Mr. Mike Piccinino reports

HELIUS MEDICAL TECHNOLOGIES, INC. PROVIDES UPDATE ON FDA'S REVIEW OF ITS REQUEST FOR DE NOVO CLASSIFICATION AND 510(K) CLEARANCE OF THE PONS DEVICE

Helius Medical Technologies Inc. has received a request for an additional information (AI) letter from the U.S. Food and Drug Administration related to the company's request for de novo classification and 510(k) clearance of the portable neuromodulation stimulator (PoNS) device

During the substantive review phase of a request for de novo classification and 510(k) clearance, FDA may request additional information in order to obtain information necessary for the agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted.

"We have enjoyed a good relationship with FDA in the development and review of our file. We believe we have the data and information to address FDA's questions and we look forward to submitting our response to enable FDA to resume its review process as expeditiously as possible," said Philippe Deschamps, Helius's chief executive officer. "We will continue to work towards securing clearance of PoNS."

Mr. Deschamps continued: "The PoNS device is a novel technology and our pursuit of a clearance is focused on providing a solution for patients suffering from chronic balance deficit due to mild-to-moderate traumatic brain injury, a condition that impacts more than two million people in the United States. We understand and appreciate the thorough and detailed approach the FDA has taken to learn about our novel technology. We look forward to receiving clearance in the United States for our non-invasive treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury."

About Helius Medical Technologies Inc.

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. The company's first product in development is the portable neuromodulation stimulator (PoNS).

About the PoNS device and PoNS treatment

The portable neuromodulation stimulator (PoNS) is an investigational, non-invasive, medical device in the United States, for which the company has requested de novo classification and 510(k) clearance from the FDA for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury when combined with targeted physical therapy. PoNS is a licensed Class II medical device in Canada. PoNS is currently not commercially available in the United States or the European Union.

We seek Safe Harbor.