When Neil Ray, MD, a pediatric anesthesiologist by training, was working in private practice in South Florida, he was surprised to learn that nearly half of women gave birth via a caesarean section, and often, these surgeries weren’t necessary as both the baby and mother were very healthy.
His observations are backed by a recent Consumer Reports study, which ranked Florida among the top three states with the highest C-section rates in the country. And while Florida’s rates exceed most, research shows that surgical birth rates are too high nationwide, particularly for first-time mothers-to-be who were at low risk of needing a cesarean. The study found that nearly half of the C-sections performed in the U.S. were unnecessary.
Many expecting mothers don’t realize that C-sections can have serious short- and long-term implications, including post-partum depression, major complications from blood clots and injury to the bladder. Babies born via C-section are also at higher risk of suffering from long-term asthma and obesity and have a harder time breastfeeding.
Determined to find a better solution, Dr. Ray noticed that the current fetal monitoring system used during childbirth doesn’t provide a good indication of a baby’s health as only the heartbeat is tracked in conjunction with a mother’s contractions.
“I knew that if I could find a way to use technology to non-invasively determine fetal oxygen levels during labor, there was an opportunity to vastly reduce the number of unnecessary C-sections,” he said.
He went to UC Davis, where he received high-level support and clinical time to refine his theory. He later formed a team with the expertise to build the device and created Raydiant Oximetry with the objective of allowing physicians to better monitor babies during the third trimester of pregnancy and labor to promote more informed decisions. The co-founders include Nicole Hlava, MD, chief executive officer; and Terry Han, Ph.D., chief scientific officer.
In just two years, the team has already built its first prototype, which uses just one device to monitor a baby and mother’s heart rate and oxygenation.
The startup is a quarter of the way through its first feasibility study at UC Davis where initial results have successfully shown the fetus and mother’s heart rate and oxygen saturation readings.
However, because this is the only such device on the market, there is nothing to compare to their values, although their readings are within the normal, expected range. As a check, they will soon undertake animal studies so they can compare how their device is tracking in comparison to arterial oxygen saturation.
To accelerate its growth, the startup applied and was accepted into the Fogarty Institute’s incubation program.
“We see immense value in being in a location where there is such expertise within the industry, and its history of creating successful startups was very appealing to us,” said Nicole Hlava, MD. “The team also appreciates being co-located with other startups, which allows for a free exchange of ideas and shared knowledge.”
The first three weeks at the Institute have already been very productive as they have received individual mentoring from Andrew Cleeland, Kerry Pope and Denise Zarins on different aspects of their business. Next, they look forward to helping host the FDA fellows who are joining the Institute this month.