’ve been pairing the Arc I’m system with an implanted brain computer interface. We call that platform our Arc BCI platform.

We’re looking at both upper limb and lower limb movement, and we have clinical feasibility studies ongoing. And later, we could look at whether this has any application in Parkinson’s disease and stroke. So a lot going on here using the three technology platforms that we have developed or are developing and each in a different stage. One is approved in commercial. The other is in clinical feasibility studies, soon to start phase three or pivotal studies, and then AHRQ BCI is in clinical feasibility study stage.

Okay. So I’ll take a breath because last year, we got a lot done. You can see there were 20 major achievements that we announced, and I am gonna walk through those. The ones that are highlighted in light shading will go into more detail. They’ll each have their own slide.

So starting in q one, we announced expansion of our ArcIM clinical feasibility study for blood pressure instability to The Netherlands. So that’s now a multisite study that helps us learn as we prepare for Empower BP, which is a multicenter study and a global study. Again, we hope to start that later this year. We were also awarded our tenth FDA Breakthrough Device Designation Award, this one for our ARC BCI brain computer interface platform. KBC Securities initiated research coverage with a buy rating in February, and we raised €20,000,000 back in March.

In second quarter of last year, we submitted our de novo application to the FDA for the ArcEX system. Stifel, which is a global investment bank based in The US, also initiated research coverage, also with a buyer rating. We obtained debt financing of up to €52,500,000 from Runway Growth Capital, which is a U. S.-based growth lender. And we published the Uplift pivotal study results in the prestigious journal Nature Medicine in May.

In Q3, we announced a publication in the journal Neuromodulation, highlighting evidence based programming for ARK E X therapy. So this gives clinicians like Mary, who you’ll hear from, an initial set of programming parameters to get people started on the therapy. We announced publication of our annual sustainability summary for the full year 2023, and we expanded our listing coverage from Brussels and Amsterdam to Paris. We were also awarded a grant to further study our BCI system, ARC BCI, for upper limb function from the Christopher and Dana Reeve Foundation, and we announced our third implant of ARC BCI to restore movement after spinal cord injury. And then Q4 was even busier.

We secured rights to the Wimagine Bci platform from the French Atomic Energy Agency. We raised €50,000,000 additional capital, including a strategic investment from Autobach, which is the world’s leading manufacturer of advanced prosthetic limbs. We welcomed a new board chair, Rob Tenhut. He was retired president of Medtronic International, longtime executive committee member of Medtronic, and also longtime chairman of MedTech Europe, the MedTech Industry Association in Europe. The ArcGX system was named one of Time Magazine’s best inventions of 2024.

That’s nice recognition. We were awarded a European Innovation Council grant to further study AHRQ BCI therapy to address upper limb movement after stroke. We were ranked in the top 15% globally for our sustainability efforts. And then the exclamation point, we received FDA authorization to begin marketing the ArcGeX system in The United States. So more detail.

So these are the results that we published in Nature Medicine from the Uplift pivotal study for ArcEx therapy. We met all primary and secondary endpoints, and here’s some of the highlights, let’s say, the left. So ninety percent of participants, nine out of ten, improved strength or function. Eighty seven percent reported improvements in quality of life. And, notably, we observed improvements up to thirty four years after an injury.

Today, if you’re injured, at least prior to our device being approved, if you’re injured, you have emergency surgery, you’re normally in rehabilitation for three months, and you’re sent home. And you’re told really nothing else can be done to help you recover function. Here we saw responders thirty four years after an injury. On the right side, you see some qualitative or other comments here. No serious device related adverse events.

Participants also reported reduced spasm, improved sleep, and improved upper body sensation, including the sense of touch, and the progress was meaningful. They were they regained enough function to lift filled cups, push a button on a remote control, pick up an object with a fork. So introducing independence or enabling independence in activities of daily life. Also, very important for us strategically, we brought in house. We now have exclusive rights to develop and commercialize the Wimagine brain computer interface technology.

We in licensed this from a leading research institution funded by the French government. This enables us to be first to market with a BCI enabled system to restore movement after paralysis. It gives us full control now. We have our spinal cord stimulation system, ArcIM, and now the BCI, so we can develop an integrated system under our quality system that’s the best fit for our therapies. And we now have the ability to advance this technology with existing, pending, potential grant funding.

