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

**背景**:Adaptix开发了一种价格合理的即时3D x射线骨科成像系统，该系统使用“数字断层合成”（DT）。该系统是超低剂量的：就辐射暴露而言，一次四肢扫描（0.01毫西弗）大约相当于食用10根香蕉，只需约5秒。FDA 510(k)于2023年1月获得批准。在准备提交510(k)的过程中，独立审查临床医生表示，他们可以观察到关节内的骨关节炎，并且可以看到远远超出该设备所替代的2D检查所见的小梁结构。**项目提案** 1：扩展设备的功能，以允许：*增强对退行性关节疾病的评估：现有设备将得到增强，以便（作为标准方案的一部分）增强类风湿关节炎/骨关节炎/炎性关节炎的识别。*增强骨质疏松和骨质减少的表征/量化：现有能力将扩展到双能成像，以允许三维（‘3D‘）双能x射线吸收测定（’DXA’也缩写为‘DEXA’）加上小梁结构的评估。当前的DXA仅为2D，代表当前的“黄金标准”。我们将通过提供骨矿物质分布的3D地图并结合小梁结构孔隙度的评估来提高护理标准。这将允许骨质疏松症的评估纳入每一次收购，从而使疾病更早地被识别和更好地表征。**NHS相关性**：皇家德文大学医院NHS基金会信托基金和埃克塞特大学是这项拨款的合作伙伴。他们将协助该方法的独立验证，并确保该设备提供临床价值，特别是与英国NHS的需求相关。这种小型/低通量/便携/可部署/低成本产品将使社区诊断中心概念（现在有92个中心）成为可能。美国疾病控制与预防中心的报告来自迈克·理查兹爵士教授的独立报告（2020年），“诊断：恢复和更新”，该报告建议采用一种新的诊断模式，在远离主要医院站点的独立地点建立设施，提供更快和更方便的同一天进行一系列检测，支持早期诊断，为患者提供更大的便利，并减少卫生不平等。**对经济的影响/全球雄心/增长潜力/物有所值**：该项目将改变骨质疏松症、骨质疏松症前期骨质减少和骨关节炎的评估和早期诊断。在老龄化社会中，这种疾病非常普遍，而且越来越重要。根据ResearchAndMarkets的数据：“2019年，全球即时医疗成像设备市场的价值为86.6亿美元，预计将出现令人印象深刻的两位数增长率，到2030年将达到198.4亿美元。”

**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."