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

诊所/MIU/ED/CDC 的骨质疏松症和类风湿关节炎的早期识别和增强表征/量化 [âDT-RHUâ]

• 批准号: 10068051
• 金额: $ 86.4万
• 依托单位: ADAPTIX LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10068051
• 关键词: Earlier; identification; enhanced; characterisation; quantification

**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."

**背景**：Adaptix 开发了一种经济实惠的护理点 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：一次四肢扫描（0.01 mSv）大约相当于吃掉 10 根香蕉所受到的辐射，并且大约需要 5 秒。 FDA 510(k) 于 2023 年 1 月获得批准\。在准备 510(k) 提交的过程中，独立审查临床医生表示，他们可以观察关节内的骨关节炎，并可视化小梁结构，其效果远远超出设备所取代的 2D 检查中看到的内容。**项目提案**l：扩展该设备的功能允许：* 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）识别类风湿性关节炎/骨关节炎/炎性关节炎增强。* 增强骨质疏松症和骨质减少症的表征/量化：现有功能将扩展到双能成像，以实现 3 维 ('3D') 双能 X 射线吸收测定法（'DXA' 也缩写为 'DEXA'）加上小梁结构的评估。当前的 DXA 仅是二维的，代表当前的“黄金标准”。我们将通过提供骨矿物质分布的 3D 图并结合小梁结构的孔隙率评估来提高护理标准。这将使骨质疏松症评估包含在每次收购中，从而能够更早地识别疾病并更好地表征。**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笔赠款的合作伙伴。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/便携式/可部署/低成本产品将使社区诊断中心成为可能概念（现在有 92 个中心）。 CDC 的结论源自迈克·理查兹 (Mike Richards) 教授的独立报告（2020 年）《诊断：恢复和更新》，该报告推荐了一种新的诊断模式，在远离主要医院地点的独立位置创建设施，提供更快、更轻松的访问一系列诊断服务的机会。当天进行检测，支持早期诊断，为患者提供更大便利并减少健康不平等。**对经济/全球的影响雄心/增长潜力/物有所值**：该项目将改变骨质疏松症、其前兆骨质减少和骨关节炎的评估和早期诊断。在老龄化社会中，此类疾病非常普遍且日益严重。 ResearchAndMarkets 表示：“2019 年全球护理点成像设备市场估值为 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。”