GALWAY, Ireland--(BUSINESS WIRE)--Signum Surgical, a company dedicated to developing minimally invasive technologies to treat colorectal diseases, today announced the company has secured €3.6 million ($4 million) through two grant funding awards. 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.”
About Anal Fistulas
Anal fistula is a painful colorectal condition that affects one in 5,000 people.1 In most cases, patients will develop an anal fistula, due to an infected anal gland that, when left untreated will abscess and burrow through the patient’s sphincter muscle. Anal fistulas cause a host of unpleasant symptoms that hamper patients’ quality of life, such as swelling and discharge of blood or pus from the anus. Current standard of care treatments, including seton placement or fistulotomy surgery, involve the opening or cutting of the channel to reach the fistula, followed by draining or scraping and flushing out the infected tissue. These treatments are rarely successful and can result in inadequate or slow healing, a high risk of incontinence, and repeat procedures.
About Signum Surgical
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. After a year of exploring the needs in gastrointestinal and colorectal care, Eoin Bambury and Moshe Zilversmit founded Signum Surgical in 2016 as a spin-out of the National University of Ireland BioInnovate programme. For more information, visit https://www.signumsurgical.com/.
About European Union Horizon 2020
Horizon 2020 is the financial instrument implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe's global competitiveness. By coupling research and innovation, Horizon 2020 is helping to achieve this with its emphasis on excellent science, industrial leadership and tackling societal challenges. The goal is to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together in delivering innovation.
About Disruptive Technologies Innovation Fund
The Disruptive Technologies Innovation Fund is a €500 million fund established under Project Ireland 2040 and is run by the Department of Business, Enterprise and Innovation with administrative support from Enterprise Ireland.
1 Ommer A et al: Clinical practice guideline: Cryptoglandular anal fistula. Dtsch Arztebl Int 2011; 108(42): 707–13. https://www.researchgate.net/publication/51826318_Cryptoglandular_Anal_Fistulas
2 Zanotti, C., Martinez-Puente, C., Pascual, I. et al. Int J Colorectal Dis (2007) 22: 1459.