NEWTOWN, Pa., June 18, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today is providing an update on its strategy to resubmit an application for De Novo clearance of its Portable Neuromodulation Stimulator (PoNS™) device with the U.S. Food and Drug Administration (the “FDA”).
Since the Company received the letter from the FDA in April denying its submission for De Novo clearance of the PoNS device, it has been developing a strategy to resubmit an application to the FDA. As part of that strategy, members of the Company’s management participated in an informational discussion with the FDA on June 3rd regarding the issues the FDA raised in its April response letter. The FDA indicated that it denied the Company’s request for clearance primarily because it was unable to ascertain the relative independent contributions of physical therapy and the PoNS device to the observed improvements in the balance of the Company’s trial participants.
The Company recognizes the importance of generating new clinical data demonstrating the independent contribution of physical therapy alone in its treatment protocol in order to demonstrate the overall impact of the PoNS Treatment™ on participants. The Company has concluded that, while it will not finalize its resubmission protocol until after it engages with the FDA in its pre-submission meeting, such a protocol will, at a minimum, need to include analyzing the effect of physical therapy alone, without use of the PoNS device. Accordingly, the Company proactively has decided to initiate a study to generate the physical therapy alone data. It has completed its new study protocol using the same design as its TBI 001 study including a 5-week treatment period and the same inclusion/exclusion requirements. In addition, the Company has identified sites at which to conduct this study and expects to be prepared to enroll participants by the end of July 2019.
The Company is also in the process of drafting its pre-submission letter to the FDA requesting a pre-submission meeting. Following the pre-submission meeting, the Company expects to finalize its resubmission strategy and looks forward to reporting on that when completed.
“We are pleased with our progress in resubmitting for FDA clearance. It is important to note that until we complete our pre-submission meeting with the FDA, we will not have a clear understanding and agreement from the FDA on full path forward,” said Phillipe Deschamps, Chief Executive Officer of Helius.
“Meanwhile, we remain focused on our Canadian commercialization and are pleased with the initial results we have achieved thus far in Canada. I look forward to updating our investors on such progress during our Q2 earnings call on August 8, 2019,” continued Mr. Deschamps.
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 commercial product 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 a licensed class II, noninvasive, medical device in Canada intended for use as an acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is limited to prescription use. The PoNS is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”), and it is currently under review for clearance by an EU Notified Body and the AUS Therapeutic Goods Administration. PoNS Treatment™ is currently not commercially available in the United States, the European Union or Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
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. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future clinical and regulatory development plans for the PoNS device, including the planned physical therapy only study, and the potential regulatory clearance of the PoNS device.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the uncertainties associated with the regulation of commercially available medical devices in Canada, including Health Canada’s ongoing assessment of post-market data, the initiation and enrollment process for the planned physical therapy only study, the clinical development, regulatory submission and approval process in the United States, the European Union and Australia, as well as the Company’s capital requirements needed to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. 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.