Movano(MOVE)

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MIT Selects Movano Health for Groundbreaking Study on Long COVID and Chronic Lyme Disease
Prnewswire· 2024-06-10 13:00
could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or or ...
Movano(MOVE) - 2024 Q1 - Quarterly Report
2024-05-17 20:27
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 ...
Movano(MOVE) - 2024 Q1 - Earnings Call Transcript
2024-05-15 23:05
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]
Movano(MOVE) - 2024 Q1 - Quarterly Results
2024-05-15 20:31
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]
Movano Health Submits Exemplary Sp02 Clinical Trial Results in Key Step Towards FDA 510(k) Clearance Decision
Prnewswire· 2024-05-09 12:00
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 ...
Movano(MOVE) - 2023 Q4 - Annual Report
2024-04-16 19:04
Financial Performance - Movano Health incurred net losses of $29.3 million and $30.3 million for the years ended December 31, 2023 and 2022, respectively, reflecting a decrease of 3% in net loss year-over-year [185][214]. - Total operating expenses for 2023 were $29.7 million, a decrease of 3% from $30.5 million in 2022, primarily due to reduced research and development costs [208][212]. - Research and development expenses decreased to $16.9 million in 2023 from $19.0 million in 2022, a reduction of $2.1 million attributed to lower design costs [209]. - Sales, general and administrative expenses increased to $12.8 million in 2023 from $11.5 million in 2022, an increase of 12% driven by company growth and preparations for the Evie Ring launch [211]. - Interest income increased significantly to $0.4 million in 2023 from $0.1 million in 2022, a growth of 206% due to higher prevailing interest rates [213]. - The company reported a net loss of $29.3 million for the year ended December 31, 2023, compared to a net loss of $30.3 million in 2022 [225]. Product Development - The Evie Ring, launched in November 2023, is designed to provide comprehensive health metrics for women, including heart rate, SpO2, and menstrual tracking [181]. - Movano Health is developing a proprietary System on Chip (SoC) for non-invasive glucose and cuffless blood pressure monitoring, with clinical trials currently underway [182]. - Movano Health plans to bring a Class II FDA-cleared device to market that includes continuous glucose monitoring and cuffless blood pressure monitoring capabilities [182]. Cash and Financing Activities - As of December 31, 2023, Movano Health had $6.1 million in available cash and cash equivalents [186]. - As of December 31, 2023, the company had cash and cash equivalents of $6.1 million, with an expected cash usage of $26.2 million in operating activities for the year [215]. - The company sold 2,531,757 shares through an at-the-market equity offering program in 2023, generating approximately $3.2 million in proceeds, with $44.4 million remaining available under the program [216]. - Financing activities provided cash of $21.6 million in 2023, including net proceeds from equity securities issued in public offerings totaling $18.4 million [229]. - The company entered into a securities purchase agreement for a private placement of 45,252,517 units at a purchase price of $0.533 per unit, generating gross proceeds of approximately $24.1 million [218][220]. - The company expects to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations [221]. Future Outlook and Concerns - The company anticipates ongoing annual losses as it continues the commercialization and development of the Evie Ring and other products, requiring additional capital [233]. - The company faces substantial doubt about its ability to continue as a going concern within one year after the issuance of its consolidated financial statements [222]. - The company plans to satisfy future cash needs through existing capital balances and a combination of financing options, but may face challenges in raising additional capital [236]. - Cash used in investing activities was $64,000 in 2023, a significant decrease from cash provided of $15.7 million in 2022 [228].
Movano(MOVE) - 2023 Q4 - Earnings Call Transcript
2024-04-10 14:23
Movano Inc. (NASDAQ:MOVE) Q4 2023 Results Conference Call April 4, 2024 5:00 PM ET Company Participants David Barnard - Senior Vice President of Investor Relations John Mastrototaro - CEO Michael Soule - VP of Business Development Jeremy Cogan - CFO & Secretary Michael Leabman - Founder, CTO & Director Tyla Bucher - Chief Marketing Officer Operator Greetings, and welcome to the Movano Health Fourth Quarter 2023 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is n ...
