The fourth and final period, RP4, of the TIES-TEST project has been characterized mainly by actions aimed towards speeding up the inclusion of patients into the clinical trial; development of next generation TIES Lid & Emptying Pouch; and damage control against the impact of the Covid-19 pandemic.
The clinical trial was significantly expanded in Europe, ending up with nine fully approved clinics in UK, Sweden, Austria, Poland and India, counteracting the difficult healthcare resource situation.
The OC website has been completely redesigned and also prepared for multilingual versions to support the clinical trial in different countries.
During RP4 we have finalised a project with a new generation of TIES Lid and Emptying Pouch for the patients. The technical designs were validated and released in Q2, 2022. Continued work has been carried out for final development and optimisation of the manufacturing processes.
In the spring of 2023, we started gaining user feedback strongly confirming our internal ideas about adding a new type of Emptying Pouch to the TIES system, a 24/7 click-on pouch, connected directly to the implant itself. The main function of this added TIES 24/7-bag is to resemble the functionality of a conventional ostomy pouch, but instead of being continuously glued to the skin with risks for leakages and skin irritation, the TIES 24/7-bag is attached to the implant with a safe, leak-free, simple to use connector, without skin contact and the related very common skin challenges. We therefore brainstormed, innovated, drafted and patented this new 24/7-bag during the spring and a patent application was prepared during Q2 in 2023. The formal submission was filed to the European Patent Office on July 12, 2023.
During the last months of RP4, OstomyCure decided to halt the with full force ongoing preparations for an MDR CE submission based on the clinical study C03 and implant TIES III. When in-depth clinical data based on our structural feedback system were starting to be available for us through clinical study reports being compiled by our independent Clinical Research Organisation, a mismatch gradually became more and more clear to us, between the detailed C03 clinical study results, the endpoints of the study, our own expectations, and the stated TIES system Intended Purpose.
Instead, an upgraded implant TIES IV has been developed during spring and summer 2023 in an intense period with multiple iterations of brainstorms, workshops, prototypes and practical evaluations, involving a reinforced OstomyCure team. This has resulted in an improved and simplified system with a simplified and improved surgical procedure. Apart from the clinical and functional improvements, the new TIES IV system entails significant simplifications and supply chain cost savings.
