Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

By Julie A. Vetalice

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

Hyalex Orthopaedics 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.

Hyalex is currently in the pre-clinical stage of development with exceptional results to date and a world-class team working towards their first-in-human clinical study. 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® Cartilage and is protected by more than 17 patents and trademarks worldwide.

FDA’s Breakthrough Device Program is a selective, voluntary program reserved for certain medical technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to help patients receive more timely access to these technologies by providing medical device manufacturers with expedited access to the FDA and speed up the development, assessment, and review processes.

Source: Hyalex Orthopaedics


Product Labels: Orthobiologic Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory