Signum Surgical, a company dedicated to developing minimally invasive technologies to treat colorectal diseases, has announced the company has secured €3.6m ($4m) through two grant funding awards.

Signum Surgical - BioHealx

Image: Signum Surgical scientific advisory board member Mark Regan pictured holding BioHealx Technology with Moshe Zilversmit, CEO and Eoin Bambury, co-founder and chief technology officer. Photo: courtesy of Business Wire.

The grants include €2.3 million from the European Union Horizon 2020 SME Instrument, and €1.3 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF).

Funds from these grants will support regulatory and clinical programs leading to the commercialization of the company’s BioHealxTM device, which is designed to treat anal fistula, a painful colorectal condition that affects one in 5,000 people worldwide.1

In the United States, a total of 64,000 surgeries are performed annually to treat anal fistula.2 Current treatments are rarely successful, leaving patients to suffer with ongoing infections and causing many to undergo multiple procedures. The BioHealx technology features a bioabsorbable implant that is designed to help seal the fistula tract and dissolve in the body after treatment. The minimally invasive, single-operation approach is designed to encourage healing, prevent reinfection, and protect patient continence.

Requiring only an outpatient procedure, the BioHealx technology may eliminate the need for multiple surgeries and substantially reduce surgical trauma and healing time for patients with anal fistulas, while reducing cost for patients and the health care system as a whole.

The Horizon 2020 and DTIF grant funding will support Signum Surgical’s FDA 510(k) and European CE mark submission, as well as the launch of a 12-month clinical study of BioHealx technology to treat patients with anal fistula.

These grants follow a €2.6 million Series A investment round, which closed in 2016. The Series A round was led by Halo Business Angel Network’s MedTech Syndicate, with additional investments from Enterprise Ireland, the Western Development Commission, Rising Tide Europe, and other angel investors.

“We are delighted to be awarded both the DTIF and Horizon 2020 SME grants, which validate the need for a viable solution where other approaches have been unsuccessful in treating this patient population,” said Eoin Bambury, co-founder and chief technology officer of Signum Surgical.

“With this funding, we look forward to accelerating the commercialization of BioHealx technology to help alleviate the suffering of people with anal fistulas – a debilitating condition that severely affects patients’ quality of life.”

“Signum Surgical is a great example of a High Potential Start-Up that has not only won competitive funding on a national basis in Ireland, but has also secured funding at the European level through the Horizon 2020 SME Instrument,” said Garrett Murray, national director for Horizon 2020 at Enterprise Ireland.

“Ireland’s highly innovative SMEs have a strong success rate in Europe for the Horizon 2020 SME Instrument, and we are looking to continue to build on this success throughout the remainder of Horizon 2020. Enterprise Ireland advises and supports companies looking to compete for this valuable source of innovation funding to bring their products closer to market.”

Based in Galway, Ireland, Signum Surgical is focused on developing innovative and effective solutions to treat colorectal diseases, starting with anal fistula, a condition that severely affects patients’ quality of life. Current treatments have failed to successfully address this condition, and Signum Surgical has developed a minimally invasive technology that offers a breakthrough for these patients.

Source: Company Press Release