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

EINDHOVEN, the Netherlands, June 17, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (OTCQX:ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces its Q1 2025 business update and year-to-date highlights:

Commercial traction: Following FDA market authorization, the Company met its Q1 objective for the limited initial phase of its US launch of the ARC-EX® System, hiring, training and deploying a field organization, establishing a sales and service process, building a roster of reference clinics, and selling ten systems.

Technology advancement: The Company's investigational ARC-IM® and ARC-BCI® platforms reached new milestones with the 4th and 5th successful BCI implants to restore thought-driven movement, and the first human implant of its investigational ARC-IM Lumbar Lead, which is designed to help restore mobility.

Scientific leadership: Further expanding the body of clinical evidence supporting the ARC-EX System, Pathfinder2 study results published in Neuromodulation: Technology at Neural Interface showed that sustained access to ARC-EX Therapy can continue to drive functional improvements. Participants continued to make gains after one year of treatment.

Financial highlights: The Company established a sponsored Level 1 American Depositary Receipt ("ADR") program to facilitate US investor trading and participation in its growth.

"Our Q1 achievements reflect ONWARD's successful transition to a commercial organization that delivers breakthrough therapies to people with spinal cord injuries," said Dave Marver, Chief Executive Officer of ONWARD Medical. "The initial demand for our ARC-EX System and strong positive feedback we've received from users gives us confidence we can deliver against expectations in 2025."

Commercial traction

ONWARD met its Q1 objective for the limited initial phase of its US launch of the ARC-EX System, hiring, training and deploying a field organization, establishing a sales and service process, building a roster of reference clinics, and selling ten systems.

Strong early demand and positive feedback from users suggest the Company expects to meet its 1H sales target of approximately 30 systems and deliver a strong 2025.

The Company also secured access to prominent US government online procurement platforms, enabling Veterans Affairs (VA) and other US government buyers to purchase the ARC-EX System.

Technology advancement

ARC-IM System

In the first quarter, ONWARD announced the first human implant of its ARC-IM Lumbar Lead. The new lead is designed for placement in the lumbar region of the spinal cord, the optimal location for therapies targeting restoration of standing, stepping, and lower limb mobility. The Company's ARC-IM Thoracic Lead has been used in humans since early 2023.

The Company also announced two new grants to support early clinical feasibility studies using its ARC-IM System to help people with Parkinson's disease. The Michael J. Fox Foundation for Parkinson's Research (MJFF) awarded the ...