So this was, for us, again, very important strategically. And the head of the neurotechnology biomedical research institute at CEA, which is that institute from whom we license the technology, Guillaume Charvet, he said the early clinical feasibility, it’s covered up by my Zoom, so I don’t know what it says, demonstrates the remarkable potential

: of the

Dave, CEO/Presenter, Onward Medical: ARC PCI system to restore thought driven movement and function after paralysis. We are pleased to partner with Onward Medical. In addition, I mentioned in our October financing, we brought aboard a strategic cornerstone, a strategic investor, ADVOC. This is a global leader in the fields of prosthetic orthotics and exoskeleton technology, bigger than you might think. Many of you perhaps haven’t heard of them.

They operate in 60 countries, more than 9,000 employees, and more than 400 patient care centers. Big company, 1 and a half billion euros in revenue, and 300,000,000 in adjusted EBITDA. And they’re now our largest shareholder. They own 10 of the company. So we are working with them to explore opportunities for development related and commercial collaboration.

From there, CEO and owner, professor Hans Georg Nader, 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. We also recruited a new board chair whom I’ve known for about twenty five years, Rob Tenhut, former Medtronic president and executive committee member, three decades of experience in med tech, successful track record in technology development, commercialization, and business model innovation, very creative person, and also former chairman of MedTech Europe, the industry association, so quite well networked. He’s now presided over at least one meeting. He’s he’s been attended two meetings and and making a significant impact.

Very, very pleased to have him here and and have the opportunity to partner with Rob. Nice recognition again. ArcEX was named one of Time Magazine’s best inventions last year. And then the most important development that ArcEx received FDA approval, formerly FDA de novo classification and US market authorization. For those of you who don’t know what de novo classification is, this is a truly novel device, a class two device for which there is no predicate.

There’s never been a device like it before. And this is a quote from the chief scientific officer of the Christopher and Dana Reeve Foundation. Calling ArQX the first ever therapeutic option for SCI shatters decades of belief that these injuries were untreatable. The impossible is now possible. Okay.

Now I’d like to turn things over to Amory, who will walk you through our full year financial results.

Amory, Financial Officer, Onward Medical: Thank you, Dave. I’m happy to walk you through our 2024 financial performance. So we closed the year with a total revenue and other income of approximately 1,700,000.0 compared to the €500,000 in 2023. This increase was primarily driven by grant income recognized from the reverse paralysis program following successful funding negotiations with the Swiss state agency, as well as our first commercial sales of two archaic systems after we received FDA clearance in December. And one that I can probably mention, as Dave also alluded to, was sold to Mary, our guest on the call today.

When we go down to operating expenses for 2024, it amounted to €36,600,000. That is slightly higher than 2023. That came in at €36,000,000. R and d and clinical, r and d expenses, including our clinical activities, decreased by about 8% to 17,200,000.0 as we streamlined our external costs. Our main focus for 2024 was advancing the FDA submission for RTX and preparing for the next pivotal study in POWER BP.

This category of costs still represents approximately 50% of our operating expenses. Moving to marketing and market access expenses, this category rose by 14% to €3,400,000, and this was driven by our commercialization efforts. This included expanding our sales team and increasing engagement within the CSI community through active participation and key industry events. Also to note included in the patent fees and related expenses is the cost of securing the exclusive right to Clinatex brain computer interface technology as also mentioned previously. And finally, general and administrative expenses rose by 11% to €12,600,000, and this is largely due to the scaling of our manufacturing operations and expanding our commercial infrastructure.

Overall, the net loss for 2024 was 35,700,000.0 compared to 36,200,000.0 in 2023. The 2024 result is in line with expectations and reflects our continued investment to bring RKX to market. And if we then turn to cash flow, please. We maintained a disciplined approach to managing our liquidity. Our cash burn for 2024 relating to operations amounted to around €36,000,000 Our financing activities provided a significant boost with net proceeds from equity fundraising totaling 64,000,000.

And as mentioned, we also repaid and replaced the Dutch innovation loan with a structured facility from Runway Growth. At year end, we had a strong cash position of €60,000,000, almost doubling from the 29,800,000.0 in 2023. This provides us with financial flexibility to execute our strategic initiatives and to support commercialization. 2024 was a pivotal year for Onward. We made significant progress towards commercialization while maintaining strong financial discipline and with a good cash position, regulatory milestones achieved and a clear path forward, we are well positioned to advance our mission and to bring our therapies to market.

Back to you, Dave.

Dave, CEO/Presenter, Onward Medical: Thank you, Amore. Nice job. Alright. So 2024 was very active, and we’re out of the gate in 2025 with that same level of activity. Here are the meaningful milestones thus far.

In January, we announced the first commercial sales that occurred in late December over the holidays. We also announced that the ArcGeX system was available on U. S. Veterans Affairs online procurement platforms. More detail on that to follow.

