Wavelet Medical and Aegis Ventures have partnered to co-develop and scale the first non-invasive artificial intelligence-powered fetal electroencephalogram (EEG) monitoring platform.
The companies aim to eliminate preventable brain injuries at birth, reduce unnecessary C-sections, and ultimately improve maternal and fetal outcomes. The companies say more than 35,000 infants in the United States suffer brain injuries at birth each year, and nearly one-third of births are delivered by cesarean section.
Obstetric care has relied primarily on fetal heart rate monitoring (FHM) for decades. This tool does not directly measure neurological function and up to 85% of births are unknown.
The Wavelet device detects fetal brain signals through a sensor on an abdominal belt worn by pregnant women, Wavelet Medical CEO Liz Golden told Fierce Healthcare in an interview. The device then extracts and evaluates the auditory signals to detect in real time when fetal distress occurs.
“From a mechanistic standpoint, the reason this hasn’t been done before is because there’s a lot of noise that needs to be filtered out to get meaningful data that can be interpreted,” Golden said.
The current standard of care is a fetal heart rate monitor, which measures the heart rate and looks for fluctuations. The test aims to detect signs of distress, such as hypoxia, as early as possible, Dr. Brian Kalish told Fierce Healthcare. Kalish, a neonatologist at Boston Children’s Hospital and associate professor of pediatrics at Harvard Medical School, is an independent medical professional.
“What has become clear is that fetal heart rate monitoring alone does not lead to improved outcomes,” Kalish said. “In fact, many studies have shown that the level of intervention increases during pregnancy but does not change outcomes.”
Subsequent interventions, including caesarean section, can put both the fetus and mother at risk.
Kalish added that if monitoring is not done in high-risk situations, it could raise “serious medical (and) legal concerns.”
“So we’re left with a very imperfect test in this context,” Kalish said.
New tools from Wavelet and Aegis aim to change that.
Dr. Jose Cortes-Briones, assistant professor of psychiatry at Yale University, designed the AI algorithm behind the device. “Until recently, non-invasive fetal EEG from the mother’s abdomen was not feasible. Now, we are leveraging AI to reconstruct fetal EEG and convert it into a quantitative marker of fetal distress,” Cortes-Briones said in a statement.
A breakthrough technology in fetal brain monitoring was developed at Yale University. Wavelet Medical was co-founded by Golden, Cortes-Briones, and Emily Lee, M.D., assistant professor of obstetrics and gynecology at Yale School of Medicine.
Early feedback from people trialling the tool suggests that if the platform works, “it will become the standard of care,” Murray Brodzinski, an Aegis partner and chairman of the Wavelet board, told Fierce Healthcare.
And both Brodzinski and Golden say early data is promising.
“Our study shows that EEG results are as accurate as those of postnatal infants with the sensor directly attached to the head, as verified by neonatal neurologists,” Golden said.
The platform is currently being tested at three clinical sites: Yale University, Los Angeles General Hospital, and Digital Healthcare Innovation at Yonsei University Health System Institute in South Korea. About 300 patients are involved in the testing, Golden said.
Golden said the company is looking for additional trial sites and aims to expand to “approximately five to seven hospitals” in urban and rural areas of the United States.
“What excites me most is that wavelets are not only a true innovation, but also life-saving,” Golden said. “Really, its impact in underserved communities is incredible.”
In addition to partnering with Aegis to commercialize the device, Wavelet has also raised $7 million in seed funding.
The Aegis team met the Wavelet team through its relationship with Yale Ventures, which helps commercialize breakthrough research emerging from universities. Yale New Haven Health also recently joined Aegis’ digital consortium of major health systems.
Brodzinski said Aegis has been working with Wavelet for the past six months. Brozinsky said the venture studio aims to “co-create what will be the next generation of impactful health technology companies,” and its portfolio also includes Hume AI and Caregentic.
Brodzinski said the studio is interested in moving healthcare “from reactive to proactive,” or what the company calls “anticipatory medicine.” “We live in this era of applied AI, and this opens up many avenues that were previously unimaginable.”
Additionally, Brodzinski said Aegis believes the entire care sector “will be revolutionized by AI.”
“AI is now enabling the ability to use new biomarkers and new vital signs to not only predict risk, but to make better diagnoses, better prognoses, and consider better treatment options,” Brodzinski said.
