You are here
Helius Medical Technologies, Inc. Provides Update on its Anticipated Submission for FDA Clearance of the PoNS™ Device
NEWTOWN, Pa., June 18, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, updated today the expected timing for the Company’s submission of a request for U.S. Food and Drug Administration (“FDA”, “Agency”) clearance of the Portable Neuromodulation Stimulator (PoNS) investigational medical device.
“As part of the submission process for de novo classification and 510(k) clearance, FDA encourages companies to engage in pre-submission meetings to obtain the Agency’s perspective and feedback,” stated Jonathan Sackier, Helius’ Chief Medical Officer. “The breakthrough nature of our PoNS technology heightens the Company’s desire to work closely with FDA in advance of our submission. We have thus proactively engaged in FDA’s Pre-Submission Program to reduce the likelihood of questions from FDA during their review of the PoNS 510(k) submission.”
Dr. Sackier continued: “We met with FDA in a pre-submission meeting held in April, which focused on the design verification testing used to support our submission. We believe this meeting was very productive and we adjusted this element of our submission to incorporate feedback from FDA. We are scheduled to meet with FDA again in July and expect this meeting to be equally productive. Given the timing of this pre-submission meeting, we now expect to submit our request for de novo classification and 510(k) clearance in the third quarter of 2018.”
“The submission of our request for FDA clearance of the PoNS device for the treatment of chronic balance deficit due to mild- to moderate-traumatic brain injury is an important milestone for Helius, which the Company has been working towards since we began our registrational clinical trial in 2015,” added Philippe Deschamps, Helius’ President, CEO and Chairman. “We are excited about our data and continued collaboration with FDA to finalize our full submission package.”
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). For more information, visit www.heliusmedical.com.
About the PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an investigational, non-invasive, medical device.
PoNS Treatment is the first and only tongue-delivered neuromodulation that combines stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function. The Company’s trials investigating the PoNS in traumatic brain injury are more fully discussed in the Company’s disclosure materials, including its Annual Report on Form 10-K and other filings with the United States Securities and Exchange Commission.
Cautionary Disclaimer Statement:
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws.
All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, the expected timing of the company’s planned pre-submission meeting with FDA and the expected timing of the Company’s submission regulatory approval of the PoNS device.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects”, “estimate”, “intend” and similar expressions.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the uncertainties associated with the FDA regulatory submission and approval process, the Company’s need to raise additional capital to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators.
The reader is cautioned that assumptions used in the preparation of any forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking statement. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Risks and uncertainties about the Company’s business are more fully discussed in the Company’s disclosure materials, including its Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com.
The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA