Spinal injury game-changer: Aneuvo’s ExaStim approved for Europe in major health milestone

Aneuvo has reached a significant regulatory and commercial inflection point by earning CE Mark certification under the European Union’s Medical Devices Regulation (EU) 2017/745 and achieving ISO 13485 compliance. These dual milestones position the California-based medical technology company to advance its non-invasive spinal cord therapy device, the ExaStim Stimulation System, across key European healthcare markets.

The CE Mark, granted after rigorous technical and clinical validation, confirms that the ExaStim Stimulation System complies with essential safety, health, and environmental standards required to commercialize medical devices in the European Economic Area. Complementing this, ISO 13485 certification underlines Aneuvo’s commitment to maintaining a globally harmonized quality management system tailored for the medical device industry, a prerequisite for scaling operations into regulated markets.

These certifications open the door for the ExaStim device to be marketed and sold across Europe, a region known for its emphasis on innovation in patient care and robust regulatory oversight. It also allows the company to build strategic clinical and distribution partnerships in countries that align closely with the EU framework.

How does ExaStim work as a non-invasive spinal cord stimulation system?

At the heart of Aneuvo’s product portfolio is the ExaStim Stimulation System, a novel non-invasive neuromodulation device developed specifically to restore motor function in individuals with chronic spinal cord injury (SCI). ExaStim delivers electrical pulses to the spinal cord through a wearable multi-electrode pad, eliminating the need for surgical procedures that are common with traditional implantable neurostimulation systems.

The device targets the corticospinal tract, a pathway critical to voluntary movement, with the goal of restoring upper limb function in people who have lost mobility due to traumatic or degenerative spinal cord conditions. Unlike traditional invasive systems, which require implantation through surgery, ExaStim uses a wireless interface and mobile device–based software to customize treatment protocols in real time. This combination of targeted stimulation and digital flexibility makes the device particularly suitable for both clinical and at-home environments.

The system is currently approved only in the European market and remains under investigation in the United States, subject to federal restrictions for non-commercial use.

Why is the European medical device market important for Aneuvo?

Europe represents a strategic launchpad for medical device innovators due to its transparent regulatory framework, emphasis on patient safety, and openness to technological advancements in rehabilitation. For Aneuvo, entering the European market with a CE Mark provides validation not just of the device’s compliance, but of its clinical potential and scalability.

The region’s healthcare infrastructure includes leading spinal cord injury rehabilitation centres and institutions actively participating in neuromodulation research. By targeting early deployments in high-impact clinical settings across Europe, Aneuvo can both build clinical evidence and foster adoption among neurologists, physiatrists, and rehabilitation specialists who are actively searching for safer, more accessible alternatives to invasive neurostimulators.

Moreover, the EU’s regulatory requirements are often used as benchmarks in other regions, including Latin America, Asia-Pacific, and parts of the Middle East and Africa, potentially laying the foundation for future international approvals and partnerships.

What is the role of the ASPIRE Home Study in validating ExaStim’s clinical value?

In parallel with its regulatory progress in Europe, Aneuvo is advancing clinical evidence for ExaStim through the ASPIRE Home Study—an extension of its earlier ASPIRE trial. This new observational study seeks to explore the feasibility of delivering neuromodulation therapy in a home-based setting, particularly for individuals who face mobility barriers that prevent regular clinic visits.

The six-month study will enrol approximately 30 to 35 participants, all of whom were previously enrolled in the original ASPIRE clinical trial. These individuals are living with chronic spinal cord injury and will use the ExaStim system at home to address impairments in upper limb motor function.

Conducted as a single-arm, prospective observational trial, the ASPIRE Home Study not only evaluates the device’s impact outside a clinical setting but also tests the operational viability of Aneuvo’s remote therapy support model. Results from the study will be instrumental in shaping reimbursement strategies, post-market surveillance, and long-term adoption pathways in both regulated and emerging markets.

How is Aneuvo positioned in the growing neurorehabilitation technology market?

Aneuvo is emerging at a time when demand for advanced neurorehabilitation technologies is rising, driven by aging populations, increasing incidence of spinal injuries, and evolving reimbursement models that favour non-invasive care. The company’s focus on non-invasive spinal cord stimulation aligns with macro trends across both healthcare policy and clinical research, where risk-reduction, portability, and home therapy delivery are becoming central to innovation.

According to global market analysis, the neurostimulation sector is expected to surpass $15 billion in value by the end of the decade, propelled by breakthroughs in non-invasive therapies and AI-guided rehabilitation tools. Aneuvo’s ExaStim stands out in this context due to its unique targeting mechanism, home compatibility, and CE-approved status—a combination that positions it competitively against more traditional invasive options from larger incumbents.

Expert observers note that the absence of surgical risk, combined with the ExaStim system’s digital programmability, gives Aneuvo a distinct edge in expanding into outpatient and at-home rehabilitation settings, which are forecast to be major growth areas within neurological care.

What’s next for Aneuvo after CE Mark approval?

With CE Mark certification secured, Aneuvo plans to roll out ExaStim in collaboration with selected European medical partners. Initial deployments are likely to focus on rehabilitation centres and clinics specializing in chronic SCI care. These early partnerships will serve as hubs for training clinicians, gathering post-market evidence, and adapting the device for local healthcare workflows.

Simultaneously, Aneuvo is expected to advance U.S.-based research through its ongoing ASPIRE initiatives while preparing for future regulatory submissions to the U.S. Food and Drug Administration. These dual tracks—European commercialization and U.S. clinical validation—reflect a strategic approach to scaling safely and sustainably across key global markets.

The broader ambition, according to company disclosures, is to build a platform of non-invasive neural therapies that can be expanded beyond spinal cord injury to other neurodegenerative and neurological conditions.

As Aneuvo continues to scale, its emphasis on clinical evidence, quality assurance, and non-invasive innovation may offer an alternative to invasive implants and stimulate a new wave of accessibility in neurorehabilitation. The CE Mark for ExaStim is more than a regulatory green light—it’s a signal that the landscape of spinal cord injury treatment is evolving toward safer, more inclusive solutions.