Nuvo Resources

Nuvo gives patients the ability to attend NST appointments from wherever they need to be - at home, at work, or anywhere else. NWC patient, Felicia, shares her experience as a patient using Nuvo:

"My experience with Nuvo has been super easy so it's been very convenient for me to use it at work." - Felicia, NWC patient using Nuvo

"It's a great patient pleaser!" - Dr. Kyle McMorries

Check out the full video here: 

Transcript:

Patient (Felicia): My experience with Nuvo has been super easy so it's been very convenient for me to use it at work. I just shut my office door get it hooked up and then I can you know cover my belly back up and I can sit at my computer and still do all of my paperwork and stuff and even have meetings and things and people never even know that I'm monitoring.

Dr. Kyle McMorries: It's a great patient pleaser! Every patient we have on it loves the fact that they're not having to miss work, they're not having to drive in, they're not having to go through parking, checkin, and all the processes. Overall it's a very positive experience and we very much recommend it.

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OBJECTIVE: Antenatal fetal surveillance is performed in high-risk pregnancies to reduce the risk of stillbirth.¹ Surveillance recommendations require numerous in-clinic appointments for nonstress tests (NSTs).¹ NST attendance is limited by transportation, childcare, and work demands.²

INVU by Nuvo is an United States food and Drug Administration–cleared, remote, self-administered maternal-fetal monitoring approach. In a prospective cohort study, 93.9% of NSTs performed remotely using INVU were clinically acceptable, and >88% were completed without in-clinic evaluation.³

In this study, we explored patient acceptability of remote fetal monitoring using quantitative and qualitative approaches to help clinicians and users understand the experience, while providing actionable insights for optimization.

STUDY DESIGN: This prospective mixed-methods study encompassed survey and qualitative portions. Patients were enrolled in 1 of 2 prospective cohorts that studied the use of INVU to remotely perform clinically indicated NSTs in high-risk pregnancies from October 2020 to March 2023. A device description and the inclusion and exclusion criteria for these cohorts are described in the Supplemental File, and the clinical data have been reported elsewhere.³ These studies were approved by the [University of Pennsylvania] Institutional Review Board.

Survey study: Cohort patients who attempted ≥1 remote NST were eligible for the weekly survey, which included a modified version of the validated Acceptability of Intervention Measure (AIM) (4-item Likert-scale measure) and open-ended questions regarding patient experience.⁴ Descriptive statistics were used, and analyses were performed using Stata, version 15.0 (StataCorp LL, College Station, TX).

Qualitative study: Beginning May 2022, after 2 attempted remote sessions, cohort patients were invited to participate in a semi-structured qualitative interview until thematic saturation was achieved. A Consolidated Framework for Implementation Research influenced interview guide⁵ elicited information on (1) experiences with in-clinic and remote monitoring, (2) barriers to or facilitators of remote monitoring, and (3) suggestions for improvement. For the analysis, an integrated approach was used in NVivo12 with excellent intercoder reliability (the Supplemental File contains detailed information on the qualitative methods).

RESULTS: A total of 56 patients enrolled in the 2 cohort studies (Table 1). Of those, 40 patients (71.4%) completed 105 surveys (median, 2; interquartile range [IQR], 1–4 surveys/person) with a median acceptability of 15 of a possible 20 (IQR, 14–16).

Table 1. Demographic characteristics of participants for each study component, namely the (1) quantitative study and (2) qualitative study

[see link to original article above for table]

When asked to provide feedback about remote monitoring, the most frequently cited issue related to belt connectivity (19/105; 18.1%) or belt fit or comfort (16/105; 15.2%). Patients reported several benefits of remote monitoring, including avoiding in-clinic interactions (53/89; 59.6%), ease and speed of INVU (13/89; 14.6%), avoiding traffic or parking issues (n=6), and decreased costs (n=2). For recommendations for improvement, many reported none (41/89; 46.1%) and others relayed recommendations for improved belt fit or comfort (33/89; 37.1%).

Qualitative: Twelve patients participated in qualitative interviews. Sample interview questions with representative quotes are shown in Table 2.

Table 2. Summary of interview questions in terms of the Consolidated Framework for Implementation Research (CFIR) constructs and representative quotes

[see link to original article above for table]

Previous experiences with in-clinic monitoring: Few participants expressed positive experiences with in-clinic sessions, including a sense of ease or comfort. However, the majority spoke about coordinating childcare and frustrations surrounding travel time, public transportation, work scheduling, and parking with each factor perceived as being financially impactful.

Patient experiences with remote monitoring: The majority reported excitement for at-home monitoring, stating a belief that it would be convenient and less costly. Participants reported feeling relieved of the logistics and expenses of in-clinic monitoring. Concerns with remote monitoring were primarily hypothetical what-ifs. Yet, when probed, the majority reported reassurance about receiving similar monitoring as received in-clinic.

