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Further funding for new device to improve treatment of anal fistula

The award will fund a clinical study across 10 UK hospitals to demonstrate clinical safety and healing endpoints in over 100 patients.

14 February 2024
Woman, looking worried

Over 12,000 people a year are diagnosed in the UK, and it is notoriously difficult to treat.

A consortium of Birmingham researchers, clinicians and industry partners has received a second £1.1m award from the National Institute for Health and Care Research (NIHR) for a three-year study supporting the further development of a novel device that could revolutionise the clinical management of anal fistula.

In this intrusive and embarrassing condition, sufferers experience daily discomfort and smelly discharge from a tunnel between the bowel and skin around the anus. It affects mostly young people and has a significant impact on employment and family life due to chronic infection and pain.

Over 12,000 people a year are diagnosed in the UK, and it is notoriously difficult to treat. The clinical challenge is to allow the fistula tract to drain and heal at the same time and preserve continence. Current treatment pathways require multiple operations under general anaesthetic, over a prolonged timeframe and usually lead to hygiene difficulties, which can be permanent.

The consortium, which comprises experts from University Hospitals Birmingham NHS Trust, the University of Birmingham, and industry partners Neotherix and Keighleycolo has developed a novel device (known currently as the “Seton-Scaffold Device”), which is less invasive and more effective than existing treatments. The device combines a bioresorbable scaffold to heal the fistula and a thin comfortable seton to achieve drainage.

I am delighted that the NIHR continues to support the development of this much-needed innovation. Our data from a small first-in-man study demonstrated this device could be more effective than anything else on the market and make a real difference to patients’ lives.

Chief Investigator Professor Tom Pinkney from the Institute of Applied Health Research

The device is made from a material that encourages the body’s cells to migrate, settle into and populate the scaffold. This is the first step in a process that should eventually lead to the complete healing of the fistula, and the scaffold material and seton thread are slowly resorbed over several weeks. The device can be delivered to the awake patient so making it a safer, and cheaper, alternative than the current treatment paradigm.

This Product Development Award from NIHR invention for innovation (i4i) programme will enable the consortium to finalise product design, manufacture sterile devices and conduct a pivotal clinical study across 10 hospitals in the UK to demonstrate the clinical safety and healing endpoints of the device in over 100 patients with anal fistula, including those with Crohn’s disease.

This is the second NIHR award for the consortium. Work funded by the previous award included education, training and usability sessions and a 20 patient study that showed the device is safe to use, and has good patient and clinician acceptance.

The consortium is now exploring commercialisation opportunities and the most effective route to market for this innovative, affordable device. Interested parties should contact University of Birmingham Enterprise.

Chief Investigator Professor Tom Pinkney from the University’s Institute of Applied Health Research said: “I am delighted that the NIHR continues to support the development of this much-needed innovation. Our data from a small first-in-man study demonstrated this device could be more effective than anything else on the market and make a real difference to patients’ lives.”

Neotherix CEO Dr Mike Raxworthy said: “This project will generate data critical to demonstrating the safety and clinical value of the Seton-Scaffold Device and will allow us to move forward with commercial partners. It is an excellent illustration of the value of a strong academic-clinical-industry collaboration working together to solve unmet medical needs.”

Professor Mike Keighley of Keighleycolo Ltd, and author of the definitive colorectal textbook (now in its 4th edition) said: “I believe this will deliver affordable and effective therapy without morbidity and the need for hospital admission worldwide.”

Notes for editors

For media information contact Ruth Ashton, University of Birmingham Enterprise, email: r.c.ashton@bham.ac.uk

The University of Birmingham: The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 8,000 international students from over 150 countries.

University of Birmingham Enterprise helps students and researchers turn their ideas into new services, products and enterprises that meet real-world needs. We also provide incubation and bio-incubation, support innovators and entrepreneurs with mentoring, advice and training, and manage the University’s Academic Consultancy Service. Follow us on LinkedIn and Twitter.

University Hospitals Birmingham NHS Foundation Trust (UHB): UHB runs Heartlands, Good Hope, Solihull and the Queen Elizabeth hospitals; UHB also hosts the Institute of Translational Medicine (ITM).

The Trust has approximately 2,700 beds, over 80 theatres and a 100-bedded critical care unit - the largest in Europe, and cares for over 2.2 million patients each year, employing over 24,000 staff.

QEHB is a Major Trauma Centre treating the most severely injured casualties from across the region.

Our hospitals are regional centres of excellence for trauma, burns, plastics, neurosciences and cancer and in 2014 became a lead genomics centre as part of the NHS 100,000 genomes project.

UHB is proud to host the Royal Centre for Defence Medicine (RCDM). The RCDM provides dedicated training for defence personnel and is a focus for medical research.

Neotherix: Neotherix has established a platform technology and pipeline of products based on electrospun advanced bioresorbable scaffolds for tissue repair. The products are positioned to alleviate worldwide healthcare spending (currently many millions of pounds) on the management of problematic, non-healing wounds. Based in York, Neotherix has built robust collaborations with academic and clinical teams across the UK. Neotherix is raising investment to enable launch of its first product and to build value in out-licence opportunities. The vision is to scale up and be the world leader in electrospun scaffolds, allowing the platform technology to be used to heal a variety of problematic wounds in a cost effective manner. Interested parties should contact CEO Dr Mike Raxworthy via mike.raxworthy@neotherix.com for further details.

Keighleycolo Ltd: The medico-legal colorectal practice of Professor Keighley keighleycolo@btinternet.com became incorporated as a limited company in 2009 with four shareholders and an Education Trust. Over half of the work involves reports on women who have sustained severe injury sometimes fistulas during childbirth. The company is also involved in four charities particularly the MASIC Foundation in which Professor Keighley is both founder and president. The company owns the IP (from 2011) for the concept of a device for treating fistulas and has spent £625,000 so far in securing the patents for which the current and previous NIHR grants have enabled the team to take this into the clinical arena for the benefit of patients.

NIHR: The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

  • Funding high quality, timely research that benefits the NHS, public health and social care;
  • Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
  • Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
  • Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
  • Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
  • Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

Grant reference: NIHR204560 Clinical Validation Study of the Seton-Scaffold Device for the treatment of Fistula-In-Ano.

Featured staff

  • Professor Thomas Pinkney

    George Drexler & Royal College of Surgeons Chair of Surgical Trials

    Staff profile page for Mr Thomas Pinkney, George Drexler & Royal College of Surgeons Chair of Surgical Trials, Institute of Applied Health Research.

    Phone: +44 (0) 121 371 5888.
    Email: t.pinkney@bham.ac.uk

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