Movano, Inc. Q1 FY2024 earnings call

Priorities

• Prepare to take B2C orders for the Evie Ring, focusing on improving product experience, hardware and software, production processes, and customer service.
• Secure FDA 510(k) clearance for the pulse oximeter feature of Evie Med.
• Refine the risk worn prototype with mmWave RF system on a chip for additional blood pressure and glucose studies.

Evie Ring Efforts

• Working on improving hardware with better resistance, enhancing software algorithms, developing Android app, and enhancing production processes like automation and assembly.
• Bolstered customer service capacity with AI-powered chatbot and new customer service head.

Evie Med Efforts

• Working closely with FDA on 510(k) clearance, submitted exemplary clinical trial results, engaged with strategic partners in pharma, medical device, and payer channels.

RF System Chip Efforts

• Making enhancements to the prototype for blood pressure monitoring, next blood pressure study in June with arterial line, and evaluating AI-based individual calibration.

In the first quarter of 2024, Movano Health shipped 5,305 Evie Rings and reported $852,000 in revenue. The Evie Ring segment is the main product segment with these financial results.

Forward-looking Statements

• With $24 million from private placement, have resources to drive D2C business, launch Evie Med, target B2B and accelerate clinical trials.
• Will hold on taking new Evie Ring orders until ensuring ongoing inventory of about 1 to 2 months by SKU.
• Expect FDA decision on 510(k) in July 2024.
• Next blood pressure study in June with arterial line.

Risks

• Operational inefficiencies and delays during initial Evie Ring launch leading to order cancellations.
• Uncertainties related to FDA 510(k) clearance process.
• Challenges in optimizing production processes and maintaining inventory levels.

Q: Could you provide any updates as it relates to the 510(k) process beyond what you mentioned in the call today?

A: Recently refiled with FDA new clinical results for another HYPOXIA study, had back-and-forth communication with reviewer, things going well.

Q: Can you provide some more detail on your plans for the launch of Evie Med with B2B partners?

A: Continue to engage with Beta partners and channels, building back-end data systems for partnerships, new group of large strategic partners interested post cuffless blood pressure clinical study results.

Q: Do you want to comment on the progress you've seen with blood pressure?

A: Next big step is arterial line test in June similar to FDA pivotal study, trying to improve algorithm.

Q: When will we start shipping Evie Rings?

A: Will hold on taking new Ring orders until ensuring ongoing inventory of about 1 to 2 months by SKU, will announce new ship start date when confident in ability to fulfill orders.

Q: Is there any update on the strategic investor and other potential partnerships?

A: Collaborative relationship with strategic investor, they offered support in areas, discussed further opportunities, continued interest in proprietary millimeter-Wave RF technology.

Q: Blood pressure, do we see the first device -- commercial device being a wrist band or a ring?

A: Our chip can go into Ring, first focus is getting through FDA with current tested product, then look at putting into Ring.

Q: For Evie Med, will that also be for men?

A: Clinical trials for SpO2 and heart rate were done for all populations including men, Evie Med is for all, not limited to women.