ONWARD Medical N.V. announces results for the first half of 2025, including meeting commercial objectives, submitting regulatory applications, achieving scientific milestones, and maintaining financial stability.
Commercial traction: The Company sold 30 ARC-EX® Systems to US clinics in H1, showing strong commercial traction for spinal stimulation therapy. Regulatory milestones: Filed a 510(k) application for ARC-EX home use in the US, CE Mark application for EU commercialization, and FDA IDE for ARC-IM® System study. Science & tech: Pathfinder2 study showed sustained improvements with ARC-EX Therapy, first human implant of ARC-IM Lumbar Lead, and two successful ARC-BCI® implants. Financials: Ended H1 with expected revenues and cash balance. CEO optimistic about future success.
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