Development and validation of a novel non-invasive device for measuring the mechanical properties of cortical bone

开发和验证一种新型非侵入性测量皮质骨机械性能的装置

• 批准号: 10407076
• 负责人: Brian C Clark
• 金额: $ 83.21万
• 依托单位: OSTEODX INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10407076
• 关键词: Achievement; Adoption; Age; Aging; Applications Grants; Biomedical Engineering; Body mass index; Bone Density; Chronic; Clinical; Clinical Research; Databases; Development; Device Designs; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Discrimination; Dual-Energy X-Ray Absorptiometry; Florida; Foundations; Fracture; Funding; Future; Health Care Costs; Hip region structure; Indiana; Individual; Interview; Investments; Leg; Life; Logistic Regressions; Market Research; Marketing; Measurement; Measures; Mechanics; Medical; Medical Device; Modality; Monitor; Names; Nutritional; Ohio; Osteoporosis; Osteoporotic; Pain; Patients; Persons; Pharmaceutical Preparations; Phase; Physicians; Postmenopause; Process; ROC Curve; Race; Recording of previous events; Research; Risk; Risk Assessment; Roentgen Rays; Safety; Small Business Innovation Research Grant; Statistical Data Interpretation; Surveys; Technology; Testing; Treatment Effectiveness; Universities; Upper Extremity Fracture; Validation; Variant; Woman; base; bone; bone imaging; bone quality; bone strength; case control; clinically significant; commercialization; comparative; cortical bone; design; diagnostic accuracy; disability; experience; fracture risk; fragility fracture; high risk; improved; lifestyle factors; mechanical properties; meetings; mortality; novel; osteoporosis with pathological fracture; performance site; programs; sex; statistics; tool; ulna

ABSTRACT → Note: AEIOU Scientific, LLC is currently in the process of converting to a C-Corp under the name of OsteoDx. This Phase 2 SBIR grant application proposes to continue development and commercialization of OsteoDx’s Cortical Bone Mechanics Technology™ (CBMT), a novel osteoporosis related diagnostic device that non-invasively measures the mechanical properties of cortical bone and provides direct information about bone strength and quality that is not accessible by other diagnostic modalities. Phase 1 successfully illustrated commercial feasibility and demonstrated that CBMT can accurately and efficiently estimate ulna bone bending strength (R2=0.99). We also generated strong evidence that CBMT provides information about cortical bone that is unique and independent of bone mineral density (BMD), which suggests CBMT may yield clinically significant information about osteoporotic fracture potential. Osteoporosis is a common, chronic medical condition causing progressive weakening of bones, eventually leading to nontraumatic or fragility fractures. These fractures are painful and, in many cases, cause prolonged or life-long disability, and dramatically increases mortality rates up to 8x within 3 months post fracture. Numerous treatments with varying mechanisms of action exist for osteoporosis and, if given to high risk individuals, could dramatically reduce the risk of fracture. However, current osteoporosis treatment decisions are heavily driven by X-ray based measurements of BMD and risk surveys. Unfortunately, these tools lack sufficient discriminatory sensitivity and accuracy to identify many individuals at high risk of experiencing a fragility fracture. There is a large unmet need to better diagnose patients who are at risk of fracture so that physicians can accurately identify individuals who would benefit from osteoporosis medications and to better monitor the effectiveness of treatment. OsteoDx CBMT technology has the potential to meet these needs. OsteoDx’s market research, interviews with key opinion leaders, and an initial meeting with the FDA identified the most important and immediate commercialization milestones necessary for FDA approval and market adoption, and resulted in the development of two Specific Aims: Aim 1) Complete device design to meet specific clinical needs, and Aim 2) Conduct a clinical study assessing CBMT’s fracture discrimination capability. To achieve the aims of this proposal and the other commercialization objectives of OsteoDx, the company has assembled a team with broad experience and relevant expertise. The team includes senior individuals with mechanical design, biomedical engineering, aging and fracture risk assessment expertise, and a CEO and Board of Directors with successful medical device commercialization experience. The team also has extensive experience conducting clinical studies.

抽象的 → 注：AEIOU Scientific, LLC 目前正在以 OsteoDx 的名义转型为 C 型企业。 此第 2 阶段 SBIR 拨款申请建议继续开发和商业化 OsteoDx 的皮质骨力学技术™ (CBMT) 是一种新型骨质疏松症相关诊断设备， 无创测量皮质骨的机械特性并提供有关骨骼的直接信息 其他诊断方式无法达到的强度和质量。第一阶段成功说明 商业可行性并证明 CBMT 可以准确有效地估计尺骨弯曲 强度（R2=0.99）。我们还提供了强有力的证据表明 CBMT 提供了有关皮质骨的信息， 是独特的且独立于骨矿物质密度 (BMD)，这表明 CBMT 可能产生具有临床意义的结果 有关骨质疏松性骨折可能性的信息。骨质疏松症是一种常见的慢性疾病，导致 骨骼逐渐衰弱，最终导致非创伤性或脆性骨折。这些骨折是 痛苦，在许多情况下会导致长期或终身残疾，并急剧增加死亡率 骨折后 3 个月内增加至 8 倍。存在多种具有不同作用机制的治疗方法 骨质疏松症，如果给予高危人群，可以大大降低骨折的风险。然而，目前 骨质疏松症治疗决策在很大程度上取决于基于 X 射线的 BMD 测量和风险调查。 不幸的是，这些工具缺乏足够的歧视敏感性和准确性来识别许多个人 发生脆性骨折的风险很高。更好地诊断处于以下状态的患者还有很大的未满足的需求 骨折的风险，以便医生能够准确识别可从骨质疏松症中受益的个体 药物治疗并更好地监测治疗效果。 OsteoDx CBMT 技术具有潜力 以满足这些需求。 OsteoDx 的市场研究、关键意见领袖的访谈以及与 FDA 确定了 FDA 批准所需的最重要和最直接的商业化里程碑 和市场采用，并导致了两个具体目标的发展： 目标 1) 完整的设备设计 满足特定的临床需求，目标 2) 进行评估 CBMT 骨折歧视的临床研究 能力。为了实现本提案的目标以及 OsteoDx 的其他商业化目标， 公司组建了一支具有丰富经验和相关专业知识的团队。团队成员包括资深 具有机械设计、生物医学工程、老化和骨折风险评估专业知识的个人，以及 具有成功医疗器械商业化经验的首席执行官和董事会。团队还有 进行临床研究的丰富经验。