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New Photo-Acoustic Imaging Process in Fetal Monitoring to Dramatically Reduce Brain Injuries in Newborns

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD102260-01
Agency Tracking Number: R43HD102260
Amount: $149,978.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-01
Award End Date (Contract End Date): 2020-12-31
Small Business Information
Sparks, MD 21152-9201
United States
DUNS: 808275890
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 472-2600
Business Contact
Phone: (410) 472-2600
Research Institution

The Brimrose Technology Corporation and Johns Hopkins University are forming a powerful new team to make
a new instrument that has the potential to dramatically reduce a major global health problem–perinatal hypoxic-
ischemic encephalopathy (HIE)–by enabling early detection during labor. HIE caused by asphyxia is a leading
cause of infant fatalities as well as a source of cerebral palsy and other long-term severe neurologic
impairments. The medical community has been limited in early diagnosis of HIE because current fetal heart
rate monitoring has poor specificity. If identified early, HIE can be treated effectively with therapeutic
hypothermia. We are proposing a fetal photoacoustic monitoring system that measures oxyhemoglobin
saturation of the sagittal sinus vein draining the fetal cerebral cortex during labor. Sagittal sinus oxyhemoglobin
saturation decreases to very low levels when placental gas exchange is impaired (hypoxia) and/or when fetal
cerebral perfusion pressure falls (ischemia). The photoacoustic instrument transmits light through the open
fontanelle or bone and into cerebral veins and tissue where ultrasound waves are generated. Using near-
infrared incident light at discrete wavelengths that are absorbed preferentially by oxy- and deoxy-hemoglobin,
ultrasound detected on the fetal scalp at each wavelength can estimate oxyhemoglobin saturation. Brimrose
has constructed a novel ultrasound detection technology with sensitivity orders of magnitude greater than the
current best-use piezo-electric sensors. This will permit the use of low-power LED light sources rather than
cumbersome laser lights now employed, thereby avoiding safety goggle use and promoting greater
deployment. The Hopkins team has already validated the ability of a standard photoacoustic system to
accurately estimate sagittal sinus oxyhemoglobin saturation through the skull of newborn piglets. The purpose
of Phase I is to demonstrate the feasibility of using safe, low power LED light sources with the new
ultrasensitive ultrasound sensor to detect critically low sagittal sinus oxyhemoglobin saturation when
oxygenation is manipulated. The platform will be based on in-silico simulation to optimize the acoustic and
optical pathways for the skull and brain. Real-time measurements on a time scale of seconds will inform the
obstetric caregiver of dynamic fluctuations of brain oxygenation during contractions. The Phase II goal is to
make a miniaturized photoacoustic device prototype that can report on fetal brain oxygenation. We believe the
resulting instrument will provide early detection brain HI with greater specificity and sensitivity, enabling early
intervention and treatment and is potentially transferrable to a commercial model for manufacture.PROJECT NARRATIVE
The Brimrose Technology Corporation and the Johns Hopkins University propose making a new instrument to
potentially dramatically reduce the incidence of hypoxic-ischemic encephalopathy (HIE), which can result in
mortality or lifelong disabilities. Our goal is to develop an intrapartum fetal brain monitor using photoacoustics
with inexpensive, safe and clinically convenient light emitting diodes (LEDs) to noninvasively and
instantaneously identify the fetus at risk for brain injury. Phase I is intended to provide a proof-of-concept using
low power LED light sources and a novel ultrasensitive ultrasound detector rather than standard laser light
sources and piezo-electric detectors.

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

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