Galway, Ireland-based startup Signum Surgical said today that it has landed more than $3 million in grants to help fund its efforts to gain U.S. and European regulatory clearance of a device intended to treat a condition that can cause fecal incontinence.
The grants include $2.04 million from the European Union Horizon 2020 SME Instrument and $1.15 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF). Part of the money will help Signum Surgical launch of a 12-month clinical study of its BioHealx device, which is designed to treat anal fistula. An anal fistula is an artificial tunnel between the rectum and skin of the buttocks that can develop due to an infected or blocked anal gland. If left untreated, an abscess may form, and the infection may travel through the patient’s sphincter muscle. The condition primarily affects young men and up to one in 5,000 people worldwide, according to a 2011 study published in Deutsches Ärzteblatt International.
Current treatments are rarely successful, leaving patients to suffer from ongoing infections and causing many to undergo multiple procedures, according to the company. The BioHealx technology includes a bioabsorbable implant designed to help seal the fistula tract and dissolve in the body after treatment. The implant is placed via a minimally invasive, outpatient procedure designed to encourage healing, prevent reinfection, and protect patient continence, the company said.
The new grants follow a $2.3 million Series A investment round that 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 Signum Surgical co-founder and chief technology officer Eoin Bambury in a prepared statement. “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.”
