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A scalable superconducting dual-shielded fetal magnetocardiography system

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44HL160257-01A1
Agency Tracking Number: R44HL160257
Amount: $1,727,246.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-05-01
Award End Date (Contract End Date): 2024-04-30
Small Business Information
Mountain View, CA 94043-2209
United States
DUNS: 094978772
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (650) 965-0500
Business Contact
Phone: (650) 387-4325
Research Institution

PROJECT SUMMARYThere are 26,000 unexplained fetal deaths in the US and over 4 million worldwide annually. Fetal cardiac
arrythmia is a significant cause of fetal demise and is diagnosed in 1-3% pregnancies. While most occurrences
are benign, serious arrhythmia can lead to life-threatening complications if undiagnosed or untreated.
Echocardiography and cardiotocography have been widely used to assess fetal cardiac function; however, their
use has not reduced the incidence of fetal sudden death. Fetal magnetocardiography (fMCG) records the
magnetic fields generated by the electrical activity of the heart, enabling direct assessment of fetal heart
electrophysiology. However, the only FDA-approved fMCG system uses expensive SQUID sensors and requires
a dedicated magnetically shielded room (MSR) to achieve the necessary sensitivity to detect the fetal magnetic
signal above environmental magnetic interference. Thus, the prohibitive expense and impracticality limits the
use of a potentially life-saving device and there remains significant need for a sensitive device that is affordable
and accessible to improve outcomes for fetal cardiac arrhythmias.Applied Physics Systems’ (APS) solution is an integrated fMCG system that uses the more affordable,
optically pumped magnetometer sensors (OPMs), which are now as sensitive as SQUID sensors, with an
innovative superconducting dual-shield. A laboratory prototype of an OPM-based fMCG with a person-sized
ferromagnetic shield has already been developed and a human subject study demonstrated feasibility of an
OPM-based fMCG system as sensitive and accurate as SQUID-based fMCG, but at a fraction of the cost.
However, the shield in the laboratory prototype allowed higher noise in the fMCG recordings compared to SQUID
in an MSR. This shielding is the remaining technical hurdle to reach commercialization. Superconducting shields
have superior shielding compared to ferromagnetic shields and APS has 40 years of success in commercializing
superconducting dual-shielding in rock magnetometer systems. Our preliminary data demonstrates proof of
concept of improved OPM sensitivity within such a shielding system. Therefore, APS will build upon these studies
to create a superconducting dual-shield system to reduce environmental noise, thus improving signal sensitivity
and usability of the system through 3 aims. In Aim 1, we will scale up our superconducting dual-shield system to
be person-sized and design the OPM sensor array and its associated software. We will demonstrate the shielding
performance of our system matches or exceed that of a standard MSR and thermal performance of the
superconducting system. In Aim 2, we will fully assemble the fMCG system with a patient conveyance system
and confirm it meets electrical safety standards. In Aim 3, we will conduct human subject studies, first in non-
pregnant subjects to confirm safety, then in pregnant subjects to confirm sensitivity and accuracy of our fMCG
system compared to the FDA-approved SQUID-based fMCG system.

* Information listed above is at the time of submission. *

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