Helius Medical Technologies And The United States Army Medical Research And Materiel Command Announce Last Subject Enrolled In TBI Registrational Clinical Trial
NEWTOWN, Pa., July 13, 2017 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (TSX:HSM) (TSX:HSM.WT) (OTCQB:HSDT) ("Helius" or the "Company"), a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, and the United States Army Medical Research and Materiel Command (USAMRMC) announce that the last subject has been enrolled in the registrational clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS™) device for the rehabilitation of chronic balance deficits caused by mild-to-moderate Traumatic Brain Injury (mTBI). The trial is intended to serve as the basis for Helius to submit applications for marketing clearance in the United States, Canada and Europe for the PoNS™ device.
The trial, “a double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS device for cranial nerve noninvasive neuromodulation (CN-NINM) training in subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (mTBI),” was conducted at seven sites in the U.S. and Canada: Oregon Health and Science University in Portland OR, Montreal Neurofeedback Center in Montreal, QB, Orlando Regional Medical Center in Orlando, FL, HealthTech Connex Inc. in Surrey, BC, MedStar National Rehabilitation Hospital in Washington D.C., Virginia Commonwealth University in Richmond, VA and the University of Wisconsin in Madison, WI. A total of 120 subjects have been enrolled in the trial and the primary endpoint, at five-weeks, is improvement in chronic balance deficit as analyzed by the NeuroCom Balance Manager - Sensory Organization Test (SOT). The SOT test is a six-condition assessment that identifies abnormalities in a patient’s use of the three systems that contribute to balance: somatosensory, visual, and vestibular. In addition, the registrational clinical trial included a wide-range of secondary outcome measures for evaluation.
“We are happy to announce that the mTBI trial has been fully recruited, with the last subject enrolled at the University of Wisconsin – Madison site. We thank all of our sites for their dedication to achieving this milestone,” said Helius’ CEO, Philippe Deschamps. “There is still significant work ahead, but this is an important milestone for this research program, our organization and our partnerships as we prepare our applications for marketing clearance from the regulatory agencies,” he added.
In February 2013, Helius and the USAMRMC entered a Collaborative Research and Development Agreement (CRADA) to support the development of the company’s PoNS device and to support research into indications relevant to injured service members. In July 2015, the USAMRMC committed to a sole-source contractual agreement to support the execution of the registrational mTBI trial. Additional research in indications such as tinnitus, post-traumatic stress, or sleep disturbances may be supported through the CRADA.
“Traumatic Brain Injury (TBI) today remains a serious public health problem both for the military and civilian populations for which there has been very limited development in regards to treatment options. The USAMRMC is pleased with the progress of the PoNS research program and our partnership with Helius. This milestone is a significant step in the development of this potential treatment option for our wounded warriors,” said Dr. Kenneth Bertram, Principal Assistant for Acquisition, USAMRMC.
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 or cognitive 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 USAMRMC
As the Army's medical materiel developer, the U.S. Army Medical Research and Materiel Command focuses on medical research, development and acquisition, and medical logistics management. The USAMRMC headquarters is located at Fort Detrick in Frederick, Maryland, and supports more than a dozen subordinate commands, agencies and research labs located throughout the world.
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. For more information, please visit www.heliusmedical.com.
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 the expected use of proceeds from the Private Placement and the business objectives of the Company.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” 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 necessity of conducting successful clinical testing to establish safety and effectiveness of the PoNS Therapy for human performance improvement, the requirement for regulatory approval for marketing for human performance improvement prior to the Company’s ability to commercialize the PoNS Therapy for such indications, 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 Transition Report on Form 10-K for the period ended December 31, 2016, which has been filed 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, and the Company’s other filings with the SEC and Canadian securities regulators from time to time.
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CONTACT Investor Relations: Josh Berg 415-205-7891 info@heliusmedical.com Media Contact: Becky Kern 914-772-2310 bkern@heliusmedical.com