Company Interview / Orthocell's pivotal path into the US

Paul Anderson, CEO of Orthocell (ASX:OCC) shares updates on their progress with US FDA approval for their nerve repair product, Remplir. He highlights the success of a pivotal study validating its safety and efficacy, positioning Orthocell towards an FDA clearance by Q1 2025.

Paul discusses their strategy for entering the US healthcare market, emphasising the significance of FDA approval. Australia and Singapore have already approved Remplir. Paul notes the strong interest from US surgeons and Orthocell's (ASX:OCC) commitment to the market, aiming for a swift submission by year's end.

Orthocell's (ASX:OCC) financial strength, supported by a recent capital raise, boosts their expansion plans. With $33 million available, the company is well-positioned to push into the US market, focusing on Remplir while managing a diverse product portfolio for soft tissue regeneration, including bone and tendon repair