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] Commercial Traction - A total of 40 ARC-EX Systems were sold in Q3 2025, showcasing continued strong commercial traction for the external spinal cord stimulation technology [4] - More than 50 clinics across the US are now equipped with the ARC-EX System, enhancing its market presence [4] Regulatory Milestones - The ARC-EX System received CE Mark certification, which is intended to improve hand strength and sensation after spinal cord injury, applicable both in clinical settings and at home [4] - The FDA approved an investigational device exemption (IDE) for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study to assess safety and efficacy in addressing blood pressure instability after spinal cord injury [4] Science & Technology Leadership - The company announced the simultaneous publication of two articles in Nature and Nature Medicine, which highlight advances in blood pressure regulation after spinal cord injury, supporting the scientific basis for the ARC-IM System [4] Financial Highlights - For the first time, ONWARD Medical exceeded EUR 1 million in quarterly revenue, marking a significant financial milestone [4]