Signum Surgical granted FDA De Novo clearance for innovative technology

Pictured L-R: Eoin Bambury, Co-Founder & CTO and Moshe Zilversmit, Co-Founder & CEO.

Pictured L-R: Eoin Bambury, Co-Founder & CTO and Moshe Zilversmit, Co-Founder & CEO.

Galway-based Signum Surgical — a medical technology company developing innovative solutions to treat colorectal diseases, has confirmed 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.

Anal fistulas are a painful colorectal condition affecting one in 5,000 people worldwide1. In the United States, over 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, BioHealxTM is a single use, bioabsorbable implant used to treat anal fistula in a minimally invasive procedure. BioHealxTM 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 BioHealxTM. 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.

Peter Ónody, Colorectal Surgeon and Principal Investigator of the clinical trial, said he is excited at the potential of BioHealx as a novel surgical option for the treatment of anal fistula and, in particular, its ease of use for physicians.

"This treatment has the potential to eliminate the need for multiple surgeries and substantially reduce surgical trauma and the rate of fistula recurrence, while reducing costs for patients and the overall health care system," he said.

Moshe Zilversmit, Co-Founder and CEO of Signum Surgical, said they are proud to develop BioHealx, now an FDA De Novo cleared medical device for the treatment of anal fistula.

"This is a significant milestone for our business and an important step to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system.

"We are currently in discussions with potential strategic commercialization partners to explore how to rapidly and efficiently make the BioHealx solution available to patients. FDA clearance for BioHealxTM, which is protected by our growing intellectual property portfolio, continues our strong momentum in addressing the unmet clinical need for the treatment of anal fistula.”

Dr Bernard Collins, Investor Director, said that Signum Surgical’s innovative BioHealx technology addresses a major unmet clinical need in colorectal care and specifically for the significant patient population suffering with anal fistula.

"In excess of 90,000 surgeries are performed annually in the United States alone to treat this debilitating condition, however current treatment options are often unsuccessful and there is a high risk of repeat procedures. With strong investor interest in Signum Surgical, FDA De Novo clearance is another transformative step for Moshe, Eoin and the team, and marks further progress towards bringing BioHealx to market in the near future for the benefit of patients and physicians," he concluded.


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