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NEWTOWN, Pa.--(BUSINESS WIRE)-- Helius Medical Technologies, Inc. (CSE: HSM) (the "Company" or "HMT") is pleased to announce that it has completed the Commercial Design Specification phase of its commercial version of the Portable Neuromodulation Stimulator device (the "PoNSTM") and received the first prototypes from Ximedica. To date, all clinical work has used experimental devices made in house by hand. The registrational clinical trials must be performed with the full commercial devices. The PoNSTM is an investigational medical device that induces neuromodulation by stimulating the cranial nerves found in the tongue.
"Transitioning the PoNSTM from a laboratory setting to the commercial space requires collaborative input and decision making. HMT is rapidly expanding clinical trial activity and must be able to provide a full commercial grade device to complete the pivotal trials. Further to that, our Collaborative Research and Development Agreement ("CRADA") with the US Army, who is funding development for Traumatic Brain Injury (TBI), requires HMT to provide a suitable number of devices to meet demand that may arise. Ximedica has this production capacity. With this milestone now complete we will be able to provide commercial devices in time for the pivotal trial program," said Philippe Deschamps, Chief Executive Officer of HMT. "Thank you to Ximedica of Providence, RI for their expertise in the design and development of the PoNSTM," he added. Prototype validation and production scale-up activity is ongoing.
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology holding company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that create portals to the brain to amplify its ability to heal itself. HMT intends to file for U.S. Food and Drug Administration clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
Ximedica is a full service ISO 13485 certified and FDA registered product development firm with an exclusive focus on medical products. With more than 25 years of experience developing medical devices, combination products and consumer healthcare, Ximedica's client base spans the globe and ranges from start-ups to the world's largest medical device manufacturers. Ximedica's mission is to create products that meet international regulatory requirements and strategic business goals. For more information, visit their website at http://www.ximedica.com.
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Safe Harbor Statement
All statements in this news release, other than statements of historical facts, are forward-looking statements. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. 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 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 information 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 information. 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. 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 the forward-looking statements except as required by applicable law.
For Helius Medical Technologies, Inc. Source: Helius Medical Technologies, Inc. Did you like this article?
John Awde, 778-588-7144
Becky Kern, 914-772-2310
For Helius Medical Technologies, Inc.
Source: Helius Medical Technologies, Inc.
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