Sam Brusco, Associate Editor06.02.21
Biorez Inc., a New Haven start-up advancing tendon and ligament healing, recently earned FDA 510(k) for two sizes of its BioBrace Implant. This new biocomposite soft tissue scaffold will be used in a wide 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,” Kevin Rocco, Biorez founder and CEO told the pres. “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.
“We expect BioBrace to be a game-changing technology for surgeons seeking to augment their repairs mechanically and biologically,” Kevin Rocco, Biorez founder and CEO told the pres. “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.