Following Nuvo’s NASDAQ Listing, Addition of Machado Brings StrongHealth and Impact Experience to Remote Pregnancy Monitoring Pioneer

TELAVIV, Israel – May 9, 2024 – Holdco Nuvo Group D.G Ltd (NASDAQ: NUVO)(“Nuvo”), a pioneer in remote pregnancy monitoring, today announced the expansion of its board of directors with the addition of Adriana Machado, who will help guide Nuvo’s mission of addressing health disparities and social determinants of care through its advanced pregnancy monitoring technology.

“We are delighted to welcome Adriana to Nuvo’s board,” said Rice Powell, CEO of Nuvo. “She will provide a substantial health innovation perspective and female leadership that supports our mission. Adriana is also a true advocate for transformation and health equity, and we look forward to working with her to expand our efforts and market impact.”

Machado brings three decades of experience in business leadership, strategic planning and international relations. A celebrated business leader in Latin America, she was the first female CEO of GE Brazil, and is Founder of the Briyah Institute, aBenefit Corporation (B Corp) that ignites leaders to transform organizations by applying systems thinking to business. Ms. Machado holds board positions with various health and civil society organizations and, in 2013, was recognized by Forbes as one of the 10 most powerful businesswomen in Brazil.

"I am excited to join Nuvo’s board of directors at such a pivotal time in the Company's development,”said Adriana Machado. “I look forward to bringing my experience of the international health innovation landscape to help the Company improve access to care for expectant mothers across the globe.”

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About Nuvo

Nuvo is leading a transformation in pregnancy care by providing clinicians and expectant mothers with access to medically-necessary remote pregnancy monitoring anytime, anywhere. Nuvo’s INVU™ platform is an FDA-cleared remote pregnancy monitoring and management system. It enables the delivery of remote non-stress tests(NSTs) and maternal and fetal heart rate monitoring, while pioneering new data-driven personalized pathways that Nuvo believes can improve future health outcomes. INVU is being used by leading health providers and research institutions across the US and Israel. Nuvo plans to continue to expand the footprint of sales in the US andIsrael and plans to introduce its INVU platform in Europe in 2024, subject to granting of the CE mark it filed in Europe in March 2023, to provide remote access and insights not previously deemed possible. Nuvo is led by a diverse team of experienced business, medical and technology leaders, united in the mission of breaking down barriers to pregnancy care to give every life a better beginning. For more information and complete indications, contraindications, warnings and precautions, and instructions for use, visit www.nuvocares.com.

Forward-LookingStatements

Certain statements contained in this press release may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of1995, Section 27A of the Securities Act and Section 21E of the Exchange Act.Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,”“likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) the possibility that other anticipated benefits of the business combination will not be realized; (ii)changes in general economic and/or industry specific conditions; (iii) the ability of Nuvo to retain, attract and hire key personnel; (iv) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the completion of the business combination;(v) legislative, regulatory and economic developments; (vi) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and any epidemic, pandemic or disease outbreak (including COVID-19), as well as management’s response to any of the aforementioned factors; and (vii) other risk factors as detailed in the registration statement(File No: 333-274803) on Form F-4 filed by Nuvo with the SEC in connection with the business combination and the prospectus/proxy statement contained therein, as well as those risk factors detailed from time to time in Nuvo’s reports filed with the SEC, including its Annual Report on Form 20-F and other documents filed with the SEC. The foregoing list of important factors is not exhaustive. Except as required by applicable law, Nuvo does not undertake any obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

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This article originally appeared on HIT Consultant: https://hitconsultant.net/2024/05/06/femtech-nuvo-goes-public-to-expand-remote-pregnancy-monitoring/

FemTech: Nuvo Goes Public to Expand Remote Pregnancy Monitoring

by Jasmine Pennic 05/06/2024

What You Should Know:

– Nuvo Group D.G. Ltd. (NASDAQ: NUVO) (“Nuvo”), a leader in remote pregnancy monitoring, today announced the successful completion of its business combination with LAMF Global Ventures Corp. I (NASDAQ: LGVC, LGVCU, LGVCW) (“LAMF”), a publicly traded special purpose acquisition company (SPAC).

– As part of the business combination, Nuvo will retain its name and existing management team, trading on the NASDAQ under the ticker symbol “NUVO” starting May 2nd, 2024.

