The PoNS device provides mild neuromuscular electrical stimulation to the dorsal surface of the patient's tongue
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Helius Medical has secured marketing authorisation from the US Food and Drug Administration (FDA) for its Portable Neuromodulation Stimulator (PoNS) as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS).
The neuromuscular tongue stimulator features a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves through the tongue to offer treatment of motor deficits.
According to the FDA, the device is designed to be used by prescription only as an adjunct to a supervised therapeutic exercise programme in patients 22 years of age and older.
The PoNS device is a portable and non-implantable device, which offers mild neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue.
Helius’ device includes a controller and a mouthpiece, which are connected to each other by a cord.
The regulator evaluated the safety and efficacy of the PoNS device via two clinical studies and a retrospective analysis of real-world data (RWD).
In the first study, 20 patients with gait deficits due to MS participated in a randomised and double-blind controlled study. The 10 patients used the PoNS device, while the remaining 10 patients used a sham control device, which did not deliver stimulation.
According to the FDA, the results demonstrated that the PoNS group on average achieved improvement in their Dynamic Gait Index (DGI) score of 7.95 at the end of the study, which was statistically significant and clinically significant, while the control group did not.
In the second study, the clinicians studied the effects of the PoNS device with cognitive rehab and physical rehab in 14 patients with MS. The patients did not know whether they had the PoNS device or the sham control device.
Helius used a PoNS device for the seven patients, while a sham device for the remaining seven patients.
The PoNS device group demonstrated a statistically significant improvement in sensory organization tasks (SOT) scores at 14 weeks compared to the baseline value. Analysis of DGI scores after 14 weeks demonstrated no significant data.
The FDA’s Center for Devices and Radiological Health’s Neurological and Physical Medicine Devices acting director Dr Christopher Loftus said: “MS is one of the most common neurological diseases in young adults. Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis.”