Signum Surgical Gains FDA Approval for BioHealx Implant

Signum Surgical reported that the FDA had given its BioHealx implant de novo approval for the treatment of anal fistulas.

According to the manufacturer, BioHealx is an original healthcare device that provides a minimally invasive, one-time use, bioabsorbable solution for treating anal fistula. Following therapy, it then dissipates in the body.

De novo clearance takes place after a non-randomized, single-arm clinical study is finished in 2023. Thirty-two individuals with recurring anal fistulas from at least one prior unsuccessful therapy were enrolled in the experiment. It also includes those patients’ follow-up for a duration of 13 to 40 months.

Moshe Zilversmit, Signum Surgical co-founder and CEO stated: “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.”