We further announced publication of interesting study out of The U. K. Showing the benefits of sustained access to ArcEx therapy of at least one year. In March, we announced we were awarded grants from the Michael J. Fox Foundation for Parkinson’s Research the US Department of Defense to advance Parkinson’s our Parkinson’s disease pipeline.

We also announced enrollment of the first participant in the early feasibility study to address mobility challenges in Parkinson’s using our ArcI’m system. And in March, we announced first in human use of our Arc I’m Lumbar Lead, which is designed for placement in the lumbar region of the spinal cord, designed to restore standing, stepping, and lower limb mobility. So more detail on these. So ArcEx system is now available for US government and other health care facilities to to purchase. It’s on the FSS, so federal supply schedule, and the GSA advantage catalog as well.

So this enables the VA and other government agencies to immediately purchase the system through online federal procurement systems. This is the first meaningful benefit that we have accrued from our partnership with Level. Level is a service disabled veteran owned small business that serves as our VA contracting and logistics partner. Also, this study, came out, earlier this year called Pathfinder two, and it was conducted out of NeuroKinex in London, sponsored by Spinal Research. The big takeaway here is that there appears to be sustained benefit from a lasting, access to RTX therapy.

They had 10 participants who used RTX therapy for at least one year, and they showed continued and ongoing improvements. Indeed, four of the 10 improved their neurological level of injury, three improved their AIS classification, and one switched from complete to incomplete classification. So quite promising, and we appreciate Spinal Research and their sponsorship of this important work. This is from the chair of Spinal Research, Tara Stewart. It’s now time to stop talking about spinal cord injury as being incurable and start talking about it as improvable.

And we certainly agree, and that’s a nice segue to our session with Mary and Dan. And we’re gonna, I’m gonna stop sharing here just so you can see them a bit better.

: Okay. Let me just move there.

Dave, CEO/Presenter, Onward Medical: Okay. That better? Good. Good. Good.

So we’re gonna conduct this, like, an interview format. So it’s just a a bit more, engaging for people. And, Mary, I’d like to start with you. If you could perhaps share your professional background as well as some background on Next Steps Chicago, the facility where you work.

Mary Jones, Physical Therapist, Next Steps Chicago: Yes. But, well, first, thank you very much, Dave, for that introduction and for having me, to share our experience. So my name is Mary Jones, and I’m a physical therapist. I’ve been a physical therapist for over twenty five years now. Hard to believe.

And I am a board certified neurotherapist specializing in spinal cord injury, but also recovery from paralysis across the spectrum of neurological conditions. At Next Steps, we were founded by a person who, John O’Connor, who had a C4 spinal cord injury, and he had his spinal cord injury about twenty years ago. And at that time, I actually was one of the therapists who treated John. And back twenty years ago, we simply said, Okay, this is what you can do at a wheelchair level. Go home and live your life in a wheelchair.

And thankfully, John refused to accept that and said, There has to be something out there. We have to really think about curing a spinal cord injury and treating it and not just accepting status quo. Very early on, he established a community based spinal cord injury specialty, a clinic for wellness, keeping wellness in the forefront of persons who had experienced paralysis. And through his philanthropy and his never ending quest for innovation in treating spinal cord injury, he was very up on all the research that was being done for spinal cord injury and made it a mission of Next Step Chicago to make innovative technologies for spinal cord injury accessible at a community level to persons, you know, whatever their background. And fast forward to 2024, sadly, John is no longer with us.

He did succumb to secondary complications of his spinal cord injury, but the mission continues to be strong. And so AHRQ EX completely is interwoven into our mission to provide innovative technology to the community and continue that onward quest for curing and treating spinal cord injury and improving quality of life for individuals.

Dave, CEO/Presenter, Onward Medical: I like that onward quest. By the way, thank you for that. So I you you already answered what was gonna be my next question, is why you chose to be an early adopter. Maybe you can comment on what interested you about RTX therapy and what has been your experience so far.

Mary Jones, Physical Therapist, Next Steps Chicago: So actually, I have been using a variety of platforms, you can say, for different devices for Transcutaneous Spinal Cord Stimulation since about 2017. And so as a physical therapist, but also I’m an academic professor at Governor State University, and so I do have a line of my academic research agenda does include transcutaneous spinal cord stimulation. And so keeping, up to date with what is available and, to me to use for this, a couple of things. Why onward? Well, not to get too scientific because I can totally geek out on all the amazing stuff there, but there are some components that allow me as a therapist to really tailor the type of stimulation that I am pairing with the person that I am working with to achieve their task specific goals.

