FDA Gives Marketing Authorization to Translingual Neuromodulation Device for Treatment of Gait Deficits in Multiple Sclerosis 

The Food and Drug Administration (FDA) authorized marketing of a tongue-delivered portable neuromodulation device (PoNS; Helius Medical, Newtown, PA) to treat gait deficit caused by multiple sclerosis (MS). The device is a prescription only adjunct to a supervised therapeutic exercise program for individuals age 22 years and more by.

In the TBI-001 trial (NCT01847755) for the device, 67.2% of participants with chronic balance impairment, had a statistically significant improvement in balance as measured by mean Sensory Organizational Test (SOT) scores at 2 and 5 weeks compared with baseline. Mean Dynamic Gait Index (DGI) scores were also significantly increased from baseline at weeks 2 and 5.

“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 chief executive officer of Helius. “For this vastly underserved population of MS patients with a clear medical need and few viable treatments, our innovative PoNS device and treatment represents a new therapeutic option with demonstrated results. Specifically, its safety and efficacy has been demonstrated in 2 clinical studies and a retrospective analysis of real-world data which were submitted to, and assessed by, the FDA as part of our request for marketing authorization. The receipt of FDA marketing authorization represents an important validation of both the strength and quality of this supporting data, and ultimately the safety and efficacy of our PoNS device.”  

Mr. Andreeff also noted that Helius plans to make the device commercially available in the first quarter of 2022 and that they will be working with the Centers for Medicaid and Medicare with the goal of obtaining reimbursement coverage under the Medicare Coverage of Innovative Technology, or MCIT, pathway for FDA cleared and designated breakthrough devices.