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

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" designation to 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 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. 


Prominent healthcare investor and entrepreneur Tom Pepin is leading SafeGuard Surgical’s Series A Round. 

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. Mr. 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." 


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 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 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.” 


SafeGuard’s COO Jill Kelley speaking at the prestigious MedTech Innovator Global Summit 

About SafeGuard Surgical: 
SafeGuard Surgical is a pioneering medical technology company dedicated to developing life- saving & sustainable solutions for surgical 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 the Harvard Biotech Club, enhancing its reputation in biotech and healthcare sectors. SafeGuard's inclusion in the prestigious MedTech Innovator competition and invitation to speak at this year’s MedTech Conference showcases 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. 


Contact Data