Orthocell Secures US Entry with FDA Approval for Remplir

Orthocell Secures US Entry with FDA Approval for Remplir™

Orthocell Limited (ASX: OCC) has achieved a transformative milestone with US FDA 510(k) clearance for Remplir™, its flagship nerve repair device. This approval unlocks access to the lucrative US$1.6 billion US nerve repair market, enabling Orthocell to begin commercial distribution. Remplir is a collagen-based wrap designed to support peripheral nerve regeneration, offering a superior alternative to traditional suturing techniques. With a production capacity of over 100,000 units annually and a logistics platform already in place, Orthocell is positioned for immediate US rollout. The company retains all product margins through in-house manufacturing and is backed by a strong cash reserve of ~AU$32 million, with no debt or royalty obligations. Sales efforts will be led by an experienced US-based team supported by a network of distributors. With market traction already established in Australia, New Zealand, and Singapore, this FDA clearance marks a critical inflection point, setting the company on a clear path toward profitability and global expansion.

 

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