PLEASANTON, Calif., May 23, 2025 /PRNewswire/ -- Movano Health (Nasdaq: MOVE)(the "Company") announced today that it received a notice (the "Notice") from the Listing Qualifications Department of the Nasdaq Stock Market ("Nasdaq") indicating that because the Company had not yet filed its Form 10-Q for the quarterly period ended March 31, 2025 (the "Form 10-Q"), the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) (the "Listing Rule") requiring Nasdaq-listed companies to timely file all peri ...

PLEASANTON, Calif., May 16, 2025 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, announced today that its Board of Directors has initiated a process to explore strategic alternatives, including a sale, merger or similar transaction involving the Company, to maximize shareholder value.  To support this process, Movano Health's Board of Directors has engaged Aquilo Partners as its financial advisor and K&L Gates LLP as its legal counsel.There can be no assurance that this process ...

Product Launch and Features - Movano Inc. launched the Evie Ring, a wearable device for women, in November 2023, designed to provide health and wellness metrics without FDA premarket clearances[17]. - The Evie Ring tracks various health metrics including resting heart rate, HRV, SpO2, and menstrual symptom tracking, aiming to help women make proactive lifestyle changes[18]. - The EvieMED Ring's FDA clearance positions it as a unique offering in the market, combining both hardware and software approvals[44]. - The EvieMED Ring is expected to enhance clinical-level confidence in monitoring capabilities, making it appealing to healthcare providers and facilities involved in clinical trials[214]. - Movano is developing a patented SoC for blood pressure and CGM systems, aiming to create wearables that can monitor glucose non-invasively and blood pressure without a cuff[215]. - The goal is to bring a Class II FDA-cleared device to market that includes CGM and cuffless blood pressure monitoring capabilities[215]. Regulatory Approvals and Compliance - In November 2024, Movano received FDA 510(k) clearance for the pulse oximetry feature in the EvieMED Ring, enabling its use in clinical trials and remote patient monitoring[19]. - The Evie Ring is classified as a general wellness device and does not require FDA premarket clearance, while EvieMED is a medical device requiring FDA clearance[56]. - The company plans to seek FDA clearance for additional monitoring capabilities and a continuous glucose monitoring (CGM) solution, which may face regulatory challenges[140]. - The typical duration to receive a 510(k) clearance is approximately nine to twelve months, while PMA approval can take about two years[141]. - Regulatory compliance costs could adversely affect the company's financial results, especially if new laws impose additional obligations[148]. - The company must comply with healthcare regulations, including the federal Anti-Kickback Statute, which could expose it to substantial penalties if violated[156]. Financial Performance and Projections - As of December 31, 2024, the company had an accumulated deficit of approximately $148.1 million and expects losses to continue for the foreseeable future due to significant investments in product commercialization and R&D[98]. - The company had total assets of approximately $11.3 million and total liabilities of approximately $4.0 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[99]. - The company may need to raise additional capital under unfavorable terms, resulting in substantial dilution for existing shareholders[164]. - The company has not paid dividends in the past and has no immediate plans to do so, intending to reinvest all earnings to develop technology and cover operating costs[183]. Market Demand and Competition - Demand for continuous glucose monitors (CGMs) is increasing, with approximately 9 million users worldwide and industry sales estimated at over $6.3 billion in 2023[27]. - The blood pressure monitoring device market is projected to reach approximately $5.0 billion in 2024, indicating a growing demand for non-invasive solutions[31]. - The company faces intense competition in the technology industry, particularly in the wellness, continuous glucose monitoring, and blood pressure monitoring markets, from established players like Apple, Samsung, and DexCom[78][79][80]. - The company may face increased competition from other companies utilizing AI technologies, which could adversely affect its business and financial condition[124]. Strategic Partnerships and Distribution - The company plans to sell products directly to consumers and enterprise customers through its website and retail channels, and to partner with OEMs and VARs to enhance product distribution[76]. - The company has formed a strategic partnership with a leading specialty foundry to strengthen its supply chain for manufacturing and supplying integrated circuits (ICs)[77]. - The company is exploring new distribution channels for the EvieMED Ring, including partnerships with healthcare institutions and durable medical equipment distributors[139]. Intellectual Property and Technology Risks - The company owns 32 issued patents and has exclusive rights to 5 pending U.S. patent applications as of December 31, 2024[54]. - The company may face challenges in protecting its intellectual property, as competitors may develop similar technologies or challenge its patents[128]. - The company relies on unpatented proprietary technology and trade secrets, and any unauthorized disclosure could harm its competitive position[129]. - The company may incur significant costs and distractions from potential intellectual property litigation or administrative proceedings[131]. Employee and Operational Considerations - The company has 32 full-time employees as of December 31, 2024, and focuses on recruiting and retaining talent to support its business strategy[84][85]. - The company’s ability to attract and retain qualified personnel is critical for executing its business strategy, but competition for skilled workers is intense[108]. Cybersecurity and Risk Management - The company operates in sectors subject to various cybersecurity risks, including intellectual property theft and fraud, and has implemented a risk-based approach to manage these threats[193]. - The board of directors oversees cybersecurity risk management and employs third-party consultants to maintain security controls[195]. - The company has not identified any cybersecurity threats that have materially affected its business strategy or financial position as of the report date[197]. Stock Performance and Market Listing - The company's stock price fluctuated between a high of $12.45 and a low of $3.01 in the twelve-month period ended December 31, 2024, adjusted for a 1-for-15 reverse stock split[173]. - On November 14, 2023, the company was notified by Nasdaq that it no longer met the minimum bid price requirement of $1.00 per share for continued listing[177]. - The company completed a 1-for-15 reverse stock split on October 29, 2024, and regained compliance with Nasdaq's minimum bid price requirement on November 12, 2024[178]. - Any future failure to satisfy Nasdaq's listing requirements could lead to delisting, negatively impacting the stock price and liquidity[178].

