Los Angeles-based Aneuvo designed ExaStim to deliver non-invasive, personalized transcutaneous SCS therapy. It supports functional neurorehabilitation for patients paralysis due to spinal cord injury (SCI). The company built its platform on neuromodulation technology designed to enable flexible, scalable, accessible therapy delivery.
ExaStim’s approval covers both clinic and home use. It’s indicated to improve hand sensation and strength in individuals aged 18 to 17 years old with chronic, non-progressive neurological deficits resulting from incomplete spinal cord injury, when used in conjunction with functional task practice.
The company says its portable neurostimulation system delivers electrical pulses to stimulate nerves along the spinal cord and dorsal roots. Software on a mobile digital device manages the system control during the flexible therapy.
Aneuvo said FDA clearance enables U.S. market introduction while it expands global access. The technology already carries CE mark in Europe. However, the company has faced scrutiny from competition, as fellow SCS developer Onward Medical made a request for preliminary injunctive relief. However, the Unified Patent Court recently upheld the denial of that request.
“This clearance represents an important step forward for individuals living with SCI,” said Dr. Yi-Kai Lo, CEO of Aneuvo. “We’re providing a non-invasive solution designed for both clinic and home use, which expands access and helps patients achieve meaningful progress in their continued recovery. As we scale globally, our focus remains on precision execution, allowing innovation to help more people.”
