Biorez Announces FDA 510(k) Clearance of Its Proprietary BioBrace™ Implant Technology
The BioBrace implant represents the first biocomposite soft tissue scaffold designed to reinforce tendon and ligament repairs, promote healing, and fully resorb
MAY 17, 2021
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 surgeries.
The novel biocomposite design of the BioBrace features a highly porous collagen matrix and resorbable PLLA microfilaments. This technical breakthrough results in 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. Historically, implant materials have been either synthetic or biologic materials, which have limited their use and effectiveness as augmentation materials in tendon and ligament repair.
More information can be found at http://www.Biorez.com and on the FDA’s website (FDA.gov) by searching K203267.
About Biorez Inc.:
Biorez is a New Haven, CT-based medical device start-up focused on advancing the healing of soft tissues using its proprietary BioBrace™ technology. The company has pioneered the BioBrace implant, a breakthrough biocomposite scaffold featuring a highly porous collagen matrix that is reinforced with bioresorbable microfilaments. The BioBrace implant is intended to reinforce soft tissue repairs in several clinical applications and is cleared by the U.S. Food and Drug Administration under K203267.
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