Just the Facts: Orthocell submits US FDA application for Remplir nerve repair product [Video]

Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Orthocell Ltd (ASX:OCC, OTC:ORHHF).

The company has submitted its US FDA 510(k) application for regulatory clearance to distribute Remplir™, a nerve repair product, in the US market.

This application seeks to grant Orthocell access to the $1.6 billion US nerve repair market, with clearance anticipated by late March or early April 2025.

The submission follows a regulatory study demonstrating Remplir’s safety and efficacy, showing outcomes comparable to an FDA-cleared device.

Remplir is already marketed in Australia, New Zealand and Singapore. Notably, the company’s Singapore distribution partner, Device Technologies Asia, achieved its first sale within two months of obtaining market access.

The product is a biocompatible, resorbable collagen membrane designed to support peripheral nerve regeneration, offering optimal handling for complex surgeries.

Orthocell is preparing for the expected US launch with expanded sales and medical affairs leadership, key opinion leader collaborations and distributor partnerships.

With $33 million in cash as of November 2024, the company is well-positioned to advance its global expansion plans, targeting markets including Canada, the UK, Europe and ASEAN.

Orthocell managing director and CEO Paul Anderson expressed enthusiasm for the FDA application and emphasised the company’s readiness to launch Remplir in the US, aiming to redefine the nerve repair market.

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