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

** 背景 **：Adaptix开发了一种经济实惠的床旁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：一次肢体扫描（0.01 mSv）在辐射暴露方面大约相当于消耗10个香蕉，需要约5秒。FDA 510（k）于2023年1月获得批准。在准备510（k）申报资料期间，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，并观察到远远超出器械所取代的2D检查中所见的小梁结构。**项目建议书 **l：扩展器械的功能，以允许：* 增强退行性关节疾病的评估：将增强现有器械，以便（作为标准方案的一部分）增强类风湿性关节炎/骨关节炎/炎性关节炎的识别。*骨质疏松症和骨质减少症的增强表征/量化：现有能力将扩展到双能成像，以允许三维（“3D”）双能X射线吸收测定法（“DXA”也缩写为“DEXA”）加上骨小梁结构的评估。目前的DXA仅为2D，代表当前的“金标准”。我们将通过提供骨矿物质分布的3D图以及骨小梁结构孔隙度的评估来改进护理标准。这将使骨质疏松症的评估包括在每一个收购允许疾病被识别更早和更好地表征。NHS相关性 **：皇家德文郡大学医院NHS基金会信托基金和埃克塞特大学是这项赠款的合作伙伴。他们将协助对该方法进行独立验证，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/便携式/可部署/低成本产品将实现社区诊断中心的概念（现在有92个中心）。疾病预防控制中心的结果从教授爵士麦克理查兹独立报告（2020年），“诊断：恢复和更新”，建议一个新的诊断模式，其中设施创建在独立的位置远离主要医院网站，提供更快，更容易获得一系列测试在同一天，支持早期诊断，更方便的病人和减少健康不平等。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、其前驱骨质减少和骨关节炎的评估和早期诊断。这种疾病状态在老龄化社会中非常普遍，而且越来越重要。根据ResearchAndMarkets：“全球床旁成像设备市场在2019年的价值为86.6亿美元，预计将以惊人的两位数增长率增长，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."