Imagine having a surgical opening in your abdomen where waste exits your body — and the acidic output keeps burning the skin around it. That's what 40% of ostomy patients deal with every day. A team in Limerick, Ireland built a special seal ring made of a clever mix of absorbent and non-absorbent materials that acts like a protective barrier, keeping acid away from the skin. In trials, patients saw a 45% improvement in skin condition in just six weeks.
Roughly 40% of all ileostomy and urostomy patients suffer from painful skin complications caused by acidic output leaking under their ostomy seal. This leads to frequent nurse visits, constant bag changes, and significantly reduced quality of life. Healthcare systems bear the cost of repeated treatments while patients endure chronic discomfort.
Ostoform built the Ostoform Seal — a Class I medical device using a patented mix of absorbent and non-absorbent materials that blocks acidic output from reaching the skin. They manufactured 10,000 units on a full production line and completed patient trials showing 45% skin improvement.
If you are a medical device distributor supplying ostomy products to hospitals and home care — this project produced a manufactured, Class I medical seal that showed 45% skin improvement in patient trials. With 10,000 units manufactured and a $725m addressable market, this is a ready-to-sell product line addition for your ostomy portfolio.
If you are a hospital network spending heavily on ostomy nurse visits and frequent bag changes due to skin complications — this device reduces both. With 40% of ileostomy and urostomy patients suffering skin problems, adopting the Ostoform Seal could lower your repeat care costs while improving patient outcomes.
If you are a home care provider managing ostomy patients who frequently need skin treatment and bag replacements — the Ostoform Seal prevents acidic output from contacting skin, demonstrated with 45% improvement in a 6-week trial. Pre-existing US reimbursement means your patients can access it through existing payment channels.
Specific pricing is not disclosed in the project data. However, the device has pre-existing reimbursement in the US, meaning insurers already cover this product category. The project aimed to improve reimbursement pricing through additional patient trial data.
Yes. A deliverable confirms 10,000 units were manufactured and ready to ship. The project established a full manufacturing line, indicating the company has moved past prototype into repeatable production.
Ostoform holds patented technologies for the seal's combination of absorbent and non-absorbent materials. The company is a spin-out from the University of Limerick. Licensing or distribution arrangements would need to be negotiated directly with Ostoform Limited in Ireland.
The Ostoform Seal is classified as a Class I medical device, which has the simplest regulatory pathway. This classification applies in both the EU and US markets. No additional complex approval processes are required for market entry.
The addressable patient population is approximately 1,000,000 in the EU and US combined, representing an annual market of $725m. With 40% of ileostomy and urostomy patients suffering skin complications, there is significant unmet demand.
A six-week study involving 12 patients demonstrated a 45% improvement in skin condition. The project also produced a formal report on patient trials demonstrating device efficacy. The company secured €1.1m in private investment on the strength of these results.
The Ostoform Seal is designed as a drop-in replacement for standard ostomy seals, requiring no changes to existing bag systems or clinical procedures. As a Class I device with pre-existing US reimbursement, integration into procurement and care pathways is straightforward.
This is a single-company project — Ostoform Limited, an Irish SME and University of Limerick spin-out, funded under the EIC SME Instrument Phase 2. The 100% industry consortium with no academic partners signals this is a commercialization-stage effort, not early research. The company used this funding to move from validated product to manufacturing scale and expanded clinical evidence. The fact that they attracted €1.1m in private investment alongside EU funding demonstrates investor confidence in the commercial potential.
Ostoform Limited is based in Ireland. Contact their business development team through ostoform.com for distribution or partnership inquiries.
Want an introduction to the Ostoform team for distribution, licensing, or bulk purchasing? SciTransfer can arrange a direct meeting with the right person.
