Los Angeles, CA, April 16, 2026 (GLOBE NEWSWIRE) — ANEUVO, a medical technology company advancing non-invasive neuromodulation for people living with spinal cord injury, today announced U.S. Food and Drug Administration (FDA) clearance for its ExaStim® Stimulation System (“ExaStim”), marking a key milestone in the company’s commercial strategy.
The ANEUVO ExaStim Stimulation System delivers personalized transcutaneous spinal cord stimulation, non-invasively, supporting functional neurorehabilitation for patients with paralysis due to spinal cord injury. The company’s platform is built upon its neuromodulation technology designed to enable flexible, scalable, and accessible therapy delivery. ExaStim is approved for both clinic and home use. It is indicated to improve hand sensation and strength in individuals aged 18 to 75 with chronic, non-progressive neurological deficits resulting from incomplete spinal cord injury, when used in conjunction with functional task practice.
ExaStim is a portable neurostimulation system that delivers electrical pulses to stimulate nerves along the spinal cord and dorsal roots. System control is managed via software loaded on a mobile digital device. The system offers patients therapy in both clinical settings and at home, enabling flexible treatment delivery and broader patient access.
FDA clearance allows ANEUVO to introduce ExaStim in the United States while continuing to expand global access to its therapy. ExaStim previously received CE Mark certification in April 2025, becoming the first transcutaneous spinal stimulation therapy broadly approved in the European market for adult spinal cord injury. This approval spans the full continuum of care, including both clinical and home use, and covers all subtypes and stages of spinal cord injury.
“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.”
As ANEUVO expands its global commercial footprint, operations in Europe remain fully uninterrupted following a recent decision by the Unified Patent Court (UPC) Court of Appeal, which upheld the denial of a request for preliminary injunctive relief related to the ExaStim® Stimulation System.
ANEUVO continues to expand access to ExaStim and advance its platform for non-invasive neuromodulation therapies worldwide.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding ANEUVO’s plans and expectations for product development, regulatory readiness and potential regulatory milestones, manufacturing scale-up and quality initiatives, commercialization and market preparation activities, and clinical and evidence-generation efforts. These forward-looking statements are based on ANEUVO’s current expectations and assumptions and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, regulatory review and outcomes; the timing and results of product development, testing, and validation activities; the ability to scale manufacturing and maintain quality systems; market acceptance and adoption; the availability of resources and partners; potential intellectual property disputes or litigation; competitive developments; and other risks inherent in the development and commercialization of medical technologies. Forward-looking statements speak only as of the date hereof, and ANEUVO undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
About ANEUVO
ANEUVO is developing revolutionary bioelectronic medicine to help restore functional independence, improve quality of life, and create a healthier and more equitable world for people living with disabling diseases and conditions. Leveraging the company’s advanced biotechnology platform and deep expertise, ANEUVO is tackling critical healthcare challenges to deliver meaningful solutions to underserved patients in need. For more information, visit www.aneuvo.com.