Helius Medical Technologies to Receive ISO 13485 Certificate

Helius Medical Technologies, Inc. (TSX:HSM, OTCQB:HSDT) (“Helius” or the “Company”) announced today that its wholly owned subsidiary, NeuroHabilitation Corporation, has been assessed by Lloyd’s Register Quality Assurance Limited (LRQA) and recommended for ISO 13485 certification for its Portable Neuromodulation Stimulator (PoNS™), an investigational non-invasive device designed to deliver neurostimulation
through the tongue. LRQA, an independent certifying agency, concluded that the company complies with the requirements of ISO 13485 for an integrated quality management system for medical devices across all functions of the business, from design and development to manufacturing and distribution.
Achievement of ISO 13485 certification constitutes an important
regulatory milestone in the commercialization process for the company’s
products. The ISO 13485 standard specifies requirements for a quality
management system where an organization needs to demonstrate its ability
to provide medical devices that consistently meet customer requirements
and regulatory requirements applicable to medical devices.
“The ISO 13485 certification illustrates our commitment to quality, our
ability to reach milestones required for product commercialization and,
above all, our dedication to seeing PoNS™ Therapy through to approval,”
said Helius CFO/COO, Joyce LaViscount.
With this certification, Helius will be proceeding with a CE Mark
application in Europe, a Health Canada Medical Device License
Application for Canada and a Therapeutic Goods Association application
for Australia.
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.
About PoNS™ Therapy
The PoNS™ device is an investigational non-invasive method to deliver
neurostimulation through the tongue. PoNS™ Therapy combines the use of
the investigational device with physiotherapy and is currently being
evaluated in a pivotal, multicenter, clinical trial for the treatment of
balance disorder in subjects with mild to moderate Traumatic Brain
Injury (TBI). The PoNS ™ Therapy is also being evaluated in the
treatment of symptoms related to other neurologic diseases including
Multiple Sclerosis and Cerebral Palsy.
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