And so there’s a lot of adaptability and nuances that align for my ability to treat my patient very patient centric, but individually. I always think about a spinal cord injury as being as unique as the fingerprint of the person that I’m treating. And ArcEX allows me to dial in to each little ridge on that fingerprint. And, because everybody presents differently, and so that’s the beauty of this system.

Dave, CEO/Presenter, Onward Medical: And when I visited you in in February, I think you had put 20 of your clients on on the therapy. I don’t know how many you’re up to now, but what has been your general experience? Could you share some observations?

Mary Jones, Physical Therapist, Next Steps Chicago: Yeah. So first of all, I would say that our response rate to, first of all, I think it’s important to align that when I see if somebody is appropriate for onward Rx, we are following, through the recommendations, just like the pivotal study, a safe criteria. So making sure that this is safe for the and the Uplift study did a beautiful job of showing the safety and the efficacy of this device. So following through with that ground background and parameters, we continue to implement that. And so I do a baseline evaluation to see where is this person just without any stimulation or without any treatment, where are they at?

And then we thoughtfully, based on my evaluation, conduct the trial with the Onward x or EX, and then see what the response is. And as you said back in February, now we’re up to over thirty people being having tried it, and I have over a ninety five percent positive response rate with motor return. So the movement. So can I elicit a volitional volitional movement, meaning the person is unable to move their limb or their fingers, their hand, primarily the upper extremity without any with their thoughts? So I wanna move my arm.

They’re moving their arm upon command. So it’s volitional. Not involuntary that might be attributed to a spasm or something like that or a reflex. This is volitional movement that I’m eliciting from the baseline of no stimulation to a stimulation. As well as sensation.

So can they feel that part of their body again? So we’re looking at motor as well as sensory and seeing any changes with and without stimulation, And again, over a ninety five percent response rate.

Dave, CEO/Presenter, Onward Medical: That’s really impressive. And again, that’s just one clinic’s experience, and Mary’s very, very good and good at her job. So I don’t want to set that expectation for everyone, but it’s certainly a very promising result from one of these two early clinics. And and we are lucky to have Dan Spencer here with us, who’s one of the 30 people whom you’ve given the therapy. Dan, could you share your professional background and maybe a bit about your what you did before your injury?

: Sure. Again, I’m Dan Spencer, and I was a orthopedic sales rep for, forty years. And so, I retired five years ago and had every thought of just traveling and enjoying life. And, I was in I, went to ski with my wife in a group, Went to ski in Switzerland. And when I was there, I was on a pretty steep area, and due to my own fault, I fell and immediately knew I was paralyzed.

And so I I I was taken to the hospital in Bern. And when I was there, they, put in, two plates, four screws, and a cage, where my fracture was, which was at c three four. And the, everyone everywhere has told me that, the, surgery was very, very successful and had been done incredibly well. So I had that going for me. The thing that, always surprises you and you don’t expect to hear because, you know, being kind of a positive person, you know, it’s kinda like, okay.

What do I gotta do? How do I get out of this? And, I, was told basically by three surgeons in two countries that I would never move again. Not just walk again, I’d never move again. Well, obviously, you don’t wanna accept that and and you wanna prove people wrong.

So I, started a rehab pretty much as soon as I got back into The States and in Chicago. And through after several months, found my way to next steps, and, Mary has, provided me with an opportunity to try ArcEX. And it has I would hope to say, from everything everybody’s telling me and the way I feel myself is basically a game changer. The what I have as a quadriplegic oh, and just to let everybody know, I have been a quadriplegic for just over a year, So I’m really kinda early in this entire process. And so, what, has well, the way it has worked for me is that you need to be able to learn how to, identify the muscle that you want to activate.

Because, naturally, in the beginning, what happens is is you want to activate you just wanna get moving. So you end up activating everything and you get nothing. It’s specific muscles do specific things. And and so that’s what you need to have your brain be able to try to help you identify. Well, you know, for me right now, the circuits are are pretty haywire.

They wanna go to the right place, but they don’t know how to get there. And so, they go everywhere. And so what happens is is with ArcEx, they are able to they they attach a couple electrodes to the back of my neck. They put the out electrodes on my iliac crest, which is where my hips are, and, and then are able to then turn up the, stimulation. When they do that and I go to activate the muscles or the muscle that I want, I can actually feel it better.

I can identify and basically isolate that particular muscle so that I can focus on on that particular movement on what it does and what it’s supposed to do. And it just helps me do that much quicker than I could without it. And that’s very important because that’s the only way you that I know of to be able to get better is to be able to, work the right muscles to do the correct activity.

