CORDIS - EU research results

Anal Fistula Treatment

Periodic Reporting for period 3 - BioHealx (Anal Fistula Treatment)

Reporting period: 2020-10-01 to 2022-06-30

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.
Summary of Exploitable Results

The BioHealx technology has progressed though successful final development and testing phases. The technological approach and final product configuration have been validated with clinicians though formal validation work and informal feedback from industry partners and non-affiliated clinical community.
A summary of the main exploitable results to date is presented below.

Overview of Key Project Achievements to Date:

• Onboarding of Manufacturing Engineer
• Validated by Irish government as part of their Disruptive Technology innovation scheme – BioHealx was selected as one of 27 projects to receive funding to expand manufacturing scale up and platform expansion of the technology.
• Filed 5 patent applications and received grant of 2 patents and 2 registered designs.
• Successfully completed GLP animal study
• Successfully completed biocompatibility and chronic toxicity testing
• Completed verification and validation testing activities

Quality System Work to Date

• Design Phase 2 exit compete
• Design Phase 3 exit complete
• Design Phase 4 exit complete
• ISO 13485 certification achieved
• FDA 510(k) submission complete
• Quality system established
The impacts outlined in the DoA remain unchanged.
Signum continues to receive extremely positive feedback from the clinical community regarding the BioHealx device, including input from Signum’s Scientific Advisers Board (SAB), non-affiliated clinicians and patients.

Signum have engaged the Nation Standards Authority of Ireland (NSAI) for certification of the Quality Management System (QMS) to ISO13485 which was granted in February 2020.
Potential Industry Partners
Signum have validated the market size, provider and patient impact and technological approach of the BioHealx device with industry partners with a view to potential future distribution collaboration.
BioHealx Delivery Device