PLEASANTON, Calif. - Movano Health (NASDAQ:MOVE) announced today that it is preparing to submit responses to the FDA's latest inquiries regarding its EvieMED Ring, a device under the 510(k) review process. The company, which specializes in health-focused wearable technology, expects to provide the necessary information next week, following a positive interaction with the FDA earlier this summer.
The EvieMED Ring, designed by Movano Health, integrates medical device features like pulse oximetry with wellness metrics tracking sleep, activity, and mood. It aims to support remote patient monitoring and clinical trials by enhancing patient compliance and data collection.
John Mastrototaro, President and CEO of Movano Health, expressed confidence in the device's potential and the company's ability to address the FDA's questions thoroughly. "We believe EvieMED will be a game-changing device for our partners in remote patient monitoring and clinical trials, as they look for a consumer-friendly solution to bolster patient compliance and better data collection," Mastrototaro stated.
Established in 2018, Movano Health is focused on developing healthcare solutions that deliver medical-grade data through wearable devices. Their aim is to empower proactive health management across various patient populations with data-driven insights.
The company's forward-looking statements in the press release indicate plans for commercial launches and anticipate FDA clearance for their products. However, they also acknowledge the risks and uncertainties inherent in such projections, as detailed in their regulatory filings with the Securities and Exchange Commission.
This press release statement serves as the basis for the information reported here. Movano Health's progress toward FDA clearance is a critical step for the company, as it seeks to introduce the EvieMED Ring into the healthcare market.
In other recent news, Movano Health has been making noteworthy strides in its FDA review process for the EvieMED Ring, a wearable device offering both medical and wellness metrics tracking. The company is in the final phase of the FDA's 510(k) clearance process, particularly for the device's pulse oximetry feature. Additionally, Movano Health is set to resume direct-to-consumer orders for its Evie Ring, introducing product enhancements and improved operational processes.
Despite shipping 1,837 Evie Rings in the second quarter, Movano Health reported an operating loss of $6.4 million. However, the company has established collaborations with two global pharmaceutical companies and a large payer, indicating potential commercial opportunities. Furthermore, Movano Health has completed a blood pressure clinical study and is redesigning the device for improved sensor placement. These developments are part of the company's ongoing efforts to improve its operations and reach a broader market.
InvestingPro Insights
As Movano Health (NASDAQ:MOVE) prepares to respond to FDA inquiries about its EvieMED Ring, investors should consider some key financial metrics and insights from InvestingPro.
The company's market capitalization stands at $30.68 million, reflecting its current valuation in the healthcare technology sector. However, Movano Health's financial position presents some challenges. According to InvestingPro Tips, the company is "quickly burning through cash" and is "not profitable over the last twelve months." This aligns with the company's reported operating income of -$27.25 million for the last twelve months as of Q2 2023, indicating significant ongoing losses.
The stock's performance has been notably weak, with InvestingPro Data showing a one-year price total return of -64.36% as of the latest data. This decline is consistent with the InvestingPro Tip that the "stock has taken a big hit over the last six months," which may reflect investor concerns about the company's path to profitability and regulatory approval progress.
On a more positive note, Movano Health "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it navigates the FDA approval process for the EvieMED Ring. Additionally, the company's "liquid assets exceed short term obligations," potentially offering a buffer for near-term operational needs.
Investors considering Movano Health should be aware that analysts "do not anticipate the company will be profitable this year," according to InvestingPro Tips. This outlook underscores the importance of the EvieMED Ring's potential FDA clearance for the company's future prospects.
For a more comprehensive analysis, InvestingPro offers additional tips and insights that could be valuable for investors evaluating Movano Health's potential. Currently, there are 8 additional InvestingPro Tips available for MOVE, providing a deeper understanding of the company's financial health and market position.
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