Helius Medical Technologies Inc. (Newtown, PA) announced on Friday, Jan. 5, that it has selected Key Tronic Corp. (Spokane, WA) 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 United States and internationally in the first half of 2018.
The PoNS is an investigational, non-invasive medical device designed to deliver neurostimulation through the tongue. