Cionic gains FDA approval for leg-worn device to improve mobility

Cionic scored FDA 510(k) approval for its Neural Sleeve, a legging that provides electrical stimulation so people with foot drop and muscle weakness can walk more easily.

The leg-worn device, which is officially the green light from the agency in mid-February, is aimed at people with neurological conditions such as multiple sclerosis, stroke and cerebral palsy. The electrical stimulation of the sleeve helps users flex the foot upward and curl the toes toward the sole, making it easier for them to move.

Cionic said the device will be available later this year.

“We are incredibly excited that the Cionic Neural Sleeve is an FDA-approved Class II medical device and is poised to meaningfully impact the lives of individuals with movement problems,” Founder and CEO Jeremiah Robison said in a statement.

“Our mission is to become the new standard of care by targeting the underlying brain-body connections, enabling confident movement and greater community involvement.”

WHY IT MATTER

Foot fall, the inability to lift the front part of the foot, can be a permanent disability if it is caused by a neurodegenerative condition such as multiple sclerosis. According to the NIH, people with the condition are more likely to fall, which can have particularly serious consequences for the elderly.

Mobility loss can also have other serious health effects. Older adults with mobility loss have higher rates of illness, disability, hospitalization and death. They will also be less likely to age in their home.

THE BIGGER TREND

Another company focused on neurodegenerative diseases is MindMaze, which announced it had Raised $105 million last month and scored $125 million in October. The company makes video game-like therapies for rehabilitation, such as the MindMotion Go platform that helps people with conditions such as stroke improve their motor skills.

MedRhythms offers a digital therapy that uses sensors in combination with an app and music to improve the movement capabilities of people with neurological disorders or injuries. The company earned the FDA’s Breakthrough Device Designation in 2020 to treat chronic gait impairment from stroke. In November, the startup announced that it had closed a $27 million Series B financing round.