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.

摘要 →注：AEIOU Scientific，LLC目前正在以OsteoDx的名称转换为C-Corp。 第二阶段SBIR赠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器械， 非侵入性测量皮质骨的机械性能，并提供有关骨的直接信息 强度和质量是其他诊断方式无法达到的。第1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）。我们还产生了强有力的证据，CBMT提供了有关皮质骨的信息， 是唯一的，独立于骨矿物质密度（BMD），这表明CBMT可能产生临床意义 关于非线性断裂可能性的信息。骨质疏松症是一种常见的慢性疾病， 骨骼逐渐变弱，最终导致非创伤性或脆性骨折。这些骨折 痛苦的，在许多情况下，造成长期或终身残疾，并大大增加死亡率， 骨折后3个月内恢复到8倍。存在许多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。但目前的 骨质疏松症的治疗决定主要由基于X射线的BMD测量和风险调查来驱动。 不幸的是，这些工具缺乏足够的识别敏感性和准确性，无法识别许多人。 脆性骨折的风险很高。有一个很大的未满足的需要，以更好地诊断病人谁是在 骨折的风险，以便医生可以准确地识别谁将受益于骨质疏松症的个人 更好地监测治疗效果。OsteoDx CBMT技术具有潜力 来满足这些需求。OsteoDx的市场研究，与关键意见领袖的访谈，以及与 FDA确定了FDA批准所必需的最重要和最直接的商业化里程碑 和市场采用，并导致两个特定目标的开发：目标1）完整的器械设计， 满足特定的临床需求，目标2）进行一项临床研究，评估CBMT的骨折识别能力 能力。为了实现本提案的目的和OsteoDx的其他商业化目标， 公司已组建了一支经验丰富、具有相关专业知识的团队。该团队包括高级 具有机械设计、生物医学工程、老化和断裂风险评估专业知识的个人，以及 拥有成功医疗器械商业化经验的CEO和董事会。该团队还拥有 丰富的临床研究经验。