Periodic Reporting for period 1 - FORESEE (Novel microsensing platform for remote patient monitoring)
Berichtszeitraum: 2023-12-01 bis 2024-11-30
Chronic heart failure is a long-term, persistent condition in which the heart is not able to efficiently pump blood to the body, causing symptoms such as limited physical activity and swelling. It is a pressing healthcare problem affecting millions worldwide, presents a 5-year mortality rate of 50 % and annual costs exceeding US 30 000 per patient. Patients’ lives are burdened by frequent hospitalisations, which affect their lives and those of their families and caregivers. Remote patient monitoring (RPM) using implanted sensors is an emerging clinical reality for patients with heart failure, as it optimizes medical management and treatment, improving their quality of life and outcomes. In this context, the EIC-funded FORESEE project will develop a novel RPM platform based on an intravascular microsensor that wirelessly powers and communicate with an external unit using the human body as an electrical conductor of energy. This method avoids the need for bulky components or batteries within the implant, resulting in thin and flexible devices. The microsensing technology promises to revolutionise chronic heart failure monitoring, improving patient care and quality of life.
The objective of FORESEE is to bring the implantable microsensing platform for RPM of heart failure patients from TRL3 up to completion of TRL5, and to develop a successful business strategy to ensure its future market access, benefiting almost 10.5 million heart failure patients in EU and US that are candidates for RPM. This includes the development and validation of four main elements for the technology, namely an intravascular microsensor, an external unit that powers and communicates with it, a delivery system to deploy it in the vascular tree, and an application to monitor the patient’s status; and the development of a business strategy to ensure future market access. The technological and business activities developed by our team, which has ample scientific and business expertise, will ensure tech-to-market transition.
The objective of FORESEE is to bring the implantable microsensing platform for RPM of heart failure patients from TRL3 up to completion of TRL5, and to develop a successful business strategy to ensure its future market access, benefiting almost 10.5 million heart failure patients in EU and US that are candidates for RPM. This includes the development and validation of four main elements for the technology, namely an intravascular microsensor, an external unit that powers and communicates with it, a delivery system to deploy it in the vascular tree, and an application to monitor the patient’s status; and the development of a business strategy to ensure future market access. The technological and business activities developed by our team, which has ample scientific and business expertise, will ensure tech-to-market transition.
FORESEE has been moving forward with the different tasks proposed for the project. This includes several activities related to technology development and validation, as well as in business development. The team has worked on a traceability matrix based on ISO 13485 to define the design input and output requirements for the RPM platform. Afterwards, several computational simulations were done to define the different geometries of the elements that conform the platform, and the different system specifications to accomplish the requirements and the key performance indicators proposed. The Intravascular microsensor’s conformation is currently being assayed in bench tests, and the microelectronic circuit to be housed inside the device is being designed by the team. The first prototype of the External unit has been already developed and tested, and will be improved in a second prototype to be subcontracted during the second reporting period. The Delivery system is currently under development, and the first prototype to be evaluated by Interventional Cardiologists and in bench tests will be ready during the first quarter of the second reporting period. In parallel, a risk management assessment based on ISO 14971 has been done and is continuously updated as a main activity of regulatory affairs, and a quality management system based on ISO 13485 is currently being implemented. In the field of business development, FORESEE has been able to improve its business proposition by developing a business plan and a health economics assessment that validates the need for this RPM platform.
The FORESEE project started its development in TRL3. Yet, several activities related to the validation of the technology in the laboratory have been done during this reporting period, moving forward to TRL4. These activities apply to the four elements of the platform, namely the Intravascular microsensor, the portable External unit, the Delivery system and the Web application. Critical components and processes have been tested in the laboratory, and additional pre-clinical trials, including the validation of the platform in animal model, are expected in the next reporting period.
In the framework of the business strategy, UPF has done several activities to create a social and economic impact. During the first reporting period, it has been identified that FORESEE could benefit more than 50,000 patients by 2035 in selected European countries with a market share of 2.5%. This could imply very high savings to the healthcare system, and less burden to patients and families. Market-access strategies will be explored in the next reporting period.
As a side-impact of the project, FORESEE is contributing to the development of industry, innovation and infrastructure of Class III medical devices in Spain. This will open new opportunities for the medical device industry in the south of Europe.
In the framework of the business strategy, UPF has done several activities to create a social and economic impact. During the first reporting period, it has been identified that FORESEE could benefit more than 50,000 patients by 2035 in selected European countries with a market share of 2.5%. This could imply very high savings to the healthcare system, and less burden to patients and families. Market-access strategies will be explored in the next reporting period.
As a side-impact of the project, FORESEE is contributing to the development of industry, innovation and infrastructure of Class III medical devices in Spain. This will open new opportunities for the medical device industry in the south of Europe.