ORTHOCELL LTD (OCC) - How Remplir Makes Nerve Repair Simpler

A medical device can be brilliantly engineered and still fail for one simple reason: it never makes it from regulatory clearance to routine use in hospitals. We talk with Paul Anderson, CEO and Managing Director of Orthocell Limited, about how his team is trying to close that gap with a collagen-based regenerative medicine platform designed to support repair of bone, nerve and tendon injuries, and why their nerve product Remplir is now the commercial focus. 

We unpack the growth story behind recent revenue momentum, starting with a successful Australian launch where Remplir is widely used and reimbursed, then moving into the US where the opportunity is huge and the work is relentless. Paul explains the hybrid commercial model, how surgeon training really happens, and why adoption often comes in waves as clinicians build confidence case by case. We also get specific about the unglamorous but decisive step in US market access: Value Analysis Committee approvals, and how building a pipeline of VAC submissions can turn a hospital “yes” into real purchasing and repeat use. 

Clinical proof sits at the centre of everything. We discuss the importance of real-world evidence, what a strong post-market dataset signals to surgeons and payers, and how that evidence supports upcoming EU and UK regulatory submissions. The conversation also explores the defence channel, including approvals across US military medical centres and what real-world use in complex trauma settings can do for credibility. If you care about ASX healthcare growth, medical device commercialisation, nerve repair innovation, and the practical realities of scaling in the US, UK and Europe, this one is for you. 

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Transcript

Andrew Musgrave

Welcome again to ASX Briefs, and today we welcome Paul Anderson, the CEO and Managing Director of Orthocell Limited, a regenerative medicine company developing best-in-class collagen medical devices for the repair of bone, nerve, and tendon injuries. Paul, thanks for joining me today and welcome to the ASX Briefs podcast.

Paul Anderson

Thanks, Andrew. A pleasure to be here.

Andrew Musgrave

Now, Paul, Orthocell has built a best-in-class platform for bone, nerve and tendon repair approved across nine jurisdictions. So, for those new to the company, can you give us an overview of the business and what makes Orthocell's collagen platform unique?

Paul Anderson

Yeah, certainly. I mean our focus is in the regenerative medicine space. And in particular, we've developed a platform technology which is around based around collagen-based medical devices. And these collagen-based medical devices are primarily applicable to the regeneration of human bone, nerve, and tendon tissue, with our primary focus now being on the nerve product called Remplir. And effectively, what these are, are collagen sheets. And I think if you can, a lot of people will remember what the old chamois looks like, which was you know a biological material that was used to clean your car. And it was a soft, compliant material that had certain qualities. And this is very much like a medical device, which is made from a very similar type of and presents itself in a very similar way. And so, what it enables surgeons to do is to improve the consistency and the predictability of their clinical outcomes. It reduces the complexity of their surgeries and provides a cost-effective approach to getting more consistent and predictable clinical outcomes, which is really what patients want, it’s what surgeons want, and it's indeed what the payers want as well.

Andrew Musgrave

Okay, and we'll touch on the financials first. The company delivered Q3 FY26 revenue of 3.2 million and your year-to-date revenue of 9.4 million, which already exceeds your full year result in FY25. So, what's driving that 45% year-on-year growth?

Paul Anderson

Yeah, so that's coming through our product revenue. And so, you know, we started out with the first regulatory approval for our product Remplir here in Australia. And so, we've done a very successful product launch of that product called Remplir, which is for the regeneration of human nerves. Effectively, what that does is it reduces the number of sutures or negates the number of sutures that are required when joining two nerves together. So, this is like a piece of collagen Velcro. And as a consequence of that, what we've seen is a really spectacular product launch here in this country, Australia. We now have over 300 surgeons, over 250 hospitals actively using the product. It's fully reimbursed in the private healthcare system. So that's provided us with a fantastic foundation. It's provided us with the ability to road test our scientific narrative, to really understand the market nuances and the applicability of this product and where it fits in clinical practice. And as a consequence of all of those learnings from a really positive introduction here in the Australian marketplace, we now have launched in the US market, the largest healthcare market in the world. So predominantly those revenue increases have come from the Australian experiences with revenue with Remplir. But increasingly, for the first time, we added some 300,000K of revenue from the United States. So, we're just starting that process and we're really excited about what we think is going to be a material revenue delivery.

Andrew Musgrave

Okay, and net operating cash flow for the quarter was broadly break-even at $5.9 million, but an improvement on Q2. So, how important is that milestone for investor confidence in the path to profitability?

