Summary: In its Q3 2024 report, Movano Health outlined key business updates, highlighting the relaunch of the Evie Ring for direct-to-consumer sales and ongoing efforts to secure FDA 510(k) clearance for the EvieMED Ring. The company says it remains focused on expanding business-to-business partnerships in the healthcare sector, particularly with the anticipated launch of the EvieMED Ring, which combines medical and wellness features. Additionally, Movano Health is advancing clinical trials on its new blood pressure monitoring wearable and other noninvasive health metrics to enhance its product offerings.
Key Takeaways:
- EvieMED Ring Nears FDA Clearance: Movano Health is in the final stages of FDA 510(k) review for its EvieMED Ring, which combines wellness tracking with medical-grade pulse oximetry.
- Direct-to-Consumer Success: The Evie Ring saw a successful relaunch, supported by improved logistics and customer service, bolstering Movano’s presence in the consumer market.
- Focus on Clinical Wearables: Movano Health continues to advance clinical trials for its cuffless blood pressure and noninvasive glucose monitoring devices, aiming to broaden its healthcare offerings.
Movano Health reported its Q3 financial results, highlighting the relaunch of its Evie Ring, progress on FDA 510(k) clearance for the EvieMED Ring, and new business initiatives targeting healthcare partnerships.
“We are pleased with our Evie Ring [direct-to-consumer] performance and continue to be laser-focused on improving the consumer experience, including the upcoming launch of our Android app, as we head into the holiday period in order to maximize our sales potential,” says John Mastrototaro, president and CEO of Movano Health, in a release. “Additionally, we look forward to the successful completion of the 510(k) application review process of the EvieMED Ring and continue to focus on the game-changing opportunities that we believe EvieMED could unlock for our healthcare partners.”
The company notes in a release that it continues to remain focused on three key business initiatives:
- Successful execution of the Evie Ring direct-to-consumer business following the Sept 17 back-in-stock launch, bolstered by an enhanced product experience and improved operations across manufacturing, logistics, and customer service.
- Securing FDA 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business commercial agreements across the healthcare sector.
- Advancing cuffless blood pressure and noninvasive glucose monitoring clinical studies with Movano Health’s proprietary and patented System-on-a-Chip.
Recent Operating Highlights and Milestones
In its third-quarter report, Movano recapped recent operating highlights and milestones. These include Movano Health launching a back-in-stock campaign for the Evie Ring direct-to-consumer business in September. On Oct 30, the company also shared the official announcement of its first brand partnership with content creator Heidi D’Amelio.
Movano notes that it continues to work with the US Food and Drug Administration (FDA) and remains in the final stage of its FDA 510(k) application review process for the EvieMED Ring. The EvieMED Ring is designed to not only provide medical device functionality with its pulse oximetry feature but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms.
This summer, Movano Health secured a positive resolution after responding to initial FDA questions related to EvieMED’s wellness features and metrics. During the week of Oct 28, the company submitted a complete response package to additional clarifying questions related to the medical aspects of EvieMED.
Additionally, Movano Health notes in a release that it continues to make progress on the business-to-business front in anticipation of an expected 510(k) clearance, re-engaging with a number of potential partners across the spectrum of healthcare use cases. For example, the company entered into an agreement phase with a large healthcare company for a pilot program in Q1 2025 using the EvieMED Ring as part of an overall metabolic solution to address chronic disease.
Movano Health also tested its newly developed blood pressure wrist wearable as part of a Nov 5-6 hypoxia clinical trial that took place at the University of California, San Francisco. The updated device features an additional 12 mmWave antenna, which, together with the company’s custom RF chip, delivers enhanced data collection with less impact of placement while also featuring a slimmer design, making it easier and more comfortable to wear.
In addition, the new wearable monitors other vital signs including pulse rate, blood oxygen saturation, respiration rate, and ECG waveforms.
Photo caption: Evie Ring
File photo/Movano Health
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