As Signum Surgical pursues broader commercialization to increase patient access to the FDA De Novo-authorized BioHealx® Anal Fistula Device, it is continuing to expand the clinical evidence supporting BioHealx Assisted Fistula Treatment (BAFT™). An ongoing multicenter post-market clinical study is generating additional data on the procedure and patient outcomes, with results intended for future publication. An earlier clinical study demonstrated an 84.4% fistula tract healing rate with no recurrence.
BioHealx® Anal Fistula Device Post Market Surveillance Study
The current study is enrolling patients with mature, cryptogenic, transsphincteric, non-branching anal fistulas.
Study sites are located throughout the US, including The Colorectal Institute (Ft. Myers, FL), Hackensack University Medical Center (Hackensack, NJ), Weill Cornell Medicine (New York, NY), Northwell Health (Staten Island, NY), Main Line Health (Bryn Mawr, PA), and Geisinger (Danville, PA).
More information about the study is available at ClinicalTrials.gov.