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Business Wire
12-05-2025
- Health
- Business Wire
Signum Surgical Publishes Positive First-in-Human Results for BioHealx® Anal Fistula Device
GALWAY, Ireland--(BUSINESS WIRE)--Signum Surgical, a medical technology company dedicated to advancing the treatment of colorectal diseases, today announced the publication of first-in-human clinical data for its BioHealx® Anal Fistula Device in the International Journal of Colorectal Disease. The results support recent De Novo clearance by the U.S. Food and Drug Administration (FDA) and mark a significant milestone in the development of this innovative treatment. Positive First-in-Human Results for BioHealx® Anal Fistula Device supports U.S. FDA De Novo clearance and sets the stage for U.S. launch Share The prospective, multi-center first-in-human study was conducted in Budapest and Szeged, Hungary, and followed 32 patients diagnosed with transsphincteric cryptoglandular fistulas over a 12-month period. The study evaluated the BioHealx® device as part of the BioHealx-Assisted Fistula Treatment (BAFT) procedure, assessing both fistula and wound healing outcomes. Key findings include: 84.4% primary healing rate without recurrence of the fistula 96.8% preservation of fecal continence-related quality of life No device-related adverse events or migrations reported The BioHealx® device is a novel bioabsorbable implant made from PLGA 8218, designed to close the internal opening of the fistula while maintaining external drainage during healing. Its helical coil shape enables compression-based tissue apposition, promoting primary healing without compromising sphincter function. 'These results demonstrate the potential for BioHealx to redefine the treatment of transsphincteric fistulas,' said Peter Ónody, Colorectal Surgeon and study investigator. 'The technique was intuitive, and the clinical outcomes are among the most promising we've seen in managing this challenging condition.' 'Our team is proud to introduce the first therapy that offers direct compression closure of the fistula tract within the anal sphincter complex,' said Carol A. Burns, CEO of Signum Surgical. 'We believe BioHealx will be a transformative option for both patients and surgeons. Following FDA clearance, we are preparing for a limited commercial launch in select U.S. centers and will begin enrollment in a 50-patient Post-Market Surveillance study.' Dr. Anthony Senagore, Chief Medical Officer, added: 'Anal fistula disease remains one of the most complex issues in colorectal surgery, with existing treatments often falling short. BioHealx offers a minimally invasive, sphincter-preserving alternative with durable outcomes and high patient quality of life.' About Anal Fistulas Anal fistulas affect primarily men aged 18–50 and can severely impact quality of life, causing pain, incontinence, abscesses, and frequent recurrence. Despite being described as early as Hippocrates, treatment options remain limited and often involve risk to continence. About BioHealx® The BioHealx® Anal Fistula Device is a bioabsorbable, single-use implant delivered under direct visualization. It is designed to close the fistula tract via compression-induced tissue healing, offering a sphincter-preserving approach to treating transsphincteric fistulas. BioHealx has received U.S. FDA De Novo 510(k) clearance.
Associated Press
12-03-2025
- Business
- Associated Press
Signum Surgical Appoints Carol Burns as CEO
GALWAY, Ireland--(BUSINESS WIRE)--Mar 12, 2025-- 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. This press release features multimedia. View the full release here: 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 worldwide 1. 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. Signum Surgical, USA, Inc 175 Strafford Avenue, Suite 1 Wayne, PA 19087 Email: [email protected] Signum Surgical, LTD New Docks, The Docks Galway, Ireland, H91E2HV Media Contacts: FTI Consulting Patrick Berkery / Rugile Nenortaite Tel: +353 86 602 5988 / +353 86 277 9905 Email: [email protected] SOURCE: Signum Surgical Copyright Business Wire 2025. PUB: 03/12/2025 06:00 AM/DISC: 03/12/2025 06:00 AM
