SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB

SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent.

Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first investors in the company. His investment marks a commitment to the stent as it could help communities of color disproportionately affected by colon cancer, SafeGuard said in a news release.

Dr. Scott Kelley developed the LeakGuard device belonging to Tampa, Florida-based SafeGuard. He said Pepin brings an “impressive track record” and dedication to initiatives that align with SafeGuard’s values.

“Tom’s leadership and resources will be instrumental in bringing this lifesaving technology rapidly to market,” Kelley said.

The patented biodegradable stent made from a medical-grade polymer protects patients from surgical leaks. Inserted during surgery across the anastomosis, it means patients don’t require a second surgery. The company says this prevents complications and costs while saving lives.

SafeGuard says placing diverting ostomies is the traditional standard of care for preventing anastomotic leaks during colorectal surgery. However, the company says these can lead to high morbidity rates, significant risks and substantial costs. For the patient, they can also lead to complex and life-altering challenges.

“SafeGuard Surgical is proud to partner with Tapper Ventures to develop a series of sustainable and scalable biodegradable solutions that will save countless lives and billions of dollars,” added Jill Kelley, COO and co-founder.