The company describes BioHealx as a first-of-its-kind medical device that offers a single-use, bioabsorbable option to treat anal fistula in a minimally invasive procedure. Galway, Ireland–based Signum designed it to close the internal opening of the fistula tract via tissue apposition. It then dissolves in the body after treatment.
Signum said it designed the single-operation approach to promote healing, prevent fistula recurrence and protect patient continence.
De novo clearance follows the completion of a single-arm, non-randomized clinical trial in 2023. The trial included 32 participants who experienced recurrent anal fistula from at least one previous failed treatment. It also includes follow-up from those patients over a period ranging from 13-40 months.
Peter Ónody, the trial’s principal investigator, said in a news release that the treatment could eliminate the need for multiple surgeries. This, in turn, could “substantially reduce surgical trauma and the rate of fistula recurrence” and reduce costs.
“We are proud to develop BioHealx, now an FDA de novo cleared medical device for the treatment of anal fistula. 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,” said Moshe Zilversmit, Signum Surgical co-founder and CEO. “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.”
