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EINDHOVEN, the Netherlands, March 31, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD -- US ADR: 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 financial and operating results for the full year 2025:
-- Commercial traction: The Company initiated the commercialization of its
first technology platform and sold 117 ARC-EX$(R)$ Systems, demonstrating
strong commercial traction for its groundbreaking external spinal
stimulation system. ARC-EX was sold to more than 80 US rehabilitation
clinics by the end of the year.
-- Regulatory milestones: The Company received CE Mark certification for the
ARC-EX System for use in both clinics and homes. In November, the US Food
and Drug Administration (FDA) granted 510(k) clearance to expand the
ARC-EX System indication for home use in the US. Additionally, the FDA
approved an investigational device exemption $(IDE)$ for the ARC-IM(R)
System, allowing the initiation of the Empower BP global pivotal study.
-- Science & technology leadership: The Company announced the simultaneous
publications of two articles in Nature and Nature Medicine, further
expanding the body of scientific and clinical evidence supporting ARC-IM
Therapy. Additional publications in Neuromodulation: Technology at the
Neural Interface and Neurology: Clinical Practice added to the body of
clinical evidence supporting ARC-EX. Four additional individuals received
the investigational ARC-BCI(R) Therapy, advancing ONWARD's leadership in
the field of brain-computer interface $(BCI)$ technology to restore
thought-driven movement.
-- Financial results: The Company reported EUR 5.4M in revenue and
successfully raised EUR 50.8M in equity capital in October. It ended the
year with a net cash position of EUR 68.1M.
"In 2025, we established a US commercial organization that drove rapid adoption of our groundbreaking ARC-EX System in US rehabilitation clinics. The FDA 510(k) for home use of ARC-EX further expands the US market opportunity and helps fulfill our mission to provide the SCI community with broad and convenient access to our therapies," said Dave Marver, CEO of ONWARD Medical. "We achieved several scientific, regulatory, and clinical milestones including the initiation of Empower BP, our second global pivotal study. With focus, discipline, and determination, we are poised to accelerate the development and commercialization of the ARC-EX and ARC-IM Systems, addressing the most pressing needs of people living with spinal cord injuries and other movement disabilities."
Commercial traction
The Company launched the ARC-EX System in the US, deploying a US field organization, and establishing a sales and service process. The Company sold 117 ARC-EX Systems in 2025. Positive feedback and continued strong demand drove commercial traction for ONWARD's groundbreaking external spinal cord stimulation technology, which was recognized as one of Fast Company's 2025 World Changing Ideas for its potential to transform lives after SCI. Demonstrating rapid US adoption, the Company sold ARC-EX Systems to more than 80 US clinics by the end of 2025, representing a market penetration of approximately 25% of specialized rehabilitation clinics in the US.
The Company secured access to prominent online US government procurement platforms, enabling the US Department of Veterans Affairs (VA) and other US government buyers to purchase the ARC-EX System.
In the last quarter of the year, the Company initiated the phased launch of ARC-EX in Europe. The Company delivered the first systems to clinics in the Netherlands, Switzerland, Germany, and the UK.
Regulatory milestones
ARC-EX System
In September, the Company received CE Mark certification for the ARC-EX System, allowing commercialization for both clinic and home use in the European Union and facilitating a streamlined regulatory pathway in other countries. As part of the CE Mark application process, the Company achieved its first certification in accordance with the European Medical Device Regulation (MDR), meeting European standards and requirements relating to patient safety, clinical performance, risk management, and post-market surveillance.
In November, the Company received 510(k) clearance to expand the ARC-EX System indication for home use in the US. ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation in people with SCI.
The ARC-EX System also received UL Mark certification, a globally recognized symbol of product safety and quality.
ARC-IM System
The US FDA approved an IDE for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study designed to assess the safety and effectiveness of this breakthrough technology to manage blood pressure instability in people with SCI. Empower BP is the first global pivotal study to evaluate the Company's implantable spinal cord stimulation system. The randomized, double-blinded, sham-controlled study is expected to involve participants across approximately 20 leading neurorehabilitation and neurosurgical research centers in the US, Canada, France, Germany, Spain, and the UK. The first participant enrollment and implant occurred in the first quarter of 2026 at Craig Hospital in Denver, Colorado. 10 clinical sites have been activated and are actively recruiting for Empower BP in the US.
Science & technology leadership
ARC-EX System
Positive results from the investigator-sponsored Pathfinder2 study were published in Neuromodulation: Technology at the Neural Interface. 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) (,5)
Additionally, results of the LIFT Home Study, published in Neurology: Clinical Practice, showed that continued use of ARC-EX Therapy at home is effective in maintaining and extending gains achieved in the clinic.(2)
ARC-IM System
The Company announced the simultaneous publication of two landmark articles in Nature and Nature Medicine. They highlighted advances in blood pressure regulation after SCI and added to the compelling body of scientific and clinical evidence supporting the ARC-IM System ahead of the initiation of Empower BP. Detailed results from multi-year clinical feasibility studies show that participants who received ARC-IM Therapy saw immediate and robust increases in blood pressure, as well as reduced frequency and severity of hypotensive symptoms. The enhanced hemodynamic stability resulted in improved quality of life and greater engagement in rehabilitation and daily life activities.(3,4)
The Company also 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 lower limb mobility.
The Company received new grants to support early clinical feasibility studies using its ARC-IM System to help people with Parkinson's disease. These grants were awarded by The Michael J. Fox Foundation for Parkinson's Research (MJFF) and the US Department of Defense.
ARC-BCI System
The Company announced that four additional individuals living with spinal cord injuries have received ARC-BCI Therapy, advancing ONWARD's leadership in BCI-enabled movement solutions for people with SCI. ARC-BCI is the world's first and most advanced purpose-designed platform pairing a brain-computer interface with an implantable spinal cord stimulation system. In total, seven study participants have now received ARC-BCI Therapy to restore movement of their own paralyzed limbs.
In May, ARC-BCI Therapy was featured on CBS's 60 Minutes with Anderson Cooper, one of the most respected and longest-running US news programs.
Corporate governance
The Company announced the appointment of Professor Tim Denison, PhD, entrepreneur and neurotechnology thought leader, to its Board of Directors. The Company also announced the appointment of Lucas Buchanan to its Board of Directors. Buchanan is a well-respected medtech operations and finance leader with NASDAQ-listed company experience.
In January 2026, the Company announced the appointment of Ali Kiboro as Chief Financial Officer, joining ONWARD from AliveDx (formerly Quotient Limited, a NASDAQ-listed company).
Financial results
The Company reported EUR 5.4M in total revenue. Revenue from the sale of ARC-EX Systems grew from EUR 0.08M in 2024 to EUR 3.7M in 2025. Other income, mainly grant income, remained consistent year over year at EUR 1.7M.
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March 31, 2026 01:30 ET (05:30 GMT)
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