FDA Clears Cionic Neural Sleeve for Patients With Mobility Issues

The Food and Drug Administration (FDA) has cleared the Cionic Neural Sleeve™ for functional electrical stimulation to provide ankle dorsiflexion and/or plantarflexion in adults with foot drop and/or to assist knee flexion or extension in adults with muscle weakness related to neurological conditions (eg, multiple sclerosis, stroke, cerebral palsy, spinal cord injury) to assist in gait.

According to the Company, the Cionic Neural Sleeve, a class II medical device, is the first product to combine movement analysis and augmentation into a wearable garment. It is designed to improve mobility by analyzing, predicting, and augmenting an individual’s movement through advanced sensors and algorithms.

The FDA clearance was based on multicenter studies evaluating its use in patients with foot drop. Patients who were outfitted with the Neural Sleeve demonstrated significant gait improvement, with 94% of patients experiencing increased ankle dorsiflexion at heel strike and 88% with reduced ankle inversion during swing. There was an average combined improvement of 9° among all patients.

Neural Sleeve is now available for pre-ordering for delivery in Fall 2022.

“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,” stated Jeremiah Robison, Founder and CEO of Cionic. “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.”

References

1. Cionic’s Neural Sleeve^TM granted FDA clearance. News release. Cionic, Inc. March 8, 2022. https://www.businesswire.com/news/home/20220308005555/en/Cionic%E2%80%99s-Neural-Sleeve%E2%84%A2-Granted-FDA-Clearance
2. The Cionic Neural Sleeve™. Cionic. Accessed March 8, 2022. https://www.cionic.com/