Participants conducted home monitoring in bed or a reclining chair. Generally, at-home sessions lasted for less than 1 hour. Participants also reported that while performing remote monitoring, some worked, whereas others watched TV. Participants reported that household members were either neutral about remote monitoring or provided enthusiastic support. One stated that remote monitoring allowed her spouse to participate, contrasting this with childcare logistics and COVID-19 restrictions.

Barriers and facilitators: Some participants mentioned the need for increased set-up support. One mentioned difficulty with staying still during the experience. For facilitators, in addition to the decreased need for childcare, transportation, and cost, several stated they appreciated clinician communication through the application.

Suggestions for future implementation: A few participants did not have suggestions for improvement, feeling that the experience was straightforward. One brought up fit, expressing body type inclusivity concerns. Other participants felt that remote monitoring may still require additional planning if the home environment includes children.

DISCUSSION: This study demonstrated patient acceptability of remote fetal monitoring using INVU with the use of quantitative and qualitative data to describe concrete barriers and suggestions for improvement. This innovation approach centered the patient, a novel step in academia-industry collaboration, and led to device modifications to improve comfort and signal reliability. These improvements have the potential to maximize the success of our ongoing randomized clinical trial, the Remote Pregnancy Monitoring to Improve Access (REACTIVE) study (https://clinicaltrials.gov/study/NCT05847790), which compares in-clinic and remote monitoring in terms of NST completion and clinical outcomes, focusing on racial and ethnic disparities.

Credit authorship contribution statement

Rebecca F. Hamm: Writing – review & editing, Writing – original draft, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization. Mary C. Steele: Writing – review & editing, Project administration, Data curation. Caroline O'Brien: Writing – review & editing, Supervision, Software, Resources, Project administration, Methodology, Investigation, Formal analysis, Data curation. Hilena Gebru: Writing – review & editing, Software, Resources, Project administration, Methodology, Investigation, Formal analysis, Data curation. Janelle Purnell: Writing – review & editing, Resources, Project administration, Methodology, Investigation, Data curation. Meaghan McCabe: Writing – review & editing, Supervision, Resources, Project administration, Methodology, Investigation, Funding acquisition, Data curation, Conceptualization. Meghan B. Lane-Fall: Writing – review & editing, Supervision, Methodology, Investigation, Funding acquisition, Conceptualization. Samuel Parry: Writing – review & editing, Supervision, Project administration, Methodology, Investigation, Funding acquisition, Conceptualization. Nadav Schwartz: Writing – review & editing, Supervision, Resources, Project administration, Methodology, Investigation, Funding acquisition, Conceptualization.

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This article was originally published by Forbes here.

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By Eva Epker, Forbes Contributor

“How is it possible that, in the 21^st century, you can’t monitor a baby outside of a hospital?” In 2014, Oren Oz and Laurence Klein asked that very question. At the time, Mr. Oz’s wife was 37 weeks pregnant with the couple’s third child. When she went for her pre-labor and delivery ultrasound, the doctor told her that the baby was in distress and recommended an immediate emergency C-section.

Emergency Cesarean sections (C-sections) – which, despite the name, don’t refer to emergencies exclusively but rather to unplanned C-sections generally – are not unusual. In fact, C-sections, both emergency and elective, are the most common surgeries performed every year in the United States and about 17 births out of every 100 are through emergency C-sections.

However, C-sections do carry risks. About 15% of emergency C-sections have complications, such as infections, lacerations, and bleeding for the mother and neonatal respiratory distress for the baby. The maternal morality rate, the mother’s recovery time, and the costs additionally increase with C-sections compared to vaginal births. A 2022 analysis found that vaginal births in the United States cost an average of $14,768 while C-sections, both emergency and elective, average $26,280. For those with insurance, the out-of-pocket costs are $2,655 and $3,214 respectively.

Nearly ten years ago, Oren Oz and his wife decided not to undergo an emergency C-section Instead, she stayed at the hospital for 24/7 monitoring, gave birth vaginally as planned, and both she and the baby were healthy. But that medical scare - and the anxiety and hospital stay that followed - led to the founding of Nuvo Cares, which has developed a self-administered solution that enables OB clinicians and their patients to conduct medically-necessary fetal monitoring remotely: where it fits into the patients’ lives. “If no one has been able to monitor pregnancy more easily and frequently, [we as a society] don’t have data at scale on pregnancy. It’s a black box,” says Nuvo investor Laurence “Larry” Klein. The mission of Nuvo is to collect this data and to transform pregnancy for the next several generations, and, as Mr. Klein emphasizes, there is “no compromise” on that mission.

Childbirth, after all, is the single most-common cause of hospital admission in the United States and accounts for an estimated four out of every five dollars spent on maternal-newborn health care. And yet, the cost of childbirth is increasing (it jumped 22% from 2017 to 2021 alone), maternal mortality is increasing (doubling over the course of 20 years and most affecting Black, Native Alaskan, and Native American women), and the number of C-sections is rising (increasing from 5.5% in 1970 to the current 32.1%). A 2022 study found that each year of “increasing maternal age [increases] the odds of emergency [C-sections] by 6%” – and the average age of first-time mothers has been increasing steadily: from 21.4 in 1970 to 24.9 in 2000 to 27.3 years old today.

