Israeli Startup Nuvo Develops a Home Fetal and Maternal Monitor for High-Risk Pregnancies

Pregnancy can be dangerous for both mother and child. Between 1987 and 2015, the number of pregnancy-related deaths in the U.S. has more than doubled from 7.2 deaths per 100,000 live births to 17.2 deaths per 100,000 live births respectively, according to the U.S. federal Centres for Disease Control and Prevention (CDC). The perinatal mortality rate in the U.S.has remained unchanged between 2012 and 2016, the year the CDC published its latest data on the topic, standing at six deaths either during the second half of the pregnancy or up to four weeks after birth per 1,000 births. In certain cases, the ability to regularly monitor the baby in the womb as well as its mother’s vitals is essential to the survival of them both. However, keeping expecting mothers hospitalised or rushing them to the doctor’s office for frequent checkups is not always realistic or viable.

Tel Aviv-based startup Nuvo Inc. set out to address the issue, helping pregnant women carry on with their daily routines, without forgoing necessary monitoring. Nuvo develops a belt-like device that offers pregnant women non-invasive fetal and maternal monitoring abilities from the comfort of the mother's home. Called Invu, Nuvo’s monitoring belt measures certain indicators of fetal and maternal wellbeing using central and acoustic sensors, including fetal ‎movements, fetal heart rate, and maternal heart rate, Noah Klein, Nuvo’s director of business development said in a Thursday interview with Calcalist.

CEO Oren Oz founded the company in 2007 during his wife’s first pregnancy. Oz wanted to interact with his child through music, so he set out to develop a music-playing belt sending sounds into the womb. In 2013, Oz’s wife underwent a high-risk pregnancy and needed to continuously monitor the baby’s heartbeat and wellbeing, leading to a company shift to create a monitoring belt, Klein said.

According to Klein, Nuvo’s device is sold strictly to medical practitioners and offered to expecting mother on loan on a prescription base only, The patient receives information from the device directly to her phone and a more comprehensive report is sent to her physician. Nuvo’s business model is to charge insurers, per report issued. Klein estimates the use of Nuvo’s device would cost approximately $300 per pregnancy.

The company has completed a clinical trial with 150 patients, according to Klein. The study was conducted in partnership with Hadassah Medical Center in Jerusalem, Heidelberg University Hospital in Germany, The Perelman School of Medicine at the University of Pennsylvania, and the Eastern Virginia Medical School.

Nuvo is currently waiting on approval from the U.S. Food and Drug Administration (FDA), and expects to get the go-ahead by the end of 2019, Klein said. The company intends to apply for European regulatory approval in the near future, Klein said. Nuvo expects to start shipping its product in early 2020 and has already received letters of intent from one of Israel’s largest health maintenance organizations, he added.