Further funding for new device to improve treatment of anal fistula
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.
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.”
For media information contact Ruth Ashton, University of Birmingham Enterprise, email: r.c.ashton@bham.ac.uk
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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.