Regular OB/GYN appointments can help mitigate some of these risks. But almost half of all counties in the United States lack practicing OB/GYNs, leaving 8.2% of all women - or more than 10 million women - with little to no access to OB/GYNs and to tools, tests, and technologies such as ultrasounds. During their pregnancy, women will have at least two ultrasounds but will sometimes have more, depending on the risk level of the pregnancy. The ultrasounds confirm the number of embryos, show the baby’s sex, calculate the baby’s due date, and, as the pregnancy progresses, check for any abnormalities, such as in the baby’s heart rate or in its developing brain, limbs, organ, spine, and more.

Even if women do have access to the needed specialists and monitoring tools, they need to be physically in a doctor’s office or hospital to reap the benefits of those services: a privilege not all women can afford. A low-wage or hourly worker, for instance, may not be able to afford time off for OB/GYN appointments, and women generally - and Black and Latina women specifically - are disproportionately likely to be low-wage workers than (white) men are.

In contrast, Nuvo can help “provide care everywhere”: an underlying premise that is simple and yet is simultaneously a major advance in healthcare, according to Dr. Lawrence “Larry” D. Platt MD, who is one of the foremost maternal fetal medicine (MFM) specialists in the United States. Widely acclaimed, accoladed, and published, his affiliations include the Center for Fetal Medicine and Women's Ultrasound, the Department of Obstetrics and Gynecology at the David Geffen School of Medicine at UCLA, and Nuvo’s Advisory Board.

Nuvo’s FDA-cleared INVU™ solution provides that "care everywhere" and allows for non-invasive maternal heart rate, fetal heart rate, and uterine activity monitoring - without requiring a visit to a hospital or doctor’s office. Instead, during their clinician-prescribed timeframes, women can apply INVU™ while they’re at home or even at work, as Dr. Platt notes. The real-time data from these monitoring sessions allows their healthcare providers to assess the condition of the fetus and the urgency for delivery - especially in, though not limited to, women with high-risk conditions for whom American College of Obstetricians and Gynecologists (ACOG) guidelines recommend regular fetal monitoring. These conditions can include medical complications that can lead to abnormal fetal growth, diabetes, stillbirth, and more.

For example, women who have previously had a stillbirth have higher risks of having pregnancy complications and of having another stillbirth – and are, therefore, tested more frequently, require more monitoring and come to the hospital more frequently out of concern – than women who have had a live birth. They are also five times more likely to develop anxiety, more than four times more likely to have post-traumatic stress disorder, and two times more likely to have depression than women who have had a live birth. With INVU™, women can have a monitored session with their healthcare provider in the convenience of their home, office, and daily life rather than having to leave their work, leave their children, and/or generally go out of their way to a hospital. But they still have the benefits of remaining connected to their healthcare provider and having their pregnancy monitored – including tracking fetal movement, which one of the most inexpensive ways to prevent stillbirth – just as they would in that healthcare setting. “In this process [INVU™] alleviates anxiety in that one group of pregnant women, not to mention many others,” Dr. Platt concludes.

That INVU™ uses different sensor technologies (ECG and acoustic sensors) than the ones used in traditional pregnancy monitors in hospitals and doctors’ offices allows it both to be an additional source of data and monitoring to ultrasounds and to provide unique physiological insights into the health of the mother and baby. As long as women are wearing their device, their healthcare providers can interact with and evaluate them at any time or place.

In turn, INVU™ can provide information and achieve milestones that otherwise may not have been possible – much less appreciated by, accepted by, and advantageous for providers and patients – such as those seen in Israel’s Sheba Hospital. Sheba Hospital, also known as Tel HaShomer Hospital, is the largest hospital in Israel, the largest medical center in the Middle East, and one of the top 10 best hospitals in the world. In addition, it cares for more injuries caused by the war than all of Israel’s other hospitals combined.

After the attack on Israel on October 7, 2023, Sheba Hospital moved some of its patients out of the hospital to free up space and resources for those injured during the war. One of the wards it moved was for geriatrics. Another was for high-risk pregnancies: pregnant women who, due to medical complications, diabetes, a previous stillbirth or another reason entirely, were mandated to be in the hospital for continuous monitoring. Sheba Hospital sent those patients home and used INVU™ to monitor them instead: a decision that, as Mr. Klein explains, would have been impossible if Sheba Hospital hadn’t believed that Nuvo could provide medical care equivalent to that of the hospital itself. Now, several months into the war, Mr. Klein calls the operation a “phenomenal success”: groundbreaking both because of the scale of the operation and because the involved pregnant women maintained, or even improved, their health, despite this move from hospital to home. In one case, a mother at Sheba whose doctors thought she would give birth at 34 weeks didn’t give birth until 37 weeks: out of the premature birth range and to the benefit of the baby.

