TGA Approval for Remplir™
Orthocell’s Remplir™ device has gained Australian regulatory (Therapeutics Goods Administration) approval, representing a paradigm shift in product design and application for complex and often life-changing nerve repair procedures.
Clinical studies have shown nerve repair with Remplir™ consistently restores arm and hand function. The addressable market on home soil is significant too, with around 11,500 surgical repairs for peripheral nerves completed in Australia each year.
Remplir™ is the first Australian-designed and manufactured medical device for nerve repair to gain regulatory (TGA)approval. A significant milestone.
Click here to read today’s ASX release.