The Food and Drug Administration (FDA) has authorized marketing of the Portable Neuromodulation Stimulator (PoNS; Helius Medical Technologies) device for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS).

PoNS is a portable, noninvasive, prescription-only device intended to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. The device delivers mild neuromuscular electrical stimulation through a mouthpiece to the dorsal surface of the patient’s tongue, which is then transmitted to the brain through natural pathways. A clinician can view and track a patient’s progress and execution of therapy by connecting the controller unit of the device to a computer.

The FDA authorization was based on safety and efficacy data from 2 clinical studies and a retrospective analysis of real-world data. Findings from a double-blind controlled 14-week study involving 20 MS patients showed that treatment with the PoNS device was associated with a statistically significant and clinically meaningful improvement in the Dynamic Gait Index (DGI) score (an index of 8 tasks used to assess gait, balance, and fall risk), compared with the control group.

In the second study, 14 MS patients were randomly assigned to receive the PoNS device or a sham control device in addition to cognitive and physical rehab. Results showed that treatment with the PoNS device led to a statistically significant improvement in sensory organization tasks (SOT) score at 14 weeks compared with baseline; no significant results were observed for DGI scores.


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As for safety, no serious adverse events were reported in the studies. Patients should not use the PoNS device if they have penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, a history of seizures, or an active or suspected malignant tumor. The device should also not be used in areas of recent bleeding or open wounds, in areas that lack normal sensation, or in patients with a sensitivity to nickel, gold or copper. The precautions for use of the PoNS device are similar to those for transcutaneous electrical nerve stimulation.

“With the receipt of FDA marketing authorization, Helius is proud to announce that our PoNS device is now the first, and only, medical device cleared in the US for this indication,” said Dane Andreeff, Interim President and CEO of Helius. “[…] Our aim in obtaining marketing authorization is to provide MS patients suffering from gait deficit with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk, and potentially enhance their safety and quality of life as a result.”

The Company expects to have the PoNS device available in the first quarter of 2022.

References

1.    FDA authorizes marketing of device to improve gait in multiple sclerosis patients. [press release]. Silver Spring, MD: US Food and Drug Administration; March 26, 2021. 

2.    Helius Medical, Inc receives US marketing authorization for the PoNS™ device. [press release]. Newtown, PA; Helius Medical Technologies, Inc.; March 29, 2021.