Nuvo’s success in high-risk mothers in Israel, as Mr. Klein observes, is representative of the benefits that Nuvo can provide, even in places that are not war-struck. “I believe that healthcare will change fundamentally when the patient says, ‘I want this,’” he says. Dr. Platt agrees, calling Nuvo “one of those innovations that will change care”. Nuvo’s INVU™ solution can be that care-changing, transformative tool that patients “want”. It can help address the issues of accessibility, cost, inequality, and risk that come with pregnancies without requiring only in-hospital monitoring: the same thesis that inspired the founding of Nuvo nearly ten years ago.

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ATLANTA, GA, USA, December 14, 2023 /EINPresswire.com/ -- In a major stride towards unraveling the complex links between racism and health disparities, Georgia State University has launched a multisite, NIH-funded study titled “Advancing understanding of racism-related health disparities beginning before birth.” Led by Dr. Sierra Carter, the pioneering study will utilize Nuvo’s FDA-cleared remote pregnancy monitoring platform in researching how racism-related stressors experienced by pregnant Black and Latina women impact maternal and fetal health and development.

This multisite study aims to break new ground by examining whether experiences of racism prenatally affect fetal health and development. This will be studied through exploring a process of “biological embedding” of racism measured daily during pregnancy, affecting the health trajectory of not only Black and Latina women but also their offspring. Georgia State University’s collaboration with Nuvo is central to this endeavor. Utilizing Nuvo’s INVU platform, a sophisticated maternal and fetal health monitoring technology, researchers will study maternal and fetal heart rate variability among 400 women in their third trimester of pregnancy. The participants will be assessed once a day for two weeks to gather comprehensive physiological data.

Dr. Carter and her team plan to correlate these heart rate measurements with the health outcomes of the mothers and their babies. The goal is to test the hypothesis that racism, as an enduring stressor, could critically influence the physiological processes of pregnant women and may extend its impact to the next generation through biological pathways.

“By integrating Nuvo’s INVU platform into our research design, we have the unprecedented opportunity to quantify the acute and chronic effects of racism,” Dr. Sierra Carter, Georgia State University principal investigator on the study, explains. “This partnership enhances our ability to measure what was previously intangible—capturing real-time data on how the stress of racial discrimination may be transferred from a mother to her child even before birth.”

Nuvo’s INVU platform, an advanced remote monitoring system, represents a leap forward in fetal and maternal medicine, enabling non-invasive, accurate, and user-friendly data collection. The technology allows for an in-depth analysis of heart rate patterns that may shed light on the health disparities faced by racial and ethnic minorities.

INVU has been used within research projects before, including other principal investigators on the study team, including Dr. Elisabeth Conradt and Dr. Sheila Crowell. Dr. Conradt and Dr. Crowell used INVU in the context of a separate NIH-sponsored trial that investigated the nature of emotion dysregulation within pregnancies. The study sought to understand how prenatal maternal distress is related to children’s health outcomes and used physiological measurements via INVU across more than 200 women in their third trimester of pregnancy to seek biomarkers and patterns.

“We are proud to partner with Georgia State University in this groundbreaking study. The racial disparities in maternal and fetal outcomes are unacceptable,” said Kelly Londy, Nuvo CEO. “Addressing maternal health inequities begins with understanding their origins and we hope this research provides insights on whether racial stressors can have intergenerational effects on mothers’ and babies’ health.”

This comprehensive research initiative, with its blend of rigorous scientific methodology and advanced technology, aspires to move beyond simply documenting disparities. It seeks to elucidate the pathways by which racism-related stress may become biologically ingrained, impacting birth outcomes and potentially predisposing infants to lifelong health challenges.

As Dr. Carter’s team at Georgia State University works closely with Nuvo to navigate this complex research terrain, the implications for public health could be far-reaching. This study holds the promise of informing more culturally sensitive and equitable healthcare practices, fostering early interventions, and ultimately contributing to the eradication of health disparities rooted in racial discrimination.

About Georgia State University
Georgia State University (GSU) is uniquely well-suited to support the GLOW study research. Founded in 1913, Georgia State is a public research university located in Atlanta, Georgia, the capital and largest city in the state, with a metropolitan regional population of more than 5.4 million. Atlanta provides a large and diverse population for conducting behavioral and clinical research. In recognition of GSU’s commitment to research, the State of Georgia has designated it as one of four research universities of the University System of Georgia. GSU is also classified as a Doctoral/Research Extensive University by the Carnegie Foundation for the Advancement of Teaching. GSU is the largest research institution of higher learning in the University System of Georgia. GSU has created a college and graduate school experience in a vibrant urban environment and has been ranked as a top public university for researchers.The Department of Psychology at Georgia State University also offers a rich environment for the GLOW research to thrive and for Dr. Carter and her team to engage in translational research work in multiple settings and systems.

