Burns’ appointment comes as the company begins commercializing its BioHealx medical device. BioHealx, a first-of-its-kind medical device, offers a single-use, bioabsorbable option to treat anal fistula in a minimally invasive procedure. Galway, Ireland–based Signum designed it to close the internal opening of the fistula tract via tissue apposition. It then dissolves in the body after treatment.
The company received FDA de novo clearance for BioHealx in July 2024.
“I am delighted to join the Signum Surgical team to lead its next phase of growth,” Burns said. “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.
Burns brings more than 25 years of founding, leading and successfully commercializing therapies in the medical device industry. Her track record spans therapies for serration angioplasty, endovascular abdominal aneurysm and endoscopic vein harvesting. She previously co-founded and served as CEO of both Cagent Vascular and Intact Vascular.
Additionally, Burns’ past roles include leadership positions at Embrella Cardiovascular (acquired by Edwards Lifesciences), Animas (acquired by Johnson & Johnson), Ventrica (acquired by Medtronic), and Guidant Corporation.
Eoin Bambury, co-founder and chief technology officer, called Burns an “ideal fit to lead the commercialization of BioHealx.”
“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,” said Moshe Zilversmit, co-founder and chief innovation officer.
