Movano Health Submits Exemplary Sp02 Clinical Trial Results in Key Step Towards FDA 510(k) Clearance Decision

Rhea-AI Summary

Movano Health submitted exemplary SpO2 clinical trial results to the FDA as part of its 510(k) filing for the Evie Med Ring pulse oximeter. The Company aims to disrupt the wearables industry and unlock partnership opportunities with potential FDA clearance expected in July 2024. The recent clinical trial results demonstrated high accuracy across skin tones, surpassing FDA guidelines and outperforming hospital-grade reference pulse oximeters. Movano Health closed a $24 million private placement, received a strategic investment from a major medical device company, and signed collaboration agreements to advance its wearable medical device solutions.

Positive

• Movano Health achieved high accuracy in its SpO2 clinical trial results, exceeding FDA guidelines and outperforming hospital-grade reference pulse oximeters, showcasing the effectiveness of the Evie Med Ring pulse oximeter.

• The Company closed a $24 million private placement, received a strategic investment from a major medical device company, and signed collaboration agreements, strengthening its financial position and paving the way for future partnerships and technological advancements.

Negative

• The FDA clearance decision for the Evie Med Ring pulse oximeter is pending until July 2024, creating a level of uncertainty for Movano Health's future commercialization plans and potential business growth until a decision is reached.

• While the recent clinical trial results were promising, any future discrepancies or delays in FDA clearance could impact Movano Health's market positioning and partnerships within the wearables and healthcare industries.

Insights

Medical Device Analyst

Movano Health's recent submission of clinical trial results for the Evie Med Ring pulse oximeter is a testament to the progress in the medical wearables space. The pooled RMSE figure of 2.46% is commendable, as it indeed falls well below the FDA's guideline of 3.5% for SpO2 measurements, which are commonly used to monitor oxygen saturation in the blood, a vital parameter for patient care. This demonstration of accuracy across all skin tones is significant for patient inclusivity and helps mitigate the concerns of bias in medical devices. Moreover, the strategic investment from a major medical device company, not only provides financial support but may also indicate confidence in Movano Health's potential and could lead to beneficial partnerships. These developments are likely to bolster investor confidence, subject to FDA approval, possibly opening doors to healthcare provider collaborations and increasing market penetration for healthcare wearables. The focus on enhanced usability is also crucial, given the competitive landscape and the consumer's increasing demand for user-friendly medical devices. Overall, this development could signal a positive industry shift, emphasizing the blend of technology and healthcare.

Financial Analyst

The $24 million in private placement funds secured by Movano Health marks a strategic step forward for the company. The investment, particularly the seed portion from a major player in the medical device industry, could be indicative of both an endorsement of Movano's technology and a vote of confidence from savvy institutional investors. The use of these funds for accelerating development in proprietary tech indicates Movano's commitment to innovation and scaling their operations. If the Evie Med Ring obtains FDA clearance, it could substantially improve the company's revenue prospects and market share. The financials surrounding the clinical trial results are yet to be fully appreciated until the FDA's decision in July 2024. However, the combination of robust trial outcomes and financial backing positions Movano Health favorably for future growth. Investors should consider these developments as potentially enhancing the long-term value proposition of Movano's stock, keeping in mind that the actual market impact will hinge on regulatory approval and successful commercialization.

Healthcare Market Analyst

The submission of clinical trial results for FDA clearance is a pivotal milestone for Movano Health that could substantially expand its market reach. The Evie Med Ring's exceeded accuracy benchmarks and the ability to cater to all skin tones may resolve a significant issue concerning inclusivity in patient monitoring devices. The accuracy of pulse oximeters has been a topic of debate especially due to discrepancies in readings for darker skin tones; hence, this presents Movano Health as a leader in addressing equity in healthcare technology. The potential for partnership with a tier-one medical device company signals a strong entry into the B2B sector upon FDA clearance. The healthcare wearables market is growing and Movano's positioning at this intersection of wellness and medical-grade monitoring could disrupt traditional models. Investors should consider the potential for Movano to capture both the consumer health tech market and institutional healthcare providers who may look to integrate such devices into patient care. The success of this device could herald a new wave of wearable medical technology, which would be a boon for Movano's business prospects.

