Movano Health is gearing up for the Evie Ring relaunch while pursuing FDA clearance for the EvieMED Ring.

Summary: Movano Health, the maker of the Evie Ring, reported its second-quarter 2024 financial results and provided a business update. The company is focusing on relaunching the Evie Ring, securing FDA 510(k) clearance for its EvieMED Ring, and advancing clinical studies on cuffless blood pressure and noninvasive glucose monitoring. Movano Health also highlighted several business-to-business opportunities and partnerships that could further expand the use of its technology in clinical and consumer applications.

Key Takeaways:

  1. Relaunch and Enhancements: Movano Health is preparing for the relaunch of the Evie Ring on Sept 17, with improvements in product experience, operations, and customer service.
  2. FDA Clearance Efforts: The company is actively pursuing FDA 510(k) clearance for its EvieMED Ring pulse oximeter, with a meeting scheduled with the FDA in mid-August to advance the process.
  3. Strategic Partnerships: Movano Health is engaging in multiple business-to-business opportunities, including potential collaborations with global pharmaceutical companies and a large payor, to leverage the EvieMED Ring for both clinical and consumer health monitoring solutions.

Movano Health, maker of the Evie Ring, reported second-quarter 2024 results and provided a business update.

After closing a $24.1 million private placement in April, Movano Health has been focused on three key initiatives:

  • Preparing for the Sept 17 back-in-stock date for the Evie Ring, including an enhanced product experience, improved operations processes, and bolstered customer service.
    • On Aug 14, the company announced an Evie Ring brand partnership with digital creator, wife, mom, and entrepreneur Heidi D’Amelio.
  • Securing US Food and Drug Administration (FDA) 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business commercial agreements across the healthcare sector. The company is scheduled to meet live with its FDA counterparts in mid-August.
  • Advancing cuffless blood pressure and noninvasive glucose monitoring clinical studies with Movano Health’s patented System-on-a-Chip.

“We are excited to be back in stock on the Evie Ring and have been laser-focused over the past quarter on improving the consumer experience across product, delivery, and customer service in order to maximize our sales potential,” says John Mastrototaro, CEO and president of Movano Health, in a release. “Additionally, we are committed to working collaboratively with the FDA to obtain a 510(k) clearance for EvieMED, the cornerstone of our enterprise initiative.” 

Recent Operating Highlights and Milestones

  • On April 21, Movano Health submitted updated clinical trial results as well as proof of enhanced medical device usability to the FDA as part of its 510(k) filing for the company’s first commercial medical device, the EvieMED Ring pulse oximeter. The Company recently announced that it will be meeting live with the FDA in mid-August to discuss the wellness aspects of EvieMED and move forward with the review process.
  • On June 10, Movano Health announced a clinical study partnership with the Massachusetts Institute of Technology MAESTRO study of the long-term effects of chronic lyme and long COVID, using the continuous health monitoring capabilities of the Evie Ring.
  • In the second quarter, Movano Health made progress with three additional business-to-business commercial opportunities that it says could leverage EvieMED in building solutions for both clinical and consumer applications.
    • In the first case, the company is in the agreement phase with a global pharmaceutical company for a program that could begin in late-2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. 
    • In the second case, EvieMED is expected to be evaluated this fall by a tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025.
    • Finally, Movano Health is engaged with a large payor looking to better manage high risk populations utilizing EvieMED. This opportunity is expected to commence in late-2024/early-2025 and could develop further into calendar 2025.
  • In June, Movano Health completed a cuffless blood pressure clinical study that included the use of an arterial blood pressure line. The company plans to execute another cuffless blood pressure clinical study in the fourth quarter of 2024.

Second Quarter 2024 and Recent Financial Highlights

  • In Q2 2024, Movano Health shipped 1,837 Evie Rings. The company did not report revenue in the period, as previously deferred revenue was offset by customer refunds.
  • The company reported an operating loss of $6.4 million in Q2 2024, compared to an operating loss of $7.4 million in Q2 2023.

Photo caption: Evie ring

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