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.
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 [1] and is protected by more than 17 patents and trademarks worldwide.
“Our goal is to help patients be active and stay active,” said Mira Sahney, Hyalex’s CEO. “Obtaining this designation will be an invaluable opportunity for our team to work closely with the FDA and expedite bringing the HYALEX Cartilage System to the millions of patients who face limited treatment options for knee pain caused by cartilage lesions.”
“The HYALEX® Cartilage System is exciting because its biomimetic material properties create the potential to replace a damaged joint surface, and thereby interrupt the progression of cartilage degeneration,” said Dr. Thomas Vail, Professor and Chair of Orthopaedic Surgery at UCSF. “This is a paradigm-changing technology that can be applied across orthopaedics. I’m thrilled to be part of this team and its very bright future.”
“We are excited to continue our collaboration with leading sports medicine physicians at the combined AOSSM-AANA meeting as we refine our products for the clinic,” says Ms. Sahney. Look for the Hyalex team at this annual conference held in Nashville, TN Wednesday, July 7th – Sunday, July 11th, 2021 [2] .
The 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 [3]. 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.
About Hyalex Orthopaedics
Hyalex is a privately held medical device company headquartered in Lexington, MA developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints.
The HYALEX® Cartilage System is under development and not available for clinical use.
For more information: www.hyalex.com
SOURCE Hyalex Orthopaedics, Inc.
[1] https://www.ors.org/Transactions/66/2446.pdf
[2] https://aossm-aana.sportsmed.org/
[3] https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program