NEWTOWN, PA — 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 “PoNS™”) 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 PoNS™ is an investigational medical device that induces neuromodulation by stimulating the cranial nerves found in the tongue.
“Transitioning the PoNS™ 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 PoNS™,” 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.
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