ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025

Core Insights - ONWARD Medical N.V. reported strong demand for its ARC-EX System in the US and achieved FDA IDE approval for the Empower BP study, indicating positive commercial and regulatory momentum [2][6]. Commercial Traction - The company successfully sold 30 ARC-EX Systems to US clinics in the first half of 2025, meeting its sales targets and demonstrating strong demand [3][7]. - Access to US government procurement platforms was secured, allowing Veterans Affairs and other government buyers to purchase the ARC-EX System [4]. Regulatory Milestones - ONWARD submitted a 510(k) application to the FDA for home use of the ARC-EX System and filed for CE Mark certification in the EU [5][7]. - The FDA approved an investigational device exemption (IDE) for the ARC-IM System, enabling the start of the Empower BP study [6][7]. Science & Technology Leadership - The Pathfinder2 study showed that sustained access to ARC-EX Therapy leads to continued functional improvements after one year of treatment [9]. - The first human implant of the investigational ARC-IM Lumbar Lead was successfully completed, aimed at restoring mobility [11]. Financial Highlights - The company reported EUR 1.2 million in revenue for the first half of 2025, with an operating loss of EUR 20.0 million [15][17]. - The cash position at the end of June 2025 was EUR 40.9 million, up from EUR 32.1 million at the end of 2024 [17]. Outlook - Continued strong demand for the ARC-EX System and positive user feedback suggest the company is on track to meet its sales targets for Q3 2025 [18]. - The company anticipates first patient enrollment in the Empower BP study before the end of the year and plans additional implants of its ARC-IM and ARC-BCI systems [19].