Portable Ultrasonometer for Osteoporosis Assessment

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 and 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.