TEL AVIV, Israel, April 15, 2020 /PRNewswire/ -- Nuvo Group, a private company focused on innovation in pregnancy care, today announced two positive publications reporting data taken from its prospective, open-label, multicenter pivotal trial supporting its 510(k) application for the groundbreaking INVU™ system—an FDA-cleared, prescription-initiated, self-administered remote monitoring platform that offers medical grade measurements of fetal heart rate ("FHR") and maternal heart rate ("MHR") via a wireless, sensor band. Taken together, the studies demonstrate INVU's safety and accuracy in obtaining FHR and MHR. The study also evaluated use of the INVU platform for remote monitoring of uterine activity, which will be used to support a planned 510(k) submission to expand the current functionality.
"Nuvo is committed to developing and validating the tools to enable more distributed pregnancy care. As we move forward as a commercial entity to bring the INVU platform to moms and providers in its first FDA-cleared indication—capturing fetal heart rate—we will continue to advance R&D efforts toward rounding out INVU's self-administered monitoring capabilities," said Oren Oz, Founder and Chief Executive Officer, Nuvo Group. "We look forward to sharing the results of our current trial exploring INVU's ability to measure uterine activity, which—together with INVU's FDA-cleared indication to obtain medical-grade fetal heart rate and maternal heart rate—will enable us to offer a more comprehensive remote monitoring platform. Subject to FDA clearance, the addition of remote monitoring capability for uterine activity would allow a virtual visit to include a remote NST, a common prenatal test that is currently given once a week or more in a healthcare setting during the final weeks of pregnancy."
A paper titled, "Wireless, remote solution for home fetal and maternal heart rate monitoring," published in the American Journal of Obstetrics & Gynecology MFM, assessed concurrent use of cardiotocography, the current standard of care for external FHR monitoring, with INVU. The primary endpoint was INVU's FHR limit of agreement within ± 10 beats per minute of FHR measured with cardiotocography. The study found that although captured by very different methods, there was a highly significant correlation between FHR measurements from INVU, a self-administered remote monitoring platform, and cardiotocography, which must be applied by a medical professional in a healthcare setting. No adverse events were reported during the study.
In a poster titled, "A Novel Non-Invasive Method for Remote Uterine Activity Monitoring Based on R-wave Modulation of Maternal Electrocardiography," which was presented at the Society for Maternal Fetal Medicine's 40th Annual Pregnancy Meeting, maternal uterine activity (UA) during peak contractions was measured in a subset of the pivotal study participants simultaneously using the INVU platform—which obtains UA measurements from the modulation of the R-wave component of the abdominal maternal EKG (mEKG)—and the traditionally used method, tocodynamometry (TOCO), which must be administered by a medical professional in a healthcare setting and may be impacted by maternal movement, habitus or sensor placement. A blinded expert assessor then manually identified and marked contractions using the INVU platform and TOCO. The results of this preliminary study support INVU as a novel method to detect and monitor maternal uterine activity with excellent sensitivity (94%) compared to TOCO.
A large multi-center comparative trial, measuring the INVU platform alongside traditional TOCO and gold standard intrauterine pressure catheter monitoring methods, recently completed enrollment, having recruited 120 mothers in the United States. Data from this study is anticipated to be used to support a 510(k) submission for INVU for remotely obtaining uterine activity.
Nadav Schwartz, MD, Clinical Director of Outpatient MFM Services and Associate Professor of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania, and investigator on the study stated, "The current COVID-19 pandemic has accelerated the need for technology solutions that can increase access and minimize avoidable exposure while providing a high degree of reliability, safety, and accuracy. Our work is exploring whether we can address longstanding issues involving access to prenatal care such as physician shortages and rural geography, while supporting the patient experience."
About Nuvo Group Nuvo Group is committed to serving providers and expectant mothers by advancing pregnancy care with new technology, tools, and practices. The INVU™ platform combines proprietary hardware, for high fidelity data collection, with innovative software solutions powered by AI tools to optimize the pregnancy care experience on a global scale. INVU has received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring. INVU™ is not yet cleared for remote monitoring of uterine activity in the United States and is limited to investigational use for this purpose. Company leadership is comprised of dedicated data engineers, experienced medical and business professionals, software designers, and proud parents who embrace a collective mission to give every life a better beginning.
For more information and complete indications, contraindications, warning, and precautions along with instructions for use, visit: www.nuvocares.com