SafeGuard Surgical receives FDA breakthrough designation, secures funding

The U.S. Food and Drug Administration (FDA) has granted “Breakthrough” designation to SafeGuard Surgical’s patented biodegradable stent, LeakGuardTM.

Revolutionary technology earns prestigious FDA Designation
The device was developed by Dr Scott Kelley, an innovator and an accomplished Ivy League cancer surgeon and global healthcare advisor on emerging technology who envisioned a way to both reduce surgeries and make them safer. “Breakthrough” designation signifies the FDA’s acknowledgment of the biodegradable stent’s potential to demonstrably improve upon existing treatments for a serious or life-threatening condition. This FDA recognition paves the way for expedited development and review, offering hope to millions of patients around the world.

Pioneering partnership accelerates advancement
SafeGuard Surgical further celebrated the news with the announcement of Series A funding, led by Tampa Bay Business Hall of Fame recipient Tom Pepin, principal at Tapper Ventures. Pepin is a distinguished entrepreneur and well-known for his commitment to impactful ventures.
Dr Kelley, President and CEO of SafeGuard Surgical, expressed his enthusiasm for the partnership: “We are thrilled to collaborate with Tom, whose impressive track record and dedication to mission-driven initiatives perfectly align with our values. Tom’s leadership and resources will be instrumental in bringing this lifesaving technology rapidly to market.”

Winning team
NFL quarterback Jameis Winston was an early believer in Kelley’s life-saving stent, becoming one of their first investors in the company. Winston, a purpose-driven entrepreneur, gravitated towards the global impact this life-saving stent would have, particularly in the most vulnerable communities of color disproportionately affected by colon cancer. Now, with the FDA designating it as “Breakthrough” medicine, the Heisman Trophy winner is excited about the future of his investment.

Looking ahead to innovation and impact
Jill Kelley, COO and co-founder of SafeGuard Surgical, expressed appreciation for the FDA’s recognition and validation. As a seasoned advisor and board executive to multinational companies, Jill believes the “Breakthrough” designation announcement, coupled with Pepin leading Series A, sets an exciting example for the future of surgery. Jill stated, “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.”
MB Bureau