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 该IIB期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™），一种新型骨质疏松症相关诊断器械， 有创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。OsteoDx已经成功地 说明了商业可行性，并证明CBMT可以准确和有效地估计尺骨 弯曲强度（R2=0.99）。OsteoDx还确定了CBMT对检测骨变化的敏感性 强度，并提供有关皮质骨的信息，这是唯一的，独立于骨矿物质密度 (BMD)这表明CBMT可能产生关于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医学疾病，导致骨骼逐渐变弱，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，导致长期或终身的 残疾，并在骨折后3个月内显著增加死亡率高达8倍。骨骼健康和 骨质疏松基金会预测，到2025年，每年将有300万例骨质疏松相关骨折 在美国，医疗费用超过570亿美元。具有不同机制的多种治疗方法 对骨质疏松症有很大的作用，如果给予高危人群，可以大大降低骨折的风险。 然而，目前骨质疏松症的治疗决策在很大程度上是由基于X射线的BMD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性和准确性， 易发生脆性骨折的高危人群。例如，全骨中<50%的变化 强度的变化可归因于BMD的变化，绝大多数脆性骨折的患者 不具有低BMD（即，他们的T-score高于-2.5）。因此，有一个很大的未满足的需要，以更好地诊断 有骨折风险的患者，以便医生能够准确地识别将受益于 骨质疏松症的药物，并更好地监测治疗的有效性。OsteoDx的市场研究， 与关键意见领袖的访谈，以及与FDA的事先会议已经确定了最重要的， FDA批准和市场采用所需的即时商业化里程碑：一项研究， 证明了最终设计生产版本的准确度（目标1）和临床精密度（目标2） 医疗器械，并提高安全性和法规遵从性（目标3）。因此，在第二阶段应用中，我们 提出了一系列的实验，测试和方法来实现上述目标。后 成功实现这些目标后，OsteoDx将被定位为提交II类重新分类医疗器械 向FDA申请非侵入性量化尺骨皮质骨的抗弯刚度。实现 该提案的目的和OsteoDx的其他商业化目标，该公司已经组装了一个 拥有丰富经验和专业知识的资深团队。