Movano, Inc. Q4 FY2023 earnings call

Key Points

• Commercially launched Evie Ring in November 2023, demand exceeded expectations but paused order intake due to capital constraints and operational challenges; a wait list of over 8,000 potential buyers was amassed in 6 weeks without paid marketing.
• Closed a $24 million private placement, including a $3 million strategic seed investment from a Tier 1 global medical device company, with management and Board investing over $3.6 million.
• Priorities: Achieve FDA clearance for pulse rate and blood oxygen monitoring, pursue B2B opportunities, and accelerate clinical trials for blood pressure and noninvasive glucose monitoring.
• B2B opportunities: Clinical trial market (pharmaceuticals, $2B annual market), payer market (insurers with 130M+ patients), remote patient monitoring (RPM) market; engaged with potential partners in beta tests.
• Blood pressure clinical trial results showed prototype met FDA standards for wearable blood pressure monitoring; RF technology for noninvasive glucose monitoring with high-fidelity data.
• Financial update: Had $6.1 million cash and cash equivalents on Dec 31, 2023, and closed $24M private placement.

No specific detailed financial performance by product segments provided in terms of absolute revenue and contribution percentages.

Forward-Looking Statements

• Expect FDA decision on 510(k) clearance in July 2024.
• Plan to relaunch Evie Ring with improved production and inventory to meet demand.
• Continue B2B partnerships and advance clinical trials for blood pressure and noninvasive glucose monitoring.

Risks

• Inherent risks in forward-looking statements, detailed in Movano Health's SEC filings (Forms 10-Q and 10-K).
• Operational challenges and capital constraints initially hindered volume production of Evie Ring.

Q: Are there any additional updates related to the first 510(k) application?

A: Tremendous progress with clinical work on Evie Ring, latest trial results were exceptional, addressed FDA questions, filing new info later this month, expect FDA decision in July.

Q: What is the difference between Evie Med and Evie Ring as a wellness product?

A: Evie Med hardware is same as Evie Ring, but different labeling for medical device aspects and app experience separates wellness and medical metrics.

Q: What has been the customer response to Evie thus far?

A: Received invaluable feedback from early adopters, over 8,000 on waitlist without paid marketing, focus on improving customer service, delivery response time, and product features.

Q: What form factor might blood pressure and glucose monitoring products take?

A: Blood pressure initially wrist-based, but may evaluate finger site; glucose monitoring more flexible in form factor, considering interstitial fluid and RF signature.

Q: When will Evie connect to Apple Health?

A: On the short list of priorities, but no exact date provided.

Q: How will the raised cash be used?

A: Funds to proceed with FDA clearance, blood pressure clinical studies, noninvasive glucose monitoring work, and scaling commercial production.