BioHealx · Anal Fistula Treatment

Signum Surgical Ltd. is a medical device company developing a solution to anal fistula disease. Anal fistulas are a common rectal disease affecting 2 out of every 10,000 people globally. An anal fistula is an artificial tunnel that, in the majority of cases, develops from an infection that begins within a blocked anal gland. If the infection cannot be cleared from the anal gland an abscess forms and the infection burrows though muscles in the rectum and exits externally at the buttocks. Patients endure a poor quality of life, experiencing pain associated with the tract and related abscesses and suffering faecal, pus and blood discharge from the fistula tract. Many patients must wear pads to control leakage, and those who seek treatment face poor surgical outcomes.There is currently no gold standard treatment for anal fistula treatment, which has not changed significantly in over 2,500 years when Hippocrates described using horse hair and silk to drain the fistula tracts. Surgeons are frustrated with the commercially available treatment options which either result in inadequate healing of the initial condition, introduce incontinence as a consequence of surgical treatment, or result in repeat procedures and additional cost to health care system.Through close collaboration with expert colorectal surgeons, Signum Surgical has developed the BioHealx device - an intuitive novel single use technology which improves upon current state of the art devices and surgical procedures to meet all identified critical clinical requirements to reliably heal anal fistulas. During this H2020 project, the company seek to demonstrate the technology in man to enable product launch and growth of sales in the U.S. and Europe.