Movano(MOVE) - 2023 Q3 - Earnings Call Transcript
2023-11-15 22:25
Movano Inc. (NASDAQ:MOVE) Q3 2023 Earnings Conference Call November 15, 2023 11:30 AM ET Company Participants Jay Cogan - Chief Financial Officer John Mastrototaro - Chief Executive Officer Tyler Bucher - Chief Marketing Officer Michael Leabman - Founder and Chief Technology Officer Stacy Salvi - Vice President, Product and Strategy Operator Hello and welcome to Movano Health Third Quarter 2023 Earnings Call. I’d like to remind everyone that this call is being recorded and a replay of the call will be avail ...
Movano(MOVE) - 2023 Q3 - Quarterly Report
2023-11-14 21:01
Financial Performance - The company reported a net loss of $9.0 million for the three months ended September 30, 2023, compared to a net loss of $8.6 million for the same period in 2022, representing a 4% increase in loss [138]. - The company incurred a net loss of $23.3 million during the nine months ended September 30, 2023, compared to a net loss of $22.4 million in the same period of 2022 [145][146]. - Cash used in operating activities increased to $20.9 million for the nine months ended September 30, 2023, from $18.6 million in the prior year, reflecting a year-over-year increase of approximately 7% [144][145]. - The company expects to continue incurring significant expenses and increasing operating losses for at least the next several years [141]. - There is substantial doubt about the company's ability to continue as a going concern within one year after the issuance of the financial statements [142]. Research and Development - Research and development expenses for the three months ended September 30, 2023, totaled $5.6 million, a 10% increase from $5.1 million in the same period in 2022 [132]. - Research and development expenses for the nine months ended September 30, 2023, were $13.7 million, a slight decrease of 1% from $13.8 million in the same period in 2022 [133]. - The company is developing a patented System-on-a-Chip (SoC) for non-invasive glucose and cuffless blood pressure monitoring, with clinical trials currently underway [127]. - The Evie Ring is expected to launch as a general wellness device without FDA premarket clearances, with plans to seek FDA clearances for its vital signs monitoring capabilities [126]. - The company plans to advance the engineering design and development of the Evie Ring and other potential products [148]. Expenses and Cash Flow - Sales, general and administrative expenses for the nine months ended September 30, 2023, were $10.0 million, a 16% increase from $8.6 million in the same period in 2022 [135]. - The total operating expenses for the three months ended September 30, 2023, were $9.1 million, a 5% increase from $8.7 million in the same period in 2022 [131]. - Other income for the nine months ended September 30, 2023, was $341,000, a significant increase of 774% from $39,000 in the same period in 2022 [137]. - Cash provided by investing activities was $14.9 million in the nine months ended September 30, 2022, compared to a cash outflow of $51,000 in the same period of 2023 [147]. - The company has approximately $10,000 in non-cancelable contractual commitments as of September 30, 2023, primarily related to vendor arrangements [153]. Financing Activities - The company sold 2,360,036 shares of common stock through an at-the-market issuance program for proceeds of approximately $3.1 million during the nine months ended September 30, 2023 [140]. - The company raised $17.9 million in financing activities during the nine months ended September 30, 2023, primarily from public offerings and an ATM equity offering program [150]. - Future cash needs may be financed through public or private equity offerings, debt financings, or corporate collaborations and licensing arrangements [141]. - The company does not have any off-balance sheet transactions as of September 30, 2023 [152].
Movano(MOVE) - 2023 Q2 - Earnings Call Transcript
2023-08-15 04:05
Movano Inc. (NASDAQ:MOVE) Q2 2023 Earnings Conference Call August 14, 2023 4:30 PM ET Company Participants Jeremy Cogan - CFO & Secretary John Mastrototaro - CEO, President & Director Michael Aaron Leabman - Founder, CTO & Director Tyla Bucher - Chief Marketing Officer Conference Call Participants Marie Thibault - B. Riley Operator Greetings and welcome to the Movano Second Quarter 2023 Earnings Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the forma ...