ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States
October 13, 2025 – Drug Discovery, Other, Pharmaceutical – ONWARD Medical, neurology, neurotechnology, spinal cord injury
13 October 2025 — EINDHOVEN, the Netherlands — ONWARD Medical N.V., 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 the following key achievements in the third quarter of 2025:
- Commercial traction: 40 ARC-EX® Systems were sold in Q3, demonstrating continued strong commercial traction for the Company’s groundbreaking external spinal cord stimulation technology. More than 50 clinics across the US are now equipped with the ARC-EX System.
- Regulatory milestones: The Company received CE Mark certification for the ARC-EX System, indicated to improve hand strength and sensation after SCI, both in the clinic and at home. Additionally, the US Food and Drug Administration (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 Company’s implanted neuromodulation platform to address blood pressure instability after SCI.
- Science & technology leadership: The Company announced the simultaneous publications of two articles in Nature and Nature Medicine. They highlight advances in blood pressure regulation after SCI and add to the compelling body of scientific and clinical evidence supporting the ARC-IM System ahead of the initiation of the Empower BP global pivotal study.1,2
- Financial highlights: For the first time, the Company exceeded the EUR 1 million mark in quarterly revenue.
“This is another quarter of strong execution marked by accelerating adoption of our ARC-EX System, which is now accessible in over 50 US clinics,” said Dave Marver, CEO of ONWARD Medical. “We look forward to providing a more fulsome update on our Q3 and year-to-date achievements in November.” The Company will deliver a comprehensive business and financial update during its upcoming quarterly call on November 11, 2025.
About ONWARD Medical
ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARC-EX System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM, designed to address several unmet needs including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement. Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com.
