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Intrapartum Transabdominal Fetal Pulse Oximetry: Demonstration in Ewe Models

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD104537-01
Agency Tracking Number: R41HD104537
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA19-270
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-15
Award End Date (Contract End Date): 2021-08-31
Small Business Information
2918 COHO PL
Davis, CA 95616-5636
United States
DUNS: 117157062
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (530) 752-0836
Business Contact
Phone: (310) 569-3330
Research Institution
1850 Research Park Drive, Suite 300
DAVIS, CA 95618-6153
United States

 Nonprofit College or University

Project Summary
Despite significant cost and clear evidence of health risks associated with Cesarean section
surgeries, an unnecessarily large number of infants are delivered via Cesarean section (C-
Section) surgeries. The high rate of C-section in the US, relative to globally accepted norms, and
the associated additional cost and complications are in part, due to high false positive rate of
intrapartum detection of fetal hypoxic distress using existing electronic fetal monitors. Our
mission is to address this problem, and improve the state of fetal health monitoring during labor
and delivery.
Specifically, a team of researchers at UCDavis has developed the technology for non-invasive,
transabdominal measurement of fetal arterial blood oxygen saturation (FSpO2). The technology
works by shining light in the abdominal area at two specific near infrared wavelengths and
subsequently, sensing the small amount of diffusely-scattered light transcutaneously. The
sensed signals are processed to remove the unwanted maternal contribution to measurements,
and to infer variations in sensed infrared light intensity that are strictly due to pulsation of fetal
arteries. The device prototype is successfully validated in several benchtop and in-vivo tests,
including in one hypoxic fetal lamb model.
In this STTR Phase I project, Storx Technologies Inc., a spinoff of UCDavis founded by two
researchers who invented the technology, will partner with a team of UCDavis clinical and
engineering researchers to demonstrate feasibility of transabdominal FSpO2 measurement in
pregnant ewe models experiencing uterine contractions. The study is organized into two
complementary arms, depending on whether the fetal lamb experiences hypoxia (n=5) or not
(n=5) during maternal uterine contractions. The project will provide the foundation and support
for intrapartum validation of the technology in human subjects in the future.
Storx has already secured the exclusive right to negotiate with UCDavis to license the underlying
intellectual property, and it is expected that we will reach an exclusive IP licensing agreement
with UCDavis in due course.Project Narrative
The long-term vision of this project is to significantly improve fetal health monitoring during
labor and delivery, by demonstrating the feasibility of a breakthrough technology for
intrapartum non-invasive, transabdominal measurement of fetal arterial blood oxygen
saturation (FSpO2). Building on our preliminary work on prototyping and validation of a
transcutaneous fetal pulse oximetry device, we will build an improved version of the device
using which, we aim to demonstrate feasibility of transabdominal fetal pulse oximetry (TFO)
under induced uterine contractions (n=5), as well as under induced uterine contractions and
fetal hypoxia (n=5) in pregnant ewe models.

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

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