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 ARC-EX System, which has received strong initial demand 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, successfully hiring and training a field organization, establishing sales processes, and selling ten systems [2][7]. - ONWARD anticipates meeting its first half sales target of approximately 30 systems, indicating a strong outlook for 2025 [2][12]. - The company secured access to prominent US government online procurement platforms, allowing Veterans Affairs and other government buyers to purchase the ARC-EX System [3]. Technology Advancement - ONWARD announced the first human implant of its ARC-IM Lumbar Lead, designed for optimal placement in the lumbar region to restore standing and lower limb mobility [4]. - The company received two grants to support early clinical feasibility studies using the ARC-IM System for addressing mobility challenges in Parkinson's disease, including a USD 1M grant from the Michael J. Fox Foundation and a USD 1.5M grant from the US Department of Defense [5]. - The company is preparing to initiate the Empower BP global pivotal study to assess the safety and efficacy of the ARC-IM System for 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 in individuals with spinal cord injuries [10]. - The company announced the successful 4th and 5th implants of its ARC-BCI technology, reinforcing its leadership in developing brain-computer interface solutions for movement restoration [8]. Financial Highlights - For Q1 2025, ONWARD reported EUR 0.4M in revenue and ended the quarter with net cash of EUR 50.5M [11]. - The company established a sponsored Level 1 American Depositary Receipt (ADR) program to facilitate US investor participation in its growth [11]. Outlook - ONWARD expects to receive FDA clearance for the ARC-EX System for home use and anticipates CE Mark authorization for marketing in Europe [13].