Transforming Pregnancy Care with INVU™

Nuvo’s innovative INVU™ platform addresses health disparities by providing expectant mothers with accessible, high-quality prenatal care. This FDA-cleared system utilizes wearable technology, artificial intelligence (AI), and machine learning to empower both patients and healthcare providers with real-time insights into maternal and fetal health.

Key Features and Benefits of INVU™:

• Physician-prescribed and FDA-cleared
• Enables remote fetal non-stress tests (NSTs) for improved accessibility
• Reduces burdens on healthcare staff
• Provides real-time data for better clinical decision-making
• Utilizes a wearable band and mobile app for data collection
• Streamlines data processing and transmission for clinicians

Business Combination Benefits

This business combination allows Nuvo to tap into capital markets for:

• Expanding commercial operations in the US and Israel
• Fueling international expansion, including European market entry in 2024 (pending CE mark approval)
• Accelerating the development of its innovative pipeline

“Nuvo is committed to solving the inherent problems of a broken pregnancy care system by enabling access to quality care with advanced remote monitoring technology,” said Rice Powell, CEO of Nuvo. "Becoming a public company provides us with the resources to redefine pregnancy care and address health disparities by ensuring that all expectant mothers can receive timely and accurate care, regardless of their background or location.”

This article originally appeared on Femtech Insider: https://femtechinsider.com/nuvo-lamf-global-ventures-public/

Remote Pregnancy Monitoring Company Nuvo Goes Public Through Merger with LAMF Global Ventures

By Femtech Insider Maternal Health, Medical Device, News May 2, 2024

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Nuvo Group, a remote pregnancy monitoring company, has reached a significant milestone by finalizing its business combination with LAMF Global Ventures, transitioning into a public company listed on NASDAQ under the ticker symbol NUVO.

At the heart of Nuvo’s platform lies its INVU platform, an FDA-cleared pregnancy monitoring and management system that harnesses wearable technology, AI, and machine learning. INVU empowers both patients and healthcare providers by offering real-time insights into maternal and fetal health, thus bridging geographical gaps and ensuring access to quality care for expectant mothers.

The platform facilitates remote fetal non-stress tests (NSTs) conducted by clinicians, eliminating access barriers, reducing staffing burdens, and providing comprehensive data for informed decision-making. Through a wearable band and mobile app, INVU captures vital maternal and fetal parameters like heart rates and uterine activity signals, which are processed in the cloud and transmitted instantaneously for clinician evaluation.

“Nuvo is committed to solving the inherent problems of a broken pregnancy care system by enabling access to quality care with advanced remote monitoring technology,” said Rice Powell, CEO of Nuvo. “Becoming a public company provides us with the resources to redefine pregnancy care and address health disparities by ensuring that all expectant mothers can receive timely and accurate care, regardless of their background or location.”

The business combination, which was approved at a special meeting of LAMF’s shareholders, held on April 1, 2024 and at an extraordinary general meeting of Nuvo shareholders on March 1, 2024, will enable Nuvo to access capital markets to fuel commercial growth, international expansion, and expedite its innovation pipeline.

Nuvo’s INVU platform, already in use by leading healthcare providers and research institutions in the US and Israel, aims to extend its footprint across Europe in 2024, subject to regulatory approvals.

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This was originally published via PRNewswire here.

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Remote Pregnancy Care Innovator Nuvo Group Ltd. Becomes Public Company Through Completion of Business Combination with LAMF Global Ventures Corp.

NEWS PROVIDED BY

Nuvo Group Ltd.

May 01, 2024, 16:30 ET

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Nuvo Solves Inherent Problems of Access to Quality Pregnancy Care With Advanced FDA-Cleared Pregnancy Monitoring and Management Platform

Company Will Begin Trading on NASDAQ Under Ticker Symbol NUVO as of Thursday May 2, 2024

TEL AVIV, Israel and LOS ANGELES, May 1, 2024 /PRNewswire/ -- Holdco Nuvo Group D.G Ltd (NASDAQ: NUVO) ("Nuvo"), a pioneer in remote pregnancy monitoring, today announced completion of its business combination with LAMF Global Ventures Corp. I (NASDAQ: LGVC) (NASDAQ: LGVCU) (NASDAQ: LGVCW) ("LAMF"), a publicly traded special purpose acquisition company and Nuvo Group Ltd. The combined company will retain the Nuvo name, along with its existing management and operational structure. The company's shares will be listed on NASDAQ under a new ticker symbol (NUVO) as of Thursday, May 2, 2024.

