ONWARD Medical Reports Strong 2025 Progress with Commercial Momentum and Key Regulatory Milestones

ONWARD Medical reported significant financial and operational progress for the full year 2025, marked by growing commercial traction, major regulatory achievements, and continued scientific advancements. “In 2025, we established a US commercial organisation that drove rapid adoption of our groundbreaking ARC-EX System in US rehabilitation clinics,” said Dave Marver, CEO of ONWARD Medical. “The FDA 510(k) for home use of ARC-EX further expands the US market opportunity and helps fulfil our mission to provide the spinal cord injury community with broad and convenient access to our therapies.”

The company generated €5.4 million in revenue during the year and strengthened its financial position by raising €50.8 million in equity capital in October. ONWARD ended 2025 with a net cash position of €68.1 million, providing a solid foundation to support ongoing development and commercialisation efforts.

Commercially, ONWARD launched its first technology platform and sold 117 ARC-EX Systems, with installations across more than 80 rehabilitation clinics in the United States. The ARC-EX system, an external spinal stimulation device, is designed to help restore movement and function in individuals with spinal cord injuries.

On the regulatory front, the company achieved several milestones. It secured CE Mark certification for the ARC-EX System for both clinical and home use in Europe, while the U.S. Food and Drug Administration granted 510(k) clearance to expand the device’s indication for home use in the United States. Additionally, the FDA approved an investigational device exemption for the ARC-IM System, enabling the launch of the global Empower BP pivotal study.

ONWARD also reinforced its scientific leadership with multiple high-impact publications, including studies in Nature and Nature Medicine, supporting the efficacy of its ARC-IM therapy. Further clinical evidence for ARC-EX was published in leading journals, while progress continued in its ARC-BCI program, advancing brain-computer interface technologies aimed at enabling thought-driven movement.

With strong momentum across commercial, regulatory, and research fronts, ONWARD Medical is well-positioned to accelerate innovation and expand access to therapies addressing spinal cord injuries and other movement disabilities.