Financial Performance - Movano Health reported an operating loss of $6.4 million in Q2 2024, an improvement from a loss of $7.4 million in Q2 2023[6]. - Movano Health's net loss for Q2 2024 was $6.19 million, compared to a net loss of $7.27 million in Q2 2023[12]. - Total cash and cash equivalents as of June 30, 2024, were $16.9 million, up from $6.1 million at the end of 2023[10]. Product Development and Launch - The company shipped 1,837 Evie Rings in Q2 2024, but did not report revenue due to previously deferred revenue being offset by customer refunds[6]. - Movano Health is preparing for the Evie Ring to be back in stock on September 17, 2024, with enhancements in product experience and customer service[1]. - The company is pursuing FDA 510(k) clearance for the EvieMED Ring and plans to meet with FDA representatives in mid-August[2]. - Movano Health is focused on launching EvieMED and securing B2B opportunities across the healthcare sector[1]. Partnerships and Studies - Movano Health is in the agreement phase with a global pharmaceutical company for a B2B program expected to start in late 2024, potentially expanding in 2025[5]. - A clinical study partnership with MIT is underway to study the long-term effects of Chronic Lyme and Long Covid using the Evie Ring[4]. - The company completed a cuffless blood pressure clinical study in June 2024 and plans another study in Q4 2024[5].

Revenue and Financial Performance - Revenue for the six months ended June 30, 2024, totaled $0.9 million, an increase of $0.9 million compared to $0 for the same period in 2023, due to the recognition of revenue from the Evie Ring Elements[104]. - The company incurred net losses of $11.9 million and $14.4 million for the six months ended June 30, 2024, and 2023, respectively, reflecting a decrease in losses of $2.5 million or 17%[98]. - Loss from operations improved to $6.5 million for the three months ended June 30, 2024, compared to $7.4 million for the same period in 2023[111]. - Net loss for the three months ended June 30, 2024, was $6.2 million, an improvement from $7.3 million in the prior year[114]. - The company used $12.3 million in operating activities for the six months ended June 30, 2024, compared to $14.0 million in the same period of 2023[121]. Expenses - Research and development expenses decreased by 30% to $2.9 million for the three months ended June 30, 2024, compared to $4.2 million for the same period in 2023[107]. - Research and development expenses decreased to $5.8 million for the six months ended June 30, 2024, down from $8.1 million in 2023, primarily due to lower research and laboratory expenses[108]. - Sales, general and administrative expenses totaled $3.1 million for the three months ended June 30, 2024, a slight decrease from $3.2 million in 2023, attributed to lower headcount and decreased marketing costs[109]. - The company expects to incur significant expenses and increasing operating losses as it advances the engineering design and development of new products[117]. Cash and Financing - The company had $16.9 million in available cash and cash equivalents as of June 30, 2024[98]. - Cash and cash equivalents totaled $16.9 million as of June 30, 2024, with $12.3 million used in operating activities during the same period[115]. - The company raised approximately $24.1 million from a private placement transaction that closed on April 5, 2024, after deducting offering fees[117]. - The company anticipates financing future cash needs through public or private equity offerings, debt financings, or corporate collaborations[118]. Product Development and Research - The Evie Ring, launched in November 2023, is designed to provide women with continuous health data and insights[94]. - The company plans to seek FDA clearance for the EvieMED Ring, which aims to be one of the first patient wearables with comprehensive FDA approval[95]. - A longitudinal study is being conducted to assess the effects of stress on blood pressure, with results pending[96]. - The company is developing a patented System-on-a-Chip for non-invasive glucose and blood pressure monitoring, with clinical trials currently underway[96]. - The company has established Movano Ireland Limited as a wholly owned subsidiary to support its operations[97]. Other Financial Information - Cost of revenue for the six months ended June 30, 2024, was $1.6 million, attributed to direct costs related to the Evie Ring Elements and shipping[105]. - The company reported no off-balance sheet transactions or non-cancelable obligations as of June 30, 2024[124][125].

