Signum Surgical’s recent publication of first-in-human clinical data for the BioHealx® Anal Fistula Device represents a major advancement in the treatment of transsphincteric anal fistulas—a complex and often recurring colorectal condition. The device demonstrated an 84.4% primary healing rate and 96.8% preservation of continence-related quality of life, with no device-related complications. These results validate BioHealx’s efficacy and safety, aligning with its recent De Novo clearance by the U.S. FDA and marking a significant milestone in offering patients a new, minimally invasive solution.

The BioHealx® device is an innovative bioabsorbable implant designed to close the internal opening of the fistula while allowing for external drainage during healing. Its unique helical coil design promotes compression-based tissue healing, supporting the sphincter’s integrity—an area where traditional treatments often fail. With its intuitive technique and promising outcomes, BioHealx offers a sphincter-preserving alternative to current surgical methods, which are often associated with high recurrence rates and risk to continence.

With FDA clearance secured, Signum Surgical is preparing for a limited U.S. launch and a 50-patient post-market surveillance study. The positive clinical results not only support broader adoption but also signal a potential shift in standard care practices for this challenging condition. As anal fistula disease continues to affect patients’ quality of life with few effective options, BioHealx stands out as a transformative technology offering durable, patient-centric outcomes.

MedTech Spectrum's Summary

Breakthrough Treatment for Anal Fistulas: Signum Surgical's BioHealx® device has shown promising first-in-human results, with an 84.4% primary healing rate and a 96.8% preservation of fecal continence, offering a sphincter-preserving solution for transsphincteric anal fistulas.

Minimally Invasive Innovation: The BioHealx® device, a bioabsorbable implant, uses compression-based tissue healing, preserving sphincter function and presenting a less invasive alternative to traditional treatments that often carry higher risks of recurrence and continence loss.

FDA Clearance and Market Potential: With U.S. FDA De Novo clearance, Signum Surgical is poised for a limited U.S. launch and further clinical studies, signaling a transformative advancement in the treatment of anal fistulas with promising clinical outcomes.