Project description
Protecting the skin in ostomy patients
Every year, thousands of people have ostomy surgery. Skin complications are frequent in ostomy patients. In fact, 40 % of ileostomy and urostomy patients suffer skin complications. The Ostoform company from the University of Limerick has a unique experience in using patented technologies to improve skin health for ostomate patients. Ostoform Seal is a product that combines the use of absorbent and non-absorbent materials to impede contact between acids and skin. The product reduces costs as it diminishes the frequency of change of ostomy bags and visits to clinics. Tests have revealed a 45 % reduction in skin complications. The EU-funded OSTOFORM project will create a complete industrial line to bring the product to market.
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.
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Funding Scheme
SME-2 - SME instrument phase 2Coordinator
N91 W5NN Mullingar Co Westmeath
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.