About Nuvo
Nuvo is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning. For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

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Innovative collaboration between Sheba Beyond virtual hospital and Nuvo extends remote monitoring for high-risk pregnant patients to the home

TEL AVIV, ISRAEL, December 11, 2023 /EINPresswire.com/ -- In a groundbreaking healthcare initiative, Sheba Beyond, one of world’s first virtual hospitals, and Nuvo Group, a pioneer in remote pregnancy monitoring solutions, have accelerated their partnership to transform the care of high-risk pregnant patients in times of crisis and beyond. Amidst the challenges posed by the recent war in Israel on October 7th, this advancement in the partnership marks a significant breakthrough in prenatal care, particularly for patients requiring inpatient maternal and fetal monitoring.

Sheba Beyond has been utilizing remote monitoring technologies from Nuvo and other remote care solutions for over a year to monitor pregnant patients that would otherwise have to go back and forth to outpatient clinics, more conveniently. As Israel entered wartime, it became imperative to use creative solutions for even more aggressive remote care models, including de-hospitalizing high risk inpatients. Given Sheba’s existing experience with INVU, it called upon Nuvo to donate additional technologies to support its urgent need to reallocate critical resources to treat civilians and the wounded, while still providing exceptional care to pregnant patients.

The collaboration between Sheba Beyond and Nuvo Group highlights a new era in healthcare resilience, demonstrating the impact of remote pregnancy monitoring even in the most difficult circumstances. If these benefits can be achieved in times of war, it stands to reason the benefits will carry forward in times of peace.

The benefits of remote pregnancy monitoring Sheba Beyond have seen include:
• Clinical Accuracy delivered remotely: Real-time data collection allows for precise monitoring of fetal and maternal health indicators, gathered whilst the patient is comfortably at home, instead of admitted to the hospital for days or weeks on end..
• Resource Optimization: This technology has been instrumental in opening up hospital rooms and reallocating clinical staff to address critical needs during the war.
• Increased Efficiency: Remote monitoring allows for effective patient management with fewer resources, enhancing staff productivity and patient care quality.
• Potentially Improved Patient Outcomes: The comfort of home care reduces maternal stress levels, which may be directly linked to better pregnancy outcomes, including increased gestational age which is directly correlated with reduced NICU admissions. More data will be required to confirm whether there is a directly causal link.

Patients and clinicians have reported positive experiences with the Sheba Beyond remote hospitalization program. Patients have attributed remarkable improvements in their health outcomes to the program, including one patient who said: “I am confident that there is a direct connection between my being hospitalized on a hybrid basis, performing all the necessary pregnancy monitoring tests remotely through your monitoring belt, and the fact that my test results improved. I managed to maintain the pregnancy from week 32 to week 37 when the doctors were certain that I would need to be induced at week 34. Continue with your amazing work, and I believe that this service should be provided in every hospital in Israel and around the world.”

The program’s user-friendliness, even for those not technologically inclined, and its efficiency compared to traditional hospital-based monitoring systems have been particularly praised. Medical professionals have commended the system for its accurate and reliable data, along with the outstanding technical support provided by Nuvo, which has significantly improved the quality of prenatal care.

“Over the past year, we've harnessed state-of-the-art technologies to transform the maternity journey. In these difficult wartime conditions, the need for agility is paramount. Our partnership with Nuvo has been instrumental in swiftly establishing a home hospitalization system for our high-risk pregnancy patients. We designed the intense remote care protocol to deliver top-notch medical attention to our patients in the comfort and safety of their homes. Moreover, being together with their family and kids is especially crucial during times of alarms and the need to remain sheltered. We're excited about the prospect of further expanding this protocol, not just in times of conflict but also, hopefully soon, in periods of peace.,” said Dr, Avi Tsur, MD Director of OBGYN at Sheba Beyond and director of the Sheba Women’s Health Innovation Center.

This innovative approach by Sheba Beyond and Nuvo Group is not only redefining prenatal care in crisis situations but is also setting a new standard for high-risk pregnancy management globally.

“Nuvo is honored to be a part of such an innovative program under incredibly difficult circumstances,” said Kelly Londy, Nuvo CEO. “Nuvo strives to give life a better beginning every day, and the amazing work done by the teams at Sheba Beyond, ARC and Nuvo is truly inspiring. We look forward to continuing our work with Sheba through this crisis and beyond.”

About Sheba Medical Center
The largest and most comprehensive medical center in the Middle East, Sheba Medical Center, Tel Hashomer is generating global impact through its medical care, research and healthcare transformation. Sheba's City of Health boasts an acute-care hospital, rehabilitation hospital, research and innovation hubs, medical simulation center, as well as a center for disaster response on one comprehensive campus in the heart of Israel. Sheba BEYOND is the medical center's innovative virtual hospital, which offers a myriad of technological solutions for advanced patient care. For more information, visit: eng.sheba.co.il

About Nuvo
Nuvo is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies.

