PLEASANTON, Calif. – Movano Health (NASDAQ:MOVE) has announced progress with the U.S. Food and Drug Administration (FDA) regarding its EvieMED Ring, following a constructive meeting on August 15, 2024. The wearable device, which provides medical and wellness metrics, is moving forward in the FDA review process aimed at obtaining a 510(k) clearance, particularly for its pulse oximetry feature.
The EvieMED Ring, designed to offer users insights into their sleep, activity, and various wellness metrics, had its updated 510(k) clearance application filed on April 21, 2024. The FDA later sought additional information on the wellness features of the device, to which Movano Health responded on July 10, 2024, leading to the recent favorable meeting outcome.
John Mastrototaro, President and CEO of Movano Health, expressed satisfaction with the collaboration with the FDA, stating, "With a positive resolution to the ring's wellness features in hand, we look forward to completing the final review of our submission."
In a separate development, Movano Health is set to resume direct-to-consumer (D2C) orders for the Evie Ring starting September 17, 2024. The launch will introduce product enhancements and improved operations processes.
Movano Health, founded in 2018, aims to bring medical-grade data to the forefront of wearable technology. The company is working on a suite of healthcare solutions designed to provide trusted data and personalized health insights to both individual customers and enterprises.
This report is based on a press release statement and the information provided is subject to the usual risks and uncertainties of the regulatory approval process. Movano Health's forward-looking statements reflect their expectations as of the date of the press release and are not guarantees of future performance.
In other recent news, Movano Health has made significant strides in its operations. The company announced during its second quarter earnings call that it is preparing for the relaunch of its Evie Ring, a health and wellness wearable device. Despite shipping 1,837 Evie Rings in the quarter, Movano Health reported an operating loss of $6.4 million. This comes alongside progress with FDA clearances and collaborations with two global pharmaceutical companies and a large payer for commercial opportunities.
Movano Health is also focusing on empowering women with better health data and insights but plans to expand its market beyond this demographic. A partnership with digital creator Heidi D'Amelio is part of a comprehensive marketing strategy to promote the Evie Ring. Furthermore, the company completed a blood pressure clinical study and is redesigning the device for improved sensor placement.
These developments are part of Movano Health's ongoing efforts to improve its operations and reach a broader market. The company aims to meet with the FDA in mid-August for the clearance decision on Evie Med and plans to test the new design with B2B customers. Despite the challenges, Movano Health continues to push forward, emphasizing the importance of wearables in monitoring chronic conditions like high blood pressure and diabetes.
InvestingPro Insights
Movano Health (NASDAQ:MOVE) is making strides with its EvieMED Ring, eyeing FDA clearance to enhance its market presence. As investors consider the implications of these developments, it's crucial to examine the company's financial health and market performance. Here are some insights based on recent data and InvestingPro Tips:
InvestingPro Data reveals that Movano Health has a market capitalization of 30.87 million USD. Despite the company's efforts in innovation, it has been facing financial challenges, as indicated by a negative gross profit margin of -87.21% for the last twelve months as of Q2 2024. This underlines the struggles in achieving profitability, with an operating income margin of -3198.83% for the same period.
Moreover, the stock has experienced a significant downturn, with a 73.1% drop in the one-year price total return. This is coupled with a sharp 60.07% year-to-date price total return decline, reflecting investor concerns and market reactions to the company's financial performance.
InvestingPro Tips suggest that while Movano Health holds more cash than debt on its balance sheet, which is a positive sign of liquidity, the company is quickly burning through cash. Additionally, analysts do not expect the company to be profitable this year, which aligns with the observed financial metrics.
For investors seeking a deeper dive into Movano Health's financials and market performance, there are additional InvestingPro Tips available at https://www.investing.com/pro/MOVE, which could provide further guidance on the company's stock potential and investment risks.
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