Funds to support ongoing regulatory submissions and clinical programs leading to the commercialization of BioHealxTM
20 September 2022, Galway, Ireland | Signum Surgical, (‘Signum’ or ‘the Company’) the medical technology company developing innovative solutions to treat colorectal diseases, announces it has successfully raised a further €2.9 million to support its ongoing regulatory and clinical programs. The financing round was led by Halo Business Angel Network’s MedTech Syndicate, a joint initiative by Enterprise Ireland, InterTrade Ireland and Invest Northern Ireland. Additional investment was secured from the Western Development Commission and other angel investors in the medical device industry.
Peter Ónody, Principal Investigator, Colorectal Surgeon, commented: “Having had the opportunity to participate in the BioHealx study I can attest first hand that the BioHealx device truly is a game changing technology. It is easy to use and the mechanism of action of internal opening closure is the solution the clinical community has been looking for since the earliest descriptions of fistula treatment. BioHealx will be the ‘go-to’ device that I will use for my anal fistula patients when it is available on the market.”
Funds from this financing round will be dedicated to Signum’s regulatory submissions and clinical studies leading to the commercialization of the Company’s BioHealxTM device, which is designed to treat anal fistula. This painful colorectal condition affects one in 5,000 people worldwide1 and in the United States over 90,000 surgeries are performed annually to treat anal fistula.2 Current treatment options are often unsuccessful, which frequently result in inadequate or slow healing, a high risk of incontinence, and repeat procedures.
Developed in collaboration with expert colorectal surgeons, BioHealxTM enables surgeons to treat anal fistula with a minimally invasive outpatient procedure, featuring a single use, bioabsorbable implant that is designed to close the fistula tract and dissolve in the body after treatment. The single-operation approach is designed to promote healing, prevent reinfection, and protect patient continence. The BioHealxTM technology has the potential to eliminate the need for multiple surgeries and substantially reduce surgical trauma and healing time, while reducing cost for patients and the overall health care system.
This financing round continues the positive momentum for Signum, which successfully raised €2.6 million in 2016 and a further €3.6 million in 2019.
Moshe Zilversmit, co-founder and CEO of Signum Surgical, commented: “We are delighted to secure an additional €2.9 million investment and grateful to our investor group for their continued support and mentorship. This investment will facilitate our regulatory submissions and clinical data collection leading to the commercialization of BioHealx TM, an innovative product with the potential to transform the lives of patients suffering with this severely debilitating condition.”
Alan Levy, Director of Signum Surgical, commented: “The strong investor interest in Signum indicates that the BioHealx TM technology is addressing a major unmet need in a significant market. We are excited to explore partnerships with corporate strategics interested in the space.”
ENDS
About Signum Surgical
Headquartered in Galway, Ireland, Signum Surgical is focused on developing innovative and effective solutions to treat colorectal diseases, starting with anal fistula, a painful and debilitating condition that severely affects patients’ quality of life. Current treatments have failed to successfully address this condition. With its BioHealxTM device, Signum Surgical has developed a minimally invasive technology that offers a breakthrough for these patients. Having explored gastrointestinal and colorectal care, and identified an unmet need of this patient population, Eoin Bambury and Moshe Zilversmit founded Signum Surgical in 2016 as a spin-out of the National University of Ireland BioInnovate programme.
In 2019, Signum Surgical secured €3.6 million through two grant funding awards. The grants included €2.3 million from the European Union Horizon 2020 SME Instrument, and €1.3 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF). This followed a €2.6 million Series A investment round in 2016 which was led by Halo Business Angel Network’s MedTech Syndicate; with additional investment from Enterprise Ireland, the Western Development Commission, Rising Tide Europe and other medical device industry angel investors.
For more information, please visit https://www.signumsurgical.com
About Anal Fistula
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.
1 Ommer A et al: Clinical practice guideline: Cryptoglandular anal fistula Deutsches Arzteblatt International 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
About Halo Business Angel Network (HBAN)
Halo Business Angel Network (HBAN) is the all-island umbrella group responsible for the development of business angel networks and syndicates. Through actively working to support the formation and operation of new and existing angel networks, as well as to increase the number of angel investors in early stage Irish companies, HBAN support the entrepreneurial community across the island of Ireland.
HBAN is managed by Furthr in partnership with the regional Irish BICs in Cork, Galway & Waterford. and with Clarendon Fund Managers in Northern Ireland.
Further information is available at: http://www.hban.org
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