Signum Surgical Completes Clinical Trial for BioHealx
- Galway based company compiling data for submission of a De Novo classification request to U.S. FDA
- Novel surgical option for the treatment of anal fistula, a painful and debilitating colorectal condition
12 September 2023, Galway, Ireland | Signum Surgical, (‘Signum’ or ‘the Company’) the clinical stage medical technology company developing innovative solutions to treat colorectal diseases, announces the completion of its single-arm, non-randomized, clinical trial to evaluate the safety and efficacy of its BioHealx™ device for the treatment of anal fistula.
The multi-centre clinical trial, led by four investigators, treated a total of 32 patients in the adult male and female patient population with BioHealx™, who had experienced recurrent anal fistula from at least one previous failed procedure. Final follow up assessments have been completed on the 32 patients over a period ranging from 13 to 40 months. This clinical trial data is currently being compiled for submission of a De Novo classification request to the U.S. Food and Drug Administration (FDA) and scientific publication in due course, which would pave the way for bringing BioHealxTM to market.
As a novel treatment option, with no legally marketed predicate device, Signum Surgical will submit a De Novo request to classify BioHealx. A DeNovo request is a risk-based classification process for which general controls alone, or general and special controls, provide reasonable assurances of the safety and efficacy for its use in the treatment of anal fistula.
Peter Ónody, Colorectal Surgeon and Principal Investigator of the clinical trial, commented: “I am excited at the potential of BioHealx™ as a novel surgical option for the treatment of anal fistula and, in particular, its ease of use for physicians. This treatment has the potential to eliminate the need for multiple surgeries and substantially reduce surgical trauma and the rate of fistula recurrence, while reducing costs for patients and the overall health care system.”
Moshe Zilversmit, Co-Founder and CEO of Signum Surgical, commented: “The completion of our clinical trial marks a significant milestone for Signum Surgical and our BioHealx™ device. We look forward to submitting our De Novo classification request to the U.S. FDA and the scientific publication of the data in due course, as we seek to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system.”
Headquartered in Galway, Ireland, Signum Surgical is a clinical stage, ISO 13485 certified, company focused on developing minimally invasive technologies to treat colorectal diseases, firstly introducing the BioHealx™ technology to address the treatment of 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 fistula2. 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, BioHealx™ will enable 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 fistula recurrence, and protect patient continence.
About Signum Surgical
Headquartered in Galway, Ireland, Signum Surgical is a clinical stage, ISO 13485 certified, company focused on developing innovative 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 BioHealx™ 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 2022, Signum Surgical successfully raised €2.9 million to support its ongoing regulatory and clinical programs. This followed the €3.6 million raised in 2019 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). In 2016, Signum Surgical raised €2.6 million in a Series A investment round in 2016 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