Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis

开发皮质骨力学技术以增强骨质疏松症的诊断

• 批准号: 10697217
• 负责人: Brian C Clark
• 金额: $ 116.05万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697217
• 关键词: Acceleration; Achievement; Adopted; Adoption; Age; Applications Grants; Bone Density; Cadaver; Clinical; Computer software; Data Security; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Electromagnetics; Enhancement Technology; Ensure; Equipment; Food and Drug Administration Device Approval; Foundations; Fracture; Health Care Costs; Individual; Injury; Interview; Market Research; Marketing; Measurement; Measures; Mechanics; Medical; Medical Device; Modality; Monitor; Nutritional; Osteoporosis; Osteoporotic; Pain; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Physicians; Positioning Attribute; Postmenopause; Preparation; Production; Reproducibility; Risk; Risk Reduction; Roentgen Rays; Safety; Seasons; Series; Small Business Innovation Research Grant; Source; Surveys; System; Technology; Testing; Treatment Effectiveness; Variant; Woman; biomaterial compatibility; bone; bone health; bone quality; bone strength; clinically significant; commercialization; cortical bone; cost; design; disability; experience; experimental study; fracture risk; fragility fracture; high risk; high risk population; human subject; improved; lifestyle factors; manufacture; mechanical properties; meetings; mortality; novel; osteoporosis with pathological fracture; prevent; prototype; response; risk mitigation; sex; tool; ulna

ABSTRACT This Phase IIB 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. OsteoDx has already successfully illustrated commercial feasibility and demonstrated that CBMT can accurately and efficiently estimate ulna bone bending strength (R2=0.99). OsteoDx also established that CBMT is sensitive to detecting change in bone strength and 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 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. The Bone Health and Osteoporosis Foundation projects that by 2025, there will be 3 million osteoporosis related fractures every year in the US, resulting in healthcare costs of more than $57 billion. 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. For instance, <50% of the variation in whole-bone strength is attributable to variations in BMD, and the vast majority of patients who sustain fragility fractures do not have low BMD (i.e., they have T-score’s above −2.5). Thus, 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’s market research, interviews with key opinion leaders, and prior meetings with the FDA have identified the most important and immediate commercialization milestones necessary for FDA approval and market adoption: a study that demonstrates the accuracy (aim 1) and clinical precision (aim 2) of the final design production version of the medical device, and advances safety and regulatory compliance (aim 3). Thus, in this Phase II application we propose a series of experiments, tests, and approaches to accomplish the above-mentioned aims. Upon successful achievement of these aims, OsteoDx will be positioned to submit a Class II de novo medical device application to the FDA for noninvasively quantifying flexural rigidity of cortical bone in the ulna. To achieve the aims of this proposal and the other commercialization objectives of OsteoDx, the company has assembled a highly seasoned team with broad experience and expertise.

抽象的 本 IIB 期 SBIR 拨款申请提议继续开发 OsteoDx 并将其商业化 皮质骨力学技术™ (CBMT™)，一种新型骨质疏松症相关诊断设备， 有创地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。 OsteoDx 已经成功 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）。 OsteoDx 还证实 CBMT 对检测骨骼变化很敏感 强度并提供有关皮质骨的独特且独立于骨矿物质密度的信息 (BMD)，这表明 CBMT 可能会产生有关骨质疏松性骨折可能性的临床重要信息。 骨质疏松症是一种常见的疾病，会导致骨骼逐渐衰弱，最终导致 非外伤性或脆性骨折。这些骨折是痛苦的，并且在许多情况下会导致长期或终生的骨折。 致残，并且骨折后 3 个月内死亡率急剧增加 8 倍。骨骼健康和 骨质疏松基金会预计，到 2025 年，每年将有 300 万例骨质疏松相关骨折 在美国，导致医疗费用超过 570 亿美元。具有不同机制的多种治疗方法 对骨质疏松症有一定的作用，如果给予高危人群，可以大大降低骨折的风险。 然而，当前的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 发生脆性骨折的高风险人群。例如，<50% 的全骨变异 强度归因于 BMD 的变化，绝大多数发生脆性骨折的患者 BMD 不低（即 T 分数高于 -2.5）。因此，更好地诊断还有很大的未满足的需求 有骨折风险的患者，以便医生能够准确识别哪些人可以从骨折中受益 骨质疏松症药物并更好地监测治疗效果。 OsteoDx 的市场研究， 与主要意见领袖的访谈以及之前与 FDA 的会议已经确定了最重要和最重要的 FDA 批准和市场采用所需的立即商业化里程碑：一项研究 展示最终设计生产版本的准确性（目标 1）和临床精度（目标 2） 医疗设备，并提高安全性和法规遵从性（目标 3）。因此，在这个第二阶段的应用中，我们 提出了一系列实验、测试和方法来实现上述目标。之上 成功实现这些目标后，OsteoDx 将提交 II 类 de novo 医疗器械 向 FDA 申请用于无创量化尺骨皮质骨的弯曲刚度。为了实现 为了实现该提案的目标以及 OsteoDx 的其他商业化目标，该公司已经组建了一个 经验丰富的团队，拥有丰富的经验和专业知识。