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.

摘要 这项IIB阶段SBIR赠款申请建议继续开发OsteoDx并将其商业化 皮质骨力学技术™(CBMT™)，一种新型的与骨质疏松症相关的诊断设备，非 无创性地测量皮质骨的力学性能，并提供有关骨的直接信息 其他诊断模式无法获得的强度和质量。OsteoDx已经成功 说明了CBMT的商业可行性，证明了CBMT可以准确、有效地评估尺骨 抗弯强度(R2=0.99)。OsteoDx还证实，CBMT对检测骨骼变化很敏感 强度，并提供关于皮质骨的信息，它是唯一的，独立于骨矿物质密度 (BMD)，这表明CBMT可能提供有关骨质疏松性骨折潜力的临床重要信息。 骨质疏松症是一种常见的医学状况，会导致骨骼的进行性衰弱，最终导致 非创伤性或脆性骨折。这些骨折是痛苦的，在许多情况下，会导致长期或终身的骨折。 骨折后3个月内的死亡率最高可达8倍。骨骼健康和 骨质疏松基金会预测，到2025年，每年将有300万例与骨质疏松相关的骨折 在美国，导致医疗成本超过570亿美元。多种不同机制的治疗方法 对骨质疏松症有作用的药物，如果给予高危个体，可以极大地降低骨折的风险。 然而，目前的骨质疏松症治疗决策在很大程度上是由基于X射线的骨密度测量驱动的 和风险调查。不幸的是，这些工具缺乏足够的区分敏感度和准确性来识别许多 易碎性骨折的高危人群。例如，全骨变异的50% 力量是由骨密度的变化引起的，而绝大多数脆性骨折的患者确实如此。 不具有低骨密度(即，T-Score‘s高于−2.5)。因此，有大量未得到满足的需求需要更好地诊断 有骨折风险的患者，以便医生可以准确地识别哪些人将受益于 骨质疏松症的药物治疗和更好地监测治疗效果。OsteoDx的市场研究， 对主要意见领袖的采访以及与FDA之前的会议确定了最重要的和 FDA批准和市场采用所需的立即商业化里程碑：一项研究 演示了最终设计生产版本的准确性(目标1)和临床精确度(目标2) 医疗设备，并促进安全和法规遵从性(目标3)。因此，在此第二阶段应用程序中，我们 提出一系列实验、测试和方法来实现上述目标。vt.在.的基础上 成功实现这些目标后，OsteoDx将能够提交新的II类医疗设备 应用美国食品及药物管理局无创性量化尺骨皮质骨的弯曲刚度。要实现 为了实现这一提议和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。