Movano Health Reports Q1 2024 Financial Results and Provides Business Update
Movano Health (Nasdaq: MOVE) reported its Q1 2024 financial results, focusing on key initiatives such as enhancing the Evie product, securing FDA 510(k) clearance for the Evie Med Ring, and advancing cuffless blood pressure studies.
The company recently closed a $24 million private placement and generated $852,000 in revenue, shipping 5,305 Evie Rings in Q1. However, it reported an operating loss of $5.8 million, a slight improvement over the $7.2 million loss in Q1 2023. Total cash and equivalents stood at $2.1 million as of March 31, 2024.
Recent milestones include successfully submitting clinical trial results for the Evie Med Ring and planning a new blood pressure study for June 2024. The company expects an FDA decision on the Evie Med Ring in July 2024.
- Generated $852,000 in revenue in Q1 2024.
- Shipped 5,305 Evie Rings in Q1 2024.
- Closed a $24 million private placement on April 4, 2024.
- Reported a reduced operating loss of $5.8 million compared to $7.2 million in Q1 2023.
- Successfully submitted updated pivotal clinical trial results for Evie Med Ring to the FDA.
- Evie Med Ring achieved an RMSE of 2.46%, below FDA guidance of 3.5%.
- Planned new blood pressure study for June 2024 with arterial line for continuous data.
- Reported an operating loss of $5.8 million in Q1 2024.
- Total cash and cash equivalents were $2.1 million as of March 31, 2024.
- Currently paused taking new orders for the Evie Ring due to the need for operational improvements.
- Future revenue and performance dependent on FDA clearance for Evie Med Ring.
Insights
Movano Health's first quarter 2024 financial results showcase some noteworthy aspects and raise several questions for investors. Despite generating $852,000 in revenue from shipping 5,305 Evie Rings, the company reported an operating loss of
One positive element is the successful close of a
Investors should pay attention to the upcoming FDA decision expected in July 2024. FDA clearance for the Evie Med Ring could be a significant catalyst, potentially opening new revenue streams and driving the stock upward. However, until the clearance is secured, there remains uncertainty.
Rating: 1
The submission of exemplary SpO2 clinical trial results as part of the FDA 510(k) process is a pivotal development. The Evie Med Ring’s reported RMSE of
Additionally, Movano Health's preparations for a blood pressure study using an arterial line are noteworthy. Unlike traditional cuffs, arterial lines provide continuous blood pressure data, which could enhance patient monitoring significantly. The use of AI-based calibration methods further hints at advanced technological integration that holds promise for superior performance.
These advancements, if successfully leading to FDA clearance, could significantly enhance Movano's product credibility and market penetration, especially in the B2B sector. However, the actual market impact will rely on subsequent FDA approvals and effective implementation.
Rating: 1
Movano Health's strategy to enhance the Evie product experience and bolster customer service is critical as it prepares to reinitiate D2C orders. High demand for the Evie Ring indicates a strong market interest, but the current pause in orders suggests supply chain or operational challenges that need addressing. Success in this area could translate to improved brand loyalty and higher sales potential.
The company's focus on B2B partnerships and enterprise initiatives with the Evie Med Ring also indicates a tactical shift towards more stable, long-term revenue sources. Such partnerships could provide steady income streams and foster growth beyond the consumer market.
However, investors should remain cautious about the competitive landscape. The health tech space is rapidly evolving with many players vying for market share.
Rating: 1
Submits exemplary Sp02 clinical trial results as part of FDA 510(k) clearance process
Plans launch of Evie Med and focuses on B2B opportunities
Plans arterial blood pressure study for June
Conference Call at 2:00 PM PT/ 5:00 PM ET Today
Following the successful close of its recent
- Enhancing the Evie product experience, improving its operations processes, and bolstering customer service in preparation to begin taking direct-to-consumer (D2C) orders again.
- Securing FDA 510(k) clearance for its pulse oximeter, the Evie Med Ring, and pursuing key business-to-business (B2B) partnerships. The Company continues to expect a decision regarding its 510(k) clearance in July 2024.
- Advancing cuffless blood pressure clinical studies with Movano Health's System-on-a-Chip (SoC).
"We learned a great deal from the recent D2C launch of the Evie Ring, and a key goal for 2024 is to continue to improve the consumer experience across product, delivery and customer service in order to maximize our sales potential," said John Mastrototaro, CEO and President of Movano Health. "Additionally, we are focused on obtaining the FDA clearances necessary to launch Evie Med, the cornerstone of our enterprise initiative."
Recent Operating Highlights and Milestones
- The Company successfully shipped its first commercial ring on January 22, 2024. Demand was extremely high, and orders are currently paused. The Company is working on improvements across all business verticals in preparation to begin taking orders again.
