A Health Technology Assessment of a breakthrough technology in the early diagnosis of Osteoporosis and other bone related diseases.

Project Information

NonInvasive Cortical Bone Microstructure Analysis

Grant agreement ID: 190115994

DOI

10.3030/190115994

Project closed

EC signature date 13 January 2023

Start date 1 February 2023

End date 31 May 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 755 018,75

EU contribution

€ 2 500 000,00

Coordinated by

POROUS GMBH
Germany

Periodic Reporting for period 1 - NonInvasive Cortical Bone Microstructure Analysis (A Health Technology Assessment of a breakthrough technology in the early diagnosis of Osteoporosis and other bone related diseases.)

Reporting period: 2023-02-01 to 2024-02-29

Summary of the context and overall objectives of the project

Osteoporosis accounts for more days in the hospital than breast cancer, heart attack, and diabetes, leading to huge healthcare costs. Despite this, bone mineral density (BMD), the current gold standard for diagnosis of osteoporosis is insufficient, and fails to detect up to 80% of people at risk of a fragility fracture. The POROUS solution aims to replace BMD as the standard for osteoporosis diagnosis. Using mobile and harmless quantitative ultrasound technology with our patented intelligent algorithms, we can for the first time measure the cortical bone quality down to the microscopic pore level. This gives a multifactorial analysis of fracture risk that overcomes the weaknesses of BMD. Due to the use of mobile ultrasound systems, this solution can be used anywhere in or outside the hospital, such as primary care facilities. It creates the ability to use the technology for prevention via screening, and opens unprecedented possibilities for the early diagnosis of osteoporosis.
The project NCBMA is dedicated to move the POROUS diagnostic towards market entry. For this, our team addresses the following objectives inside the project:
a. Stakeholder work to generate acceptance and prepare for market entry
b. Product development to TRL8 (grant) and TRL9 (post-grant)
c. Software development to optimize performance, usability & prepare for stand-alone product
d. Clinical development to validate POROUS as superior diagnostic of osteoporosis

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

Within the first year of the NCBMA project, efforts were dedicated towards hardware and software development, to the preparation of the clinical evaluation and to connect to stakeholders. The main achievements are:
• Custom-developed ultrasound device for POC bone analysis
• Complies with EN 60601 for medical ultrasound devices
• Used for non-invasive measurement of bone biomarkers such as pore density distribution, cortical thickness (non-diagnostic)
• Fullfilled requirements for CE certification as a measuring device for clinical research: MDR audit scheduled for July 2024
• User friendly interface with interactive measurement procedure to allow a robust and simple measurement
• Software optimizations carried out (workflow, speed, stability)
• Adaption of the software: module architecture which allows hardware independence
• Review and revision of cybersecurity in respect to interfaces.
• Improvement of the backscattering methods
• Improvement of (graphical) user interfaces
• Developed clinical evaluation design with integration of scientific, ethical and regulatory advise from Scientific Advisory Board, Notified body and CRO
• Regulatory documents prepared and submitted to regulatory authorities (ethics committee)
• 6 Clinical centers recruited & started to prepare

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)

With the work of the first year we have reached beyond the state of the art and laid the foundation for significant impact:
1) POROUS has moved forward a novel ultrasound measurement of cortical bone microstructure parameters and achieved compliance with General Safety and Performance requirements. This provides the foundation for CE, market access, commercialisation and internationalisation.
2) The Clinical Evaluation is set up to validate POROUS as fracture risk assessment according to guidelines. The basic goal is the achievement of market approval. By this we lay the foundation for positive impact on patient health and health economics by addressing the shortcomings of the current standard of osteoporosis diagnostic (BMD) by a robust, radiation-free, earlier and more accurate diagnostic at the point-of-care.

POROUS R2C ultrasound device for cortical bone microstructure assessment.