Signum Surgical granted FDA De Novo clearance for BioHealx™

Signum Surgical (‘Signum’ or ‘the Company’), a medical technology company developing innovative solutions to treat colorectal diseases, is pleased to announce that its BioHealxTM 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.
Signum Surgical, headquartered in Galway, is compiling data for a De Novo classification request to the U.S. FDA for its novel surgical option addressing anal fistula, a painful colorectal condition. The completion of a single-arm, non-randomized clinical trial, treating 32 patients with recurrent anal fistula using the BioHealx™ device, marks a significant milestone for the company. Led by four investigators,
Signum Surgical, a medical technology company based in Galway, Ireland, has been granted a new US patent for its BioHealxTM device, extending its intellectual property protection in the key US market. This marks a significant milestone for the company's innovative solutions aimed at treating colorectal diseases, particularly anal fistula, a debilitating condition affecting one in 5,000 people globally. The patented