Signum Surgical granted FDA De Novo clearance for BioHealx™

  • Novel surgical option for the treatment of anal fistula, a painful and debilitating colorectal condition
  • Milestone follows recent completion of clinical trial evaluating the safety and efficacy of the device
  • FDA clearance paves the way for BioHealx™ commercialization

03 July 2024, Galway, Ireland | Signum Surgical (‘Signum’ or ‘the Company’), a medical technology company developing innovative solutions to treat colorectal diseases, is pleased to announce that its BioHealx™ technology has been granted marketing clearance by the U.S. Food and Drug Administration (FDA), as a first-of-its-kind medical device for the treatment of anal fistula.

Anal fistulas are a painful colorectal condition affecting one in 5,000 people worldwide1. In the United States, over 90,000 surgeries are performed annually to treat anal fistulas2. 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™ is a single use, bioabsorbable implant used to treat anal fistula in a minimally invasive procedure. BioHealx™ is designed to close the internal opening of the fistula tract via tissue apposition and dissolve in the body after treatment. The single-operation approach is designed to promote healing, prevent fistula recurrence, and protect patient continence.

The De Novo classification and clearance by the FDA, represents a significant milestone for Signum and follows the completion of a single-arm, non-randomized, clinical trial in 2023 designed to evaluate the safety and efficacy of BioHealx™. The multi-centre clinical trial, led by four investigators in Hungary, treated a total of 32 patients (both male and female adults) who had experienced recurrent anal fistula from at least one previous failed treatment. Final follow up assessments have been completed on the 32 patients over a period ranging from 13 to 40 months.

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: “We are proud to develop BioHealx™, now an FDA De Novo cleared medical device for the treatment of anal fistula. This is a significant milestone for our business and an important step to bring this novel treatment to market for the benefit of patients, surgeons, and the healthcare system. We are currently in discussions with potential strategic commercialization partners to explore how to rapidly and efficiently make the BioHealx™ solution available to patients. FDA clearance for BioHealx™, which is protected by our growing intellectual property portfolio, continues our strong momentum in addressing the unmet clinical need for the treatment of anal fistula.”

Dr Bernard Collins, Investor Director, commented: “Signum Surgical’s innovative BioHealx™ technology addresses a major unmet clinical need in colorectal care and specifically for the significant patient population suffering with anal fistula. In excess of 90,000 surgeries are performed annually in the United States alone to treat this debilitating condition, however current treatment options are often unsuccessful and there is a high risk of repeat procedures. With strong investor interest in Signum Surgical, FDA De Novo clearance is another transformative step for Moshe, Eoin and the team, and marks further progress towards bringing BioHealx™ to market in the near future for the benefit of patients and physicians.”


About Signum Surgical

Headquartered in Galway, Ireland, Signum Surgical is an ISO 13485 certified medical technology 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 often fail 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.

Signum Surgical successfully raised €5.5 million in equity in two investment rounds to support its clinical and regulatory programs. In addition, Signum received €3.6 million in 2019 through two non-dilutive grant funding awards from the European Union Horizon 2020 SME Instrument and Ireland’s Disruptive Technologies Innovation Fund (DTIF). The Company’s equity shareholders include Halo Business Angel Network’s MedTech Syndicate who served as lead investor in both funding rounds, as well as Enterprise Ireland, the Western Development Commission, Rising Tide Europe and other medical device industry angel investors.

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 often unsuccessful 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.

2 Zanotti, C., Martinez-Puente, C., Pascual, I. et al. Int J Colorectal Dis (2007) 22: 1459

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