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Optimization and clinical testing of Transcutaneous Implant Evacuation System.

Periodic Reporting for period 1 - TIES-TEST (Optimization and clinical testing of Transcutaneous Implant Evacuation System.)

Reporting period: 2019-01-01 to 2019-12-31

What is the problem/issue being 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% to 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.

Whys is it important for 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 60,000 people undergo ileostomy surgery every year and there are more than 300,000 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: The disruptive Transcutaneous Implant Evacuation System (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® System in the market in late 2022 will improve the quality of life of over 25,000 patients in Europe and over 8,000 in the USA in the period between 2022 and 2026. This would also allow us to reach significant sales volume in the high-tech industry with manufacturing in Europe.

What are the overall objectives:
The overall objectives are to clinically validate the solution as safe and user friendly, obtain the CE mark according to the new MDR regulatory 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/user group

Please see the technical report for an overall view on the first reporting period.
1.Clinical progress

a) Established two university clinics in the UK with all formal permittances including ethical committees. These being the university hospitals of Leeds and Plymouth. We have 8 more clinics in the pipeline in the UK. Based on current experience, we need a higher number of clinics in order to recruit the planned number of patients. Activities are on-going to establish 5-10 clinics across Sweden, Poland, and Austria.
b) Four patients implanted during 2019 and one in February 2020. One patient scheduled for operation on 30/6/2020.

2. Production move of disposables

We have changed our supplier of injection molding tools and molded parts during 2019 related to quality and capacity issues. With this move of the existing tools, we decided to postpone the planned investment in high-volume steel tooling. Frohe can meet our needs during 2020 and possibly also 2021 with the current aluminum tooling. The chosen supplier will be a good partner for increased volumes, steel tooling and automation (high volume manufacturing).

3. Port Kit manufacturing

During 2019, our partner 3DSystems manufactured 50+ implants in four batches. These were sterilized together with corresponding surgical aids, meaning that we currently have more than 60 complete Port Kits in stock, ready for use on patients.

4. Adaptations of QMS to MDR

Work is continuously ongoing to update and adapt our QMS to be in compliance with the new MDR regulations. We have decided to withhold our ISO13485 certification by a renewal audit spring 2020 but wait with the new CE-mark certification of the TIES System according to MDR until we have gathered enough clinical data, expected late 2020 or early 2021.

5. Improving Lid

We have identified improvement needs for the current TIES Lid, amongst them usability, technical feature and manufacturing yield.

6. Port manufacturing

We continuously work in cooperation with our partner 3DSystems to make process improvements in the TIES Port implant manufacturing, for example solutions for UDI (Unique Device Identifier) and streamlining postproduction process.
Progress beyond state of the art:

Through the histology analysis of the explanted devices, we have obtained solid underpinning data for strong ingrowth between the soft tissue and the implant. This is very encouraging and something we would not have seen before towards the end of the project without these explantations.

Expected results until the end of the project:

We experienced a delay in the clinical progression based on slower recruitment of sites ready for surgeries and suitable patients. In addition, we have had a halt related to three explantations we then needed to analyze. Based on the positive analysis of the reasons for the explantations, we continue to believe that we will reach the goals by the end of the project even if the number of patients (planned for up to 200) most likely will be lower. We plan for faster patient inclusion in the last 1.5 years of the project than we originally planned. For clinical validation and regulatory approval (CE-mark), the originally planned 200 patients would be more than required as we see it now. The commercial launch is expected to take place later in 2022 than originally planned. Thus the actual sales volumes could not be achieved within the project period but are highly likely to take place with some time lag. The project is expected to continue after the project period as a continuous activity within further development and commercialization.

Potential impacts:

With regard to the socio-economic impact, new data support our initial estimates for saving healthcare costs from a lifetime perspective. With regard to patients' safety and patient benefit, the project progress so far underpins our estimates and assumptions.