Novel Device for Improving Ostomy Skin Condition

Objective

Ostoform is a spin-out medical device company from the University of Limerick, Ireland with a range of patented technologies, and the potential to scale, becoming a global leader in the area of ostomy skin health. There is enormous opportunity to address needs in the ostomy market, with 40% of all ileostomy and urostomy patients suffering from skin complications. The Ostoform Seal- the company’s first, award-winning product- uses a unique, patented combination of absorbent and non-absorbent materials to prevent acidic output from contacting the patient’s skin. Patient benefits of this product include healthier skin, better usability, increased patient confidence and improved patient quality of life. The devicecan also reduce costs for healthcare systems by reducing visits to ostomy nurses and by reducing the frequency with whichpatients change their ostomy bags.

The addressable patient population for the Ostoform Seal is approximately 1,000,000 in the EU and US combined, resulting in an annual market of $725m.

The device is a Class I medical device with a clear regulatory pathway and pre-existing reimbursement in the US. A 45% improvement in skin condition has already been demonstrated in a six-week study involving 12 patients. Following completion of the SME Instrument Phase I, Ostoform has secured €1.1m in private investment. This capital, along with SME Instrument Phase 2 funding will support further patient trials, which in turn will improve reimbursement pricing for the device. A full manufacturing line will also be established, with the company being fully market ready by December 2020.