- On April 22, 2024, Movano Health successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability 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 pulse oximeter. During the trial, each subject wore four Evie Med Rings. The four Evie Med Rings achieved a pooled root mean square error (RMSE) of2.46% in over 800 paired samples, which was once again well below the FDA guidance of3.5% for SpO2. Additionally, the Evie Med Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study. The Company continues to expect a decision on its 510(k) clearance from the FDA in July 2024. - Following positive results from a blood pressure clinical study conducted in October 2023, the Company has been making enhancements to the prototype used in that study and is planning another blood pressure study to take place this June, which will be the first study conducted with an arterial line, the precursor to an FDA pivotal study. Unlike a cuff which provides only one blood pressure value, an arterial line will provide continuous data on patients. In addition, Movano Health is also evaluating AI-based individual calibration methods to further enhance the future performance of the platform.
First Quarter 2024 and Recent Financial Highlights
- On April 4, 2024, Movano Health closed a
$24.1 million - In Q1 2024, Movano Health generated
$852,000 - The Company reported an operating loss of
$5.8 million $7.2 million - Total cash and cash equivalents at March 31, 2024 were
$2.1 million
Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a business update today at 2:00 pm PT/5:00 pm ET.
Attendees can access the live webcast here or on the investors section of Movano Health's website at https://ir.movano.com. The conference call can be accessed by dialing 1-877-407-0989 (domestic), or 1 201-389-0921 (international). Attendees can also use the Call Me Link in which they will be dialed in to the conference call instantly on the number provided with no hold time. An archived webcast will be available on Movano Health's website approximately one hour after the completion of the event and for two years thereafter.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, Movano Health's devices offer an innovative approach to delivering trusted data to both customers and enterprises, capturing a comprehensive picture of an individual's health data and uniquely translating it into personalized and intelligent insights.
Movano Health's proprietary technologies and wearable medical device solutions will soon enable the use of data as a tool to proactively monitor and manage health outcomes across a number of patient populations that exist in healthcare. For more information on Movano Health, visit https://movanohealth.com/.
Forward Looking Statements
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding plans with respect to the commercial launches of the Evie Ring and Evie Med; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development and features, product releases, clinical trials and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that 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 oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Movano Inc. | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(In thousands) | ||||
(Unaudited) | ||||
March 31, | December 31, | |||
2024 | 2023 | |||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 2,145 | $ 6,118 | ||
Payroll tax credit, current portion | 514 | 450 | ||
Vendor deposits | 396 | 399 | ||
Inventory | 1,064 | 1,114 | ||
Prepaid expenses and other current assets | 326 | 442 | ||
Total current assets | 4,445 | 8,523 | ||
Property and equipment, net | 299 | 342 | ||
Payroll tax credit, noncurrent portion | 64 | 169 | ||
Other assets | 327 | 387 | ||
Total assets | $ 5,135 | $ 9,421 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||
Current liabilities: | ||||
Accounts payable | $ 3,977 | $ 3,118 | ||
Deferred revenue | 251 | 1,252 | ||
Other current liabilities | 2,341 | 1,529 | ||
Total current liabilities | 6,569 | 5,899 | ||
Noncurrent liabilities: | ||||
Early exercised stock option liability | 11 | 23 | ||
Other noncurrent liabilities | 33 | 50 | ||
Total noncurrent liabilities | 44 | 73 | ||
Total liabilities | 6,613 | 5,972 | ||
Stockholders' equity (deficit): | ||||
Common stock | 6 | 6 | ||
Additional paid-in capital | 128,616 | 127,823 | ||
Accumulated deficit | (130,100) | (124,380) | ||
Total stockholders' equity (deficit) | (1,478) | 3,449 | ||
Total liabilities and stockholders' equity (deficit) | $ 5,135 | $ 9,421 | ||
Movano Inc. | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||
(In thousands, except share and per share data) | ||||||
(Unaudited) | ||||||
Three Months Ended March 31, | ||||||
2024 | 2023 | |||||
Revenue | $ 852 | $ — | ||||
COSTS AND EXPENSES: | ||||||
Cost of revenue | 1,215 | — | ||||
Research and development | 2,887 | 3,894 | ||||
Sales, general and administrative | 2,504 | 3,309 | ||||
Total costs and expenses | 6,606 | 7,203 | ||||
Loss from operations | (5,754) | (7,203) | ||||
Other income (expense), net: | ||||||
Interest and other income, net | 34 | 107 | ||||
Other income (expense), net | 34 | 107 | ||||
Net loss and total comprehensive loss | $ (5,720) | $ (7,096) | ||||
Net loss per share, basic and diluted | $ (0.10) | $ (0.19) | ||||
Weighted average shares used in computing net loss per share, basic and diluted | 56,023,273 | 37,541,070 | ||||
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SOURCE Movano
FAQ
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