ONWARD Medical Advances in Neurotechnology and Commercial Traction in 2025

ONWARD Medical N.V., a leading player in neurotechnology, reports significant advancements in the first half of 2025. The company sold 30 ARC-EX® Systems to US clinics, demonstrating strong commercial traction. Regulatory milestones include filing a 510(k) application with the FDA for home use clearance and a CE Mark application for European commercialization. Additionally, the FDA approved an investigational device exemption for the ARC-IM® System, enabling the Empower BP study to commence. The study aims to evaluate how the technology addresses blood pressure instability post-spinal cord injury (SCI).

The company continues to lead in science and technology with long-term improvements observed in the Pathfinder2 study using ARC-EX Therapy. The ARC-IM platform achieved a new milestone with its first human implant. ONWARD is also expanding its brain-computer interface applications, indicated by recent ARC-BCI® Therapy trials. Financially, the company posted EUR 1.2 million in revenue with a positive cash balance of EUR 40.9 million, aligning with its forecasts.