ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States

Core Insights - ONWARD Medical N.V. has reported strong execution in Q3 2025, with the ARC-EX System now available in over 50 US clinics, indicating accelerating adoption of its neurotechnology solutions [1][4] - The company will provide a comprehensive business and financial update on November 11, 2025 [1] Company Overview - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [2] - The company has developed ARC Therapy, receiving 10 Breakthrough Device Designations from the FDA, and its ARC-EX System is cleared for commercial sale in the US and Europe [2] Commercial Performance - In Q3 2025, ONWARD Medical sold 40 ARC-EX Systems, demonstrating strong commercial traction [4] - The company has surpassed EUR 1 million in quarterly revenue for the first time [4] Regulatory Milestones - The ARC-EX System received CE Mark certification for improving hand strength and sensation after spinal cord injury [4] - The FDA approved an investigational device exemption for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study [4] Scientific Contributions - The company announced the publication of two articles in Nature and Nature Medicine, highlighting advances in blood pressure regulation after spinal cord injury [4]