Project description DEENESFRITPL A novel medical device for treating anal fistulas Glands within the anus may get clogged and infected, leading to abscess formation, which develops into a fistula. Anal fistulas are painful, they swell, and patients often have to wear pads to control leakage. The gold standard treatment of an anal fistula is surgery, but it is associated with poor outcomes and the need for repeated procedures. After close collaboration with experts, the EU-funded BioHealx project has developed a novel medical device for healing anal fistulas. It is a single-use device that has demonstrated success in preclinical models and will be tested in clinical studies prior to its commercialisation. Show the project objective Hide the project objective Objective Signum Surgical Ltd. is a medical device company developing a solution to anal fistula disease. Anal fistulas are a common rectal disease affecting 2 out of every 10,000 people globally. An anal fistula is an artificial tunnel that, in the majority of cases, develops from an infection that begins within a blocked anal gland. If the infection cannot be cleared from the anal gland an abscess forms and the infection burrows though muscles in the rectum and exits externally at the buttocks. Patients endure a poor quality of life, experiencing pain associated with the tract and related abscesses and suffering faecal, pus and blood discharge from the fistula tract. Many patients must wear pads to control leakage, and those who seek treatment face poor surgical outcomes.There is currently no gold standard treatment for anal fistula treatment, which has not changed significantly in over 2,500 years when Hippocrates described using horse hair and silk to drain the fistula tracts. Surgeons are frustrated with the commercially available treatment options which either result in inadequate healing of the initial condition, introduce incontinence as a consequence of surgical treatment, or result in repeat procedures and additional cost to health care system.Through close collaboration with expert colorectal surgeons, Signum Surgical has developed the BioHealx device - an intuitive novel single use technology which improves upon current state of the art devices and surgical procedures to meet all identified critical clinical requirements to reliably heal anal fistulas. During this H2020 project, the company seek to demonstrate the technology in man to enable product launch and growth of sales in the U.S. and Europe. Fields of science medical and health sciencesclinical medicinesurgerysurgical procedures Keywords Anal Fistula disease Programme(s) H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs Main Programme H2020-EU.3. - PRIORITY 'Societal challenges H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies Topic(s) EIC-SMEInst-2018-2020 - SME instrument Call for proposal H2020-EIC-SMEInst-2018-2020 See other projects for this call Sub call H2020-SMEInst-2018-2020-2 Funding Scheme SME - SME instrument Coordinator SIGNUM SURGICAL LIMITED Net EU contribution € 2 323 412,00 Address NEW DOCKS, THE DOCKS H91NNY6 GALWAY Ireland See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Northern and Western West Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 3 319 161,25
