4th November,
2021 – Helius Medical Technologies issued a press
release, which is summarized as follows:
Helius Medical
Technologies, Inc. today announced it received market authorization from the
Australian Therapeutic Goods Administration (TGA) for the sale of PoNS as a
Class IIa medical device. The Company’s representative in Australia is working
with the TGA to finalize the exact scope of the authorization, which is
expected to cover the use of PoNS to improve balance and gait when used as an
adjunct to a therapeutic exercise program.
“We are thrilled that we will be able to introduce
this groundbreaking therapy for patients in Australia needing to improve their
balance and gait,” said Dane C. Andreeff, President and Chief Executive Officer
of Helius. “This marks the third country in which PoNS is authorized and
further validates the effectiveness of our innovative PoNS therapy. We will
begin evaluating the pathway toward commercialization in Australia once the
scope of the authorization is finalized.”
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