Core Insights - Movano Health has announced new features for the Evie Ring's companion app, enhancing support for women's wellness journeys through data personalization and trend tracking [1][2] - The Evie Ring is priced at $269 with no subscription fees, making it accessible for users, and is eligible for HSA/FSA reimbursement [2] Product Features - Integration with Apple Health allows automatic import of Evie data, enabling users to view information from both platforms in one location [5] - The app now includes 7- and 30-day trend graphs for sleep metrics, helping users understand their health patterns over time [5] - Daily basal body temperature logging has been added to assist users in tracking their menstrual cycles [5] - Heart rate mapping provides a visual representation of users' heart rates throughout the day, categorized by activity levels [5] - The expansion of workout tracking allows users to manually log past workouts, ensuring they receive credit for calories burned [5] - The Daily Summary home screen now includes menstrual cycle day and phase, enhancing the app's one-stop value for tracking health metrics [5] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearables [3] - The company's Evie and EvieMED devices aim to deliver trusted health data and personalized insights to users [3]

Core Insights - Movano Health has initiated a clinical trial for its new cuffless blood pressure wrist wearable, aiming to enhance signal fidelity and monitor various vital signs [1][2] - The trial will involve at least 70 participants and is expected to be completed by mid-February 2025, comparing the new device's data with that from a hospital-grade blood pressure device [1][2] - The company has previously conducted three clinical trials in late 2024 and 2023, gathering data from over 60 participants to refine its technology [2] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through innovative wearable devices [3] - The company's products aim to deliver comprehensive health data and personalized insights to users, enhancing proactive health management [3][4] - Movano Health is committed to advancing its proprietary technologies to improve health outcomes across diverse patient populations [4]

