Periodic Reporting for period 2 - FlowAssist Pouch (FlowAssist Pouch will help to improve the skin condition of ostomy pouch users, while introducing novel design features, dramatically improving their lifestyle and management of their condition)
Période du rapport: 2024-01-01 au 2024-12-31
The goal of the FLOWASSIST pouch project is to build upon the recently-developed FLOWASSIST technology, which improves the lives of people who have a stoma, by preventing adhesive breakdown of ostomy appliances, and thereby improving ostomy skin health. The patented FLOWASSIST technology works by preventing corrosive stoma output from contacting the skin surrounding the stoma, keeping the skin healthy, and improving patients’ comfort. This technology can also result in fewer leaks and longer ostomy appliance wear time. By extending appliance wear time, it is possible to reduce the amount of waste created by these disposable medical devices.
The FLOWASSIST Seal has been developed by Ostoform, and with the support of this project, commercial scale-up is now being implemented. This project also supports the development of the FLOWASSIST Pouch, an additional product range, which will make the FLOWASSIST technology available to a wider population of people who have a stoma.
The FLOWASSIST Seal has been developed by Ostoform, and with the support of this project, commercial scale-up is now being implemented. This project also supports the development of the FLOWASSIST Pouch, an additional product range, which will make the FLOWASSIST technology available to a wider population of people who have a stoma.
As part of the FLOWASSIST Pouch project, a novel manufacturing method has been developed that will enable enhanced 3-dimensional design of ostomy appliances, which in turn, will result in enhanced usability features.
Further, a pouch, incorporating FLOWASSIST has been developed to regulatory approval. Bench testing against state of the art has been conducted, and demonstrates that the FLOWASSIST Pouch lasts longer than industry-standard products.
Further, a pouch, incorporating FLOWASSIST has been developed to regulatory approval. Bench testing against state of the art has been conducted, and demonstrates that the FLOWASSIST Pouch lasts longer than industry-standard products.
A clinical study will take place to further validate the performance of the FLOWASSIST pouch, with respect to ostomy skin health, longer wear time, and enhanced usability. The FLOWASSIST pouch will be commercially available in the US in 2024, with regulatory approval in place all reimbursement codes now assigned. It is anticipated that the FLOWASSIST Pouch will also be commercially available in Europe upon completion of the project.
The FLOWASSIST Seal will be commercially available in numerous European countries, before completion of the project, including Czech Republic, Germany, France, and Spain.
The FLOWASSIST Seal will be commercially available in numerous European countries, before completion of the project, including Czech Republic, Germany, France, and Spain.