Signum Surgical, a Galway-based medical technology company developing solutions to treat colorectal diseases, has announced that its BioHealx technology has been granted marketing clearance by the US Food and Drug Administration (FDA), as a device for the treatment of anal fistula.
Anal fistulas are a painful colorectal condition affecting one in 5,000 people worldwide.
In the United States, over 90,000 surgeries are performed annually to treat anal fistulas.
Signum said 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, BioHealx is a single use, bioabsorbable implant used to treat anal fistula in a minimally invasive procedure," the company said in a statement.
"BioHealx 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," it added.
The De Novo classification and clearance by the FDA follows the completion of a single-arm, non-randomised, clinical trial in 2023 designed to evaluate the safety and efficacy of BioHealx.
"I am 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," said Peter Ónody, Colorectal Surgeon and Principal Investigator of the clinical trial.
"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 added.
Moshe Zilversmit, co-founder and CEO of Signum Surgical, said today marks a significant milestone for the company.
"This is an important step to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system," he said.
"We are currently in discussions with potential strategic commercialisation partners to explore how to rapidly and efficiently make the BioHealx solution available to patients," he said.
"FDA clearance for BioHealx, 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," he added.