Event Overview - The 8th edition of "Italy on the Move" will be hosted by the Italian Trade Agency (ITA) and the Ministry of Foreign Affairs and International Cooperation during the 43rd annual J P Morgan Healthcare Conference 2025 [1] - The event aims to promote investment opportunities in Italy's €270 billion life sciences sector, including biotech, healthcare, medical devices, and pharmaceuticals [1] - It will take place at INNOVIT, San Francisco's Italian Innovation and Culture Hub, on January 15, 2025, starting at 5:00 PM [1] Key Speakers and Participants - Opening remarks will be delivered by the Ambassador of Italy to the U S, H E Mariangela Zappia, and the Consul General of Italy in San Francisco, Sergio Strozzi [2] - Mauro Battocchi, Director General for the Promotion of the Italy System, will provide an overview of the Italian life sciences ecosystem [3] - A panel discussion titled "Navigating Transatlantic Partnerships in Life Sciences" will be moderated by Audrey Greenberg, Founder of the Center for Breakthrough Medicines and CEO of AG Capital Advisors [3] - Five Italian startups—Aavantgarde, Butterfly Decisions, Cellply, Medlea, and Sibylla Biotech—will present pitch presentations [4] Italian Life Sciences Sector Highlights - The Italian life sciences sector has a turnover of €270 billion, equivalent to 11% of the country's GDP [3] - Italy ranks 1st among EU economies in pharma CDMO manufacturing value and 4th worldwide in patents productivity in Life Sciences [3] - Nearly 50 life science multinationals have established production and R&D bases in Italy [3] - Pharmaceuticals and medical devices are the third most significant Italian export globally, surpassing iconic "Made in Italy" goods like apparel and wines [3] Event Objectives and Opportunities - The event serves as a platform for U S healthcare companies and investors to meet Italian companies for partnerships or investments [3] - It highlights Italy's potential as a competitive hub for international scientists, researchers, companies, and investors in the life sciences sector [3] - The event will showcase innovative SMEs and startups, offering opportunities for collaboration and investment [3] About the Organizers - The Italian Trade Agency (ITA) is a government agency that promotes the globalization of Italian firms and facilitates economic and trade relations with foreign countries, focusing on SMEs and partnerships [5] - INNOVIT, the Italian Innovation and Culture Hub, is a strategic initiative by the Italian Government to connect Italian innovative companies and startups with Silicon Valley and U S ecosystems [6]

Core Insights - Movano Health has launched EvieAI, the first wearable-based virtual wellness assistant trained exclusively with data from medical journals, enhancing the Evie smart ring for women [1][3] - The EvieAI feature allows users to receive personalized health responses based on their individual health metrics captured by the ring's sensors [2] - EvieAI ensures data accuracy by utilizing information from over 100,000 medical journals, differentiating it from general-purpose digital assistants [3] Product Features - The Evie smart ring is designed to accommodate daily fluctuations in finger size, ensuring a comfortable fit, and has a battery life of over 4 days, recharging in 60 minutes [5] - The ring is available in gold, rose gold, and silver finishes, with sizes ranging from 5 to 12, and is priced at $269 with no subscription fees [5] - The beta version of EvieAI is currently available for iOS users at no cost for existing Evie Ring customers [6] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearable technology [7] - The company aims to proactively monitor and manage health outcomes across various patient populations using its proprietary technologies [8]

Core Insights - ERA Real Estate has launched a new marketing campaign titled "It's time to move up" to enhance its brand promise to agents and consumers [1][3] - The campaign is based on research findings and highlights the brand's 99% recommendation rating, positioning its agents as community experts [2] Marketing Strategy - The campaign commenced in November 2024 with a focus on social media platforms such as Facebook, Instagram, and LinkedIn, allowing local brokers and agents to customize content [3] - Key elements include user-generated content capturing "MoveUpMoments" that reflect personal experiences and transformations related to moving [3] Brand Performance - As of October 2024, traffic to ERA.com has increased by 131% year-over-year, and leads from the site have risen by 68% [4] - TextERA has emerged as the leading source of leads for the brand [4] Leadership and Organizational Changes - The campaign coincides with a period of growth and leadership changes, including Alex Vidal's appointment as president in June 2023, focusing on collaborative culture and brand pride [5] - Gino Caropreso was brought in as vice president of learning, leading to a nearly 300% increase in engagement with online learning resources since February 2024 [6] Market Expansion - Frank Malpica has been appointed as senior vice president of franchise development, focusing on expanding the ERA brand in various markets [7] - 55% of ERA brokerages have been with the brand for over 20 years, indicating strong retention [7] Marketing Team Enhancements - David Marine has taken the lead on marketing efforts, supported by Erin LeBan and Leah Wright, to elevate the brand's marketing approach and consumer messaging [8] Company Overview - ERA Real Estate operates a network of over 43,000 affiliated brokers and approximately 2,400 offices across the U.S. and 39 other countries [10]

