FDA approves new nerve repair product from Orthocell

Orthocell announced it has received 510(k) clearance from the FDA for Remplir, its flagship nerve repair product.

The company says Remplir is a collagen-based wrap used in nerve repair surgery, designed to support regeneration and improve outcomes for damaged nerves. It provides compression-free protection to the nerve, generating an ideal microenvironment to aid nerve healing.

Here’s their one-pager on the product, and diagram below:

Orthocell reports that its FDA application, submitted in December, followed a regulatory study in which Remplir successfully met all required endpoints.

Orthocell notes that Remplir is lightweight, has a three-year shelf life, and can be efficiently shipped via air freight. The company will work with a US logistics partner that maintains a central warehouse for customer service and order fulfillment.

Orthocell CEO and managing director Paul Anderson commented: “It is a defining moment for our company and puts us in rarefied air among Australian biological medical device companies and regenerative medicine companies to have an FDA approval.”

Remplir will be manufactured at Orthocell’s certified Good Manufacturing Practice (GMP) facility located at Murdoch University in Perth, using the company’s proprietary SMRT manufacturing technology. SMRT technology was originally developed with Orthocell’s Chief Scientific Officer, Professor Minghao Zheng, in collaboration with the University of Western Australia.

According to the company, its US team has already established relationships with key opinion leaders, hospitals, and regional distributors, aiming to engage approximately 12 distributors within the next six to 12 months.

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