🔒New Haven startup seeking to speed up tendon, ligament surgery healing

In any given year in the U.S., there are more than 100,000 anterior cruciate ligament (ACL) ruptures and more than 3 million rotator cuff injuries, according to the National Institutes of Health.

Together, they account for the majority of the estimated 1 million ligament and tendon-related surgeries performed nationally on an annual basis, with recovery times that typically can run from six months to two years.

With youth sports activities in the U.S. alone accounting for 3.5 million orthopedic injuries and an aging population worldwide (13% of people around the globe are over age 60), the worldwide tendon and ligament repair market is expected to grow by more than 11 percent annually through 2027.

Biorez, a New-Haven based startup founded in 2016, is looking to play a significant role in that market through its new patented tissue-engineered scaffold technology, called the BioBrace, which is designed to stabilize and reinforce the ACL or rotator cuff, increase the speed of tissue regeneration and be reabsorbed — or naturally absorbed — by the patient’s body.

This past May, the company received 510(k) approval from the Food and Drug Administration to commercialize its product, which completed pre-clinical trials last year.

Biorez CEO Kevin Rocco says the BioBrace implant was not designed to replace the current surgical procedures for repairing torn ACLs or rotator cuffs, but to augment or enhance them. This allowed the BioBrace to get FDA clearance with rigorous and extensive preclinical trials. Biorez’s goal, Rocco says, is twofold: reduce the recovery time that patients need to heal and reduce re-injury rates, which is not uncommon with the current standard of care for tendon and ligament surgeries.

“For many decades [surgeons have] harvested a tissue graft from a patient or a cadaver to reconstruct an ACL,” Rocco explained. “Typically, that’s a solid, dense piece of connective tissue that’s got some mechanical durability, but is not porous.”

The result, Rocco says, is that while the tendon that’s reattached to the bone may be stable, the tissue regeneration and healing process often takes longer.

Other products in the market, he notes, foster tissue repair, but lack the structure and stability component.

“We’ve constructed a highly-porous collagen and polymer fiber structure that provides reinforcement while the body [tissue] heals and then is naturally broken down,” Rocco said.

It’s an approach that is not only drawing attention in the medical community, but from investors, too, including more than $1.5 million from Connecticut Innovations (CI), the state’s quasi-venture capital arm.

“Biorez has learned a great deal through their early stages of development and testing,” said Dan Wagner, managing director of CI, who also serves on the company’s six-member board.

This past February, Rocco and William Walsh, the director of surgical and orthopedic research laboratories at the University of New South Wales and a member of Biorez’s eight-member scientific advisory board, presented the results for two recently concluded preclinical trials for the BioBrace at the Orthopedic Research Society’s annual meeting.

“I was encouraged by the rapid biologic incorporation into the scaffold and the formation of the thicker tendon, which was assessed by MRI and histology,” said Walsh, the study’s lead author. “Biochemical testing demonstrated a rotator cuff repair with the BioBrace implant that was as strong as the native rotator cuff tendon within 12 weeks.”

Walking before running

While Rocco is encouraged by the company’s early results, which were based on surgical testing of sheep, he said Biorez is still early in its development stage. He says they need to raise additional capital and build a network of orthopedic surgeons to incorporate the BioBrace into their ACL and rotator cuff procedures.

To date, the company has collectively raised more than $7 million in seed funding from a handful of venture capital sources, including the New York Angels, the company’s largest investor, the Pritzker Vlock Family Office, Brainchild Holdings and The Vertical Group.

As Biorez looks to collect additional clinical results of its product efficacy and durability in humans, Rocco says he’ll be seeking Series A funding over the coming year, hoping for additional investment of up to $15 million.

For 2021, Rocco says, his priority is getting the procedure right with the first group of U.S.-based surgeons the company will work with to test his product.

“It’s really important that we [build] the clinical data,” he said.

In May, Rocco hired David Hook — one of 10 company employees — as Biorez’s vice president of sales. Hook has nearly a quarter-century of experience in sports medicine, including running surgical education globally under a Johnson & Johnson subsidiary, Depuy Mitek, and more recently, holding senior market development roles with two early-stage orthopedic companies.

Hook says his focus to start is less about product sales than drawing interest — and feedback — about the product from surgeons.

“Every surgeon [we work with] has a unique style and brings a different type of strength, and having a diverse group of surgeons bringing their individual [input] together can only help [our company] bring a better product to help patients around the world.”

And word is spreading.

In July at the combined annual meeting of the American Orthopedic Society for Sports Medicine and Arthroscopy Association of North America, a panel of orthopedic surgeons awarded the BioBrace implant an ACE Award — one of only three given — as one of the most innovative products at the conference.

Rocco said he is proud of and encouraged by Biorez’s progress and early accomplishments, but knows much work remains ahead.

“It’s still very early for us as a company,” Rocco said. “We need to walk before we can run.”