Helius Medical Technologies Announces Extension Of Collaborative Research And Development Agreement (CRADA) With US Army
Published: Sep 13, 2017
NEWTOWN, Pa., Sept. 13, 2017 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (TSX:HSM) (OTCQB:HSDT) ("Helius" or the "Company") announced today that, through its wholly owned subsidiary NeuroHabilitation Corporation (“NHC”), it has executed an extension to its Cooperative Research and Development Agreement (“CRADA”) with the US Army Medical Research and Materiel Command (“USAMRMC”) through 2018 and extended the deadline for commercialization of the PoNSTM Therapy to December 31, 2021.
The CRADA partners Helius and the USAMRMC in the clinical development and commercialization of the Company’s Portable Neuromodulation Stimulator (PoNS) device, a non-invasive brain stimulation device, currently being developed for the treatment of chronic balance disorder in patients with mild to moderate traumatic brain injury.
The CRADA is also intended to support the development of other potential indications of the device, relevant to injured service members who have suffered a traumatic brain injury, such as treating tinnitus, post-traumatic stress, sleep disturbances or chronic pain.
“We are pleased to formally extend our development partnership with the U.S. Army, and the commitment to explore other war-fighter indications for the PoNS™ Therapy upon FDA clearance,” said Philippe Deschamps, CEO of Helius. “We are encouraged with the progress to date on our TBI trial as all study subjects have completed their treatment; an important milestone as we work towards FDA clearance forecasted for the first half of 2018. We continue to appreciate the US Army as our development partner.”
About PoNS™ Therapy
The Portable Neuromodulation Stimulator (PoNS) is an investigational non-invasive device designed to deliver neurostimulation through the tongue. PoNS Therapy combines the use of the device with physical therapy and is currently being evaluated in a multicenter clinical trial for the treatment of balance disorder for subjects with mild to moderate traumatic brain injury.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
The Toronto Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
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 (“forward-looking statements”).
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, statements regarding ongoing or planned clinical research, expected future development timelines, regulatory submissions and approvals or other business initiatives and objectives.
Forward-looking statements are often identified by terms such as “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 failure of the Company 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 and 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.
Josh Berg, 415-205-7891
Becky Kern, 914-772-2310