Aneuvo has received CE mark certification for its ExaStim Stimulation System, allowing the company to begin commercial rollout of its non-invasive spinal cord therapy device across Europe.
The certification was granted under Medical Devices Regulation (EU) 2017/745 and confirms that the ExaStim system meets the European Union’s health, safety, and environmental standards.
The company stated that this regulatory clearance enables it to introduce ExaStim to the European market through a targeted rollout to selected partner sites. The rollout is described as a critical step in addressing unmet patient needs.
ExaStim is a portable, non-invasive neurostimulation device designed to improve motor function in individuals with chronic spinal cord injury.
The system delivers targeted spinal cord stimulation through a multi-electrode pad and is operated via proprietary programming software installed on a standard mobile digital device. The stimulation is applied externally and does not involve surgical procedures or insertion into the body.
Aneuvo co-founder and Yi-Kai Lo said: “Achieving CE mark certification is a defining moment for ANEUVO and a testament to our commitment to delivering safe, effective, and innovative therapies for individuals with chronic spinal cord injury.
“This accomplishment opens the door for real-world clinical adoption in Europe and the ability to help countless individuals who have been patiently waiting for another therapeutic option.”
Alongside CE mark certification, Aneuvo has also achieved ISO 13485 compliance. This international standard for quality management systems in the medical device sector supports the company’s efforts to align with global safety and reliability requirements.
The company confirmed that the ExaStim Stimulation System is currently only approved for use in the European market. In the US, the device remains investigational and is limited by federal law to investigational use only.
In March, Aneuvo announced the launch of the ASPIRE Home Study, a clinical research initiative intended to expand access to the ExaStim system for individuals with chronic spinal cord injury. The study focuses on the use of ExaStim in a home setting to support improvement in upper limb motor function.
The ASPIRE Home Study will enrol approximately 30 to 35 participants who previously took part in the initial ASPIRE trial. It is structured as a single-arm, prospective, observational study expected to last six months from enrolment to completion. All participants will receive ExaStim therapy for the duration of the study.
