SafeGuard Surgical Receives FDA "Breakthrough" Designation, Secures Funding from Tom Pepin and NFL QB Jameis … – GlobeNewswire

Tampa, FL, March 14, 2024 (GLOBE NEWSWIRE) -- SafeGuard Surgical, a leading medical technology company focused on life-saving biodegradable solutions, announced today a major milestone in its mission to improve global healthcare. The U.S. Food and Drug Administration (FDA) has granted"Breakthrough" designationto SafeGuard Surgical's patented biodegradable stent,LeakGuardTM.This rare honor and recognition by the FDA has only ever been bestowed upon approximately 800 medical devices.

FDA awards SafeGuard Surgical Breakthrough Device Designation.

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 stents 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.

Prominent healthcare investor and entrepreneur Tom Pepin is leading SafeGuard Surgicals Series A Round.

Pioneering Partnership Accelerates Advancement

SafeGuard Surgical further celebrated the news with the announcement of Series A funding, led byTampa Bay Business Hall of Famerecipient Tom Pepin, principal at Tapper Ventures. Mr. Pepin is adistinguished entrepreneurand well-known for his commitment toimpactful 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. Toms leadership and resources will be instrumental in bringing this lifesaving technology rapidly to market."

Philanthropists, Impact-Driven Entrepreneurs, and Cofounders: Dr. Scott & Jill Kelley being recognized by the Medical Technology Enterprise Consortium at the MedTech Innovator Cohort

Winning Team

NFL quarterback Jameis Winston was an early believer in Kelleys 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 aseasoned advisor and board executiveto multinational companies, Jill believes the Breakthrough designation announcement, coupled with Mr. 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.

SafeGuards COO Jill Kelley speaking at the prestigious MedTech Innovator Global Summit

About SafeGuard Surgical: SafeGuard Surgicalis a pioneering medical technology company dedicated to developing life- saving & sustainable solutions forsurgical patients. As a leader in medical technology, SafeGuard Surgical is revolutionizing global healthcare with its groundbreaking biodegradable stent, LeakGuardTM. This innovation, scalable to multiple surgeries, transcends traditional products, positioning SafeGuard as a trailblazer in the field. The company's commitment to cutting-edge research and development is underscored by support from theHarvard Biotech Club, enhancing its reputation in biotech and healthcare sectors. SafeGuard's inclusion in the prestigiousMedTech Innovatorcompetition and invitation tospeakat this yearsMedTech Conferenceshowcases its innovation and leadership. With a disciplined focus on patient well- being and sustainability, SafeGuard Surgical is focused on reimagining and reinventing healthcare through its breakthrough biodegradable solutions.

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SafeGuard Surgical Receives FDA "Breakthrough" Designation, Secures Funding from Tom Pepin and NFL QB Jameis ... - GlobeNewswire