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）：衰老引起的骨质疏松症以及某些药物的副作用是一个严重的公共卫生问题。缺乏足够的手段来早期发现骨骼劣化是最小化药物治疗副作用对骨骼系统以及监测骨质疏松疗法的最关键问题。骨超声扫描仪（BUS）旨在根据长骨中各种轴向声波的传播特征的测量，用于对骨质疏松症的早期检测和监测。临床测试证实了总线可以区分骨萎缩阶段的能力，尤其是从正常骨质减少症的变化。骨骼恶化的早期阶段没有其他当前的超声技术的区别，但在监测药物诱导或代谢加速骨质流失方面尤其重要。这些创新是在公共汽车上实施的，并在发布和尚待美国专利和Artann出版物中进行了描述。以及对沿着骨骼传播的散装，表面和引导超声波的波形的全面分析，海绵状和紧凑的成分比例各不相同。 Artann建立了许多战略关系，将提供工程，临床，监管，报销，制造和营销支持/专业知识，以实现该项目的目标。我们的合作伙伴包括：宾夕法尼亚州费城的Mayo Clinic，Rochester，MN和Health Smart Medical Center，以进行FDA应用所需的验证和规范性临床研究；霍根（Hogan）和哈特森（Hartson），有限责任公司（LLP），监管和报销伙伴，旨在完成多项临床研究和FDA提交的方向；可扩展解决方案集团，一家监管合规公司，重点是满足FDA和国际标准所需的设计控制； Intertek TOL进行验证和验证测试和危害分析；以及Healthcare Investors，LLC致力于为公交技术的商业化提供必要的财务和管理资源，以补充NIH对项目的支持。实现该项目的目标将确保市场引入便携式，易于使用和具有成本效益的巴士，以进行早期骨质疏松症检测，药物诱导的骨骼劣化的管理以及对药物治疗的监测。公共卫生相关性：开发一种方法来监测衰老引起的骨骼劣化以及各种药物的副作用，将通过诊断在风险患者身上并进行干预，以防止进一步的骨质流失，增加骨骼脆弱性和衰减骨折，从而为社会带来可观的好处。众所周知，骨质疏松症会影响4400万美国人，导致150万个骨折，估计每年成本180亿美元。缺乏可以评估骨矿物质含量总体变化之前可以评估骨质劣化早期的诊断工具的有效使用来治疗骨质疏松症治疗骨质疏松症。实验室测试和临床研究表明，在Artann Laboratories开发的骨超声扫描仪（BUS）对骨质流失和骨结构变化的早期阶段高度敏感。公共汽车可能非常适合监测有骨质疏松症风险的骨骼劣化和早期鉴定。该项目的长期目标是将公交技术推向市场，同时还满足巨大的临床和患者需求。