FDA Grants Marketing Clearance to Helius Medical’s PoNS Device

Helius Medical Medical Inc. has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its Portable Neuromodulation Stimulator (PoNS) device.

“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 U.S. for this indication,” said Dane Andreeff, pnterim president and CEO of Helius. “This milestone represents the most important achievement of our organization since its inception, and I would like to thank our dedicated employees, our shareholders, and the people who participated in the research for making it possible. MS is a chronic, degenerative and often debilitating disease that is estimated to affect approximately 1 million patients in the U.S. Many of these patients experience problems with their gait, or walking, as a result of MS which can severely restrict their mobility and daily activities. 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 PoNS device is indicated for use as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only .
 
“For this vastly underserved population of MS patients with a clear medical need and few viable treatments, our PoNS device and treatment represents a new therapeutic option with demonstrated results. Specifically, its safety and efficacy has been demonstrated in two 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,” Andreeff said. “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.”  
 
The PoNS product is a non-surgical medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. The PoNS device is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS device is an investigational medical device in the European Union and Australia. It is currently under premarket review by the AUS Therapeutic Goods Administration.

“Looking ahead, Helius remains committed to providing our PoNS Treatment to patients as efficiently and effectively as possible. We are focused on preparing to commercialize our PoNS Treatment in the U.S., which we expect to begin in the first quarter of 2022. As part of our pre-commercial activities, we will continue to work 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. Longer-term, we also intend to pursue additional indications for our PoNS device to expand access to our platform technology in order to help as many patients as possible,” Andreeff concluded.