Paul Anderson

Yeah, look, I think it I think it's really important. I mean, I think you, you know, our model that we've employed here at Orthocell is a hybrid model where we have you know direct employees that manage and govern and educate a distributed network you know across the globe. And so, you know, that hybrid model, which is replicated by some of the largest orthopaedic companies in the world, the Biomets, the Strykers, the Zimmers of this world, they all have these hybrid models, but just because of the size of that US market. And so, as a consequence of that, you know, your cost base can be minimized. You're not missing out on delivery of your messaging, but you're certainly doing it in a more cost-effective way.

Andrew Musgrave

Okay, and looking at the US launch in just over nine months since your first US sale on 26th of June 2025, you've reached 55 hospitals and 49 surgeons with 115 units sold in Q3 alone. Compound growth rates of over 275% across those metrics. How are you building upon that momentum?

Paul Anderson

Yeah, look, it's a really exciting phase. And you know, I've been involved in the delivery of and launch of products, you know, internationally throughout my career. And I'm really pleased to say that this is a ripper. This is one that's really coming along in leaps and bounds. And so, you know, what we're seeing here is that we're seeing key opinion leader-led, centre of excellence-driven approaches that are really generating and increasing the number of hospitals that are able to use our product and the number of surgeons who are trained to do so. And so, we're continuing on that pathway of continuing to train top quality surgeons in how to use our product and broadening the hospital base that lays in front of us. And so, it's really important to note that, you know, getting an FDA approval is one thing and clearance is one thing, but there's still a hell of a lot of work that needs to be done in the background to then enable that clearance, that approval to generate revenue. And one of those examples is what we call a Value Analysis Committee submission, which you have to do to each hospital that you that you get into. And they assess the value, the pricing, and it is surgeon-led in a scenario. So those VAC committee applications are really important to getting access to the marketplace. And so, we have some 55 hospitals that we can be used in, but we have now over 200 hospitals that we're that we're actively involved in getting VAC approvals and submissions into. So, we're seeing this funnel that we've developed, which is now starting to spit out you know cases at the other end.

Andrew Musgrave

Okay, and touching on those VAC approvals, that is one of the three key focus areas for you, including expanding the commercial channel and onboarding new surgeons. So, where are you seeing the greatest traction right now?

Paul Anderson

Yeah, so you know, surgeons are very particular in their habits, and they will, you know, understand your scientific narrative, understand the uniqueness of your product, understand how that can be translated into their clinical practice. But they're the holders of the knife, right? They're the ones that take the ultimate risk. And so, we see a pattern of behaviour where a surgeon will do one, two, three, or four cases, and then they'll sit and wait for a couple of months just to make sure that everything's okay, that in their own hands and their own confidence that that the product is safe and efficacious to use. And so, we're really very much in that phase at the moment where we have the early adopters are now becoming more consistent, and the new adopters are putting their toe in the water, trying out the product and waiting to see how successful that is. And so, the whole game here is about broadening your market access and broadening the number of VACs, broadening the number of hospitals that you're that you're now approved to use in, so that you're freeing up the surgeon to make those good clinical decisions.

Andrew Musgrave

Okay, and if we turn to Canada now, what does the market look like there for Remplir and how does your distribution network there compare to the US setup?

Paul Anderson

Yeah, so you know, Canada is a by and large a public health-driven market, which is slightly different to the Australian and the US. But it's a really important adjunct to the North American market, right? And so, you know, the health models from a surgeon training are very similar. You know, Australia or the US and Canada share surgeon training, if you like, through fellowships and visiting surgeons. And so, we see it's an important global market in the synergies between the European, the Australian, the US from a surgeon perspective. And so, look, it's not going to be the biggest market that we enter, but it's certainly going to be an important one.

Andrew Musgrave

Okay, and looking at clinical data now, you've just announced a compelling 89.7% treatment success rate in the Remplr Real World Evidence study across 66 patients and 78 nerve procedures with no adverse effects reported. So, how does this data strengthen your commercial position?

