Clinical News

Expanding the Clinical Evidence for BioHealx®

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

Main Line Health Surgeon First in Pa. to Implant Cutting-Edge Device for Challenging Colorectal Condition

Bryn Mawr, PA — A Main Line Health team has become the first in Pennsylvania to implant a new, cutting-edge device for a challenging condition that causes a painful, sometimes debilitating condition in the rectal area and has long frustrated

Northwell Performs First U.S. Procedure with New BioHealx® Device

Northwell’s Staten Island University Hospital Performs First U.S. Procedure with New BioHealx® Device for Complex Anal Fistulas STATEN ISLAND, N.Y. – (BUSINESS WIRE August 6, 2025) Northwell’s Staten Island University Hospital (SIUH) is the first medical center in the United

Signum Surgical Publishes Positive First-in-Human Results for BioHealx® Anal Fistula Device

GALWAY, Ireland--(BUSINESS WIRE)--Signum Surgical, a medical technology company dedicated to advancing the treatment of colorectal diseases, today announced the publication of first-in-human clinical data for its BioHealx® Anal Fistula Device in the International Journal of Colorectal Disease. The results support

Signum Surgical Completes Clinical Trial for BioHealx

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

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