Signum Surgical granted new US patent for BioHealx

Signum Surgical granted new US patent for BioHealx,,TM

Extends intellectual property protection for its BioHealx,TM, technology in key US market

30 March 2023, Galway, Ireland | Signum Surgical, (‘Signum’ or ‘the Company’) the medical technology company developing innovative solutions to treat colorectal diseases, announces that the Company has been granted a new patent by the US Patent Office covering its BioHealxTM device. Signum’s growing intellectual property portfolio consists of 35 patents globally, including five issued US patents owned or under license.

Moshe Zilversmit, Co-Founder and CEO of Signum Surgical, commented: “We are pleased to receive another US patent covering our innovative BioHealxTM technology which is focused on the treatment of anal fistula. Our growing IP portfolio is a key asset for future development and bringing this technology to market. BioHealxTM has the potential to transform the lives of patients suffering from this debilitating condition.”

Headquartered in Galway, Signum Surgical is 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, BioHealxTM 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 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 costs for patients and the overall health care system.


About Signum Surgical

Headquartered in Galway, Ireland, Signum Surgical is 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 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 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.

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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.

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

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