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 这一阶段IIB 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™），这是一种与非骨质疏松症相关的诊断装置 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。 Osteodx已经成功 插图商业可行性，并证明CBMT可以准确有效地估算尺骨 弯曲强度（R2 = 0.99）。 Osteodx还确定CBMT对检测骨骼的变化很敏感 强度并提供有关皮质骨的信息 （BMD），这表明CBMT可能会产生有关骨质疏松骨折潜力的临床重要信息。 骨质疏松症是一种常见的医学疾病，导致骨骼的逐渐减弱，最终导致 非创伤或脆弱的片段。这些碎片很痛苦，在许多情况下会导致长时间或终身 残疾，并在骨折后3个月内大幅提高死亡率高达8倍。骨骼健康和 骨质疏松基金会预计，到2025年，每年将有300万个骨质疏松症的骨折 在美国，导致医疗保健费用超过570亿美元。许多具有不同机制的治疗方法 骨质疏松症的作用存在，如果给予高危个体，可能会大大降低骨折的风险。 但是，当前的骨质疏松治疗决策是由BMD的基于X射线的测量很大的驱动 和风险调查。不幸的是，这些工具缺乏足够的歧视性灵敏度和准确性来识别许多 患有脆弱性的人有高风险。例如，全骨的变化的50％ 力量归因于BMD的变化，并且绝大多数维持脆弱性骨折的患者确实如此 BMD没有低的BMD（即，它们的T分数高于-2.5）。那，有很大的未满足需要更好的诊断 有骨折风险的患者，以便医生可以准确地识别将受益的人 骨质疏松药物，以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批准和采用市场所需的即时商业化里程碑：一项研究 演示了最终设计生产版本的准确性（AIM 1）和临床精度（AIM 2） 医疗设备，并提高安全性和法规合规性（AIM 3）。那是在这二阶段应用中 提出一系列实验，测试和方法，以实现上述目的。之上 成功实现了这些目标，Osteodx将被定位为提交II类Nevo医疗设备 应用于FDA，用于非侵入性量化尺骨中皮质骨的柔性刚度。实现 该提案的目的以及Osteodx的其他商业化目标，该公司已集会 经验丰富的经验和专业知识，经验丰富的团队。