Dave, CEO/Presenter, Onward Medical: Well, thank you, Dan, for sharing that, and and it’s still early for you. You you haven’t been on the therapy for that long, but is there anything in your daily life that you can point to where you’ve experienced an improvement or it’s had an impact?

: Absolutely. One thing for sure is in my my hands and in my fingers. I can move all my fingers in my hand. I can also move my wrist, and I can bend my elbow 90 degrees from a a straight position. Everybody’s working me well and at next steps in order to be able to get me to get my hand to my mouth so that I can feed myself.

And so I like to say I’m kinda halfway there at 90 degrees, but, I need the rest. And I’m also, weak, as far as being able to raise my hand. So I need to use, a what they have is, a Sable, which kind of keeps my arm up elevated so that I can then, they can help me kinda bring my hand to my mouth. It’ll be, it’ll be a slower process, but, I’m getting there, and I’m getting a little stronger all the time.

Dave, CEO/Presenter, Onward Medical: Has it affected your, let’s say, social life engagement in any way? Are you are you doing things that you wouldn’t have done before?

: Yeah. I actually, had some friends over a few weeks ago, and they brought a board game over and where you throw the dice. And I I was able to pick up I couldn’t pick up both dice at the same time without it taking too much time. So I picked up one dice and threw it and then threw the other dice. So that was probably the first activity I’ve done since the fall.

Dave, CEO/Presenter, Onward Medical: That’s amazing.

: It was nice to be able to do that.

Dave, CEO/Presenter, Onward Medical: I saw you looked over to your right, so I’m I’m wondering if your wife Christine is there. And I don’t wanna put her on the spot, but I’m hoping Christine can maybe comment on the impact RTX therapy has had on on you, Dan, and what she’s observed.

Christine, Patient’s Wife: Hi. How are you?

Dave, CEO/Presenter, Onward Medical: I’m Christine.

Christine, Patient’s Wife: Thank you for asking me in. I don’t I I do go to therapy with him sometimes, but sometimes I stay at home and just try to keep everything going along. But the thing that I have noticed the most is, as he said, with the stimulation, he has more control over his different muscles. And when he comes home, he feels like he’s accomplished so much. And the one thing that we’ve learned about spinal cord injury is that it is a long and arduous road.

And to give him hope and encouragement and to feel like he’s making improvement helps his attitude so much. And that’s probably, for me, the biggest thing that I’ve seen with him. He’s he’s encouraged, and he’s happy.

Dave, CEO/Presenter, Onward Medical: Oh, thank you so much. Thank you so much for sharing, Dan and Christine and Mary as well. Thank you for joining. Very generous of you. I know it’s early your time as well.

I think let’s, conclude the this portion and open it up for questions, and we’ll we’ll give the the question, box a little bit of time to populate. Has anything come in from the? Oh, sorry. I have more to do. I was reminded by my team here.

So let me share again. This won’t take long. I promise. I promise. Okay.

Yep. You can see that? Fine. Okay. You saw their beautiful faces already.

So this is the outlook for 2025, and I’ll keep it simple here. Again, my Zoom screen’s kind of covering it. But what do we expect going forward? This is a catalyst rich year, 2025. We’re looking for home use authorization from the FDA.

We’re looking for CE Mark so that we can commercialize this in Europe and other countries that respect CE Mark. We’re looking to, also have first commercial sale outside The US. That’s all for ArcEX. For ArcIM, we are looking to publish the results from the clinical feasibility study, the first fourteen people to receive this therapy for blood pressure instability after spinal cord injury. If you wanna talk more about that, we have an expert on the line in Mary.

Also, IDE approval from the FDA to start our Empower BP global pivotal study using the Arc I’m system and first participant enrollment in that study, and then also using Arc I’m to address bladder, so urinary incontinence. Currently today, people with paralysis, many of them have to insert a catheter every time they urinate, which is difficult, but also can lead to frequent infection and so forth. And we expect to announce additional brain computer interface implants as they occur throughout the year. So, again, a catalyst rich year upcoming. And, hopefully, now, Alex, I’m done.

Oh, yeah. One more thing. We’re gonna do our first quarter update. This is a 2024 full year update. We’re gonna do our first quarter update on June 17 just because we wanted to create a bit of space between now and then so that, so that there’s time for some of these milestones to hit, and we’ve got a a lot to talk about at that point.

Okay. So now we can go to the q and a. I have a couple of questions, as well. Let me know if anybody raises their hand, one of our our analysts. Let me take it first from David Pepper.

Okay. I’m gonna take my glasses off. Alright. Let me take David Pepper’s, then we’ll go to Thomas from KBC. So David asks about, the current indication for use and the scope of the FDA approval.

