Regulatory success for Orthocell's Remplir

Orthocell (ASX: OCC), a leader in regenerative medicine, has successfully completed a pivotal U.S. FDA 510(k) study for Remplir™, its nerve repair product. The study confirmed Remplir as a safe and effective device for peripheral nerve repair, meeting all necessary endpoints for further regulatory steps.

Orthocell's strategic roadmap and future outlook

Orthocell has achieved a key milestone with the successful completion of the pivotal U.S. FDA 510(k) study for its product, Remplir. This study supports the company's plans to submit for U.S. market clearance in December 2024, anticipating clearance in the first quarter of 2025. With the U.S. nerve repair market valued at over US$1.6 billion, Orthocell is strategically positioned for entry, supported by a robust financial position and a strong team. The clinical results, showing a high rate of functional recovery, bolster Remplir's potential in the market. Orthocell is also progressing its tendon cell therapy in the U.S. and planning to expand into key international markets. The company's upcoming focus will be on regulatory submissions and preparing for a commercial launch, leveraging Remplir's advantages and clinical success.

Direct insights from Orthocell

The successful study completion is a significant milestone for Orthocell, demonstrating that Remplir can meet the needs of surgeons and patients in the large and lucrative U.S. market. We are confident in the regulatory pathway and look forward to bringing this innovative product to market,' said Paul Anderson, CEO of Orthocell.