4 April 2025 – Big moment for Perth-based Orthocell (ASX: OCC)—the company has landed 510(k) clearance from the U.S. FDA for its flagship nerve repair device, Remplir™, unlocking access to the world’s largest nerve repair market, worth an estimated US$1.6 billion.
This is a company-defining milestone. The FDA green light means Orthocell can now begin commercial sales of Remplir in the United States, with first orders expected soon thanks to pre-established logistics, distributor networks, and an experienced U.S. executive team.
Remplir’s time to shine
Remplir is a collagen-based nerve wrap used during surgery to aid in nerve repair and regeneration. It’s already gaining traction in Australia, New Zealand and Singapore, and the FDA nod sets the stage for rapid adoption in the U.S., where the device market is still under-penetrated (only ~10% uptake). That means Remplir doesn’t need to unseat an incumbent—it just needs to meet a growing need.
Orthocell CEO Paul Anderson said the company has been gearing up for this exact moment, with production capacity of 100,000 units per year already in place at its GMP-certified facility in Perth. And with no debt, no royalty payments, and full ownership of the product and manufacturing process, every dollar of margin stays in-house.
Commercial rollout locked and loaded
The U.S. rollout will combine:
- A dedicated internal team including VPs of Sales, Marketing, and Medical Affairs
- A growing distributor network, targeting 12 partners in the next 6–12 months
- Support from key opinion leaders and leading hospitals as reference sites
Logistics will be straightforward thanks to the product’s 3-year shelf life and lightweight packaging, making air freight into the U.S. both easy and efficient.
With $32 million in cash, Orthocell says it’s fully funded to deliver on the U.S. launch and expand into additional global markets, including Canada, Thailand, the EU, and UK in the coming year.
Big picture
This milestone puts Orthocell firmly on the path to breakeven and profitability, backed by global ambitions and a smart, capital-light commercial strategy. The global addressable market for nerve repair is estimated at US$3.5 billion, and Orthocell is aiming to become a major player across North America, Asia-Pacific, and Europe.
