Earlier identification and enhanced characterisation/quantification of Osteoporosis and Rheumatoid Arthritis for Clinics/MIU/ED/CDCs [“DT-RHU”]

**Background**: Adaptix has developed an affordable point-of-care 3D X-ray orthopaedic imaging system that uses 'Digital Tomosynthesis' ('DT'). The system is ultra-low dose: one extremity scan (0.01 mSv) is approximately equivalent to consuming 10 bananas in terms of radiation exposure and takes ~5 seconds. The FDA 510(k) was granted in January 2023\. During preparation for the 510(k) submission, independent reviewing clinicians stated that they could observe osteoarthritis within the joint and visualise trabecular structure far beyond what is seen within the 2D exams that the device replaces.

**Project proposa**l: To extend the capability of the device to allow:

* Enhanced assessment of degenerative joint diseases: The existing device will be enhanced such that (as part of a standard protocol) identification of rheumatoid arthritis/osteoarthritis/inflammatory arthritis will be enhanced.
* Enhanced characterization/quantification of osteoporosis and osteopenia: Existing capability will be extended to dual-energy imaging to allow for 3 dimensional ('3D') Dual-energy X-ray absorptiometry ('DXA' also abbreviated to 'DEXA') plus an assessment of the trabecular structure.

Current DXA is 2D only and represents the current 'gold standard'. We will improve on the standard-of-care by providing a 3D map of bone mineral distribution combined with assessment of the porosity of trabecular structure. This will allow osteoporosis assessment to be included in every acquisition allowing disease to be identified earlier and characterised better.

**NHS Relevance**: Royal Devon University Hospitals NHS Foundation Trust and the University of Exeter are partners on this grant. They will assist in the independent validation of the approach and ensure that the device delivers clinical value, specifically relevant to the needs of the UK NHS.

This small/low-flux/portable/deployable/low-cost product will enable the Community Diagnostics Centre concept (now 92 centres). CDC's resulted from Professor Sir Mike Richards independent report (2020), "Diagnostics: Recovery and Renewal" that recommended a new diagnostics model, where facilities are created in free standing locations away from main hospital sites, providing quicker and easier access to a range of tests on the same day, supporting earlier diagnosis, greater convenience to patients and the reduction of health inequalities.

**Impact-on-economy/global ambition/potential-for-growth/value-for-money**: This project will transform assessment and early diagnosis of osteoporosis, its pre-cursor osteopenia, and osteoarthritis. Such disease states are highly prevalent and increasingly significant in an ageing society. Per ResearchAndMarkets: "The Global Point-of-Care Imaging Devices Market was valued to be $8.66 billion in 2019 and is anticipated to witness an impressive double-digit growth rate, to reach $19.84 billion by 2030."