Core Insights - Movano Health has received FDA 510(k) clearance for its EvieMED Ring, which opens up a total addressable market (TAM) of $40 billion in healthcare B2B opportunities [1][2] - The EvieMED Ring is designed to provide clinical-grade health monitoring solutions for applications such as clinical trials and remote patient monitoring, targeting pharmaceutical companies, medical device manufacturers, and payors [2][3] Company Developments - The company is currently in the agreement phase with a large payor for a pilot study related to high-risk populations, expected to commence in early 2025 [2] - Movano Health is also in discussions with a global pharmaceutical company and a leading clinical research organization (CRO) for the use of the EvieMED Ring in upcoming clinical trials [2] - The EvieMED Ring has been selected for a study at MIT focusing on long COVID and chronic Lyme disease [2] Product Features - The EvieMED Ring combines the accuracy of a medical device with the comfort of a wearable, addressing shortcomings of conventional pulse oximeters [3] - It measures blood oxygen levels and heart rate, while also collecting wellness metrics such as sleep, activity, temperature variability, calories burned, and respiration rate [4] - The device is available in eight sizes to accommodate a wide range of patients [4] Future Plans - Movano Health aims to accelerate the distribution of the EvieMED Ring and is looking to secure additional FDA clearances for other health metrics [3] - The company is exploring opportunities to leverage proprietary radio frequency technology for cuffless blood pressure and noninvasive glucose monitoring [3]

Financial Data and Key Metrics Changes - The company reported an operating loss of $7.4 million in Q3 2024, an improvement from an operating loss of $9.1 million in the same period last year [34] - Cash and cash equivalents stood at $11.3 million as of September 30, 2024, with a cash burn of approximately $5.6 million for the quarter [34] - A 1-for-15 reverse stock split was implemented to increase the bid price of the company's common shares, successfully regaining compliance with Nasdaq listing requirements [35][36] Business Line Data and Key Metrics Changes - The company shipped 339 Evie Rings during the third quarter following a successful back-in-stock announcement on September 17 [32] - The EvieMED Ring is in the final stages of the FDA 510(k) review process, with expectations for clearance to drive higher sales volumes in both B2B and D2C markets [34][17] Market Data and Key Metrics Changes - The wearables industry is rapidly growing, with smart rings becoming increasingly popular; however, only about 1 million smart rings are expected to be sold in 2024 compared to over 100 million wellness devices sold globally [10] - The leading competitor in the smart ring market is projected to generate approximately $500 million in revenue in 2024 [10] Company Strategy and Development Direction - The company is focused on expanding its D2C business and exploring B2B opportunities, particularly with the EvieMED Ring [38] - Movano Health aims to differentiate itself by combining consumer device features with medical device accuracy, positioning itself as a valuable asset in the emerging smart ring sector [12][62] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA clearance for the EvieMED Ring and the potential for significant growth in both consumer and healthcare markets [38][17] - The company is committed to improving health monitoring through a broad suite of analyte sensors, including blood pressure and glucose monitoring [31] Other Important Information - The company is investigating stock manipulation related to the reverse stock split, having uncovered suspicious trading activity prior to the split [36] - Movano Health is planning two third-party studies around sleep and menstrual cycle tracking to enhance its product offerings [19] Q&A Session Summary Question: What are the next steps for the cuffless blood pressure measurement program? - Management is excited about the recent study results and is currently merging data to evaluate accuracy, with more trials planned for the year [40][41][44] Question: Will the Android app have the same functionality as the iOS app? - Yes, the Android app will have all the same features as the iOS app, with approximately 40% of the market being Android users [45][46] Question: How will operating expenses unfold in Q4? - The company will continue to manage spending judiciously while preparing for increased marketing efforts during the holiday season [48][51] Question: What types of questions are remaining with the FDA for the EvieMED? - The remaining questions primarily relate to labeling and other medical device aspects, with management feeling confident about their responses [52][56] Question: How does the company plan to address its valuation discrepancy? - Management acknowledges the challenges in capital markets but remains focused on executing their strategy and increasing visibility to improve valuation [75][80]