Novel Device for Improving Ostomy Skin Condition

Project Information

OSTOFORM

Grant agreement ID: 858615

DOI

10.3030/858615

Project closed

EC signature date 9 May 2019

Start date 1 April 2019

End date 31 October 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 835 801,25

EU contribution

€ 1 285 060,88

Coordinated by

OSTOFORM LIMITED
Ireland

Periodic Reporting for period 2 - OSTOFORM (Novel Device for Improving Ostomy Skin Condition)

Reporting period: 2020-04-01 to 2021-10-31

Summary of the context and overall objectives of the project

Skin complications are a common problem among people living with a stoma. The main cause of skin complication is from stoma output leaking onto the surrounding skin. Once somebody has an ostomy skin complication, they must continually place an ostomy bag onto broken, damaged skin. Because the landing site for the ostomy bag is damaged, the bag might not stick properly, causing further leaks, meaning that the skin does not have a chance to heal. Also, this can result in an increased risk of the ostomy pouch falling off, so it has a major impact on quality of life.

Ostoform, through the H2020 SME Instrument, is developing a novel solution to help prevent stoma output from contacting the user’s skin – The Ostoform Seal with FLOWASSIST Protection. The solution uses a combination of absorbent and non-absorbent materials to direct the flow of stoma output into the ostomy pouch, thus keeping the user’s skin healthy and improving the quality of life for people who use an ostomy pouch.

Through the H2020 project, Ostoform will conduct a user trial and build on its data to demonstrate the safety and efficacy of the new device. By the end of the project, the design and manufacturing method will be finalised, and distributors will be identified for device commercialisation.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Ostoform has completed a multi-site clinical investigation, which has demonstrated a clear trend towards improvements in skin condition, and very encouraging user-feedback. This study has been accepted for publication in the scientific journal Advances in Skin and Wound Care.
The company has now set up a high-volume manufacturing line for The Ostoform Seal with FLOWASSIST. A successful pilot launch has been completed in the Netherlands. A reimbursement has been assigned in the US and the company is now working with a major distributor to promote the product in the US market.

The device is patented in Europe, the US, Japan and China and the company has built a team to develop pipeline products and continue to build market traction.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Ostoform, through clinical and bench testing, has developed a robust health economic argument, demonstrating cost savings for healthcare systems, while improving patient quality of life.
The Ostoform Seal with FLOWASSIST is now available to purchase in the Netherlands, Denmark and the US, with reimbursement available in each region. Ostoform will expand into additional territories in 2022.

Ostoform Seal with FLOWASSIST Protection