FDA grants breakthrough device designation for Hyalex Cartilage System
Hyalex Orthopaedics Inc. has announced it received FDA breakthrough device designation for its Hyalex Cartilage System for use in cartilage repairs, according to a press release.
The new system is intended to mend cartilage damage and defects in addition to rehabilitating knee function for patients with loss of knee articular cartilage and bone requiring surgery. Once Hyalex completes the pre-clinical stage of development, it plans to launch its first-in-human clinical study for the system.
“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,” Thomas Vail, MD, professor and chair of orthopedic surgery at University of California, San Fransico, said.
“Our goal is to help patients be active and stay active,” Mira Sahney, CEO of Hyalex, said. “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.”