Seton-Scaffold Device™

Fistula-in-ano is an intrusive and embarrassing condition where sufferers experience daily discomfort 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 are often unsuccessful.

The Seton-Scaffold Device™ (SSD) is a narrow, thin piece of biomaterial that has been designed to be placed and fixed in the fistula tract.

The SSD combines the benefits of ongoing active seton drainage simultaneously with a bioresorbable scaffold structure for tissue regrowth – to produce superior results, via a simpler, less invasive (eventually, local rather than general anaesthesia) and economically advantageous solution.

The Seton-Scaffold Device material encourages the body’s cells to migrate, settle into and populate the scaffold, which is the first step in a process that should eventually lead to the complete healing of the fistula. The scaffold then slowly resorbs over several weeks.

With promising clinical data from a first in man study (15 patients), we are now preparing for a multi-centre pivotal study (>100 patients) to further demonstrate the safety and clinical performance of the new device.

Seton Scaffold Device

Achievements

Awarded two NIHR i4i product development awards, totalling over £2M
Collaborative project working with leading colorectal surgery group at Queen Elizabeth Hospital Birmingham
First-in-man study demonstrated safety of device and potential for improved healing
Multi-centre pivotal clinical study to take place 2024
Bionow "Partnership and Collaboration" award finalist 2024

Get in touch with us

We’re always happy to hear from potential investors and funding partners as well as researchers, universities and networks interested in our products and development work.