ONWARD Medical N.V. announced its Q3 results, including 40 ARC-EX Systems sold and over EUR 50 million raised in equity capital. The FDA approved home use of the ARC-EX System, expanding its market reach, while the ARC-IM System received IDE approval for a global pivotal study to address blood pressure instability after SCI.

The Company received CE Mark certification for the ARC-EX System, allowing commercialization in the EU and US. First commercial sales in Europe are expected in Q4, with the ARC-EX System now cleared for home use in the US. The ARC-IM System also received FDA approval for a pivotal study.

Key scientific publications in top journals supported ONWARD’s innovative therapies, demonstrating improvements in blood pressure regulation after SCI with the ARC-IM System. Financially, the Company reported EUR 1.7 million in Q3 revenue and raised over EUR 50 million in equity capital, extending cash runway into Q1 2027.

CEO Dave Marver highlighted the Company’s strong commercial execution, scientific milestones, and financial performance. With continued demand for the ARC-EX System and positive user feedback, ONWARD is poised for growth in 2026. The Company plans to enroll the first patients in the Empower BP pivotal study and explore future indications for its technology.

Read more at GlobeNewswire: ONWARD Medical Drives Strong US ARC-EX Adoption and