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Full press release available here.

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This letter to the AJOG editors was originally published November 7, 2023 here.

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To the Editors:

Upon reading the recent American Journal of Obstetrics & Gynecology publication—“Utilization of a wireless monitoring device to perform nonstress tests in high-risk pregnancies from home” by Hamm et al¹ from the University of Pennsylvania—I was struck by the alignment of their findings with our experience at Banner Health.

Banner Health is continuously committed to ensuring that every patient we serve in rural areas is provided with the same safe, high-quality perinatal care we administer to patients in more resourced urban, metro, or academic centers. Our telemedicine obstetrical programs are designed to address the limited access to obstetrics care in these rural areas. Many telehealth solutions in obstetrics do not address fetal monitoring. However, this emerging technology solves that problem.

In our endeavor to provide exceptional care and service to high-risk pregnancies, we integrated the INVU platform, monitoring patients during the past year. As we engaged in multiple sessions, a pattern of reliability and efficiency emerged, successfully obtaining an interpretable nonstress test (NST) in most appointments.

The use of the INVU platform was accompanied by a discernible improvement in visit compliance rates. Patients using INVU did not miss appointments because barriers to access to care were eliminated. Mirroring the study’s feedback, most of our patients have expressed a preference for the convenience and reassurance of remote NSTs.

The article’s conclusion, emphasizing INVU’s potential to address healthcare inequities and enhance perinatal outcomes, resonates deeply with Banner’s mission—“Making healthcare easier, so life can be better.” As a community of clinicians, recognizing and embracing these transformative innovations will be instrumental in shaping the future of maternal healthcare.

Thank you Hamm et al and AJOG for your unwavering dedication to pushing the boundaries of obstetrics and gynecology towards ongoing improvement. With platforms, such as INVU, I believe that we are on the cusp of a new era in maternal care, marked by safety, equity, and innovation.

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This research was published in the AJOG, June 9, 2023 here.

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Objective

The need for serial in-office nonstress tests (NSTs) adds substantial burden to high-risk pregnancies and exacerbates care disparities.INVU by Nuvo Group, Ltd, is a novel Food and Drug Administration-cleared, remote, self-administered maternal-fetal monitoring solution, previously validated for fetal and maternal heart rates and uterine activity measurements. Here, we sought to determine the clinical interpretability and usability of INVU to enable patients to perform NSTs from home.

Study Design

This was a prospective, open-label, single-site study of a wireless, remote pregnancy monitoring system (INVU by Nuvo Group, Ltd) in high-risk pregnancies to remotely perform clinically indicated NSTs instead of in-clinic NSTs. This study was approved by the University of Pennsylvania Institutional Review Board, and participants provided informed consent.

The INVU belt contains 8 biopotential and 4 acoustic sensors, which passively record abdominal signals (Figure, A). The monitoring system includes a Health Insurance Portability and Accountability Act–compliant mobile application that allows clinicians to view and interpret the NST and communicate with the patient in real time (Figure, B).

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We enrolled singleton pregnancies at ≥32 weeks of gestation with clinical indications for antenatal fetal surveillance, pregravid body mass indices (BMIs) of ≤50 and ≥15 kg/m², and Wi-Fi access. Exclusions were uncontrolled hypertension, major fetal anomaly, abdominal skin issues, or an implanted electronic device.

The primary outcome was whether the remote NST was deemed acceptable for clinical utility (interpretability). For the secondary outcomes, we evaluated reactivity rates among NSTs deemed clinically acceptable (reactivity) and the frequency and reason for recommending an in-clinic evaluation. Moreover, participants completed the validated System Usability Scale (SUS).

Descriptive analyses were performed using SAS (version 9.4; SAS Institute, Cary, NC).

Results

We enrolled 34 high-risk patients at a mean gestational age of 34.5±1.1 weeks and a BMI of 35.8±6.3 kg/m² from December 10, 2020, to March 6, 2022. Fetal testing indications included advanced maternal age (n=14), BMI of ≥40 kg/m² (n=11), gestational diabetes mellitus (n=10), chronic hypertension (n=3), antiphospholipid syndrome (n=2), and other (n=9).

Of note, 5 consented patients failed to complete device training. The remaining 29 patients had 131 qualifying remote NST sessions. INVU successfully obtained an interpretable NST in 93.9% of appointments (n=123), of which 98.3% (n=121) were deemed reactive. Patients avoided an in-office visit in 88.5% of visits. Only 2 appointments (1.5%) resulted in a recommendation for nonurgent delivery, both for elevated blood pressure and neither related to the NST tracing. Only 1 patient (2.9%) experienced mild, transient soreness at the sensor site without redness or bruising.

