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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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