Company's first 510(k) clearance unlocks a TAM of $40 billion in healthcare B2B opportunities
PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring. The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health monitoring solutions needed for applications such as clinical trials, post-clinical trial management, and remote patient monitoring for both healthcare providers and payors.
Movano Health Receives FDA Clearance for EvieMED Ring
"We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels," said John Mastrototaro, President and CEO of Movano Health. "This FDA 510(k) clearance marks a major milestone for the Company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles."
In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with a number of potential partners operating across the entire healthcare industry spectrum and expects its partner pipeline to expand further following the news of a clearance. The Company is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025 related to the health management of high-risk populations and is also in discussions with a global pharmaceutical company and leading clinical research organization (CRO) to use the EvieMED Ring in upcoming clinical trials. In addition, the EvieMED Ring was recently selected for a groundbreaking MIT study on long COVID and chronic Lyme disease.
"This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses," continued Mastrototaro. "We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring."
Pulse oximeters measure blood oxygen (SpO2) levels and heart rate, but conventional solutions have significant shortcomings and can be uncomfortable, discouraging compliance that is needed to ensure reliable information for evaluating a patient's health. The EvieMED Ring eliminates those limitations by combining the accuracy of a medical device with the comfort of a wearable that can be worn continuously, thanks in part to an award-winning design with a small gap in the ring surface and slight flex that accommodates finger swelling. A pivotal study also found that the EvieMED Ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin color classification.
In addition, the EvieMED Ring collects wellness metrics including sleep, activity, temperature variability, calories burned and respiration rate that can give both patients and healthcare providers a broader picture of the user's overall wellness.
The EvieMED Ring will be available in eight sizes ranging from 5 to 12 to accommodate the widest selection of patients.
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 EvieMED; our expectations regarding potential commercial opportunities; 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.
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