Nuvo is addressing health disparities and breaking down barriers to accessing quality pregnancy care with INVU™️, an advanced pregnancy monitoring and management platform. INVU harnesses wearable technology, AI and machine learning to empower patients and healthcare providers with real-time, actionable insights into maternal-fetal health.

The physician-prescribed, FDA-cleared platform enables clinicians to conduct fetal non-stress tests (NSTs) with patients anywhere, improving accessibility to care, reducing staffing burdens and enhancing the quality and depth of information available for decision-making. The wearable band and mobile app capture maternal and fetal heart rates and uterine activity signals, which are processed in the cloud and transmitted in real-time for clinician interpretation.

The combined company will be led by Nuvo's chief executive officer Rice Powell, a 40-year industry veteran with a proven record for meeting consumer health needs while satisfying payor and provider requirements. Rice is the former CEO and Chairman of the Management Board of Fresenius Medical Care, a dual listed company on the Frankfurt and New York stock exchanges, and a leading global provider of kidney dialysis products and services. He has held several senior leadership positions at Fresenius Medical Care, as well as senior positions at Biogen Inc. and Baxter International Inc. Rice was appointed to Nuvo's Board of Directors in September 2023.

"Nuvo is committed to solving the inherent problems of a broken pregnancy care system by enabling access to quality care with advanced remote monitoring technology," said Rice Powell, CEO of Nuvo. "Becoming a public company provides us with the resources to redefine pregnancy care and address health disparities by ensuring that all expectant mothers can receive timely and accurate care, regardless of their background or location."

The business combination, which was approved at a special meeting of LAMF's shareholders, held on April 1, 2024 and at an extraordinary general meeting of Nuvo shareholders on March 1, 2024, will enable Nuvo to access capital markets to fuel commercial growth, international expansion, and expedite its innovation pipeline.

Nuvo was represented on the business combination by Greenberg Traurig and Meitar, and LAMF was represented by White & Case and Herzog Fox & Neeman.

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About Nuvo

Nuvo is leading a transformation in pregnancy care by providing clinicians and expectant mothers with access to medically-necessary remote pregnancy monitoring anytime, anywhere. Nuvo's INVU™ platform is an FDA-cleared remote pregnancy monitoring and management system. It enables the delivery of remote non-stress tests (NSTs) and maternal and fetal heart rate monitoring, while pioneering new data-driven personalized pathways that Nuvo believes can improve future health outcomes. INVU is being used by leading health providers and research institutions across the US and Israel.  Nuvo plans to continue to expand the footprint of sales in the US and Israel and plans to introduce its INVU platform in Europe in 2024, subject to granting of the CE mark it filed in Europe in March 2023, to provide remote access and insights not previously deemed possible. Nuvo is led by a diverse team of experienced business, medical and technology leaders, united in the mission of breaking down barriers to pregnancy care to give every life a better beginning. For more information and complete indications, contraindications, warnings and precautions, and instructions for use, visit www.nuvocares.com.

Forward-Looking Statements

Certain statements contained in this press release may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act, including statements regarding the Business Combination involving LAMF, Nuvo and Holdco, and the ability to consummate the Business Combination. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) the possibility that other anticipated benefits of the Business Combination will not be realized, and the anticipated tax treatment of the Business Combination; (ii) the risk that shareholder litigation in connection with the Business Combination or other settlements or investigations may affect the timing or occurrence of the Business Combination or result in significant costs of defense, indemnification and liability; (iii) changes in general economic and/or industry specific conditions; (iv) possible disruptions from the Business Combination that could harm Nuvo's business; (v) the ability of Nuvo to retain, attract and hire key personnel; (ix) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the completion of the Business Combination; (vi) legislative, regulatory and economic developments; (vii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and any epidemic, pandemic or disease outbreak (including COVID-19), as well as management's response to any of the aforementioned factors; and (viii) other risk factors as detailed in the registration statement (File No: 333-274803) on Form F-4 filed by Holdco with the SEC in connection with the Business Combination and the prospectus/proxy statement contained therein, as well as those risk factors detailed from time to time in Nuvo's reports filed with the SEC, including its Annual Report on Form 20-F and other documents filed with the SEC. The foregoing list of important factors is not exhaustive. Except as required by applicable law, Nuvo does not undertake any obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

No Offer or Solicitation

This press release is for informational purposes only and is neither an offer to purchase, nor a solicitation of an offer to sell, subscribe for or buy any securities or the solicitation of any vote in any jurisdiction pursuant to the Business Combination or otherwise, nor shall there be any sale, issuance or transfer or securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom, and otherwise in accordance with applicable law.

