NEWTOWN, Pa., Jan. 05, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (TSX:HSM) (TSX:HSM.WT) (OTCQB:HSDT) (“Helius” or the “Company”), a medical technology company focused on neurological wellness, announced today that it has completed its competitive selection process and has contracted with Key Tronic Corporation (“Key Tronic”) as its commercial contract manufacturing partner for the Portable Neuromodulation Stimulator (“PoNS”). Helius intends to submit applications for marketing clearance of the PoNS™ in the US and internationally in the first half of 2018.
The commercial design of the PoNS will be manufactured and assembled at Key Tronic’s facilities located in Oakdale, Minnesota. Key Tronic leverages decades of experience in manufacturing medical devices, a 1.6 million square foot global manufacturing footprint and a multi-disciplinary team necessary to optimize manufacturing of the PoNS device.
“The execution of a commercial contract manufacturing agreement is a critical step for Helius in its efforts to obtain marketing clearance for the PoNS device, and we look forward to continuing our partnership with Key Tronic,” said Joyce LaViscount, CFO/COO of Helius. “This partnership has developed over the last several years, as Key Tronic has proven to be a reliable supplier and partner during previous phases of PoNS’ product development and clinical manufacturing as they were subcontractors for the clinical mouthpiece builds. Key Tronic has also played an integral role in planning and transferring the Company’s scaled manufacturing efforts over the previous 6 months and we are confident in their ability to lead commercial manufacturing, balancing our company’s need for quality and cost control.”
“We are pleased to be selected by Helius for the commercial manufacture of the PoNS device,” added Craig Gates, president and chief executive officer of Key Tronic. “Our Oakdale facility is very well matched to manufacture developing medical products.”
About PoNS™ Therapy
The PoNSTM is an investigational, non-invasive, medical device designed to deliver neurostimulation through the tongue. Clinical research has shown that electrical stimulation of the tongue activates two major cranial nerves – the trigeminal nerve and the facial nerve. Electrical stimulation of these cranial nerves creates a flow of neural impulses that are then delivered directly into the brain stem and cerebellum. PoNSTM Therapy combines the use of the PoNSTM device with physical therapy. The Company has completed its clinical trials for balance disorder in patients with mild to moderate Traumatic Brian Injury (TBI) and plans to submit applications for marketing authorization in the US and other jurisdictions for the PoNS device in [the first half of] 2018. Additional trials in multiple sclerosis, stroke and cerebral palsy have shown promising results and provide support for pursuing additional indications for use.
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 Key Tronic Corporation
Key Tronic specializes in PCB assembly, plastic molding, precision metal stamping, fabrication and finishing, and full product assembly, with products ranging from simple consumer devices to complex, high-end commercial and industrial electromechanical products. Headquartered in Spokane Valley, Washington, Key Tronic was founded in 1969 as an OEM manufacturer and later transitioned to be a premier electronic manufacturing service (EMS) provider in numerous industries, including the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. To ensure success, the company provides their customers and unparalleled level of customer service. They are small enough to be nimble, flexible and responsive while still providing the combination of world-class pricing and off-shore manufacturing normally available from only much larger EMS providers.
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Josh Berg, 415-205-7891