Of note, 23 patients (79.3%) who attempted at least 1 remote NST completed the SUS, with a mean score of 76.5 (±15.9) of 100.0, indicating “good” usability, with 22 patients (95.7%) agreeing they would prefer remote NSTs vs in-office testing in a future pregnancy. Further details and discussion are available in the Supplemental Materials and Methods.

Conclusion

In this prospective cohort study, >90% of NSTs performed remotely using INVU were acceptable for clinical utility, and >88% of NST appointments were completed without in-clinic evaluation. In addition, INVU demonstrated an excellent safety profile and good patient usability. Future research is warranted to determine how to best leverage this novel capability to address inequities in patient access and improve perinatal outcomes.

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Combination of clinical telehealth excellence & FDA-cleared remote monitoring platform provides a one-of-a-kind solution for next generation pregnancy care

The innovative offering from Nuvo & Ouma addresses critical gaps in pregnancy care journeys while maintaining the highest levels of medical care, allowing patients access when & where they need it.”— Kelly Londy, CEO of Nuvo Group

TEL AVIV, ISRAEL, December 13, 2022 /EINPresswire.com/ -- Nuvo Group (Nuvo), the creators of INVU by Nuvo™, an FDA-approved remote pregnancy monitoring platform, and Ouma Health (Ouma), a total maternity telehealth services company, today announced a strategic partnership to deliver an innovative joint solution that provides clinical excellence in maternity telehealth and FDA-cleared remote fetal surveillance technology. The joint solution is designed to address some of the biggest challenges in pregnancy care today, by enabling equitable access to care, improving preventative care delivery, and reducing high individual and system-level costs.

The joint solution is a “one-stop shop” for remote pregnancy care that includes:

● Innovative platform for remote patient monitoring (RPM) including FDA-cleared non-stress tests (NST), along with devices for diabetes and hypertension management
● 24/7/365 maternity telehealth clinical services available in all fifty US states, including access to maternal-fetal medicine specialists, midwives, perinatal nurse navigators, lactation consultants, and behavioral health specialists with expertise in perinatal mood disorders

Nuvo and Ouma were both founded with shared principles: building solutions based on clinical evidence, improving clinical outcomes, and increasing patients’ access to care and peace of mind. Nuvo’s FDA-cleared, clinically validated remote monitoring solution and Ouma’s network of telehealth clinicians extend medical-grade monitoring and highly trained maternity care experts to fit into patients’ lives and schedules.

“The innovative joint offering from Nuvo and Ouma addresses critical gaps in the pregnancy care journey while maintaining the highest levels of medical care and allowing patients access when and where they need it,” said Kelly Londy, CEO of Nuvo Group. “We are happy to work with Ouma to give employers, health systems, and payers the ability to impact areas of pregnancy care that need it the most.”

“An effective strategy aimed at improving maternity outcomes needs to include an early recognition system coupled with immediate access to expert care,” said Sina Haeri, MD, MHSA, CEO and co-founder of Ouma. “By combining a market-ready RPM solution with world-class clinical services, we aim to deliver the clinical care in the comfort of the patient’s home, saving the family unnecessary time commuting to appointments, absenteeism from work for routine visits, and most importantly, immediate access to expert care in case of clinical need for timely intervention.”

Self-insured employers, health systems, and payers can all benefit from adopting this new solution for the flexibility, scalability, and convenience it provides their organizations, patients, and members. More than half (54%) of counties in the United States offer very limited or no access to maternity care. Within these counties, more than 2.2 million women of child-bearing age live in full maternity care deserts – areas with no hospital offering obstetric care, no birthing center, or no obstetric provider. Additionally, 1-in-3 patients change insurance providers from preconception to postpartum, though this solution provides an important competitive advantage to improve member satisfaction, retention, and improved outcomes.

If you are interested in learning more about this joint solution, please reach out to info@nuvocares.com or info@oumahealth.com

About Nuvo Group
Nuvo Group Ltd. ("Nuvo") is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a variety of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020, 2022), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning.

For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

About Ouma Health
Ouma Health is a total maternity telehealth platform with the vision of expanding access to expert care for all pregnant individuals. Ouma leverages telehealth to provide access to expert maternity clinicians including Maternal-Fetal Medicine (MFM) physicians, midwives, perinatal nurse navigators, lactation specialists, and behavioral health specialists with expertise in perinatal mood disorders. Ouma clinicians are US-based, and licensed to practice medicine in all fifty states, and have the ability to diagnose and prescribe. Ouma was founded by a physician and is led by a seasoned team of telehealth operators and serves self-funded employers and state medicaid plans nationally.

For more information, visit: www.oumahealth.com.

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Full press release available here.

Sometimes problems are relative, sometimes they are absolute. In the United States, maternal mortality is both. As of April 2022, the U.S. ranked last among other high income nations for maternal mortality rates. In absolute terms, the U.S. maternal mortality rates trend up, year after year. Most notably, maternal mortality among black women is staggeringly high. In fact, black women are three times more likely to die from pregnancy related causes than their white counterparts in the U.S. These sobering stats are true despite the fact that the U.S. spends more than any other nation on in-hospital maternity care. Despite significant publicity, women continue to die needlessly in their quest to bring new life into the world. This must change.

