A successful response to requests for additional information would bring the Company one step closer to introducing this pioneering healthcare product to the marketPLEASANTON, Calif., Oct. 24, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that it plans to submit updated responses next week to all clarifying questions that it recently received from the FDA as part of the final phase of the Company's 510(k) application review. The Company secured a positive resolution this summer after res ...

The Company continues to work closely with the FDA to bring this pioneering healthcare product to market PLEASANTON, Calif., Oct. 10, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that the Company recently received additional clarifying questions from the FDA related to medical aspects of the EvieMED Ring, as part of the final phase of the Company's 510(k) application review process. The Company secured a positive resolution this summer after responding to initial FDA questions related t ...

Orders Reopen with Enhancements to AI Powered Health Insights, Sleep and Heart Rate Measurements and More PLEASANTON, Calif., Sept. 17, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) today announced the immediate availability of its Evie Ring, the first smart ring designed specifically for women. The ring features the same industry-first, award-winning open design that accommodates fluctuations in finger size, and is accompanied by an updated app that enhances users' ability to track and understand key m ...

Following the positive outcome of a recent agency meeting, the Company will continue to work closely with the FDA to bring this pioneering healthcare product to market PLEASANTON, Calif., Sept. 3, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that a productive in-person meeting with the FDA on August 15, 2024, resulted in a positive outcome regarding the EvieMED Ring's wellness features and metrics. Following this development, the Company will be working with the agency to move forward w ...

Movano Inc. (NASDAQ:MOVE) Q2 2024 Earnings Conference Call August 14, 2024 5:00 PM ET Company Participants Jay Cogan - CFO John Mastrototaro - CEO Tyla Bucher - Chief Marketing Officer Michael Leabman - Founder and Chief Technology Officer Michael Soule - Chief Commercial Officer Conference Call Participants Bruce Jackson - Benchmark Company Operator Greetings and welcome to Movano Health Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer ...

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 ...