Pivotal data supports U.S. FDA De Novo clearance and sets the stage for U.S. launch

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.

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BioHealx® Anal Fistula Device

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.

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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