The Food and Drug Administration (FDA) has approved the marketing of the device for wearable neuromodulation stimulators (PoNS ™; Helius Medical Technologies) for the short-term treatment of gait deficits due to mild to moderate symptoms due to multiple sclerosis (MS).
PoNS is a portable, non-invasive, prescription 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 naturally transmitted to the brain. A clinician can view and track the progress and implementation of a patient’s therapy by connecting the device’s control unit to a computer.
The FDA approval was based on safety and efficacy data from two clinical studies and a retrospective analysis of real-world data. Results of a double-blind, controlled 14-week study with 20 MS patients showed that treatment with the PoNS device was associated with a statistically significant and clinically meaningful improvement in the DGI (Dynamic Gait Index) score (an index of 8 used for evaluation Tasks) gait, balance and fall risk) compared to the control group.
In the second study, 14 MS patients were randomly selected to receive the PoNS device or a sham monitor in addition to cognitive and physical rehab. The results showed that treatment with the PoNS device led to a statistically significant improvement in the SOT (Sensory Organization Tasks) score compared to the initial value after 14 weeks. No significant results were observed for the DGI scores.
For safety reasons, no serious adverse events were reported in the studies. Patients should not use the PoNS device if they have a pervasive brain injury, neurodegenerative disease, oral health problem, chronic infectious disease, untreated high blood pressure or diabetes, pacemaker, history of seizures, or an active or suspected malignant tumor. The device should also not be used in areas with recent bleeding or open wounds, in areas without normal sensation, or in patients with sensitivity to nickel, gold, or copper. The precautions for using the PoNS device are similar to those for transcutaneous electrical nerve stimulation.
“With FDA marketing approval, Helius is proud to announce that our PoNS device is now the first and only medical device approved in the US for this indication,” said Dane Andreeff, Interim President and CEO of Helius. “[…] Our goal in obtaining marketing authorization is to provide gait deficit MS patients with non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk, potentially improving their safety and quality of life. ”
The company expects the PoNS device to be available in the first quarter of 2022.
1. The FDA Approves the Marketing of Gait Improvement Devices in Multiple Sclerosis Patients. [press release]. Silver Spring, MD: US Food and Drug Administration; March 26, 2021.
2. Helius Medical, Inc receives US marketing approval for the PoNS ™ device. [press release]. Newtown, PA; Helius Medical Technologies, Inc .; March 29, 2021.
This article originally appeared on MPR