NASCENT DEVICES INC. — Department of Health and Human Services SBIR Phase I: 300

Description

Iron overload affects life of many people in the US and around the world Liver iron concentration provides a direct indicator of body iron level Among various noninvasive methods Biomagnetic liver susceptometry BLS has been proven to provide the only direct means of determining hepatic iron stores However BLS requires cost prohibitive million and complex K liquid helium SQUID magnetometer which limits the clinical adoption of this technology The objective of this SBIR project is to develop a low cost compact size and portable room temperature biomagnetic liver susceptometry PM BLS based on piezoelectric biomagnetic sensor for general clinical use to quickly easily noninvasively and quantitatively assess liver iron concentration The proposed effort explores the unique opportunity afforded by recent advances in piezo magnetic sensors that exhibit ultra high AC magnetic sensitivity in the presence of strong DC magnetic background and breakthrough at Prof Zhang s laboratory of Penn State University PSU in successful demonstration of the performance of piezo magnetic sensor using liver phantoms Specifically Nascent Devices LLC proposes to develop a piezoelectric magnetic PM sensor susceptometer and carry out a direct comparison with the SQUID BLS at UCSF Benioff Children s Hospital Oakland CA In Aim we will develop a compact PM sensor susceptometry a first order gradiometer configuration and ready for clinical study In Aim we will carry out calibration of the PM sensors with Liver phantoms of different iron concentrations and compared with computer simulation results In Aim direct comparison of the first order PM biomagnetic susceptometry with the SQUID BLS on human subjects Available test results reveal that our PM BLS will have equal or better sensitivity to SQUID BLS in assessing liver iron concentration LIC due to closer distance to the liver improved SNR at higher scan rate and greater flexibility and mobility with much lower cost andlt $ The PM BLS technology to be developed in this program is both conventional and disruptive It is conventional because this technology will adopt the principle of SQUID based BLS which has been proven to be effective in quantifying LIC It is disruptive because the technology can lead to breakthroughs in cost and size which would lead to the development of a portable physician clinics or patient bed side BLS device in the future SBIR Phase II and Phase III applications Development of a low cost and portable biomagnetic liver susceptometry BLS will greatly improve the clinical practice in managing the diseases associated with iron overload To reach this goal we propose to develop BLS based on piezoelectric biomagnetic sensor for general clinical use to quickly easily noninvasively and quantitatively assess liver iron concentration The proposed development effort explores the unique opportunity afforded by recent advances in piezo magnetic sensors that exhibit ultra high AC magnetic sensitivity in the presence of strong DC magnetic background