Core Insights - Movano Health is preparing for the restock of the Evie Ring on September 17, 2024, and has announced a brand partnership with digital creator Heidi D'Amelio [1] - The company is focused on launching the EvieMED and securing B2B opportunities, including obtaining FDA 510(k) clearance [1][2] - Movano Health reported an operating loss of $6.4 million in Q2 2024, an improvement from a loss of $7.4 million in Q2 2023 [3] Business Initiatives - The company successfully closed a $24.1 million private placement in April 2024, which included investments from a tier-one multi-billion dollar medical device company [2] - Movano Health is advancing clinical studies for cuffless blood pressure and noninvasive glucose monitoring using its proprietary System-on-a-Chip (SoC) technology [1][2] - The company is in the agreement phase with a global pharmaceutical company for a potential program starting in late 2024, with further evaluations planned for EvieMED [2] Financial Performance - In Q2 2024, Movano Health shipped 1,837 Evie Rings but did not report revenue due to customer refunds offsetting previously deferred revenue [3] - Total cash and cash equivalents as of June 30, 2024, were $16.9 million, an increase from $6.1 million at the end of 2023 [3][6] - The company reported a net loss of $6.19 million for Q2 2024, compared to a net loss of $7.27 million in Q2 2023 [7]

Company Overview - Movano Inc. (Nasdaq: MOVE), founded in 2018, is focused on developing healthcare solutions that provide medical-grade data through wearable technology, aiming to deliver personalized health insights [2][8] - The company is set to showcase its Evie enterprise solutions at an upcoming virtual event, highlighting the potential for B2B applications in healthcare [4][10] Event Details - Movano Health will host a virtual event titled "B2B: The Next Wearables Boom" on July 11, featuring expert participants including Dr. Fatima Rodriguez and Matt Hughes [10] - The event aims to discuss the enterprise needs in wearables and the innovative possibilities that Movano's solutions can offer [4][10] Expert Participants - Dr. Fatima Rodriguez, an Associate Professor in Cardiovascular Medicine at Stanford University, specializes in cardiovascular disease prevention and the use of technology to enhance health equity [11] - Matt Hughes, Managing Partner at Allele Capital, brings 15 years of experience in the financial industry, particularly in biotechnology and specialty pharmaceuticals [7]

Enhancements address significant clinical enterprise need in wearables for a variety of healthcare applications "Utilizing deep learning is significantly better than standard techniques as it is the optimal solution for removing the effects of motion, eliminating the noise and motion artifacts in the optical signal," said Leabman. "We believe that this is a first of its kind implementation and an innovation that has the potential to enhance the reliability of wearable health monitors, providing users with m ...

Core Insights - MIT has partnered with Movano Health for the MAESTRO study, aiming to enhance understanding of long COVID and chronic Lyme disease through continuous health monitoring using Movano's Evie Ring [2][6][10] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearable devices, offering personalized health insights [11] - The Evie Ring is designed to meet HIPAA and cybersecurity standards, providing a reliable alternative to existing health monitoring devices [10] Study Details - The MAESTRO study will recruit 300 adults aged 18-35 from four cohorts: acute Lyme disease, chronic Lyme disease, long COVID, and a control group [6] - Approximately 40 million Americans are affected by long COVID, with over 600,000 new Lyme disease cases annually, 10-15% of which may develop into chronic Lyme disease [6] Research Significance - The collaboration is expected to provide valuable longitudinal data on vital signs and wellness, enhancing the understanding of long COVID and chronic Lyme disease [10] - The Tal Research Group, led by Dr. Michal Caspi Tal, specializes in chronic illness research and aims to bridge knowledge gaps in diagnostics and treatment for complex chronic conditions [10]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-40254 MOVANO INC. (Exact name of registrant as specified in its charter) (State of incorporation) (I.R.S. Employer Delaware 82-4233771 Identification No.) 6800 K ...