Right now, it’s for use in the clinic only, and we’re submitting a $5.10 k to get expansion of the labeling so that it can be used in the home. These are, the the the the target population as people with tetraplegia. Not so easy to get to the clinic frequently. So we really do wanna make this technology available for use in the home where it can be used more frequently even on a daily basis to facilitate better recovery. Right.

Thomas, let’s, turn on your line. Go ahead, Thomas. Thomas Franken.

Thomas Franken, Analyst, KBC Securities: Yes. Can you hear me properly? Yes. Perfect. Thank you very much for taking my And of course, congrats on the big progress in 2024.

Really exciting to hear also from the physician and the patient that the therapy is really working. A couple of questions from my side. Maybe first of all, could you share some sentiment on ongoing commercialization where you stand there? We understand that now in Q2, you would be going to that next stage. What does that mean specifically?

And also in terms of ramping the organization, how do you think about that going forward towards this year? And then as a second question, maybe you ask wanted to ask Mary Jones if she could provide a bit more detail on how the ordering process went. I assume you did that directly with onwards, so not through level, but would be interesting to have some insights there. And also on the side of the patients, whether or not then they are already able to get to get the therapy reimbursed, etcetera. And then maybe a final question for Amory with regards to the runway financing, if could speak with regards to the requirements that are necessary to unlock the next tranche of financing there and whether you are on track there.

Thank you very much.

Dave, CEO/Presenter, Onward Medical: Thomas, you got your money’s worth. I I I would have let you do a follow-up. It was a good thing I took notes. So the you know, this is a limited launch. That’s what we said would happen.

We’re spooling our production. And as well, we hired our initial sales organization. We’ve got six territories. Those folks are hired, trained. They’re out there now conducting evaluations and and detailing the therapy.

So everything is proceeding according to that plan. The I don’t wanna comment too much on first quarter results because we have another call for that. This is a full year results call from last year, but I I will say that, again, things are progressing as planned. The interest level is high. The activity level is high.

And at this time, we have no reason to, to question analyst consensus, so the projections made by yourself, Thomas, and, and your four colleagues from the other banks. So that’s that’s about all I wanna say on the in terms of sentiment as guide and guidance is just there’s a lot of interest in this, and and people are calling Mary, and and people are just really interested in in how this thing is working. So now let’s take the rest of your questions in order. I’ll quarterback this a bit. Mary, what was the ordering process like for you?

Mary Jones, Physical Therapist, Next Steps Chicago: Very, very easy. We didn’t make known our absolute interest in the device, and the ordering process is very simple. I let them know that I would like the device. We wrote a check, and it was delivered. Now that being said, you we’re here in The US.

So if there’s any things with customs or anything like that, we didn’t experience any, but those would also be potential hiccups, I guess. I would just call them a hiccup. But the but ours did not have any issues with that, and I had the device within, I think, two weeks of the whole the whole process, start to finish.

Dave, CEO/Presenter, Onward Medical: Yeah. And then, Mary, you, he also asked about reimbursement, which doesn’t really apply because we don’t have home use yet. But you’re billing for the sessions and technology assisted sessions and things of that nature. And so for you, it’s a

Mary Jones, Physical Therapist, Next Steps Chicago: Yeah. Yeah. So from The US standpoint, because we have a variety of different carriers from reimbursement, there’s many modes how that can happen. And, essentially, there’s a little bit of an art to negotiate all all or or navigate, not negotiate, navigate how reimbursement looks. But essentially, as a therapist, I am billing any insurance Medicare or commercial for the therapy that I’m doing.

You know, the the yes and I I document that I am my parameters and what I am doing with the device, but I’m not necessarily billing for the the ArcX. There isn’t a a true billing code that represents this. And and so from a clinic decision, we have been billing for our therapy that we provide because I and this is just my personal opinion. This is such groundbreaking revolutionary technology. I do not want to misrepresent that technology by using a general code that is similar to a TENS unit for pain.

Totally different and so I that’s just my opinion And so that’s why we as a clinic have chosen not to do that type of billing, but billing for our therapy services. So that’s therapeutic exercise, therapeutic activities, and neuromuscular reeducation, which is really what we’re doing at this stage of the game. So that’s what how we bill it on our side.

Dave, CEO/Presenter, Onward Medical: Thank you, Mary. And, Amory, do you wanna talk about tranche two?

Amory, Financial Officer, Onward Medical: That’d two. Yeah. Yes. So we did meet the milestone to unlock tranche two, when we received the FDA clearance in December. Tranche two is available to us to draw down until the end of twenty twenty five, and we will draw down in the course of this year when required or when needed.

