A New Haven medtech startup is headed to market with its first device, a soft tissue scaffold that can be completely broken down by the body and aims to speed the recovery time for common orthopedic surgeries.
Biorez Inc. announced Monday that it has won 510 (k) clearance from the U.S. Food and Drug Administration for two sizes of its “resorbable” BioBrace implant.
Company officials said the device can be used to reinforce tendon and ligament repairs in a broad range of surgical procedures, including to repair common knee and shoulder injuries like torn ACLs (anterior cruciate ligament) and rotator cuffs.
In traditional ACL surgery, tissue grafts are repopulated with new cells and blood vessels, essentially allowing the body to grow a new ligament to replace the ruptured ACL.
Recovery time is long and re-injuries often result in the need for additional surgeries, according to company officials.
The BioBrace acts as a reinforcement to shore up the soft tissue and help with regeneration and healing before the device is naturally broken down by the body, the company said.
Biorez describes the product as the first biocomposite soft tissue scaffold, meaning it contains both synthetic and biologic components.
It consists of a highly porous collagen sponge, reinforced with polymer microfilaments that are fully “resorbed” by the body. This technology results “in a bio-inductive scaffold with strength, which is designed to both reinforce tendon and ligament repairs and promote healing,” according to the company.
“We expect BioBrace to be a game-changing technology for surgeons seeking to augment their repairs mechanically or biologically,” CEO Kevin Rocco said in a statement. “Our goal is to help patients return to full activity sooner, and potentially reduce re-injuries.”
The company, based in the District at 470 James St., raised $3.5 million last September to advance the product toward commercial launch.
Patrick Helfrich, vice president of marketing and business development for Biorez, told New Haven Biz in an email Tuesday afternoon that the company plans a limited commercial release in the next 30 days, meaning it will start off by selling the product to a limited number of selected customers. It expects to sell primarily to sports medicine surgeons, which is a subspecialty within orthopedic surgery, he said.
Helfrich said the startup’s next round of expansion will focus on building a salesforce that will be located throughout the country. It currently has seven full-time employees based in New Haven, along with a network of consultants and advisors.
Contact Natalie Missakian at news@newhavenbiz.com
This story has been updated.
