Signum Surgical, the Galway-based medical technology company developing treatments for colorectal diseases, has raised €2.9m for its ongoing regulatory and clinical programs to support the commercialisation of its BioHealx device for treatment of anal fistula.
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, with additional investment from the Western Development Commission and other angel investors in the medical device industry.
Signum previously raised €2.6m in a 2016 Series A investment round and a further €3.6m in 2019, including €2.3m through the EU Horizon 2020 SME instrument and €1.3m from Ireland's Disruptive Technologies Innovation Fund (DTIF).
Moshe Zilversmit, CEO of the company, which is a spin-out of the National University of Ireland BioInnovate programme, expressed gratitude to the firm's investor group for their continued support and mentorship.
"This investment will facilitate our regulatory submissions and clinical data collection leading to the commercialisation of BioHealx, an innovative product with the potential to transform the lives of patients suffering with this severely debilitating condition," he added.
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Alan Levy, director of Signum Surgical, said the investor interest indicated that BioHealx would address "a major unmet need in a significant market. We are excited to explore partnerships with corporate strategics interested in the space.”
Anal fistula affects one in 5,000 people worldwide, causing unpleasant symptoms that hamper patients' quality of life. In the US, over 90,000 surgeries are performed annually to treat anal fistula.
Present treatments are invasive, rarely successful and can result in inadequate or slow healing, a high risk of incontinence and repeat procedures.
BioHealx has been developed in collaboration with colorectal surgeons and enables them to treat anal fistula with a minimally invasive outpatient procedure with a single use, bioabsorbale implant that is designed to close the fistula tract and dissolve in the body after treatment.
Signum said BioHelax 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.
Peter Ónody, principal investigator and 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.”
Photo: Mark Regan (centre), consultant colorectal surgeon at University Hospital Galway with Moshe Zilversmit, CEO and Eoin Lewis, CTO of Signum Surgical. (Pic: Johnny Bambury)
