Signum Surgical’s BioHealx Resorbable Implant Earns FDA De Novo OK

Signum Surgical has earned U.S. Food and Drug Administration (FDA) de novo clearance for its BioHealx device to treat anal fistula, a painful and debilitating colorectal condition.

BioHealX is a single-use, bioabsorbable implant that treats anal fistula in a minimally invasive procedure. It closes the internal opening of the fistula tract via tissue apposition and dissolves in the body after the treatment.

The single-operation approach, according to Signum, promotes healing, prevents fistula recurrence, and protects continence.

The de novo nod follows completion of a 2023 clinical trial led by four investigators in Hungary. It treated a total of 32 male and female adult patients who had recurrent anal fistula from at least one previous failed treatment. Final followup assessments were completed on the patients in a period ranging from 13 to 40 months.

“We are proud to develop BioHealx, now an FDA De Novo cleared medical device for the treatment of anal fistula,” said Moshe Zilversmit, co-founder and CEO of Signum Surgical. “This is a significant milestone for our business and an important step to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system. We are currently in discussions with potential strategic commercialization partners to explore how to rapidly and efficiently make the BioHealx solution available to patients. FDA clearance for BioHealx, which is protected by our growing intellectual property portfolio, continues our strong momentum in addressing the unmet clinical need for the treatment of anal fistula.”