EIT Health Supported Signum Surgical gets FDA Approval for BioHealx Device

Signum Surgical, a Galway-based medical technology company supported by EIT Health, has reached a significant milestone with the De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx device recently. This approval marks a pivotal step in advancing the treatment and recovery of anal fistulas, a condition affecting thousands of patients annually.

BioHealx is a single-use, bioabsorbable implant designed to treat anal fistulas through a minimally invasive procedure. The device works by closing the internal opening of the fistula tract and then dissolving in the body, offering a safer and more effective alternative to traditional treatments. The FDA clearance follows a successful clinical trial that demonstrated the safety and efficacy of BioHealx, highlighting its potential to reduce surgical trauma, lower the rate of fistula recurrence, and protect patient continence.

Each year, approximately 90,000 surgical procedures are performed to treat anal fistulas in the US alone. Existing treatment options often yield poor outcomes, posing risks of permanent incontinence, insufficient healing, and the need for repeat surgeries..

BioHealx 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 healthcare system.

Signum Surgical’s journey has been supported by EIT Health. The company received grant funding through the EIT Health Headstart programme in 2017, which played a crucial role in the early development of the BioHealx technology.

“We recognised the potential of Signum Surgical’s BioHealx device early on, and we are thrilled to see their innovation receive FDA approval. EIT Health is proud to support innovative start-ups like Signum Surgical as they advance healthcare solutions that make a difference in patients’ lives. This milestone underscores the importance of supporting start-ups that are making significant advancements in healthcare,” said Graham Armitage, Managing Director, EIT Health Ireland-UK.

Founded in 2016 by Eoin Bambury and Moshe Zilversmit during the University of Galway’s BioInnovate Fellowship Programme, Signum Surgical has continually advanced its mission to develop innovative solutions for colorectal conditions. The company has successfully raised substantial funding, including a €2.9 million investment round in 2022, €3.6 million in 2019, and €2.6 million in 2016.

Eoin Bambury, Co-Founder & CTO, Signum Surgical said, “The support of EIT Health is much appreciated in the progress we have made to secure the FDA De Novo clearance for BioHealx. Now recognised as a first-of-its-kind medical device for the treatment of anal fistula, this innovative device has the potential to transform the lives of patients suffering with this severely debilitating condition. FDA De Novo clearance represents a pivotal milestone for our company and the next step towards bringing BioHealx to market for the benefit of patients, surgeons, and healthcare systems.”

With the FDA clearance secured, Signum Surgical is set to commercialise its BioHealx device, aiming to make a significant impact on the treatment of anal fistulas. The company is actively seeking strategic partners to bring this innovative solution to market, promising to improve patient outcomes and reduce healthcare costs.

Are you part of a health innovation start-up looking to accelerate your business in Europe? Explore EIT Health’s programmes to find current opportunities and apply today.