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: 10258644
• 负责人: Brian C Clark
• 金额: $ 116.59万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258644
• 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; 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 →注意：AEIOU Scientific，LLC目前正在以Osteodx的名义转换为C-Corp。 这阶段2 SBIR赠款申请提案，以继续开发和商业化 Osteodx的皮质骨力学技术™（CBMT），这是一种新型的骨质疏松症与诊断设备 非侵入性测量皮质骨的机械性能，并提供有关骨骼的直接信息 其他诊断方式无法获得的力量和质量。第1阶段成功说明了 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）。我们还产生了有力的证据，表明CBMT提供有关皮质骨的信息 独特，独立于骨矿物质密度（BMD），这表明CBMT可能会产生临床意义 有关骨质疏松骨折潜力的信息。骨质疏松症是一种常见的慢性医学疾病 骨骼逐渐削弱骨骼，最终导致非创伤或脆弱性骨折。这些断裂是 痛苦，在许多情况下会导致长时间或终身残疾，并大大提高死亡率 骨折后3个月内到8倍。有许多具有不同动作机制的治疗方法 骨质疏松症，如果给予高风险个体，可能会大大降低骨折的风险。但是，当前 骨质疏松治疗决策是由BMD和风险调查的基于X射线的测量值驱动的。 不幸的是，这些工具缺乏足够的歧视性灵敏度和准确性，无法确定许多人 经历脆弱性骨折的高风险。有很大的未满足需要更好地诊断为 骨折的风险使医生可以准确识别将从骨质疏松症中受益的人 药物并更好地监测治疗的有效性。 Osteodx CBMT技术具有潜力 满足这些需求。 Osteodx的市场研究，对主要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 并采用市场，并开发了两个具体目标：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断裂歧视的临床研究 能力。为了实现该提议的目的和骨的其他商业化目标， 公司召集了一个具有广泛经验和相关专业知识的团队。团队包括高级 具有机械设计，生物医学工程，衰老和破裂风险评估专业知识的人 拥有成功的医疗设备商业化经验的首席执行官和董事会。团队也有 进行临床研究的丰富经验。