NEVA ELECTROMAGNETICS LLC — Department of Health and Human Services SBIR Phase I: NIAMS

Description

PROJECT SUMMARY ABSTRACT More than million Americans have osteoporosis and an additional million have low bone density or osteopenia Osteoporosis represents a major health problem resulting in substantial increases in national health care costs Current methods to detect osteoporosis rely upon ionizing techniques such as Dual energy X ray Absorptiometry DXA and Quantitative Computed Tomography QCT A pilot study conducted by our collaborators indicated a possible correlation between readings of an array of passive on skin MHz Radio Frequency Identification RFID tags surrounding a wrist and an osteoporotic bone condition established via DXA measurements We therefore hypothesize that a professional acquisition testbed using this novel low cost non ionizing technique can detect osteoporosis Specific Aim PHASE I Design and construct a novel on body passive RFID antenna array testbed for highly sensitive and repeatable measurements of wrist bone signature In contrast to a common microwave imaging setup with multiple antennas the use of an RFID array instead of one tag is solely intended for more accurate and stable reading of the single parameter the average received power through the wrist given different anatomical and physiological conditions Specific Aim PHASE I Determine the sensitivity of the bone signature measured by the testbed for differentiating between normal and osteoporotic bones at wrists using in vivo pilot studies The ultimate technical goal of Phase I and partially of Phase II is to achieve a sufficient measurement accuracy of the testbed i e guarantee the average received power variability for each wrist of less than dB factor of for at least of tested wrists This threshold value will make it possible to extract the desired signal from the surrounding noise and detect the osteoporosis related power variation which is expected to be in the range dB factor of Specific Aim PHASE II Finalize the major antenna concepts and protect the RFID antenna bone density testbed by filing at least one full scale patent with the special emphasis on the unique reader tag antenna array design and on possible extensions Convert the RFID antenna testbed to a semi commercial product One feature of the present study will be a novel and unique on body antenna design which will allow us to realize a highly sensitive detection method in practice Specific Aim PHASE II Calibrate the finalized RFID antenna testbed by performing and processing a representative in vivo study and delivering a final detection protocol Finalize and perform premarket regulatory submission of the developed wrist sensing RFID device to the U S Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health We hypothesize that the newly designed testbed will differentiate between normal osteopenic and osteoporotic bone sufficiently to warrant a premarket regulatory FDA submission related to a specific Class III device Specific Aim PHASE II Approach the production stage by either teaming up with a larger medical company or a rd party manufacturer Potential candidates include Biotronik Boston Scientific St Jude Medical Inc and Medtronic Inc PROJECT NARRATIVE Osteoporosis represents a major health problem resulting in substantial increases in national health care costs Current methods to detect osteoporosis rely upon ionizing techniques such as Dual energy X ray Absorptiometry DXA and Quantitative Computed Tomography QCT The objective of this proposal is to create and validate a low cost non ionizing method which uses modern RFID technology and to construct the corresponding premarket testbed