Cionic’s first product offering, the lightweight leg-worn Cionic Neural Sleeve, has been granted FDA clearance for “functional electrical stimulation to assist in gait for people with foot drop and leg muscle weakness,” the company announces.
This FDA clearance allows Cionic to take its Neural Sleeve to market and begin actively helping people with mobility issues due to multiple sclerosis (MS), stroke, cerebral palsy (CP), and other neurological conditions. The Cionic Neural Sleeve combines movement analysis and augmentation into a wearable garment.
“We are incredibly excited for the Cionic Neural Sleeve to be an FDA cleared Class II medical device and are ready to start impacting the lives of individuals with movement challenges in meaningful ways,” says Jeremiah Robison, Founder and CEO of Cionic. “Our mission is to become the new standard of care by addressing the underlying brain body connections, enabling confident movement, and greater engagement in the community.”
The lightweight and durable Neural Sleeve is designed to help people walk, a fundamental activity key to independent living. However, Cionic has built its platform from the ground up to enable solutions across the mobility spectrum. Cionic completed human factors and efficacy testing and submitted the Neural Sleeve for FDA clearance in November 2021.
“This would not have been possible without the more than 70 individuals across multiple sclerosis, stroke, cerebral palsy, and spinal cord injury who participated in our trials. Together with our research partners at Cleveland State University we were able to demonstrate statistically significant improvement to foot clearance, leading to more stable and confident walking,” Robison continues.
Jim Vecchi, who has been participating in Cionic’s MS trials, describes his experience with the Neural Sleeve.
“Wearing the Neural Sleeve, I move in a way that is more flowing and natural. I am walking more quickly and smoothly, while using less energy in doing so. Already I feel that I am getting stronger and more endurant,” he says. “I should also mention that the Neural Sleeve is surprisingly comfortable and my body has become accustomed to wearing it surprisingly quickly. I do not have the words to properly explain the positive effects on my confidence and outlook. I very much look forward to seeing what progress I can make with the help of the Neural Sleeve.”
To pre-order the Neural Sleeve for delivery later this year visit Cionic to join the Founder’s Program.