ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Reinforces its Brain-Computer Interface Leadership in Q1 2025

Core Insights - ONWARD Medical N.V. has successfully transitioned to a commercial organization, achieving significant milestones in the first quarter of 2025, particularly with the launch of the ARC-EX System and positive user feedback [1][12] Commercial Traction - The company met its Q1 objective for the initial phase of the US launch of the ARC-EX System, hiring and training a field organization, establishing sales processes, and selling ten systems [2][7] - Strong early demand indicates the company expects to meet its first half sales target of approximately 30 systems [2][12] - ONWARD secured access to US government online procurement platforms, allowing Veterans Affairs and other government buyers to purchase the ARC-EX System [3] Technology Advancement - The first human implant of the ARC-IM Lumbar Lead was announced, designed for optimal placement in the lumbar region to restore mobility [4] - The company received two grants for early clinical feasibility studies using the ARC-IM System to assist individuals with Parkinson's disease, totaling USD 2.5 million [5] - Preparations are underway for the Empower BP global pivotal study to assess the ARC-IM System's efficacy in addressing blood pressure instability after spinal cord injury, pending FDA approval [6][13] Scientific Leadership - The Pathfinder2 study results published in a peer-reviewed journal demonstrated that sustained access to ARC-EX Therapy can lead to continued functional improvements over one year [10] - The company announced successful implants of its ARC-BCI technology, reinforcing its leadership in developing brain-computer interface solutions for spinal cord injury [8][9] Financial Highlights - The company reported EUR 0.4 million in revenue for Q1 2025 and ended the quarter with net cash of EUR 50.5 million [11] - A sponsored Level 1 American Depositary Receipt (ADR) program was established to facilitate US investor participation [11] Outlook - ONWARD anticipates FDA clearance for the ARC-EX System for home use and CE Mark authorization for marketing in Europe [13] - The company plans to continue additional implants of the ARC-IM System and ARC-BCI to explore further indications in spinal cord injury and Parkinson's disease [13]