Signum Surgical said its BioHealx technology has been granted marketing clearance by the U.S. Food and Drug Administration (FDA), as a first-of-its-kind medical device for the treatment of anal fistula.
Anal fistulas are a painful colorectal condition affecting one in 5,000 people worldwide. In the United States, more than 90,000 surgeries are performed annually to treat anal fistulas. Current treatment options are often unsuccessful, which frequently result in inadequate or slow healing, a high risk of incontinence, and repeat procedures. Developed in collaboration with expert colorectal surgeons, BioHealx is a single use, bioabsorbable implant used to treat anal fistula in a minimally invasive procedure. BioHealx is designed to close the internal opening of the fistula tract via tissue apposition and dissolve in the body after treatment. The single-operation approach is designed to promote healing, prevent fistula recurrence, and protect patient continence.
The De Novo classification and clearance by the FDA, represents a significant milestone for Signum and follows the completion of a single-arm, non-randomized, clinical trial in 2023 designed to evaluate the safety and efficacy of BioHealx. The multi-centre clinical trial, led by four investigators in Hungary, treated a total of 32 patients (both male and female adults) who had experienced recurrent anal fistula from at least one previous failed treatment. Final follow up assessments have been completed on the 32 patients over a period ranging from 13 to 40 months.