Dave, CEO/Presenter, Onward Medical: Yeah. Thomas said, so we’ve already qualified. We don’t need it. Why pull it down and incur interest expense? So we’ll pull it down at the latest possible moment.

Okay. So Thomas set the tone here, so I have to be fair to Maria and Ed. Maria, why don’t we do ladies first? You can now ask five questions if you wish.

Maria, Analyst: Perfect. Can you hear me?

Dave, CEO/Presenter, Onward Medical: Yes.

Maria, Analyst: Yes. Great. I would like to start, with Mary Jones, and I would like to ask her, you know, a bit about her her experience. Obviously, you’re super experienced with twenty five years in the clinic. And I was wondering, you know, what kind of technologies have you come across that could, you know, get close to RTX or not even?

You know? I mean, obviously, it’s pretty groundbreaking technology, but, you know, any other things that you see in the market. And, also, how easy it was to get around the technology to use it for the first time? I believe you were not involved in the pivotal study. So how easy was the onboarding, and what was provided in that sense from Onward?

Thank you.

Mary Jones, Physical Therapist, Next Steps Chicago: So, on we received training, so, Onward did send their, clinical expert, who I I believe he was, involved at some point, I don’t know which center exactly during the study, and so he came and he, you know, trained us and, very generous with his time because we also did have a patient who met inclusion criteria And so we paired it very well with a live demo and and that really was unique to the experience. So it wasn’t like the device was dropped off and just said, okay. Here you go. Good luck with things. The onward personnel actually took time.

We troubleshot chat with a live patient, and so everybody got a true authentic hands on training experience with that. I in full disclosure, as I said, I have used transcutaneous spinal cord stimulation for a number of years, so I’m pretty versed in that. Maybe not every clinician would have that experience. But so I have I’ve I’m pretty familiar with the dev but the device is very easy easily used. It’s clear cut.

It’s you know, after your training, you do know what parameters and what safety features to use, And it’s they’ve done an excellent, excellent job of setting up the pad that pairs with the actual stimulation device to the clinician can walk through. And there’s a nice visual so there’s no confusion as to, oh, did I put the electrode here or there? It’s it’s and your leads are very clearly identified. So it is very even you know, this can translate, I see, to home use very easily because they’ve done such a nice job setting this up for any pretty much anybody to use.

Dave, CEO/Presenter, Onward Medical: Oh, thank

Christine, Patient’s Wife: you, Karen.

Maria, Analyst: I I wanted to follow-up specifically on that, on the home use. You know, for now, obviously, it’s only approved in the clinic, but once they get the home use approval, how do you see this this transition and how easy you see it from patients that you’re already training? And will you actually recommend this extended use and home use, let’s say, for the majority of your patients, or you think it’s more depending on the cases?

Mary Jones, Physical Therapist, Next Steps Chicago: So as I kinda said earlier, yeah, every spinal cord injury, I kinda think about it as as a fingerprint. Right? It’s very unique, and it’s unique to that individual, and each individual has their own goals. That being said, I I think that the transition to using this at home is an essential but natural step. Because as with any therapy, I have somebody that I I kind of think of myself as a coach, you know, I’m that therapeutic coach that teaches them, empowers them to do this on their own.

And sometimes that does involve a caregiver, so I’m instructing caregivers as well, but I may be only able to see somebody in the clinic two hours a week. If we know from just common wellness principles, we should be doing something every day as humans. We are, you know, we need to move every day for health. So this is a natural transition. If this tool can get into the homes, that carryover, that’s that’s huge.

That’s that is going to be life changing, life changing for people because that they now have control for health and wellness to have control over your own health. I mean, it what a what a restoration of a basic gift that could be for people. So, you know, I’m a % supportive. I am fully there are safe ways we can implement the technology within the home so that, you know, people and their loved ones can continue their journey, you know, towards it’s almost I I I really do believe that this can be limitless, you know, taking away barriers. So I don’t have any concerns about safety and efficacy.

I think we can program, you know, they meet with me, program it, I give them the exercise program, They go home and execute that. They come back periodically to check with me. I might be able to change parameters. Are we troubleshoot via telehealth? You know?

I I think that this is a natural but essential partnership for, continued recovery. I really do. Thank you. Thank you very much. This was very helpful.

Dave, CEO/Presenter, Onward Medical: Thanks, Maria. Alright. So we have a couple of minutes left. Let’s go to Ed. He’s had his hand up for quite some time.

Ed, your mic is open.

