ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025
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EINDHOVEN, The Netherlands, Sept. 02, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (OTC:ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announces its results for the first half of 2025:
Commercial traction: The Company met its objective of 30 ARC-EX® Systems sold to US clinics in H1 as part of the planned phased launch, demonstrating strong commercial traction for this groundbreaking external spinal stimulation system.
Regulatory milestones: The Company submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand the ARC-EX label to include home use. The Company also filed a CE Mark application to enable ARC-EX commercialization in Europe. Additionally, the FDA approved an investigational device exemption (IDE) for the ARC-IM® System, allowing the initiation of Empower BP, a global pivotal study designed to assess the safety and efficacy of the technology to address blood pressure instability after SCI.
Science & technology leadership: The Pathfinder2 study found that sustained access to ARC-EX Therapy can continue to drive improvements after one year of treatment. The ARC-IM platform reached a new milestone with the first human implant of the investigational ARC-IM Lumbar Lead, designed to help restore mobility. Two additional individuals received the investigational ARC-BCI® Therapy, leveraging ONWARD's brain-computer interface (BCI) technology to restore thought-driven movement.
Financial highlights: The Company ended the first half of the year with revenues, cash balance, and a financial profile in line with expectations.
"In the first half of 2025, we saw robust demand for our ARC-EX System in the US and continued to gain commercial traction," said Dave Marver, Chief Executive Officer of ONWARD Medical. "We also achieved a significant regulatory milestone with FDA IDE approval for the Empower BP study. With continued focus and capital efficiency, we look forward to successfully completing that study so we can bring the ARC-IM System to people with SCI challenged by blood pressure instability."
Commercial traction
The Company met its Q1 objectives for the limited initial phase of the ARC-EX System launch, deploying a US field organization, establishing a sales and service process, and building a roster of reference clinics. ONWARD further delivered a strong performance in Q2. In line with its H1 sales target, a total of 30 systems were sold to US clinics in the first half of the year. Positive feedback and strong demand from users reinforce confidence in the Company's outlook for the second half of the year.
Earlier in 2025, the Company secured access to prominent online US government procurement platforms, enabling Veterans Affairs (VA) and other US government buyers to purchase the ARC-EX System.
Regulatory milestones
ARC-EX System
ONWARD announced the submission of two major regulatory applications intended to offer improved and more convenient access to the ARC-EX System for people living with SCI in the US and EU. Following the successful initial phase of its US launch to clinics, the Company submitted a 510(k) application to the FDA seeking clearance to expand its label for home use. The Company also filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU and other countries recognizing CE Marking.
ARC-IM System
ONWARD recently announced that the FDA has approved an investigational device exemption (IDE) for the ARC-IM System. This approval allows the initiation of Empower BP, a global pivotal study to assess the safety and efficacy of the implantable neurostimulation technology to address blood pressure instability after SCI.
Empower BP is a randomized, double-blind, sham-controlled study that is expected to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada, and Europe. First patient enrollment is anticipated before the end of the year. The study will target participants with injuries at spinal cord levels C2-T6, injury severities of AIS A-D, and blood pressure instability characterized by chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia (AD).
Science & technology leadership
ARC-EX System
Earlier this year, positive results from the investigator-sponsored Pathfinder2 study were published in Neuromodulation: Technology at the Neural Interface. The study results further expanded the body of clinical evidence supporting the ARC-EX System. The one-year trial found that ARC-EX Therapy, combined with activity-based rehabilitation, delivered significant functional improvements and continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit.1
As the first and only FDA-cleared technology indicated to improve hand strength and sensation in people with SCI, the ARC-EX System was recognized as one of Fast Company's 2025 World Changing Ideas for its potential to transform lives.
ARC-IM System
The Company announced the first human implant of its ARC-IM Lumbar Lead. The new proprietary lead is designed for placement in the lumbar region of the spinal cord, the optimal location for therapies targeting restoration of standing, stepping, and ...
