FDA Clears Leg-worn ‘Neural Sleeve’ to Aid Walking

Cionic has received authorization from the U.S. Food and Drug Administration (FDA) to market its lightweight, leg-worn Neural Sleeve to improve walking in people with multiple sclerosis (MS) and other conditions that affect mobility.

The decision comes four months after the company submitted the device — the first to combine movement analysis and augmentation into a wearable garment — for FDA clearance.

Neural Sleeve may be used to facilitate walking in patients with foot drop and/or leg muscle weakness.

“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,” Jeremiah Robison, Cionic’s CEO, said in a press release.

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“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,” added Robison, who founded the company in 2018 to create ways to improve the life of his daughter, who has cerebral palsy.

“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 said.

“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,” Robison added.

Voluntary movement, such as walking, depends on the fast and effective communication between the brain and the involved muscles. That communication, however, often is impaired in people with certain neurological conditions, such as MS, cerebral palsy, stroke, and spinal cord injury.

As such, these patients often experience muscle weakness that frequently affects walking.

Foot drop, a common problem among people with these neurological diseases, is characterized by a person’s inability to raise the toes normally when taking a step. With the toes dragging on the ground, patients are more likely to fall, particularly when walking on uneven surfaces or climbing stairs.

While many of these patients try to compensate by lifting their foot higher when walking, this can be tiring and lead to back and hip pain, which may increase movement instability. Foot drop also can make other aspects of everyday life more challenging, including driving.

Neural Sleeve is the first algorithm-powered bionic clothing designed to help restore mobility in people with neurological conditions.

Made with soft, flexible fabric that is fitted to a person’s leg, the device comes in several colors. Inside that fabric is a dense array of sensors that allow the device to analyze, predict, and augment a person’s movement through the use of advanced algorithms.

It can read the signal sent from the brain to the muscles and predict a person’s movement 1/10th of a second before their foot lifts off the ground. This short time interval allows the device to deliver electrical stimulation to activate the muscles needed to produce a more natural movement, as well as to provide real-time adjustments.

Results from a previous multicenter study, testing the Neural Sleeve in people with foot drop, showed the device led to an average reduction of 143% in foot drop. Also, more than 87% of patients experienced improvements in several parameters involved in foot drop.

Jim Vecchi, an MS patient who participated in Cionic’s trials, said that “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.”

The device “is surprisingly comfortable and my body has become accustomed to wearing it surprisingly quickly,” Vecchi added.

“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,” he said.

Notably, the Neural Sleeve is controlled by its Cionic app, allowing users to easily customize their intervention program, gain insight into their progress, and share data with their healthcare team.

Cionic launched its Founder’s program, in which interested patients can pre-order the Neural Sleeve for $200, with an expected delivery this fall. By adhering to this program, the company’s first set of customers will pay $200 per month for a year, without obligation. Other pricing models may follow.

The payment will cover the sleeve, replacement pieces, and monthly progress assessments.