Ed, Analyst: Perfect. Thanks, Dave, and good afternoon, everyone else. Just first question would just be on PowerBP. Any updated thoughts here along the clinical trial design, number of patients? Any updated thoughts here would be great.

And then maybe second question, I have to ask it just given the uncertainties around tariffs. The the the pass through of anything that sort of imported is is a hit to your p and l, or is the list price change? Any thoughts there would be great. And then maybe a question for Mary Lovell. Just on the the number of traumatic cases you have in the SCI population, I think Dan mentioned that the use of plates and screws.

I mean, does is it is there any efficacy here difference between someone with plates and screws inserted near the injury or or not? I’d just be curious to to find out. Thanks.

Dave, CEO/Presenter, Onward Medical: Alright. I’ll take the first two. First, for EmpowerBP, Ed, we wanna wait to talk to provide more detail about the study design, outcomes, measures, things of that nature until we get IDE approval. And then there’s absolute certainty what the design will look like, and we’re getting close. So that’s, again, something we’ve guided.

We’ll receive, we believe, in the first half, and then we’ll, probably convene a webinar like this, a KOL webinar, and go through the the indication in detail, the need, but also the the study design and how we intend to to conduct it. So that’s an upcoming event. As far as the tariffs are concerned, we don’t believe we have exposure there. And, indeed, we may be exempted from tariff exposure because there’s something called the Nairobi protocol that exempts products that benefit people with long term disabilities. So if indeed tariffs are applied to this category, we’re going to apply for an exemption under the Nairobi protocol, and we’re hopeful that that will be successful.

So, we’re we’re staying abreast of developments there, ever changing

: Right.

Dave, CEO/Presenter, Onward Medical: Like a lot of things in the world right now. And, but at this point, we don’t foresee that that’s a problem. And, Mary, would you like to answer Ed’s questions about the the, the impact of hardware in on or around the injury site and and how that impacts therapy delivery with ArcEx?

Mary Jones, Physical Therapist, Next Steps Chicago: So, yeah, thank you for that question. Thus far, and actually in all my experience with the transcutaneous over the years, I haven’t ever really had any issue with the hardware being impacted. Once in a while, what will impact is the scar tissue formation over those incisions. So if the person had surgery posteriorly to sometimes that scar tissue can be thickened and it may have a little bit of impedance with that, but there are some nuances that I found to work with that, or somebody might have a the shape of the scar might be more cavernous. So I’ve being that this is where being an older, experienced seasoned therapist comes in.

Back in the days when we used to use sponges for peripheral stim, you can do some adaptations to the electrodes to still deliver safely the electrical stim. So we haven’t had any adverse and the same with the UPLIFT study. There were no adverse effects with that. So there are other there is a unique feature that is unlike any other transcutaneous device out there that ONWARD, the ARC X has, and that is something called the carrier frequency. And the carrier frequency, in my experience, number one, makes the delivery of the stimulation very comfortable to the patient.

There’s no sometimes, with other devices and other methods of doing transcutaneous spinal cord stimulation, the without carrier frequency, it can be a little overwhelming to the nervous system and the person will get into a very co contracted, meaning a very stiffed position. So the whole ex the nervous system is excited and the person becomes very stiff, and then you have to kind of modulate around that. The ARC x system has a carrier frequency, which was a you know, I I again, I can go down the the rabbit hole with this technology, but the ARCHX has this carrier frequency and that makes it extremely unique and adaptable and malleable to the patient at a variety of levels. And we’re learning every day with this. So there and this is stuff that, you know, my mind goes where with this specific with Onward’s technology, we are able to treat a variety of different presentations with spinal cord, again, safely, but with a high efficacy with dialing in.

And, Dan, I’m gonna borrow words from you, when you had a panel. Could we get to recovery, eventually? Yes. But what this device does, it makes it a lot quicker. I mean, immediate to within three sessions, I’m seeing stuff, where before I might have ten, twelve sessions, but there I’m seeing exponentially faster.

And I believe that it’s wholeheartedly due to some of this extraordinary scientific technology that onward whoever is the magician in the back room has assembled and has put it into this beautiful package that I’m able to go ahead and use clinically. It it really is remarkable.

Ed, Analyst: Alright. Thank you very much.

Dave, CEO/Presenter, Onward Medical: We’re over time. I wanna be respectful to Dan and Mary, so I’ll conclude here. Thank you again so much, Dan and Mary, for sharing your your time and your experience with us. Thank you, Christine, as well for your cameo there. And there’s some additional questions.

I’ll try to answer those via email. But, again, thank you so much, everyone, for joining.

: Thank you. Thank you.

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