ANEUVO’s ExaStim® Earns CE Mark Certification
Key Milestone Signals Readiness for European Market Entry and Commitment to Quality
ANEUVO, a pioneer in non-invasive therapy development, proudly announces two pivotal milestones that set the stage for global expansion: achieving ISO 13485 compliance and securing CE Mark certification for its flagship device, the ExaStim® Stimulation System (‘ExaStim’). These accomplishments not only validate ANEUVO’s commitment to the highest standards of quality and safety but also pave the way for the introduction of ExaStim to the European market, starting with a targeted rollout of the therapy to key partner sites, a critical step in addressing unmet patient needs worldwide.
The CE Mark certifies that ExaStim meets the European Union’s stringent health, safety, and environmental protection standards under Medical Devices Regulation (EU) 2017/745. This certification clears the way for the device to be marketed and sold in Europe, enabling clinicians and patients to access a new, innovative therapy that is entirely noninvasive—meaning it does not require surgery, incisions, or insertion into the body—and designed to enhance motor function in individuals with chronic spinal cord injuries (SCI).
"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,” said ANEUVO co-founder and CEO Dr. Yi-Kai Lo.
Achieving ISO 13485 compliance, an internationally recognized standard for quality management systems in the medical device industry demonstrates ANEUVO’s dedication to global safety and reliability standards.
European market introduction represents an important step in ANEUVO’s expansion plans, as the company looks forward to introducing ExaStim in a geography renowned for its leadership in medical innovation. The CE Mark and ISO 13485 compliance signify ANEUVO’s readiness to scale its efforts worldwide, providing industry-changing technology to clinicians and patients globally.
About the ExaStim® Stimulation System
The ExaStim Stimulation System delivers targeted and selective spinal cord stimulation, non- invasively, to facilitate the restoration of damaged corticospinal connections. ExaStim is a portable neurostimulation device that sends pulses of electricity to a multi-electrode pad to stimulate nerves along the spinal cord and dorsal roots. The system is controlled via proprietary programming software on a standard mobile digital device.
The ExaStim® Stimulation System is only approved for the European Market and is an investigational device, limited by Federal (US) law for investigational use in the United States.
Diane Mulligan
