Periodic Reporting for period 3 - TIES-TEST (Optimization and clinical testing of Transcutaneous Implant Evacuation System.)
Reporting period: 2021-01-01 to 2022-03-31
Prob. addr.:
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 late 23 will improve the quality of life of over 25k patients in Europe and over 8k in the USA in the period 23-27. This would also allow us to reach significant sales volume in the high-tech industry with manufacturing in Europe.
Obje.:
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
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 late 23 will improve the quality of life of over 25k patients in Europe and over 8k in the USA in the period 23-27. This would also allow us to reach significant sales volume in the high-tech industry with manufacturing in Europe.
Obje.:
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
In RP3, the work has been focussed towards speeding up the inclusion of patients into the clinical trial; development of next generation TIES Lid & emptying system; and damage control against the impact of the C19 pandemic.
The clinical trial has been significantly expanded in Europe. We now have nine fully approved clinics in UK, SWE, Austria POL and India, all ready to go, as soon as the difficult healthcare resource situation ease up. Further, we have 8more clinics in the pipeline, in the final stages of approvals.
The OC website has been completely redesigned and also prepared for multilingual versions to support the clinical trial in different countries.
We have been working intensely on a project with a new generation of TIES Lid and emptying system for the patients. The technical designs were ready early in 22 and they will be validated and released in 2Q22. Continued work is planned for further development and optimisation of the manufacturing processes.
The new Lid and emptying system require an amendment of the clinical study before the new devices can be introduced to the patients in the study. To support this amendment we have reworked, improved and updated the Instructions for Use (a 28-page richly illustrated folder) for the patient, in all relevant languages, reflecting the new devices, as well as the surgeon IfU.
Requests for a study amendment, including the new IfUs, an updated Investigators Brochure and several other significant documents in relevant languages, have been submitted to the national Competent Authorities and the concerned Ethical Committees during Q1 2022. Some approvals have now been granted and before end of Q2 we expect to have all approvals secured.
Another focus area is optimisations of the manufacturing processes involved for the implant, the TIES Port.
Since the core of the project currently lies within the clinical trial, which is progressing very slowly, certain project activities have been forced into a halt. Notably, only limited amount of new public dissemination material has therefore been created, but we have been working on an updated version of the TIES information leaflet in four languages, released in 1Q2022.
It is also worth mentioning that we now have over ~3k interested ostomates from all over EUR and RoW in our database, all of which have contacted us and basically asked when they can start using TIES. Realities like this make the core team, the partners and the investors continue to believe strongly in TIES
The clinical trial has been significantly expanded in Europe. We now have nine fully approved clinics in UK, SWE, Austria POL and India, all ready to go, as soon as the difficult healthcare resource situation ease up. Further, we have 8more clinics in the pipeline, in the final stages of approvals.
The OC website has been completely redesigned and also prepared for multilingual versions to support the clinical trial in different countries.
We have been working intensely on a project with a new generation of TIES Lid and emptying system for the patients. The technical designs were ready early in 22 and they will be validated and released in 2Q22. Continued work is planned for further development and optimisation of the manufacturing processes.
The new Lid and emptying system require an amendment of the clinical study before the new devices can be introduced to the patients in the study. To support this amendment we have reworked, improved and updated the Instructions for Use (a 28-page richly illustrated folder) for the patient, in all relevant languages, reflecting the new devices, as well as the surgeon IfU.
Requests for a study amendment, including the new IfUs, an updated Investigators Brochure and several other significant documents in relevant languages, have been submitted to the national Competent Authorities and the concerned Ethical Committees during Q1 2022. Some approvals have now been granted and before end of Q2 we expect to have all approvals secured.
Another focus area is optimisations of the manufacturing processes involved for the implant, the TIES Port.
Since the core of the project currently lies within the clinical trial, which is progressing very slowly, certain project activities have been forced into a halt. Notably, only limited amount of new public dissemination material has therefore been created, but we have been working on an updated version of the TIES information leaflet in four languages, released in 1Q2022.
It is also worth mentioning that we now have over ~3k interested ostomates from all over EUR and RoW in our database, all of which have contacted us and basically asked when they can start using TIES. Realities like this make the core team, the partners and the investors continue to believe strongly in TIES
Prog.:
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.
Exp. results:
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 most likely will be lower. We expect a faster patient inclusion in the last 1-1,5 years of the project than originally planned. For clinical validation and regulatory approval (CE), the originally planned 200 patients are more than required (latest information point to 20 patients needed to obtain CE mark). The commercial launch is expected to take place in 2023. Thus the actual sales volumes could not be achieved within the project period but are likely to take place with some time lag. The project will continue after the project period as a continuous activity within further development and commercialization.
Pot. impacts:
With regard to the S-E 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.
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.
Exp. results:
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 most likely will be lower. We expect a faster patient inclusion in the last 1-1,5 years of the project than originally planned. For clinical validation and regulatory approval (CE), the originally planned 200 patients are more than required (latest information point to 20 patients needed to obtain CE mark). The commercial launch is expected to take place in 2023. Thus the actual sales volumes could not be achieved within the project period but are likely to take place with some time lag. The project will continue after the project period as a continuous activity within further development and commercialization.
Pot. impacts:
With regard to the S-E 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.