Cionic announced today that the FDA granted clearance for its second-generation product, the Neural Sleeve 2.
Neural Sleeve 2 facilitates muscle re-education to help rewire walking for people with neurological conditions. Those conditions may include multiple sclerosis, cerebral palsy, spinal cord injury, stroke and more. With FDA clearance in hand, the company plans to begin launching the new product across the country.
FDA clearance for the latest Neural Sleeve offering comes more than three-and-a-half years after the company’s first FDA clearance in March 2022. Data shared as recently as last year demonstrated significant improvements in gait for those with multiple sclerosis.
San Francisco-based Cionic says the solution establishes a new benchmark, expanding its indications to include muscle spasm relaxation. Using AI-driven MutliStim technology, the device simultaneously activates muscle movement and relaxes muscle spasms.
With its new indication, the Neural Sleeve 2 not only addresses a neglected challenge for patients, the company says. It also features advanced technology in a sleek, bionic-clothing-inspired form factor for all-day wear. Cionic says its new design enhances flexibility and sizing to fit more users and inspire confidence.
“We are thrilled to launch the Neural Sleeve 2 and reset the standard of mobility care for millions of people with neurological conditions that impact walking,” said Jeremiah Robison, Cionic founder and CEO. “Spasticity is one of the most persistent barriers to mobility, yet it has been neglected for too long. By seamlessly integrating functional muscle activation with relaxation of muscle spasms, our new Neural Sleeve has even greater power to transform daily life for our users.”