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 pulse oximeter. An FDA clearance would bring Movano Health a significant step closer in its pursuit to disrupt the wearables industry while unlocking significant partnership opportunities. The Company continues to expect a decision regarding its 510(k) clearance in July 2024.

"From the outset, our vision has been to develop a wearable that fits with any lifestyle and is cleared by the FDA as a medical device," said John Mastrototaro, CEO of Movano Health. "The exemplary results of our latest study are a critical component of our FDA filing and lay the groundwork to fulfilling all aspects of that goal."

In January 2024, Movano Health completed a second hypoxia trial with the University of California, San Francisco (UCSF) confirming the accuracy of its Evie Med Ring pulse oximeter exceeds the U.S. Food and Drug Administration (FDA) guidelines. Notably, this accuracy applied to all skin tones on the Fitzpatrick Scale. This latest UCSF study used the production model ring, which will be sold under the brand name Evie Med, and reflected several design improvements from the pre-commercial model used in an earlier study.

During the trial, each subject wore four Evie Med Rings. The four Evie Med Rings achieved a pooled root mean square error (RMSE) of 2.46% in over 800 paired samples, which was once again well below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Med Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study.

Movano Health also recently closed a $24 million private placement with a select group of institutional and accredited investors. As part of the transaction, the Company received a strategic seed investment from a tier-one multi-billion dollar medical device company and signed an agreement to explore future collaborations relating to development and commercialization. This strategic investment combined with the recent clinical results solidify Movano Health's edge over traditional wellness trackers, paving the way for impactful partnerships with healthcare providers and other industry leaders.

The net proceeds of the private placement are expected to be used for general corporate purposes and working capital, including accelerating the development of Movano Health's proprietary technologies and wearable medical device solutions for healthcare enterprises, including pharmaceutical, medical device and health insurers.  

About The Evie Med Ring

The Evie Med Ring combines medical device and wellness metrics to give a full picture of one's health. In addition to pulse oximeter medical data (SpO2 and pulse), these wellness metrics will be provided:

• Activity: log a workout, active minutes, steps, distance traveled, heart rate, and calories burned
• Sleep: start time, stop time, duration, and cycles (awake, light, deep, and rapid eye movement (REM)), resting heart rate average, oxygenation maximum, heart rate variability, respiration rate, skin temperature variability average)
• Women's health tracking: menstrual cycle and ovulation, mood, energy, and symptom tracking
• Goal setting (sleep, active minutes, steps, mood and symptoms, workout sessions)
• Daily Summary graphic (activity, calories, steps, and sleep, mood and energy logging)

This data is delivered through a companion mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help consumers make manageable lifestyle changes and patients and their health care providers to take a more proactive approach to managing and treating chronic disease in healthcare and home environments.

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 the closing of the private placement transaction; plans with respect to commercial launch of the Evie Ring; planned cost-cutting initiatives; anticipated FDA clearance for the Evie Ring and other products in development; 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.

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SOURCE Movano

FAQ

When did Movano Health submit the updated pivotal clinical trial results for the Evie Med Ring pulse oximeter to the FDA?

Movano Health submitted the updated pivotal clinical trial results on April 22, 2024 to the FDA.

What is the expected timeline for the FDA 510(k) clearance decision regarding the Evie Med Ring pulse oximeter?

Movano Health expects a decision regarding its 510(k) clearance in July 2024.

What was the pooled root mean square error (RMSE) achieved by the Evie Med Ring in the clinical trial?

The Evie Med Ring achieved a pooled RMSE of 2.46% in over 800 paired samples, surpassing the FDA guidance of 3.5% for SpO2.

What recent financial transaction did Movano Health close to accelerate the development of its wearable medical device solutions?

Movano Health closed a $24 million private placement to fund general corporate purposes, working capital, and accelerate the development of its proprietary technologies and wearable medical device solutions.