Update!
$Movano (MOVE.US)$ Movano Health Reports Q2 2024 Financial Results and
Provides Business Update
Prepares for September 17, 2024, Evie Ring back in stock date
Announces brand partnership with digital creator Heidi D’Amelio
Focuses on launch of EvieMED and securing B2B opportunities
Conference Call at 2:00 PM PT/ 5:00 PM ET Today
PLEASANTON, Calif. – August 14, 2024 – Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported second quarter 2024 results and provided a business update.
Following the successful close of the Company’s April 2024 $24.1 million private placement that included a seed investment from a tier 1 multi-billion dollar medical device company, Movano Health has been focused on three key initiatives:
● Preparing for the September 17th back in stock date for the Evie Ring, including an enhanced product experience, improved operations processes, and bolstered customer service.
● Today, the Company announced an Evie Ring brand partnership with digital creator, wife, mom, and entrepreneur Heidi D’Amelio.
● Securing FDA 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business (B2B) 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 proprietary and patented System-on-a-Chip (SoC).
“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,” said John Mastrototaro, CEO and President of Movano Health. “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 4, 2024, Movano Health closed a $24.1 million private placement, totaling 45.3 million units, with each unit consisting of one share of the Company’s common stock (or pre-funded warrant in lieu thereof) and one warrant to purchase a share of common stock, to a select group of investors that included a tier-one multi-billion dollar medical device company, institutional and accredited investors, and members of the Company’s management team and board of directors.
● On April 21, 2024, Movano Health successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability to the U.S. Food and Drug Administration (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 to move forward with the review process.
● On June 10, 2024, Movano Health announced a clinical study partnership with the Massachusetts Institute of Technology (MIT)’s 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 important progress with three additional B2B commercial opportunities that could leverage EvieMED in building unique 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 2024, 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.
● Total cash and cash equivalents at June 30, 2024 were $16.9 million.
Provides Business Update
Prepares for September 17, 2024, Evie Ring back in stock date
Announces brand partnership with digital creator Heidi D’Amelio
Focuses on launch of EvieMED and securing B2B opportunities
Conference Call at 2:00 PM PT/ 5:00 PM ET Today
PLEASANTON, Calif. – August 14, 2024 – Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported second quarter 2024 results and provided a business update.
Following the successful close of the Company’s April 2024 $24.1 million private placement that included a seed investment from a tier 1 multi-billion dollar medical device company, Movano Health has been focused on three key initiatives:
● Preparing for the September 17th back in stock date for the Evie Ring, including an enhanced product experience, improved operations processes, and bolstered customer service.
● Today, the Company announced an Evie Ring brand partnership with digital creator, wife, mom, and entrepreneur Heidi D’Amelio.
● Securing FDA 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business (B2B) 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 proprietary and patented System-on-a-Chip (SoC).
“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,” said John Mastrototaro, CEO and President of Movano Health. “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 4, 2024, Movano Health closed a $24.1 million private placement, totaling 45.3 million units, with each unit consisting of one share of the Company’s common stock (or pre-funded warrant in lieu thereof) and one warrant to purchase a share of common stock, to a select group of investors that included a tier-one multi-billion dollar medical device company, institutional and accredited investors, and members of the Company’s management team and board of directors.
● On April 21, 2024, Movano Health successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability to the U.S. Food and Drug Administration (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 to move forward with the review process.
● On June 10, 2024, Movano Health announced a clinical study partnership with the Massachusetts Institute of Technology (MIT)’s 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 important progress with three additional B2B commercial opportunities that could leverage EvieMED in building unique 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 2024, 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.
● Total cash and cash equivalents at June 30, 2024 were $16.9 million.
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