Optimization and clinical testing of Transcutaneous Implant Evacuation System.

Project Information

TIES-TEST

Grant agreement ID: 831144

DOI

10.3030/831144

Project closed

EC signature date 20 December 2018

Start date 1 January 2019

End date 30 June 2023

Funded under

• Horizon 2020 Framework Programme

Total cost

€ 3 558 125,00

EU contribution

€ 2 490 687,50

Coordinated by

OSTOMYCURE AS
Norway

Periodic Reporting for period 4 - TIES-TEST (Optimization and clinical testing of Transcutaneous Implant Evacuation System.)

Reporting period: 2022-04-01 to 2023-06-30

Summary of the context and overall objectives of the project

Problem addressed:

An Ostomy is an artificial opening located on the lower third of the abdominal wall, also known as stoma, that is made to eliminate body wastes such as urine, mucus, and stool, in patients undergoing a surgical procedure in which the large intestine has to be (partially or completely) removed. Plastic/rubber bags or pouches, known as ostomy drainage bags, are used to collect these wastes. Ileostomy involves bringing the ileum (the last portion of the small intestine) to the abdominal surface after the complete resection of the colon (large intestine).
Common Concerns for State of the Art ileostomy procedures are leaks; odor; noise; body Image; clothing; sleeping; sex; sports; travel; leisure; activities; feeling dirty. The stoma bag is carried all the time. Unluckily, stoma complications are common. For end ileostomy, the complications rate ranges from 35%-60% and include poor stoma siting, high output, ischemia, retraction, parastomal hernia, and prolapse; skin irritation and inflammation, a common problem affecting up to 60% of patients, is mainly due to exposure to intestinal contents, the use of the stoma bags and the chemical products used to remove the glue and prepare the skin for the bag. Serious complications requiring reoperations can also occur, as can minor problems that will subject the patient to daily and nightly discomfort.

Society:
This project will result in partially or totally solving the above-mentioned problems for a large group of people globally. In Europe alone, around 60k people undergo ileostomy surgery every year and there are more than 300k people currently living with an ileostomy in Europe alone. The project will bring to the market the game-changing TIES® system that will allow the patient to live a life without the need to wear a stoma bag. It will make life easier and also dramatically increase the quality of life by helping those with a stoma take back control and live a more carefree life. Our Solution: TIES is a result of several years of research combined with the latest 3D manufacturing technology. It consists of a small tube made of pure titanium surrounded by a porous structure that allows smooth integration with the body tissues. The implant is built up layer by layer into one solid piece with 3D laser sintering technology. This produces a unique structure with optimized surfaces and enables the use of a material that is clean and without impurities; together these factors promote reliable tissue ingrowth. Additionally, health care costs could be reduced in a lifetime perspective per patient and environmental benefits could be obtained by reducing the volume of plastic disposables.

Solving the problems facing the stoma patients by rolling out TIES in the market in -25 will improve the quality of life of over 25k patients in Europe and over 8k in the USA in the period 25-29. This would also allow us to reach significant sales volume in the high-tech industry with manufacturing in Europe.

Objective.:
The overall objectives are to clinically validate the solution as safe and user friendly, obtain the CE mark according to the new MDR requirements, and launch the product commercially in order to validate the business concept as financially rewarding and as a game-changer in the stoma business globally and thus improve the life for a huge patient group

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

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.

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)

Prog.:

During the last months of RP4, OstomyCure took the decision to halt the ongoing C03. When in-depth clinical data was finally starting to be available for us from the C03 clinical based structural feedback system; a mismatch gradually became more and more clear, between the detailed study results compiled by our independent contract research organization (CRO), Devicia, and the endpoints of the study, our own expectations, and the TIES system.

Exp. results:

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 only two sterile devices instead of four, a simplified surgical procedure and the need for a new clinical study, C04, which is currently in preparation. Thanks to the present study in this development, we have succeeded to identify clear areas of improvement to solve all feedback issues. The commercial launch is expected to take place in 2025.

Pot. impacts:

A new clinical study, C04, aimed at showing the significantly enhanced efficacy of the TIES IV system is currently in preparation.

TIES poster (second page)

TIES user with lied attached to the implant