ONWARD Medical Surges on Commercial Success, Eyes NASDAQ Listing

EINDHOVEN, the Netherlands – March 31, 2026 – Neurotechnology firm ONWARD Medical N.V. has marked a pivotal year in its transition from a research-focused entity to a commercial powerhouse, reporting significant sales growth and major regulatory victories for its therapies aimed at restoring function in people with spinal cord injuries (SCI).

In its full-year 2025 results announced today, the company revealed total revenues of €5.4 million, a sharp increase from €1.7 million in the previous year. This growth was overwhelmingly driven by the successful US launch of its ARC-EX® System, an external device that uses programmed electrical stimulation to improve hand strength and sensation. Product sales skyrocketed from a mere €80,000 in 2024 to €3.7 million in 2025, signaling strong market acceptance and validating the company's commercial strategy.

Bolstering its financial position, ONWARD successfully raised €50.8 million in new equity capital in October, ending the year with a robust net cash position of €68.1 million. This financial cushion is projected to fund operations into the first quarter of 2027 and fuel the company's ambitious plans, which include a potential initial public offering on the NASDAQ stock exchange within the next 12 to 18 months.

“In 2025, we established a US commercial organization that drove rapid adoption of our groundbreaking ARC-EX System in US rehabilitation clinics,” said Dave Marver, CEO of ONWARD Medical. “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.”

A Commercial Leap into the US Market

The company’s 2025 performance underscores a successful leap into the competitive US healthcare market. ONWARD sold 117 ARC-EX Systems to over 80 rehabilitation centers, achieving what it estimates to be a remarkable 25% market penetration of specialized US clinics within its first year of commercialization. This rapid adoption suggests a significant unmet need for non-invasive therapies that can produce tangible functional gains for individuals with SCI.

The ARC-EX system, recognized by Fast Company as one of its 2025 World Changing Ideas, works by delivering targeted electrical stimulation to the spinal cord through pads placed on the skin. This therapy, combined with functional task practice, has been shown in clinical studies to improve upper body strength, sensation, and trunk control. The company also secured access to key US government procurement platforms, opening the door for sales to the Department of Veterans Affairs (VA) and other federal agencies.

While the US was the primary focus, ONWARD also began a phased launch in Europe during the last quarter of 2025, delivering its first systems to clinics in Germany, the Netherlands, Switzerland, and the UK.

Breaking Barriers: From Clinic to Home

A critical component of ONWARD's strategy is expanding patient access beyond the walls of rehabilitation centers. The company achieved two monumental regulatory milestones in 2025 that are central to this goal. In November, the US Food and Drug Administration (FDA) granted 510(k) clearance for the ARC-EX System to be used in a home setting. This makes it the first and only FDA-cleared technology of its kind for home use, allowing patients to continue their therapy and potentially maintain and extend gains achieved in the clinic.

This US clearance followed the receipt of a CE Mark certification in Europe, which approved the ARC-EX System for both clinical and home use across the European Union. Achieving this certification under the stringent new European Medical Device Regulation (MDR) further solidifies the product's safety and performance credentials on the global stage.

“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,” Marver noted in the company's announcement.

The Next Frontier: Implants and Brain-Computer Interfaces

While ARC-EX drives current revenue, ONWARD is aggressively advancing its pipeline of next-generation implantable technologies. The company received a significant green light from the FDA with an Investigational Device Exemption (IDE) for its ARC-IM® System. This approval allowed for the initiation of the Empower BP global pivotal study, a randomized, double-blinded trial designed to evaluate the implantable system's effectiveness in managing blood pressure instability, a severe and common complication following spinal cord injury. The first participant was enrolled and implanted in early 2026.

Scientific validation for this approach was bolstered by the simultaneous publication of two articles in the prestigious journals Nature and Nature Medicine, highlighting the therapy's potential to restore hemodynamic stability and improve quality of life. The ARC-IM platform is also being developed to target other functions, with the company announcing plans for a first-in-human study to explore its potential to restore bladder control.

Perhaps the most futuristic element of ONWARD's work is its ARC-BCI® System, which pairs the spinal implant with a brain-computer interface (BCI) to restore thought-driven movement. The company announced that four more individuals with paralysis received the investigational therapy in 2025, bringing the total to seven participants who are pioneering this groundbreaking approach. The technology, which captured public imagination through a feature on CBS's 60 Minutes, represents a potential paradigm shift in treating paralysis.

Fortifying the Financial Future for Sustained Growth

ONWARD's strategic advancements are backed by a carefully managed financial plan. While the company's operating loss grew to €40.9 million in 2025 from €34.9 million in 2024, the increase was a planned consequence of its growth. Marketing and market access expenses surged by 142% to €8.1 million as the company built its US commercial infrastructure. At the same time, R&D spending decreased by 11% as projects transitioned from development to clinical and commercial stages.

This calculated investment was made possible by a successful €50.8 million equity financing round in October. The strong support from new and existing investors provides the company with a cash runway projected to last into the first quarter of 2027, enabling it to execute its ambitious clinical and commercial roadmaps.

As a clear signal of its global ambitions, ONWARD filed an F-1 registration statement with the U.S. Securities and Exchange Commission (SEC) for a potential NASDAQ listing. To support this, the company has strengthened its leadership, appointing a new CFO and two new board members with deep experience in NASDAQ-listed medtech companies. A successful US listing would provide access to a deeper pool of capital and raise the company's profile as it continues to push the boundaries of what's possible in neurorehabilitation.