Company Summary: Kestra Medical Technologies, Ltd.

Overview

• Industry: Medical device and digital healthcare
• Focus: Transforming patient outcomes in cardiovascular disease through innovative monitoring and therapeutic intervention technologies
• Core Product: Cardiac Recovery System platform featuring the ASSURE WCD, a next-generation wearable cardioverter defibrillator (WCD)

Key Products & Platform Components

• ASSURE WCD:

  • Purpose-built for patients at elevated risk of sudden cardiac arrest (SCA)
  • Monitors heart rhythm continuously and delivers defibrillation shocks if needed
  • Designed to improve patient comfort, compliance, and reduce false alarms
  • Available in gender-specific styles and multiple sizes
  • Delivers a 170 Joule shock (higher efficacy) with capacity for 25 shocks
  • Approved by the FDA in July 2021
  • Worn by over 20,000 patients since full commercial launch in August 2022

• Digital and Support Solutions:

  • ASSURE patient mobile app
  • Kestra CareStation remote patient data platform
  • Heart Alert Services for real-time arrhythmia alerts
  • ASSURE Assist services for emergency and post-event support
  • ASSURE wearable ECG (launched in May 2024) for post-WCD monitoring

Business Model

• Revenue: Primarily from leasing the ASSURE WCD to healthcare providers
  • Operating as a lease business, with devices returned for reconditioning and reuse
  • Approximate revenue for FY2025: $59.8 million, a 115% increase from FY2024
• Gross Profit:
  • FY2025: $24.2 million
  • FY2024: $0.4 million
• Net Loss:
  • FY2025: $113.8 million
  • FY2024: $94.1 million
• Employees: Over 330 employees, all based in the United States

Market & Customer Base

• Market Penetration:
  • No established public market for the company's shares before March 6, 2025
  • Started trading on Nasdaq on March 6, 2025
  • As of July 16, 2025, 51,348,656 shares outstanding
• Customers:
  • Over 20,000 patients have worn the ASSURE WCD since market launch
  • Focus on hospitals, cardiologists, electrophysiologists
  • Approximately 2,700 hospitals in the U.S. actively prescribe WCDs (based on industry estimates)
• Market Opportunity:
  • U.S. addressable market estimated at $10 billion annually based on patient data and reimbursement rates
  • International markets (including Europe, Japan, etc.) potentially represent an additional $14 billion annual opportunity outside the U.S., with estimates based on epidemiology and reimbursement data
• Insurance & Reimbursement:
  • Broad coverage in the U.S., over 285 million lives covered (~90%) as of April 2025
  • Reimbursed under HCPCS code K0606, approx. $3,519/month for months 1-3
  • Increasing Medicare reimbursement rates (compound annual growth rate of 4.7% from 2021 to 2025)

Strategic Position

• Clinical & Regulatory Milestones:
  • FDA PMA for ASSURE WCD received in July 2021
  • Over 8 clinical publications, including pivotal trials ACE-DETECT and ACE-CONVERT
  • Continuing post-market registry (ACE-PAS) with enrolled over 20,000 patients
• Competitive Advantage:
  • Superior design focused on comfort, compliance, and reduced false alarms
  • Fully integrated digital health platform
  • Patent portfolio with over 365 patents worldwide
  • Digital platform is FDA Class I exempt, enabling rapid updates
• Growth Strategies:
  • Expanding U.S. sales force and clinical support
  • Increasing provider and patient awareness
  • International expansion planned, focusing on CE Mark approval in Europe
  • Building clinical evidence to support broader indications and guidelines
  • Enhancing the digital ecosystem and product offerings

Summary

Kestra Medical Technologies develops and sells the ASSURE WCD, a wearable defibrillator designed to improve patient safety and compliance for those at risk of cardiac arrest. The company has sold over 20,000 units since launching, with revenue reaching nearly $60 million in FY2025. It employs over 330 staff members in the U.S. and trades on Nasdaq (since March 2025). The company targets a US market estimated at $10 billion annually and international markets worth an additional $14 billion, with broad insurance coverage and FDA approval since 2021.