CONTACTS:

Investor Relations Contact
Nuvo Group
Ryan Kraudel
ryan.kraudel@nuvocares.com

Media Relations Contact
FINN Partners for Nuvo Group
Danny Sudwarts
danny.sudwarts@finnpartners.com
(+1) 469-297-2515

Photo - https://mma.prnewswire.com/media/2402997/Nuvo_Group_Ltd_1.jpg

SOURCE Nuvo Group Ltd.

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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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‍Powell is a Proven Multinational CEO & Business Builder Known for Addressing Consumer Health Needs While Addressing Payer, Policymaker & Provider Priorities

TEL AVIV, ISRAEL, February 12, 2024 /EINPresswire.com/ -- Nuvo Group Ltd. (“Nuvo”), an FDA-cleared leading innovator in pregnancy care, announced today that Rice Powell assumed the position of Chief Executive Officer (CEO) as Kelly Londy departs after accepting a leading position at a non-competitive multinational healthcare company. Powell will lead Nuvo into its commercial phase and Nasdaq public market listing and continue as a member of the Nuvo Board of Directors and chair of its Finance Committee. Londy remains connected to Nuvo and joins the Company’s Strategic Advisory Council.

“We extend our congratulations and appreciation to Kelly Londy, who shepherded Nuvo successfully for the past 2.5 years and brought us through the regulatory process and preparations to become a public company,” said Jerry Ostrov, Nuvo Board Chair. “The combination of Kelly and Rice has been formidable, and we have been fortunate to have them both as we prepare to go public.”

“Rice has an ideal background and experience to lead Nuvo toward anticipated commercial growth and public market performance,” added Ostrov. “As the chief executive at Fresenius Medical Care, he was both a leader and a strategist in building Fresenius Medical Care into a company with $20 billion in revenue. We believe he can rally a business community and meet with influential community leaders to educate them on patient care urgencies and tackle health care disparities. Rice and Kelly will work closely together in the coming weeks for a smooth transition. We believe Kelly put our success in motion, and Rice will accelerate our momentum.”

Rice Powell has experience in addressing consumer care, health professional, payer, and policymaker priorities. He is a former chief executive officer and chairman of the Fresenius Medical Care management board, one of the world’s largest providers of products and services for people with chronic kidney failure. He held other executive positions at Fresenius as Vice Chairman of the management board for the North American region from 2010 to 2012 after Rice joined Fresenius Medical Care in 1997. He was appointed to the company’s management board and co-chief executive officer of Fresenius Medical Care North America in 2004. Powell, with 40 years of experience in the industry, has held several senior positions with Baxter International Inc. and Biogen Inc. in the United States. He has been a member of the Nuvo Board of Directors since September 2023.

“The need of the market to provide accurate and timely care for women with a wide range of pregnancy monitoring needs and concerns is great,” said Powell. “In the United States, not everyone has timely access to their health professional, with nearly 36 percent of U.S. counties lacking hospitals providing obstetric care, birth centers, an OB/GYN or certified nurse midwife. Some women have higher-risk pregnancies, while others live in more remote, rural areas or face the challenges of health disparities. We maintain our responsibility to physicians, pregnant women, their families, and the potential they carry within to champion people’s health. I have confidence in the Nuvo Board of Directors and our company leaders and staff, and I look forward to guiding us as we commercialize the INVU platform.”

“We are fortunate to have a leader as experienced as Rice as we begin to commercialize our product and the anticipated consummation of our go-public transaction,” said Ostrov. “We believe our entire board has appropriate expertise across the marketing and public market continuum to guide Nuvo into the future successfully. We thank Kelly for her outstanding performance in establishing the Nuvo commercial growth phase infrastructure.”

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 and fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve future health outcomes for all expectant mothers and unborn babies. The technology and patent estate that underpin the INVU platform has been awarded several 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 several 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, and instructions for use, visit www.nuvocares.com.

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Full press release available here.

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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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