ANEUVO, a Los Angeles-based neurostimulation company, has received FDA 510(k) clearance for its ExaStim system, a transcutaneous spinal cord stimulator designed to improve upper extremity motor function in adults with chronic spinal cord injury. The clearance, filed as K252893 and granted on April 16, makes ExaStim the first transcutaneous spinal stimulator cleared for both clinical and home use in the US.
The device delivers electrical stimulation through a flexible pad containing 16 electrodes placed on the skin over the spinal cord. It does not require surgical implantation. Patients control stimulation sessions through a tablet app, and clinicians can adjust parameters remotely. The system is intended for use alongside standard rehabilitation, not as a replacement for it.
The clearance is supported by results from the ASPIRE trial, a multi-site study led by principal investigator Dr. Rebecca Martin at the Kennedy Krieger Institute. ANEUVO says participants who used ExaStim in combination with rehabilitation showed twice the functional improvement in upper extremity tasks compared to those who received rehabilitation alone. Full trial data have not yet been published in a peer-reviewed journal.
ExaStim received its CE mark under Europe’s Medical Device Regulation in April 2025, making it the first spinal cord stimulator to clear MDR. The FDA clearance extends its regulatory footprint to the US market.
ANEUVO was co-founded by CEO Dr. Yi-Kai Lo and Dr. Wentai Liu, a professor of bioengineering at UCLA whose research on implantable electronics spans several decades. The company has not disclosed the price of the ExaStim system or its commercial launch timeline.
The device enters a space occupied by ONWARD Medical’s ARC-EX, another transcutaneous spinal stimulator that received FDA breakthrough device designation. Where ARC-EX has focused primarily on clinical settings, ANEUVO is positioning ExaStim for combined clinical and home use — a distinction that could matter for long-term adoption if insurance coverage follows.