Hyalex Orthopaedics receives FDA Breakthrough Device Designation for novel HYALEX® Cartilage System
LEXINGTON, Mass., July 7, 2021 /PRNewswire/ -- Hyalex Orthopaedics, Inc., announced that the HYALEX Cartilage System has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
- LEXINGTON, Mass., July 7, 2021 /PRNewswire/ -- Hyalex Orthopaedics, Inc., announced that the HYALEX Cartilage System has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
- The HYALEX Cartilage System is intended to repair cartilage defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery.
- Unlike other cartilage solutions requiring multiple surgeries and regeneration, HYALEX Cartilage is a biomimetic materials platform designed to provide a single-step, off-the-shelf, high strength, low friction, low wear solution.
- Hyalex Orthopaedics has published evidence of preservation of the cartilage counter-face with its HYALEX Cartilage1 and is protected by more than 17 patents and trademarks worldwide.