Wavelet Medical and Aegis Ventures have partnered to co-create and scale the first noninvasive artificial intelligence-powered fetal electroencephalography (EEG) monitoring platform.
The companies aim to eliminate preventable brain injury at birth and reduce unnecessary Cesarean sections, ultimately improving maternal-fetal outcomes. More than 35,000 infants suffer brain injuries at birth annually in the U.S., according to the companies, and nearly one-third of births are delivered via C-section.
For decades, obstetrics has relied primarily on fetal heart rate monitoring (FHM), a tool that does not directly measure neurological function and is indeterminate in up to 85% of births.
The Wavelet device detects fetal brain signals through sensors on an abdomen belt worn by a pregnant person, Wavelet Medical CEO Liz Golden told Fierce Healthcare in an interview, giving a first look at the technology. The device then extracts auditory signals and evaluates them to detect when fetal distress occurs in real-time.
“In terms of mechanics, the reason this hasn't been done before [is] there's a lot of noise that needs to be filtered out in order to get meaningful data that can be interpreted,” Golden said.
The current standard of care is a fetal heart rate monitor, which measures heart rate to look for fluctuations. The test aims to detect signs of distress, such as hypoxia, as early as possible, Brian Kalish, M.D., told Fierce Healthcare. Kalish, a neonatologist at Boston Children’s Hospital and associate professor of pediatrics at Harvard Medical School, is an independent medical expert.
“What’s become clear is that fetal heart rate monitoring alone does not result in improved outcomes,” Kalish said. “And in fact, many studies have shown that it results in increased levels of interventions during pregnancy, but not a change in outcome.”
Subsequent interventions, which include C-sections, can put both the fetus and mother at risk.
Kalish added “significant medical [and] legal concerns” can arise if no monitoring is done under high-risk situations.
“So we're left with a highly imperfect test in this context,” Kalish said.
The new tool from Wavelet and Aegis seeks to change that.
Yale University Assistant Professor of Psychiatry Jose Cortes-Briones, Ph.D., engineered the AI algorithms behind the device. “Until recently, noninvasive fetal EEG from the maternal abdomen was not feasible; we are now harnessing AI to reconstruct fetal EEG and translate it into quantitative markers of fetal distress,” Cortes-Briones said in a statement.
The breakthrough in fetal brain monitoring was developed at Yale. Wavelet Medical was co-founded by Golden, Cortes-Briones and Emily Lee, M.D., assistant adjunct professor of obstetrics and gynecology at Yale School of Medicine.
Early feedback from those piloting the tool says if the platform works, “it would become the standard of care,” Murray Brozinsky, Aegis partner and Wavelet board executive chair, told Fierce Healthcare.
And, early data is promising, according to both Brozinsky and Golden.
“Our studies show that we provide EEG results as accurate as those for post-birth infants wearing sensors directly on their head, as validated by neonatal neurologists,” Golden said.
The platform is currently being tested at three clinical sites: Yale University, LA General Hospital and Korea’s Yonsei University Health System Institute for Innovation in Digital Healthcare. Around 300 patients are involved with the tests, according to Golden.
Golden said the search is underway for additional trial sites, with a goal of expanding to “about five to seven hospitals” in the U.S. in both urban and rural areas.
“What excites me most is that Wavelet is not only a real innovation, but it's also something that saves lives,” Golden said. “So really, that impact in an underserved area is incredible.”
Alongside the partnership with Aegis to commercialize the device, Wavelet also picked up $7 million in seed funding.
The Aegis team met the Wavelet team through its relationship with Yale Ventures, which supports the commercialization of breakthrough research emerging from the university. Yale New Haven Health has also recently joined Aegis’ Digital Consortium of leading health systems.
Aegis has been working with Wavelet for the last six months, Brozinsky said. The venture studio seeks to “co-create what we hope will be the next generation of impactful health technology companies,” according to Brozinsky, which also has Hume AI and Caregentic in its portfolio.
Brozinsky said the studio is interested in making healthcare “move from reactive to proactive,” which the company calls “anticipatory medicine. “We're in this era of applied AI, and so it opens up a lot of avenues that previously just were unimaginable,” he said.
Moreover, Brozinsky said Aegis believes the entire care spectrum “is going to be revolutionized by AI.”
“AI is now enabling the ability to use new biomarkers and new vital signs to not only predict risk, but also look at better diagnosis, better prognosis and then better treatment choices,” Brozinsky said.