Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

By Julie A. Vetalice

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

Biorez received FDA 510(k) clearance to market two sizes of the BioBrace™ Implant. This new biocomposite soft tissue scaffold is intended to be used in a range of surgical procedures to reinforce soft tissue where weakness exists, and can be used with existing surgical techniques and instrumentation.

Biorez BioBrace

Biorez BioBrace Biocomposite Soft Tissue Scaffold

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 surgeries.

The novel biocomposite design of BioBrace features a highly porous collagen matrix and resorbable PLLA microfilaments. This yields a bio-inductive scaffold with strength, which is designed to both reinforce tendon and ligament repairs and promote healing. The implant is fully resorbable, and is naturally broken down by the body.

BioBrace offers an alternative to implant materials that are either synthetic or biologic, which limits their use and effectiveness as augmentation materials in tendon and ligament repair.

“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.”

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory