NEW YORK and TEL AVIV, Israel, April 12, 2018 /PRNewswire-USNewswire/ -- Nuvo Group, LTD, an emerging leader in maternal-fetal connected health, today announced the start of a prospective, open label, comparative, multi-center study to compare the data collected and digitally recorded from its PregSense™ maternal fetal monitoring system with the current standard of care (cardiotocography [CTG]). PregSense™ is Nuvo Group's patented sensor-based wearable monitoring technology designed to advance the delivery of maternal-fetal care.
"Pregnancy monitoring technology has changed little in the past 30 years, putting it at odds with the expectations and needs of today's expectant parents and health professionals," explains Oren Oz, CEO of Nuvo Group. "Current approaches fail to provide the continuous, real-time access to information that digital natives – parents and physicians alike -- have come to expect. We hope to challenge this status quo with PregSense so that we can create a new approach to meet the needs of the modern parent. "
The PregSenseTM trial will be conducted across four sites; Heidelberg University in Germany, Hadassah Medical Center in Israel, East Virginia Medical School (EVMS) and the University of Pennsylvania (UPenn) in the US. The primary objective of the study is to assess the agreement between PregSenseTM data collection, and values measured via the standard of care used for prenatal monitoring (CTG) and to assess the safety of PregSense™. The trial endpoints will include fetal HR, maternal HR and uterine activity collected via PregSense™ and via cardiotocography (CTG). The trial will involve in up to 200 pregnant women with singleton gestation > 32+0 weeks of pregnancy and is expected to last up to 24 months.
PregSenseTM measures markers of fetal and maternal wellbeing including fetal movements, fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) using surface electrodes on the maternal abdomen.
"We anticipate a wireless wearable system that will record both fetal and maternal parameters non-invasively and continuously," continues Oren Oz. "Our advancements in connected pregnancy technologies have the potential to better serve a segment of healthcare that has remained largely unchanged for decades."
About PregSense™ PregSense™ has the potential to provide ultimate, real-time and continuous information on fetal and maternal parameters. Application and set-up take only minutes, allowing rapid data collection. The non–invasive PregSense™ brings a much-awaited innovation in the field of maternity monitoring.
PregSense™ is based on measurements of fetal and maternal wellbeing including: fetal movements, mother & fetal heart rate and uterine activity. The clinically validated mature wearable system will simultaneously record both fetal and maternal parameters wirelessly and non-invasively. The product is designed to provide the same parameter measurements as the gold standard monitoring methods, in a convenient home-use wearable platform.
PregSense™ is currently undergoing clinical investigation to support FDA clearance and is not yet available for sale in the United States.
About Nuvo Group, LTD Nuvo Group is committed to transforming pregnancy care for a new generation. Proprietary software solutions combined with innovative product design utilize big data analytics to optimize pregnancy healthcare on a global scale. Nuvo Group leadership is comprised of dedicated data engineers, medical professionals, software designers, and proud parents who share a collective vision to create new solutions for both patients and doctors, creating an immediate impact on maternal care worldwide.