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
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
Read the article in full here.