Signum Surgical’s BioHealx technology obtains FDA clearance

Signum Surgical has received De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx technology, designed to treat anal fistulas. BioHealx is a single-use, bioabsorbable implant developed for a minimally invasive procedure, marking a significant advancement in colorectal disease management.

Created in collaboration with colorectal surgeons, BioHealx aims to close the internal opening of the fistula tract, prevent recurrence, promote healing, and protect patient continence. The FDA's De Novo classification and clearance follow a thorough  clinical trial completed last year. This trial, conducted across multiple centers in Hungary, involved 32 adult patients and evaluated the efficacy and safety of BioHealx in real-world settings.

The patients in the trial had previously experienced at least one failed treatment for recurrent anal fistulas. Final follow-up assessments ranged from 13 to 40 months, providing a new solution for those suffering from this condition.