Signum Surgical Publishes Positive Trial Results for its BioHealx Anal Fistula Device

Signum Surgical is sharing encouraging first-in-human study data for its BioHealx Anal Fistula Device. Published in the International Journal of Colorectal Disease, the clinical results support the product’s U.S. Food and Drug Administration De Novo clearance last summer.

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.

“Our team is proud to introduce the first therapy that offers direct compression closure of the fistula tract within the anal sphincter complex,” Signum Surgical CEO Carol A. Burns said. “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.”

Key findings include:

• An 84.4% primary healing rate without recurrence of the fistula
• A 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 fistula’s internal opening while maintaining external drainage during healing. Its helical coil shape enables compression-based tissue apposition, promoting primary healing without compromising sphincter function. BioHealx is delivered under direct visualization and is designed to close the fistula tract via compression-induced tissue healing, offering a sphincter-preserving approach to treating transsphincteric fistulas.

“These results demonstrate the potential for BioHealx to redefine the treatment of transsphincteric fistulas,” said Peter Ónody, a 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.”

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.

“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,” Signum Surgical Chief Medical Officer Dr. Anthony Senagore added.

Based in Galway, Ireland, Signum Surgical develops solutions to treat patients with colorectal diseases, starting with anal fistula.