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Movano Inc.

CIK: 17347502 Annual ReportsLatest: 2025-04-09

10-K / April 9, 2025

Revenue:$1,000,000
Income:-$23,727,000

10-K / April 29, 2024

Revenue:$2,000,000
Income:-$10,000,000

10-K / April 9, 2025

Company Overview: Movano Inc.

Core Business

  • Industry Focus: Development of healthcare technology platforms that integrate medical-grade diagnostics into consumer health devices.
  • Primary Goal: Deliver purpose-driven healthcare solutions by providing high-quality, continuous health data directly to consumers and healthcare providers.

Key Products

1. Evie Ring

  • Launched in November 2023.
  • Design: Wearable, specifically targeted at women.
  • Functionality: Offers health and wellness metrics including:
    • Resting heart rate
    • Heart rate variability (HRV)
    • Blood oxygen saturation (SpO₂)
    • Respiration rate
    • Skin temperature variability
    • Menstrual tracking: period and ovulation
    • Menstrual symptoms
    • Activity profile: steps, active minutes, calories burned
    • Sleep stages and duration
    • Mood tracking
  • Market Status: Commercialized as a general wellness device without FDA premarket clearance.

2. EvieMED Ring

  • FDA 510(k) clearance received in November 2024.
  • Functionality: Adds FDA-cleared pulse oximetry (pulse rate, SpO₂).
  • Use: Focused on clinical, post-clinical trial management, remote patient monitoring, and apps requiring medical-grade data.
  • Market Approach: Sold via prescription only.

3. Proprietary System-on-a-Chip (SoC)

  • Development: Smallest patented SoC designed for blood pressure and continuous glucose monitoring (CGM).
  • Capabilities:
    • Non-invasive, cuffless blood pressure tracking
    • Non-invasive CGM, aiming for a Class II FDA-cleared device
    • Uses multi-antenna RF technology to identify RF properties in arteries to measure blood glucose and blood pressure
  • Current Status: Conducting clinical trials; accuracy studies (e.g., October 2023 blood pressure study showing promising results).

Technology & Innovation

  • Combining optical sensors for pulse and SpO₂.
  • Developing RF-based sensors for non-invasive blood pressure and glucose.
  • Incorporating machine learning and cloud analytics for trend analysis and predictive insights.
  • Targeting integration of multiple vital signs (heart rate, HRV, SpO₂, glucose, blood pressure) into wearable form factors.

Customer & Market

  • Consumers: Women (initial focus), along with potential clinical, research, and healthcare provider markets.
  • Healthcare & Clinical Applications:
    • Remote patient monitoring
    • Clinical trials
    • Long-term health management
  • Regulatory Milestones:
    • FDA clearance for pulse oximetry (EvieMED Ring) in November 2024
    • Plans to seek additional FDA clearances for glucose and blood pressure monitoring.

Business & Financials

  • Number of Employees: 32 full-time employees (as of December 31, 2024).
  • Revenue:
    • 2024: ~$1.0 million (generated from product sales).
    • 2023: $0 (no revenue recognized).
  • Net Loss:
    • 2024: $23.7 million.
    • 2023: $29.3 million.
  • Liquidity:
    • Cash & equivalents (Dec 31, 2024): $7.9 million.
    • Cash used in operations (2024): ~$22.5 million.
  • Market Capitalization: ~$25.2 million as of the last business day of Q2 2024.
  • Outstanding Shares: 7,036,953 shares as of April 7, 2025.

Business Strategy

  • Direct-to-consumer sales via website and retail.
  • Partnership with OEMs, VAs, and industry collaborators.
  • Emphasis on clinical and enterprise markets (e.g., remote health monitoring, clinical trials).
  • Focus on obtaining further FDA clearances for advanced health metrics.

Intellectual Property

  • Owns or has exclusive rights to 32 issued patents (expiring 2039-2040).
  • 5 pending patent applications in the U.S. and international markets.
  • Patents cover system, method, and device innovations for health monitoring.

Regulatory Status

  • Consumer Devices: No FDA clearance required.
  • Medical Devices (EvieMED Ring): FDA cleared in Nov 2024; classified as Class II.
  • Planned Future Devices: Aiming for additional FDA clearances for blood pressure and glucose monitoring.
  • Certifications & Regulations: Subject to FDA, FCC, and privacy laws (e.g., HIPAA, GDPR).

Summary

Movano Inc. develops cutting-edge wearable health devices that provide continuous, medical-grade vital signs data primarily aimed at women and healthcare settings. The company has launched the Evie Ring for wellness purposes and recently obtained FDA clearance for the EvieMED Ring’s pulse oximetry feature. It is actively working on ultra-compact RF SoC technology for cuffless blood pressure and non-invasive glucose monitoring, with clinical trials ongoing. The company is in the early stages of commercial revenue, with a net loss and limited liquidity, heavily reliant on future capital raises and regulatory approvals.