Financial Data and Key Metrics Changes - The company reported revenue of $852,000 for the first quarter of 2024, with 5,305 Evie Rings shipped during the period [68] - Operating loss for Q1 2024 was $5.8 million, an improvement from an operating loss of $7.2 million in the same period last year [68] - Cash burn in Q1 2024 was $4.1 million, which included costs related to the Evie Ring launch and FDA submission [10] Business Line Data and Key Metrics Changes - The Evie Ring was launched during the Black Friday 2023 holiday period, with revenue tied to the timing of ring shipments starting in January 2024 [9] - The company ceased all paid marketing as of December 1, 2023, and temporarily halted taking orders in February 2024 due to capital constraints [9] Market Data and Key Metrics Changes - The company is preparing for a re-launch of the Evie Ring and anticipates a significant demand increase once orders are resumed [21] - The market opportunity identified for chronic management of cardiovascular, metabolic, obesity, and pulmonary patients is estimated at $20 billion per year [54] Company Strategy and Development Direction - The company is focused on three priorities: preparing to take direct-to-consumer orders for the Evie Ring, securing FDA 510(k) clearance for the Evie Med brand, and refining the wrist-worn prototype for additional studies [36] - The company is enhancing automation and production processes to increase yield and efficiency in preparation for the re-launch [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA decision regarding the 510(k) clearance, expected in July 2024, which is seen as a significant milestone [7][38] - The company is confident that recent funding and operational improvements will act as a catalyst for success throughout the year [69] Other Important Information - The company has implemented an AI-powered customer response chatbot and onboarded a new Head of Customer Service to enhance customer experience [53] - The company is in discussions with a strategic investor and has received positive feedback on its strategic plan [28] Q&A Session All Questions and Answers Question: Can you provide any updates as it relates to the 510(k) process? - The company has had ongoing communication with the FDA and is working closely to ideally get the product cleared for market [72] Question: Can you provide more detail on your plans for the launch of Evie Med with B2B partners? - The company is engaged with strategic partners in the pharmaceutical and medical device sectors, focusing on continuous and secure medical-grade data [61] Question: What progress has been seen with blood pressure monitoring? - The company is preparing for pivotal studies and is focused on improving algorithms and production processes for blood pressure monitoring [46]

Financial Performance - Movano Health generated $852,000 in revenue for Q1 2024, shipping 5,305 Evie Rings during the period[8] - The company reported an operating loss of $5.8 million in Q1 2024, an improvement from a loss of $7.2 million in Q1 2023[8] - Total cash and cash equivalents decreased to $2.1 million as of March 31, 2024, down from $6.1 million at the end of 2023[8] - Research and development expenses decreased to $2.9 million in Q1 2024 from $3.9 million in Q1 2023[15] Clinical and Regulatory Developments - Movano Health successfully submitted clinical trial results showing a pooled root mean square error (RMSE) of 2.46% for the Evie Med Ring, below the FDA guidance of 3.5%[4] - The company expects a decision on its FDA 510(k) clearance for the Evie Med Ring in July 2024[4] - The company plans to conduct an arterial blood pressure study in June 2024, which will provide continuous data on patients[5] Business Strategy and Initiatives - Movano Health closed a $24.1 million private placement on April 4, 2024, to fund working capital and corporate purposes[8] - The company is enhancing the Evie product experience and preparing to resume direct-to-consumer orders[4] - Movano Health is pursuing key business-to-business partnerships as part of its enterprise initiative[2]

Unlocking business-to-business opportunities with Evie Med, Movano Health's ring pulse oximeter, remains a key priority for the Company. PLEASANTON, Calif., May 9, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced that it successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability on April 22, 2024 to the U.S. Food and Drug Administration (FDA) as part of its 510(k) filing for the Company's first commercial medical device, the Evie Med Ring p ...