ONWARD Medical Drives Strong US ARC-EX Adoption and Achieves Important Scientific and Regulatory Milestones in Q3 2025

Core Insights - ONWARD Medical N.V. reported strong commercial execution and achieved significant scientific and regulatory milestones in Q3 2025, enhancing its market position in neurotechnology for spinal cord injuries [1][7] Commercial Traction - The company sold 40 ARC-EX Systems in Q3 2025, indicating robust demand for its external spinal cord stimulation technology [2][7] - ARC-EX Therapy is now available in over 60 clinics across the US, expanding access to innovative therapies for the SCI community [2] Regulatory Milestones - ONWARD Medical received CE Mark certification for the ARC-EX System, allowing for commercialization in both clinic and home settings within the European Union, with first sales expected in Q4 2025 [3] - The company obtained 510(k) clearance from the US FDA for the ARC-EX System for home use, marking it as the first FDA-cleared technology to improve hand strength and sensation in individuals with SCI [4] - The FDA also approved an investigational device exemption (IDE) for the ARC-IM System, enabling the start of the Empower BP global pivotal study to assess blood pressure management in SCI patients [5][7] Science & Technology Leadership - Two landmark articles were published in Nature and Nature Medicine, showcasing advances in blood pressure regulation after SCI and supporting the clinical evidence for the ARC-IM System [6][7] - Results from the LIFT Home Study published in Neurology: Clinical Practice demonstrated the effectiveness of continued ARC-EX Therapy at home in maintaining and extending clinical gains [8] Financial Highlights - The company reported EUR 1.7 million in revenue for Q3 2025, surpassing the EUR 1 million mark for the first time [9][7] - In October 2025, ONWARD Medical successfully raised over EUR 50 million in equity capital, providing a cash runway into Q1 2027, with a cash balance of EUR 77.7 million as of October 31, 2025 [10][7] Outlook - Continued demand for the ARC-EX System and positive user feedback suggest a strong commercial performance in 2026, supported by recent regulatory approvals [12] - The company anticipates the first patient enrollment in the Empower BP pivotal study before the end of 2025 and plans to explore additional indications for its ARC-IM and ARC-BCI Systems [13]