Galway-based medical device company, Signum Surgical, has been granted marketing clearance by the US Food and Drug Administration (FDA) for its BioHealx technology.
BioHealx has been granted De Novo classification and clearance by the FDA, which paves the way for the Signum Surgical to commercialise its technology. The start-up was granted a US patent covering this tech last year.
Signum Surgical develops treatments for colorectal conditions and has created the BioHealx device, which is designed to treat anal fistulas, a painful condition that frequently results in slow healing, a risk of incontinence or repeat procedures due to current treatment options.
The start-up’s BioHealx device is a single use, bioabsorbable implant that is designed to treat the anal fistula in a minimally invasive procedure. The implant works by closing the internal opening of the fistula tract and it dissolves in the body after it is used.
Signum Surgical said this implant is able to protect a person’s continence, as well as prevent reinfection and promote healing. The FDA clearance follows the completion of a clinical trial last year, which was designed to evaluate the safety and efficacy of BioHealx.
Dr Peter Ónody, a Colorectal Surgeon and Principal Investigator on the clinical trial, said he was “excited” at the potential of the device and 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,” Ónody said.
Signum Surgical was founded in 2016 and managed to raise €2.6m in a Series A funding round the same year. This was followed by €3.6m from grant awards in 2019 and a €2.9m funding round in 2022.
The start-up’s Co-Founder and CEO Moshe Zilversmit said the FDA marketing clearance is a “significant milestone” for the business and an important step in bringing the treatment to more patients.
“We are currently in discussions with potential strategic commercialisation partners to explore how to rapidly and efficiently make the BioHealx solution available to patients,” Zilversmit 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.”
