Dive Brief:

• FDA has authorized Helius Medical Technologies' neuromodulation stimulator to improve the gait of multiple sclerosis patients as a short-term treatment of motor deficits due to mild to moderate MS symptoms.

• The non-implantable device delivers neuromuscular stimulation to the patient's tongue to send electrical signals to the central nervous system. Across two studies, researchers linked the breakthrough-designated device to improved gait and balance.

• Helius secured approval via the De Novo pathway almost two years after FDA knocked back a request for authorization in mild-to-moderate traumatic brain injury, leading the company to pivot to MS.

Dive Insight:

Damage to the parts of the brain that control muscle balance can cause walking problems in people with MS. Researchers linked electrical stimulation to improvements in walking speed in MS patients more than a decade ago, offering encouragement to work at University of Wisconsin, Madison to use the tongue as an interface for electrical signals.

The university and its spinout NeuroHabilitation put the cranial nerve non-invasive neuromodulation device through two small randomized clinical trials from 2009 to 2016. Helius gained control of the device through its 2014 takeover of NeuroHabilitation. 

Two years ago, FDA rejected a De Novo request and asked Helius to provide additional information to show the device improved on the results of physical therapy. Helius planned to run a new study but by March 2020 had identified the use of existing MS data as the fastest path to market. The most recent of the two randomized MS trials wrapped up in 2016.

Helius submitted results from the two trials, which enrolled 16 and 20 subjects, alongside real-world data on the use of the device in clinical rehabilitation settings. One of the clinical trials linked use of the device for 14 weeks to improved gait. Patients used the device for an hour of gait, balance and relaxation training, plus a further one-hour relaxation session before bed. 

The second study found no significant difference in the gait of the treatment and control groups but did link the device to improvements in a measure of balance. No serious adverse events were seen in either study or the real-world analysis shared by FDA. The device is already on the market in Canada. 

Other companies are targeting the MS market. Acorda Therapeutics sells a medicine, Ampyra, that is intended to improve walking in adults with MS. On the device side, multiple other companies sell functional electrical stimulation products, including in the form of an exercise bike, and exoskeletons are available for patients who need rehabilitation.