Portable Ultrasonometer for Osteoporosis Assessment

用于骨质疏松症评估的便携式超声波仪

• 批准号: 7913453
• 负责人: Armen Sarvazyan
• 金额: $ 21.95万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7913453
• 关键词: Acoustics; Adverse effects; Affect; Age; Aging; American; Atrophic; Bone Mineral Contents; Cancer Patient; Characteristics; Clinic; Clinical; Clinical Engineering; Clinical Research; Complement; Computer software; Confidential Information; Detection; Deterioration; Development; Devices; Diagnosis; Diagnostic; Disease; Documentation; Drug Monitoring; Early Diagnosis; Early identification; Electronics; Environment; Fracture; Freezing; Frequencies; Funding; Generations; Glucocorticoids; Goals; Health; Healthcare; Inflammatory; Institutes; International; Intervention; Laboratories; Lead; Legal patent; Marketing; Measurement; Medical center; Metabolic; Methods; Metric; Monitor; Osteoporosis; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Philadelphia; Principal Investigator; Process; Property; Public Health; Publications; Reproducibility; Resources; Risk; Safety; Scanning; Secure; Skeletal system; Small Business Innovation Research Grant; Societies; Software Design; Solutions; Staging; Structure; Surface; Techniques; Technology; Testing; Thick; Ultrasonic wave; Ultrasonics; United States National Aeronautics and Space Administration; United States National Institutes of Health; Validation; Woman; base; bone; bone loss; chemotherapy; commercialization; cost; cost effective; data acquisition; design; graphical user interface; hazard; improved; innovation; long bone; malignant breast neoplasm; meetings; prevent; prototype; public health relevance; research clinical testing; tool; validation studies; verification and validation

DESCRIPTION (provided by applicant): Osteoporosis induced by aging as well as a side effect of certain drugs is a serious public health problem. The lack of adequate means for early detection of bone deterioration is the most critical issue in the problem of minimization of side effects of pharmaceutical treatment on skeletal system as well as in monitoring osteoporosis therapy in general. Bone UltraSonic Scanner (BUSS) is intended for the early detection and monitoring of osteoporosis based on the measurements of propagation characteristics of various modes of axial acoustic waves in long bones. Clinical testing confirmed BUSS's capability to discriminate between stages of bone atrophy, particularly the changes from normal to osteopenia. This early stage of bone deterioration is not distinguished by other current ultrasonic techniques but is particularly important in monitoring drug induced or metabolic accelerated bone loss. The innovations, which are implemented in BUSS and described in the issued and pending U.S. patents and in numerous publications of Artann, include: simultaneous use of various modes of acoustic waves generated in a wide frequency band, axial scanning mode of bone examination; and comprehensive analysis of waveforms of bulk, surface and guided ultrasonic waves propagating along the bone with varied proportion of spongy and compact components. Artann has established a number of strategic relationships that will provide engineering, clinical, regulatory, reimbursement, manufacturing and marketing support/expertise to accomplish the goals of the project. Our partners includes: Mayo Clinic, Rochester, MN, and Health Smart Medical Center, Philadelphia, PA, to conduct validation and normative clinical studies necessary for FDA application; Hogan and Hartson, LLP, the regulatory and reimbursement partners to provide direction in completing multiple clinical studies and FDA submissions; Scalable Solutions Group, a regulatory compliance company with the focus on design control needed to satisfy FDA and international standards; Intertek tol conduct verification & validation testing and hazard analysis; and Healthcare Investors, LLC that made a commitment to provide necessary financial and managerial resources to the commercialization of the BUSS technology complementing NIH support of the project. Accomplishing the objectives of the project will secure market introduction of the portable, easy to use and cost effective BUSS for the early stage osteoporosis detection, management of drug-induced bone deterioration, and monitoring of pharmaceutical treatment. PUBLIC HEALTH RELEVANCE: Development of a method for monitoring of bone deterioration induced by aging as well as a side effect of various drugs will provide a substantial benefit to society by diagnosing at risk patients and intervening to prevent further bone loss, increased bone fragility and debilitating fracture. Osteoporosis is known to affect 44 million Americans resulting in 1.5 million fractures and an estimated $18 billion in costs each year. Effective use of the pharmaceutical armament to treat osteoporosis is substantially impaired by the lack of the diagnostic tools that could assess early stages of bone deterioration preceding gross changes in bone mineral content. Laboratory tests and clinical studies have shown that Bone Ultrasonic Scanner (BUSS) developed at Artann Laboratories is highly sensitive to early stages of bone loss and changes in bone structure. BUSS could be ideally suited for the monitoring bone deterioration and early identification of those at a risk for osteoporosis. The long-term goal of this project is to move the BUSS technology to market while also meeting a significant clinical and patient need.

描述（由申请人提供）：由衰老以及某些药物的副作用引起的骨质疏松症是一个严重的公共卫生问题。缺乏足够的手段来早期检测骨退化是最关键的问题，在最大限度地减少药物治疗对骨骼系统的副作用，以及在监测骨质疏松症治疗一般的问题。骨超声扫描仪（BUSS）旨在通过测量长骨中各种模式的轴向声波的传播特性来早期检测和监测骨质疏松症。临床试验证实了BUSS区分骨萎缩阶段的能力，特别是从正常到骨质减少的变化。这种骨退化的早期阶段不能用其他现有的超声技术来区分，但在监测药物诱导或代谢加速的骨丢失方面特别重要。在BUSS中实施的并且在已发布和待审的美国专利以及Artann的许多出版物中描述的创新包括：同时使用在宽频带中产生的各种模式的声波、骨检查的轴向扫描模式;以及对沿着具有不同比例的海绵状和致密成分的骨沿着传播的体、表面和引导超声波的波形的综合分析。Artann已经建立了许多战略关系，将提供工程、临床、法规、报销、制造和营销支持/专业知识，以实现项目目标。我们的合作伙伴包括：马约诊所（罗切斯特，明尼苏达州）和健康智能医疗中心（费城，宾夕法尼亚州），进行FDA申请所需的验证和规范性临床研究; Hogan and Hartson，LLP，监管和报销合作伙伴，为完成多项临床研究和FDA申报提供指导; Scalable Solutions Group，一家监管合规公司，专注于满足FDA和国际标准所需的设计控制; Intertek将进行验证和确认测试以及危险分析; Healthcare Investors，LLC承诺为BUSS技术的商业化提供必要的财务和管理资源，以补充NIH对该项目的支持。实现该项目的目标将确保将便携式、易于使用和具有成本效益的BUSS引入市场，用于早期骨质疏松症检测、药物引起的骨退化的管理和药物治疗的监测。公共卫生关系：开发用于监测由老化引起的骨退化以及各种药物的副作用的方法将通过诊断处于风险中的患者并进行干预以防止进一步的骨损失、骨脆性增加和使人衰弱的骨折而为社会提供实质性益处。骨质疏松症影响着4400万美国人，导致150万例骨折，估计每年花费180亿美元。由于缺乏能够在骨矿物质含量发生显著变化之前评估骨退化早期阶段的诊断工具，有效使用药物治疗骨质疏松症受到严重影响。实验室测试和临床研究表明，Artann实验室开发的骨超声扫描仪（BUSS）对骨丢失的早期阶段和骨结构的变化具有高度敏感性。BUSS可以理想地适用于监测骨退化和早期识别那些有骨质疏松症风险的人。该项目的长期目标是将BUSS技术推向市场，同时满足重要的临床和患者需求。