With the US$1.6 billion nerve repair market now firmly in its sights, Orthocell Ltd (ASX:OCC, OTC:ORHHF) has submitted a 510(k) regulatory application to the United States Food and Drug Administration (FDA) for clearance to commercially distribute its nerve repair product, Remplir™, in that market.
Safe and effective
The submission follows the successful completion of a pivotal regulatory study, which met all primary endpoints and provided the key data required for the FDA submission.
This study demonstrated that Remplir is safe and effective for surgical peripheral nerve repair, with outcomes comparable to existing FDA-cleared devices.
Orthocell CEO and MD Paul Anderson said: “We are thrilled to submit our US 510(k) regulatory application following successful pre-submission meetings with the FDA and completion of our pivotal regulatory study.
“We believe Remplir is redefining the nerve repair market and leading the way in successful nerve repair surgery.
“With a strong balance sheet, and US sales and medical affairs team leads in place, we are now resolutely focused on preparing for launch and to commence selling Remplir in the largest healthcare market in the world.”
Orthocell anticipates clearance by late March or early April 2025, following the FDA’s standard 90-day review process and allowing for festive season closures.
Surgeons’ endorsement
Remplir is already approved and available in markets including Australia, New Zealand and Singapore, where it has gained traction and endorsement among surgeons for its unique nerve repair properties.
Orthocell is actively preparing for its US commercial launch, recently appointing sales and medical affairs executives and engaging with potential distributors.
With a robust balance sheet of A$33 million in cash as of November 2024, the company says it is well-positioned to drive its US launch and expand regulatory efforts into other jurisdictions, including Canada, Europe, the United Kingdom (TADAWUL:4280) and other ASEAN markets.
The US nerve repair market, estimated at more than US$1.6 billion annually, promises generous growth for the company as it continues to innovate and lead in the field of nerve repair solutions.