Paul Anderson

Yeah, great question and really important. So, the relevance now of Real World Evidence is now really, really important. So, this real world evidence or post-market clinical follow-up enables you to collect a much broader data set than you would within a clinical study that has very strict inclusion and exclusion criteria. And so, you know, in this study, I think the youngest patient that we treated was a 14-year-old, the oldest was in the 80s. And so that's a really broad range. And not only within the age group, but within the indications, we've treated, increasingly more carpal tunnel revisions, we're treating a lot more nerve transfers. And so, this study is able to capture all of that. And so, for us to replicate the success or improve, indeed, improve on the success rates that we've reported in our published data really shows the robustness of this technology. It shows the utility of this technology that it can be used in different ages and different nerve repairs that are done in clinical practice. And so, we couldn't be more delighted with the 90% success rate in what is a really robust post-market clinical follow-up or real-world evidence generation.

Andrew Musgrave

Okay, and how important is this RWE data for your upcoming EU and UK regulatory submissions?

Paul Anderson

Yeah, no, that's a great question too, because the collection of this data is relevant to those submissions, and this data will be used for that submission into the EU. Obviously, the EU and the UK are probably the second largest healthcare markets in the world. They're a little bit trickier in that there's a lot more countries that you have to get access to, but it is fundamentally the second largest healthcare market in the world. So tremendously successful launch here in Australia, translating that now into what has been a really fantastic launch into the US and at the same time making sure that we've got the regulatory pathways and applications underway for the European market. So, we're excited about that European market. It's going to be a significant add it to the jurisdictions that we can sell and promote our products into.

Andrew Musgrave

Looking now at the defence industry, Remplir has now been approved across 221 US military medical centres, and 23 soldiers were treated in Ukraine. How significant is the defence channel as a growth driver? And what does real-world use in complex trauma settings mean for the product's profile?

Paul Anderson

Yeah, so we've had a really strong strategic approach to the use of this product within the military setting. And that started with a philanthropic donation of our product into the Ukrainian theatre, if you like. And I mean that in war theatre and in the operating suite theatres. And so, what we've seen is a really strong uptake of the product in the war zone. And in actual fact, that we've got one of the surgeons who's using the product in the Ukraine, coming to visit us in the middle of this year and to provide us with really strong insights into the product's success and how it's been used in in a war zone. So, we know that it has a track record now of being used in the battlefield and in surgeries. So, we know that you know that other militaries and armed forces globally you know have a strong interest in this product. Its utility and its usability is with second to none. And so, we're using that as a real footprint, if you like, as a real leapfrog into the US market from a military perspective. So, to get approval within the Department of Defence and Veteran Affairs, as you mentioned, add some 221 hospitals to the pool that we can get access to. So not only do we now have access to the Department of Defence and VA, but we've also got evidence to show that this product is really useful in not just nerve repair, but nerve repair and injuries caused by the war zones that these people are operating in. So, you know, that's been a delight for us to be able to penetrate that market and for us to get the DoD approval and then within two days do our first military patient was really quite outstanding. So, we're really excited about that opportunity. We're going to be delving into that a lot more with possible clinical studies. And so, we're really excited about what that that lays in front for us.

Andrew Musgrave

You've also appointed LEDA Orthopaedics as an exclusive UK distributor ahead of anticipated regulatory clearance. So, what's the go-to market plan for the UK and Europe once you have that approval?

Paul Anderson

Yeah, so LEDA is one of the most respected distribution partners in the in the UK, and they have a particular focus on regenerative medicine products. And so, for them, this product is a perfect fit, and for us, LEDA is a perfect fit for us. And so, you know, we we're looking to be in a position where we're educating surgeons in the UK. We've appointed our distributor, and so upon approval from the EU and the UK regulatory authorities, we've ready, we're ready to go in that market and using the UK as our initial launch-off spot for the European market.

Andrew Musgrave

Now, Paul, finally, what does success look like for Orthocell over the next six to twelve months? What are the key milestones, clinical, commercial, and regulatory, that investors should be watching out for?

Paul Anderson

Well, I think certainly from a regulatory let's start there is you know approval within the EU and UK market is something that we're anticipating in the second half of this year. And so, we're excited about adding another large market. We're excited about the product launch into the UK with LEDA, as we mentioned. But I think really what we're looking to see here is we've got such a large funnel now of hospitals that have the ability to use this product. We've now got you eight direct sales force plus coverage across a number of jurisdictions over 45 different states in the US. And so, we're really looking to see that funnel now convert into revenue. So, we're now in a material revenue growth phase, and that's really what I think investors are looking for over this next period for us, and that's really what we're striving to achieve.

Andrew Musgrave

Okay, Paul. Well, it's been great to chat today. So, thanks for your time. We wish you all the best, and we look forward to further updates from Author Cell in the upcoming months.

Paul Anderson

Thanks for having me, Andrew. A real pleasure.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.