Hyalex Cartilage System Named Breakthrough Device
Lexington, Mass.-based Hyalex Orthopaedics’s Hyalex cartilage system has received a Breakthrough Device designation from the FDA.
The system, which is intended to restore function for patients with loss of knee cartilage and bone, uses biomimetic materials to replace the damaged joint surface and interrupt cartilage degeneration.
The Hyalex system is still in the pre-clinical stage, but the company has demonstrated that it helps with preservation of cartilage.
The FDA’s breakthrough devices program gives manufacturers additional opportunities for interacting with agency experts during premarket reviews.