【Helius Medical Technologies-Product PoNS】Helius Medical, Inc Receives U.S. Marketing Authorization for the PoNSTM Device

Partner News

29th March, 2021
– Helius Medical
Technologies released a piece of
news, which is summarized as follows: 

First and only
tongue-delivered neuromodulation therapy provides new treatment option for U.S.
patients living with gait deficit due to symptoms from multiple sclerosis

Helius Medical Technologies, Inc. today announced that its
wholly owned subsidiary, Helius Medical, Inc, has received marketing
authorization from the U.S. Food and Drug Administration (“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 (“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 .

“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. 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.”

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 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. 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

Mr. Andreeff concluded: “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.”

Original website Link: https://heliusmedical.com/index.php/newsroom/news-release/2021/471-eliusedicalnceceivesarketinguthorizationf20210329103000