Signum Surgical Appoints Carol Burns as CEO

- Medtech expert to drive commercialization of BioHealx^® for the treatment of anal fistula.

- Pivotal milestone follows U.S. FDA De Novo clearance for BioHealx^® in 2024.

Signum Surgical, (‘Signum’ or ‘the Company’) the medical technology company developing innovative solutions to treat colorectal diseases, is pleased to announce the appointment of Ms. Carol Burns as Chief Executive Officer.

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Carol A. Burns, CEO, Signum Surgical (Photo: Business Wire)

Ms. Burns’ appointment is a pivotal milestone for Signum, as the Company initiates commercialization of BioHealx^®, a first-of-its-kind medical device for the treatment of anal fistula, a painful and debilitating colorectal condition that affects one in 5,000 people worldwide¹. Commercialization follows U.S. FDA Food and Drug Administration (FDA) De Novo clearance for BioHealx in 2024. The BioHealx device safely closes anal fistulas with a bioabsorbable implant that creates tissue apposition for primary healing, reducing lengthy and costly repeat procedures and diminishing the incidence of incontinence.

With a distinguished career in the medical device industry, Carol has a proven track record of over 25 years founding, leading and successfully commercializing innovative therapies which include serration angioplasty, endovascular abdominal aortic aneurysm, and endoscopic vein harvesting. She previously co-founded and served as CEO of both Cagent Vascular and Intact Vascular. Additionally, she has held leadership positions at Embrella Cardiovascular (acquired by Edwards Lifesciences), Animas (acquired by Johnson & Johnson), Ventrica (acquired by Medtronic), and Guidant Corporation.

Carol Burns, CEO, Signum Surgical, commented: “I am delighted to join the Signum Surgical team to lead its next phase of growth. This innovative technology is the first treatment of fistula-in-ano which directly closes the fistula tract by tissue apposition, without sacrificing sphincter muscle function. We believe this technology will become the standard of care for the management of fistula-in-ano while also preserving fecal continence.

The First-in-Human (FIH) study results, to be published later this year, showed excellent primary healing with no recurrence at 12+ months. Our commercial plan includes a Post Market Surveillance Study to build upon the FIH experience. We are excited to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system.”

Eoin Bambury, Co-Founder and Chief Technology Officer, added: “With a proven track record of introducing innovative technologies, commercializing products in highly specialized fields and driving strategic growth, Carol is an ideal fit to lead the commercialization of BioHealx and our next phase of development.”

Moshe Zilversmit, Co-Founder and Chief Innovation Officer, commented: “Carol’s deep expertise in the medical device industry and unwavering dedication to improving patient outcomes, aligns perfectly with our mission to revolutionize the surgical management of fistula-in-ano. We are delighted to have her on board.”

About Anal Fistulas

Anal fistula disease occurs more often in men, ages 18-50. Fistulas have complicated pathogenesis resulting in poor quality of life due to frequent recurrence, fecal incontinence, abscess, odor, and pain. Fistulas were first described by Hippocrates over 2,500 years ago, yet surgical procedures are often associated with suboptimal treatment results including incontinence and the need for repeat procedures due to recurrence.

About BioHealx Technology

The Signum Surgical BioHealx^®Anal Fistula Device is designed to close the fistula tract by tissue apposition to deliver primary healing. The device contains a single synthetic absorbable implant in the shape of a helical coil, preloaded into a special purpose single use delivery system. The device is designed for introduction and implant delivery under direct visualization. The BioHealx device has received FDA De Novo 510(k) Clearance.

¹Ommer A et al: Clinical practice guideline: Cryptoglandular anal fistula Deutsches Arzteblatt International 2011; 108(42): 707–13. https://www.researchgate.net/publication/51826318_Cryptoglandular_Anal_Fistulas

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