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  • Helius Medical has received marketing authorization from the U.S. FDA for the Portable Neuromodulation Stimulator (PoNS™) device
  • The PoNS device is indicated for use as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis
  • Commercialization of the PoNS Treatment in the U.S. is expected to begin in the first quarter of 2022
  • Helius Medical Technologies is a neurotech company focused on neurological wellness
  • Helius Medical Technologies Inc. (HSM) is down 4.81 per cent, trading at C$21.75 per share at 10:30 am ET

Helius Medical Technologies (HSM) subsidiary, Helius Medical, Inc has received marketing authorization from the U.S. FDA for the Portable Neuromodulation Stimulator (PoNS™) device.

The PoNS device is indicated for use as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis 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.

“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, Interim President and Chief Executive Officer 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. 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.”

Mr. Andreeff continued,

“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 have 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. 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 concluded,

“Looking ahead, 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, the 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.”

Helius Medical Technologies is a neurotech company focused on neurological wellness. The company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself.

Helius Medical Technologies Inc. (HSM) is down 4.81 per cent, trading at C$21.75 per share at 10:30 am ET.

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