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SafeGuard Surgical secures FDA breakthrough designation for its biodegradable stent.

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

In addition to this regulatory milestone, the company disclosed the successful completion of its Series A funding round. Leading the financing is Tom Pepin, principal at Tapper Ventures. Notably, NFL quarterback Jameis Winston has joined as one of the initial investors, showcasing a commitment to the stent’s potential impact on communities of color disproportionately affected by colon cancer, as per SafeGuard’s news release.

Dr. Scott Kelley, based in Tampa, Florida, is the developer behind the LeakGuard device under SafeGuard’s umbrella. 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, crafted from a medical-grade polymer, serves to shield patients from surgical leaks. Its insertion during surgery across the anastomosis eliminates the need for subsequent surgical procedures, thereby preventing complications and costs while potentially saving lives.

SafeGuard highlights that diverting ostomies have conventionally served as the standard preventive measure against anastomotic leaks during colorectal surgery. Nonetheless, the company underscores the high morbidity rates, significant risks, substantial costs, and complex challenges faced by patients as a result.

“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.

 

© SafeGuard Surgical Inc.

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