SBIR-STTR Award

Development of a portable beat-to-beat fetal ECG system
Award last edited on: 2/3/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$256,322
Award Phase
1
Solicitation Topic Code
865
Principal Investigator
Anita Krishnan

Company Information

Auscultech Dx LLC

4059 Candle Light Drive
Dayton, MD 21036
   (202) 355-3560
   N/A
   www.auscultechdx.com
Location: Single
Congr. District: 07
County: Howard

Phase I

Contract Number: 2023
Start Date: ----    Completed: 1/18/2023
Phase I year
2023
Phase I Amount
$256,322
There are 24,000 stillbirths per year in the United States, and 2.6 million stillbirths per yearworldwide, with no significant decrease in the last decade. Abnormal fetal heart rhythms, suchas long QT syndrome, are thought to play an important role in these deaths, and may cause 3-10% of unexplained stillbirths. This is in addition to known fetal arrhythmias, which affect 1-3%of pregnancies per year. A magnetocardiogram is the gold standard to detect these disorders,but is not portable or practical for widespread use. Other available tools such as ultrasound andcardiotocography cannot measure the intervals needed to diagnose and guide management oflife threatening arrhythmias. The ideal tool for diagnosing and guiding therapy for arrhythmias isan electrocardiogram (ECG). Unfortunately, clinicians do not widely use the existing fetalelectrocardiogram (fECG) devices for a variety of reasons: they do not work throughout all ofgestation, can miss brief arrhythmias, have a delay between the actual rhythm and displayedrhythm, do not work in multiple gestations, and lack resolution of important intervals.Our team has refined a prototype fECG during an ongoing R21 funded study. This proposal willbuild on our preliminary work to create a compact version of the fECG which can be utilizedmore widely in ambulatory settings. In this proposal we aim to:1. Develop a compact amplifier system2. Develop a new user interface3. Pilot test the new system in a cohort of ten pregnant women carrying fetuses 22-40 weeks gestation to determine whether it is comparable to or superior to the current system in fECG quality and CTI measurements.If successful, fetal cardiologists could use this tool to diagnose and treat known and latent fetalarrhythmias. Globally, it could serve as a low cost tool to screen for arrhythmias that lead tostillbirth and to monitor fetuses for compromise during surgery, maternal medication use, andfetal interventions. Clinically implementing this critical diagnostic tool will be a landmark in thefield of fetal cardiology.

Public Health Relevance Statement:
Project Narrative Abnormal fetal heart rhythms, such as long QT syndrome, contribute to a significant percentage of unexplained stillbirths. The ideal tool for diagnosing and guiding therapy for these arrhythmias is a fetal electrocardiogram (fECG). We propose to transition our fECG prototype device to a portable clinical version by developing a compact amplifier, building a new user interface, and bench testing the new system in 10 patients.

Project Terms:
<0-11 years old><2nd trimester><3rd trimester>

Phase II

Contract Number: 1R41HD109072-01
Start Date: 12/31/2024    Completed: 00/00/00
Phase II year
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Phase II Amount
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