Biorez Announces FDA 510(k) Clearance of Its Proprietary BioBrace™ Implant Technology (press release)
Biorez Inc., a New Haven start-up advancing tendon and ligament healing, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for two sizes of its BioBrace Implant. This new biocomposite soft tissue scaffold is intended to be used in a broad range of surgical procedures to reinforce soft tissue where weakness exists, and can be used with existing surgical techniques and instrumentation.
“We expect BioBrace to be a game-changing technology for surgeons seeking to augment their repairs mechanically and biologically,” said Kevin Rocco, Biorez founder and CEO. “Our goal is to help patients return to full activity sooner, and potentially reduce re-injuries. We look forward to partnering with surgeons to demonstrate the clinical effectiveness of BioBrace for their patients.”
Tendon and ligament injuries often require surgical intervention, with approximately one million surgical procedures annually in the United States. Surgeons and patients remain challenged by long recoveries and high re-injury rates that often lead to additional sur...
