Few joints work as hard as the shoulder. Whether you’re an elite golfer hitting a drive or just reaching for a glass from an overhead cabinet, the shoulder is in constant motion, making it one of the most injury-prone joints in the body.
Rotator cuff injuries affect about a quarter of the population, with an estimated 500,000 rotator cuff repairs completed annually in the United States. Because proximal biceps tendon disorders are commonly associated with rotator cuff tears, addressing these tendon issues is often critical to relieving shoulder pain and restoring function.
There are currently three treatment methods for biceps tendon disorders. The first involves debridement, or “cleaning up” the damaged tissue, which doesn’t always resolve the problem. The second is tenotomy, a procedure that severs the tendon. While it produces positive outcomes for roughly 80% of patients, it can lead to cosmetic deformities, functional limitations and cramping. The third, and most common, treatment is biceps tenodesis, where the surgeon cuts and reattaches the tendon, anchoring it to the bone or soft tissue.
While biceps tenodesis is effective, current arthroscopic techniques can be technically demanding and time-consuming, meaning not all surgeons offer the procedure and fewer patients can benefit from it. That’s where Cinch Innovations, the newest member of Fogarty’s Company Accelerator Program (CAP) program, is poised to make a difference.
Led by three cofounders: CEO Nathaniel Cohen, MD, CMO Treg Brown, MD, and COO Stewart Kume, along with staff engineer Connor Wilson, the company is developing a novel implant for the treatment of proximal biceps tendon disorders. The suture-based device aims to reduce the time needed complete the procedure to less than five minutes, with early mock-up prototypes achieving positive results relative to existing treatment methods.
Built on deep expertise
Cohen and Brown are both long-tenured, practicing orthopedic surgeons who specialize in sports medicine. They’re also serial entrepreneurs who have developed several medical technologies, including three that were acquired by major medical device companies. Kume has been working on the technical side of the medical device field since the early 1990s. His experience spans clinical engineering, device development, clinical training and support for a wide range of medical technologies, primarily in the cardiovascular and orthopedics sectors.
The three first started working together in the early 2010s at Eleven Blade Solutions, a startup co-founded by Brown and Cohen that developed the Q-Fix suture anchor. The device was acquired by ArthroCare/Smith & Nephew in 2013 and is used worldwide for rotator cuff, labral, and ligament and tendon repairs.
The Cinch team is currently navigating an ambitious timeline. The next step will be to refine their prototype and complete design review to prepare for FDA 510(k) submission, a premarket notification demonstrating that a new medical device is substantially equivalent (safe and effective) to a legally marketed predicate device.
Once they receive regulatory approval, they’ll pivot to manufacturing and early sales testing on their way to distribution.
The Fogarty advantage
As seasoned entrepreneurs, the Cinch cofounders recognize the value of the Fogarty environment, and plan to leverage both the resources and the expertise on offer as they maintain a small and efficient team.
“We appreciate the opportunity to continue to hone our skills as we work with a team who is so focused on innovation in so many different spaces and deeply understands the landscape as we move forward,” Cohen said. “In particular, we’ll be relying on their regulatory expertise, which will help us devise a strategy to gain approval and be able to bring the device to the market and to investors.”
And of course, the Cinch trio also recognizes the benefits of being part of the community and the creative environment Fogarty fosters. “We miss being able to have spontaneous interactions with other professionals, from potential mentors to peers and colleagues,” said Kume. “This environment is conducive to cross-pollination, and we’re looking forward to sharing the expertise we’ve gleaned along the way and learning from others.”