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