Houston, Texas-based Noninvasix, Inc. is working to commercialize a novel monitoring system using optoacoustic technology to provide accurate, non-invasive measurement of cerebral venous blood oxygen saturation in fetuses during late stage labor.
The device was developed by University of Texas Medical Branch (UTMB) traumatic brain injury expert Donald Prough, MD, professor and chairman of the department of anesthesiology and Rinat Esenaliev, PhD, director of the laboratory for optical sensing and monitoring at the center for biomedical engineering.
A tiny probe, about the size of a stethoscope ear tip, is inserted transvaginally and placed atop the baby’s anterior fontanel. Pulsing frequencies at 1,000 times per second of near-infrared light are sent into the brain’s Superior Sagittal Sinus vein. Hemoglobin in the blood absorbs the light at different frequencies depending on whether or not it is carrying oxygen. Absorption causes rapid thermal expansion of the hemoglobin resulting in a measureable acoustic wave. The software analyzes the signal and returns an absolute measurement of oxygen saturation.
This optoacoustic system provides accurate measurement of oxygen saturation (R2 = 0.990), specifically in the superior sagittal sinus, because high (optical) contrast and high (ultrasound) resolution permit direct probing of blood vessels.
Although fetal heart rate monitoring provides an indirect indicator of fetal oxygenation, to date, there are no commercially available monitors that directly monitor the adequacy of fetal cerebral blood flow. With its enhanced fetal monitor, Noninvasix aims to improve maternal and fetal health by lowering the rate of cesarean sections and improving the financial outcomes by lowering the costs of care and medical liability claims.
“Obstetricans and hospitals are in the direct line of fire as c-section rates continue to be above the WHO standard and average malpractice claims in obstetrics are the highest of any medical practice,” said Noninvasix CEO Graham Randall, Ph.D. “The need for new innovation to improve outcomes for all stakeholders is particularly pressing.”
The Noninvasix team of scientists and researchers have previously demonstrated in in vitro, animal, and clinical tests that the optoacoustic prototype measures cerebral oxygenation (SO2) in individual brain blood vessels accurately and precisely (correlation: r2 = 0.99; bias = 2.47%; SD = ±2.3%) in comparison to invasive hemoximetry, the gold standard for those measurements.
While the primary application for the device is fetal welfare monitoring, the company has also demonstrated that optoacoustic technology can detect cerebral ischemia in premature newborn infants and can non-invasively detect shock and monitor brain ischemia in traumatic brain injury.
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