Startup company develops noninvasive device to monitor fetal brain oxygenation levels
Giving birth can be a stressful time for all involved. It is of the utmost importance that the oxygen levels for the baby are accurately monitored, which is currently done by using a fetal heart rate monitor. Introduced in the 1970s, the monitor is an elastic band that has sensors on it and is used during the late stages of labor.
Despite it being the only current method of fetal monitoring, the heart rate monitor does not provide a direct measurement of fetal brain oxygenation and cannot accurately predict when a baby’s oxygen levels are low. As a result, the number of new cerebral palsy cases in the United States has not diminished since the introduction of the fetal heart rate monitor.
“Obstetricians today monitor the well-being of the baby with the fetal heart rate monitor, which uses the heart rate as a proxy for brain oxygenation, but this doesn’t work so well because a lot of factors influence heart rate,” said Dr. Graham Randall, CEO of Noninvasix. “Fetal heart rate monitors have a false positive rate of 89 percent for predicting fetal distress, which means that nine times out of ten when the physician orders a C-section the baby is perfectly fine.” These unnecessary C-sections can also put the life of the mother at risk, as well as adding additional costs he said.
Noninvasix, Randall’s startup company, was the winner of the 2015 Texas A&M New Ventures Competition (TNVC). In collaboration with obstetricians at The University of Texas Medical Branch at Galveston, the company has developed a noninvasive device that utilizes optoacoustic technology to provide more accurate neonatal and fetal monitoring. Optoacoustic technology uses light to excite chromophores (molecules that absorbs light), which sends back an acoustic signal.
The inventors of the technology, with funding from the Department of Defense, had originally developed an application for soldiers with traumatic brain injury. However, when talking with the inventors about how to commercialize the optoacoustic technology, Randall researched brain hypoxia and malpractice, and discovered the need for technology to monitor fetal and neonatal brain oxygenation levels in babies.
The monitoring system that Noninvasix has developed uses a small fetal probe that uses pulse laser light to excite hemoglobin, a protein in the blood that carries oxygen, and sends back a pressure wave that will be detected by a sensitive microphone (ultra sound transducer). Not only will the device be able to provide accurate, real-time monitoring of the baby’s oxygenation levels, but it could also reduce the risk of neurological impairments like cerebral palsy and unnecessary C-sections.
Since winning first prize at the TNVC in 2015, Noninvasix has been able to develop the technology further. Their latest prototype has been debugged and they are now able to collect data. The team has made progress using the technology for hemoglobin concentration monitoring, and has also improved the design of the patient interface for babies in the NICU. Randall said it will take about one or two years for them to build a final device that will be ready for the marketplace, and then another six months for clinical studies before they can submit it to the Federal Drug Administration.
As a result of participating in the TNVC, Randall said Noninvasix has gained a great deal of attention from the media and it helped solidify several key relationships at Texas A&M.
“To go out and pitch your idea and win is a really big confidence boost. When you’re an entrepreneur you spend a lot of time having people tell you that [your idea] is not good, and you’re wasting your time. So, to actually get some validation like that is really important,” said Randall.
“We need more programs like the Texas A&M New Ventures Competition to help support startups and to generate interest and excitement around startups in order to get people to want to get into these things. I think that’s where innovation comes from and it is extremely important to the Texas economy because new technology is being developed here. The New Ventures Competition can support startups financially, and with feedback and strategic advice, I think is extremely valuable.”