Galveston, Texas-based medtech startup Noninvasix, Inc. showcased its novel optoacoustic fetal monitoring technology at the South By Southwest Discover UT Future Finders held last Saturday, March 14 in Austin for companies spun out from University of Texas System campuses.
“What better place than at SXSW to show off the best innovations coming out of the UT System” commented Noninvasix President and CEO Graham Randall, Ph.D. in a release.
Dr. Randall was previously President of Intubix LLC, a venture capital-backed startup commercializing a Class I medical device for respiratory care, where he was responsible for the entire development process, design, manufacturing, IP, regulatory, marketing, and sales. As an Entrepreneur-in-Residence at AlphaDev, a life science-focused venture capital firm, Dr. Randall secured a seed investment of $250,000 for Intubix and took the product from the prototype stage to human testing within six months.
Using patented optoacoustic technology, Noninvasix, Inc. has developed a safe, accurate, and noninvasive solution for fetal welfare monitoring during labor and delivery that it claims will significantly improve outcomes for mother and baby during labor, reduce incidence of unnecessary cesarean sections, and lower the risk of malpractice lawsuits and high insurance premiums for doctors, and is expected to also reduce the risk of severe neonatal morbidity including cerebral palsy. The device is backed by 15 years of optoacoustic research and more than $6.5 million in research grant funding, as well as validation in peer-reviewed journal articles.
Noninvasix explains that, instead of relying on detection of changes in basal heart rate to indirectly assess fetal asphyxia as traditional fetal welfare monitoring systems do, its device utilizes optoacoustic monitoring to track cerebral venous oxygenation in the superior sagittal sinus, thereby directly measuring the amount of oxygen being delivered to the baby’s brain.
Collaborating with obstetricians at University of Texas Medical Branch at Galveston, Noninvasix engineers designed a small fetal probe which emits light pulses delivered to the superior sagittal sinus — a large central cerebral vein located immediately under the top of the skull. These pulses generate acoustic waves that are transmitted to an electronic monitoring system for signal amplification, acquisition, and recording. With the generated ultrasound signal returned directly from the superior sagittal sinus, actual hemoglobin saturation in the vein can be accurately measured in real time.
Noninvasix has 6 issued patents protecting its Optoacoustic technology and its applications, and are continuing to build their IP portfolio — now on their third generation of monitors.
When light pulses are introduced into blood in a vessel, blood hemoglobin absorbs light and emits ultrasound in proportion to concentration in the vessel. Ultrasound waves travel without scattering and arrive at specific times proportionate to blood vessel depth. Once the sensor detects the ultrasound, compute software determines the location, size, and oxygenation of blood in the vessel.
Noninvasix notes that competitors’ oximeters based on NIRS can only measure a mixture of light from arteries, veins, capillaries, muscle and other absorbing chromophores in a large cone of tissue, maintaining that their optoacoustic technology is superior because it provides: 1) direct measurement of cerebral venous oxygenation with high spatial resolution; 2) absolute, accurate measurements of blood oxygenation; 3) continuous, real-time monitoring; and 4) Platform Technology that uses a common platform to address a wide variety of biomedical applications and related health issues.
Thanks to the versatility of Platform technology, Noninvasix say their fetal brain monitor is just their first in a projected range of products.