The UK’s National Institute for Health and Care Research (NIHR)has awarded a $1.1m grant to a consortium of experts to advance a device to treat anal fistula.
The NIHR awarded an initial grant in 2019 that funded education, training and usability sessions, as well as a 20-patient study that showed the Seton-Scaffold device is safe to use.
Following the $1.1m grant, researchers from University Hospitals Birmingham NHS Trust, the University of Birmingham, and industry partners Neotherix and Keighleycolo will conduct a three-year study supporting the development of the device.
Neotherix’ device integrates a bioresorbable scaffold for fistula healing and a thin seton for drainage, constructed from a material that promotes cell migration and integration into the scaffold, it initiates the healing process. Over several weeks, both the scaffold material and seton thread gradually dissolve. The device can be delivered to patients awake, offering a safer and more cost-effective alternative to the current treatment paradigm.
Anal fistulas are abnormal connections between the anal canal and surrounding skin that can affect Crohn’s disease and inflammatory bowel disease (IBD) patients, due to inflammation. They cause pain, swelling, and infection.
According to a report on GlobalData’s Pharma Intelligence Center, the global Crohn’s disease market size will be $25.5bn in 2032, growing at a compound annual growth rate (CAGR) of 6.2% from $14bn in 2022.
In the announcement accompanying the funding, Neotherix CEO 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.”
Wound management company RedDress raised $26m last year in a Series D financing round to advance its graft technology ActiGraft, which creates an in-vitro blood clot from the patient’s blood. The company has ongoing clinical trials in the US for treating anal fistulas in patients suffering from Crohn’s or IBD.
