Medical grade sensor for continuous hydration monitoring and early detection of fluid imbalances.

Project Information

ReBalans

Grant agreement ID: 969065

DOI

10.3030/969065

Project closed

EC signature date 17 February 2021

Start date 1 March 2021

End date 29 February 2024

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 567 500,00

EU contribution

€ 2 497 250,00

Coordinated by

MODE SENSORS AS
Norway

Periodic Reporting for period 2 - ReBalans (Medical grade sensor for continuous hydration monitoring and early detection of fluid imbalances.)

Reporting period: 2022-03-01 to 2024-02-29

Summary of the context and overall objectives of the project

Fluid disorders represent a major problem in healthcare. Especially for patients in risk of dehydration or overhydration, such as heart and renal disease patients in hospital wards or elderly population with reduced thirst and cognitive problems. Improper fluid management has important implications for patients, caregivers and economies: increase mortality, increase risk of suffering co-morbidities (infections, longer hospital stays, acute kidney injuries) and increase costs (e.g. proper hydration could lead to €1bn savings in UK per year). Current practice for fluid monitoring uses Fluid Balance Charts, which are inaccurate, incomplete, time-consuming and cumbersome to complete. Mode Sensors developed a revolutionary solution for fluid monitoring, the Re:Balans patch sensor, a non-invasive, connected, disposable and wearable sensor for remote and continuous monitoring of body hydration. Re:Balans is built 1) with robust sensor combination to meet medical level accuracy data, and 2) to be user-friendly and fit into everyday worker and patient procedures. Re:Balans will be a game-changer in the healthcare because: 1) it has better accuracy than the best-practice method in clinical settings; 2) it is cheaper and more efficient to use than current alternatives. Re:Balans will have a major impact by: 1) reducing unnecessary costs and casualties by preventing dehydration, such as comorbidities, readmission to hospital or longer hospital stays; 2) improving doctors and nurses daily activities, substituting time-consuming measurements by automatic, remote and continuous accurate data, and 3) strengthen healthcare systems with a solution that directly addresses the EU’s challenges of ageing population, multimorbidity and healthcare worker shortages.

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

Since the End of Reporting Period 1 (28th of February 2022) until project completion (29th of February 2024), MODE has achieved the following key results:
• Updated patent and IPR strategy.
• Updated risk matrix and mitigation actions.
• Developed and verified new sensor-patch with improved performance in terms of wearability, water, resistance, stability, and bioimpedance measurement accuracy.
• Developed and verified production testers responsible for automatic programming, verification of performance, etc. suited high-volume manufacturing.
• Improved the on-device hydration calculation algorithm by implementing quality assurance, the proprietary tissue model, other compensation filters using data from the other sensors on the sensor-patch, hereunder accelerometer and thermistor.
• Developed prototype for IoT-gateway and API Bluetooth interface, incl. integrator manual.
• Finalized clinical validation report from study on nursing home residents.
• Performed all safety and performance testing required for regulatory submission and clearance, incl. biological safety testing, electrical safety, bench-performance testing, etc.
• Completed technical files for 510(K) Clearance and CE-marking, incl. verification & validation documentation, labelling, instructions for use, etc.
• Implemented a full QMS according ISO13485 and performed internal audits and notified body pre-assessments proving compliance with the standard.
• Updated business plan, competitive analysis, and financial forecast.
• Secured three commercial co-development agreements with multinational commercial partners in med-tech, military, welfare technology markets.

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)

Re:Balans® is the 1st spectral bioimpedance wearable device able to filter out confounding factors and give a correct and complete representation of the user’s daily fluid levels. This gives many opportunities to progress beyond the state of the art, which MODE intends to patent, exploit commercially, and make a socio-economic impact by creating value for patients, caregivers, and the healthcare system:
• Improving millions of lives by preventing disease, health complications, etc. in vulnerable individuals.
• Reducing cost in healthcare by preventing hospital admissions and readmission due to fluid imbalance.
• Making the healthcare sector more sustainable by providing a tool for remote care.

Re:Balans® prototype for clinical trials and demonstration

Improved Re:Balans® sensor-patch for regulatory clearance

Re:Balans® demo-system illustration