Eindhoven, Netherlands — Nov. 24, 2025 — ONWARD Medical N.V. announced a series of major scientific, regulatory, and commercial milestones during Q3 2025, including strong U.S. adoption of its ARC-EX® System, FDA and CE Mark regulatory successes, and publication of key clinical evidence supporting its neuromodulation technologies designed to restore movement and function for people with spinal cord injury (SCI)
Science Significance
ONWARD Medical’s progress reflects a growing scientific foundation behind non-invasive and implantable neuromodulation systems aimed at restoring sensation, strength, and blood pressure stability in SCI patients. Breakthrough publications in Nature, Nature Medicine, and Neurology: Clinical Practice provided compelling evidence that both ARC-EX and ARC-IM platforms deliver measurable improvements: ARC-IM demonstrated immediate stabilization of blood pressure and reduction in hypotensive symptoms, while continued ARC-EX home therapy was shown to extend and maintain functional gains achieved in clinical setting. These peer-reviewed findings significantly strengthen the clinical rationale for next-generation neurotechnology applications.
Regulatory Significance
The company achieved multiple regulatory advances, marking a pivotal quarter for device compliance and global market access. The ARC-EX System received CE Mark certification, enabling commercialization across the European Union for both clinical and home use. In the United States, ONWARD secured FDA 510(k) clearance for home use of ARC-EX, making it the first and only FDA-cleared technology proven to improve hand strength and sensation in individuals with SCI. Additionally, the FDA granted an Investigational Device Exemption (IDE) for the ARC-IM System, allowing initiation of the Empower BP global pivotal trial targeting blood-pressure instability — a major unmet clinical need in SCI care. These regulatory steps create a robust global pathway that aligns with evolving device-quality, safety, and post-market surveillance expectations.
Business Significance
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ONWARD delivered strong commercial momentum, meeting its target of 40 ARC-EX systems sold in Q3, reflecting increased U.S. adoption and availability in more than 60 clinics nationally. Financially, the company exceeded the EUR 1 million quarterly revenue mark for the first time, posting EUR 1.7 million in Q3 revenue. A successful EUR 50 million equity raise in October extended ONWARD’s operational runway into Q1 2027 and attracted high-quality institutional investors, supporting long-term scalability and product development. With multiple analysts initiating coverage with Buy ratings, ONWARD is establishing itself as a leading innovator within the MedTech sector.
Patients’ Significance
For SCI patients, ONWARD’s milestones represent transformative progress toward greater independence, functional recovery, and real-world usability of neurotechnology therapies. The availability of ARC-EX for home use dramatically expands access, allowing patients to continue therapy outside clinical environments and sustain improvements in hand function. The upcoming Empower BP pivotal trial may pave the way for treatment of blood-pressure instability, a life-altering complication for many SCI individuals. Together, these developments enhance the therapeutic landscape and reinforce the company’s mission to deliver non-pharmacological, technology-driven solutions that materially improve quality of life.
Policy Significance
ONWARD’s regulatory success in the U.S. and Europe aligns with broader health-policy priorities encouraging patient-centric device innovation, home-use medical technologies, and expanded access to advanced rehabilitation solutions. The CE Mark and FDA clearances support international harmonization of device-quality standards and may influence future policies governing neuromodulation, digital health integration, and AI-supported medical devices. As ONWARD advances its implanted systems and brain-computer interface-enabled applications, policymakers may increasingly look to such technologies when forming strategies around long-term disability care, rehabilitation reimbursement models, and supportive regulatory pathways for breakthrough devices.
ONWARD Medical’s Q3 2025 achievements represent a significant acceleration across science, regulation, business operations, and patient impact. With strong ARC-EX commercial adoption, expanding global approvals, landmark scientific publications, and a strengthened financial position, the company is poised to advance next-generation neuromodulation therapies into broader clinical use. As Empower BP and additional ARC-IM and ARC-BCI programs progress, ONWARD continues to set a high standard for innovation in neurotechnology and the transformation of SCI care worldwide.
Source: ONWARD Medical N.V. press release