Sadly, these trends are old news. From 1955 until 1985 maternal mortality in the United States decreased by 99 percent. This enormous public health victory halted after 1985. Since 1985 U.S. maternal mortality rates have trended steeply up. There is no consensus on why the U.S. fares so poorly compared to other developed nations - and even lags behind some underdeveloped countries. However, there is consensus around one thing - it is time to fix these trends and save women’s lives.

Albert Einstein said that if he had an hour to solve a problem he would spend 55 minutes thinking about the problem and five minutes thinking about the solution. There is no question that we are thinking about this problem. High-profile news outlets are publicizing this crisis. This year alone, CNN, ABC, and the Wall Street Journal all published prominent articles about maternal mortality and lack of care in the United States. These articles represent noble efforts to galvanize support to halt and reverse these painful trends. Our federal government has introduced no less than 26 bills to address maternal mortality. State governments have introduced even more than that. Celebrities like Serena Williams, Beyonce, Michelle Obama, and Kamala Harris have all been shouting from the mountaintops about the black maternal mortality crisis. Major entities like Optum, Merck, and the Wilson Center all dedicate enormous resources to publicizing and understanding the maternal mortality problem.

No doubt, publicity, funding, and legislation like this is good. But the harsh reality is that elevating the profile of maternal mortality is only good if it induces action. We are heeding Albert Einstein’s advice - sort of - by spending time and resources on the problem. Einstein’s quote implies, however, that those 55 minutes should be dedicated to really digging into the roots of the problem, why it exists, and how it came to be. That we have not done.

Unless and until we move from awareness to action, we will not reverse these harrowing trends. We owe it to women to value their lives and the lives of their babies enough to find a new way of thinking about maternal mortality.

To solve this problem we need to focus on three things:

• Interest
• Investment
• Innovation
  

Interest

Given the publicity mentioned earlier, calling for more interest may seem counterintuitive. Yet, even with all of the publicity and attention, the U.S. population generally, and the medical/public health community specifically, does not focus on maternal mortality in the United States. Other than Merck, there are no Fortune 500 companies that devote their charitable dollars towards maternal mortality improvements. Sure, giants like Walmart, Target, Medtronic, Genentech, State Farm, Best Buy, and Accenture have teamed up to create the Black Community Innovation Coalition. But maternal/fetal health is only a small subset of this effort. While black maternal mortality is an outsized problem compared to maternal mortality for other demographics, focusing exclusively on the problem for black women does not address the problem for everyone. In short, most of Corporate America is not yet focused on fixing this problem.

There is also a dearth of interest from the public generally. As former Congressman and Obstetrician, Phil Gingrey, points out, “more must be done; more coordination, more dedication, and more dollars.” This issue cannot be solved until Americans across the map recognize the problem and demand change from their representatives, corporations, and doctors.

Investment

Interest is necessary but not sufficient. Maternal health needs investment. In 2016, pregnancy and postpartum care cost private insurers $52.8 billion - making it the third highest cost condition in the United States. However, conditions like diabetes and back/neck pain impact far more people than pregnancy at any given moment in time. Much of that $52.8 billion dollars could be saved with more investment into new innovations and technologies for prenatal care.

Investment trends for FemTech are, admittedly, good. VC funding for FemTech between 2015-2021 went from $600 million to $1.9 billion. Even with this increase, FemTech and maternal care is still sorely underfunded. Just 2% of medtech funding goes towards non-cancer related women’s conditions. The trends are in maternal care’s favor. We have reason to be hopeful. But there is still a large gap between the need in the market and the funding to scale solutions. We urgently need passionate and brave investors to see the massive opportunity that exists to modernize pregnancy care and get in on the ground floor of new maternal health technology that opens access, utilizes telemedicine, and changes standards of care.

Innovation

Finally, we must see innovation in this space. Obstetric ultrasound was created in 1956. In the 1970’s OB ultrasound exploded as the standard of care. But the 1970’s were the beginning and the end of significant technological innovation in maternal care. In the last 50 years, image quality has improved but there has been virtually no significant technological change for maternal care. Doctors still use 40 year old technology to measure and examine pregnant mothers and their fetuses. But there is hope and we are on the cusp of a revolution.

Technologies like Nuvo’s remote maternal-fetal monitoring, PulseNmore’s remote OB ultrasound, and Ouma Health’s telemedicine network will change not just how women are treated, but also who can access excellent care. Until these, and other innovations are created, approved, and adopted at scale, we cannot change the status quo of maternal morbidity and mortality in the U.S. Once real changes in interest, investment, and innovation happen, more mothers will get to see their beautiful babies grow and thrive. The time has come to make this a reality.

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This article was published in collaboration with Andrea Wolf on LinkedIn.

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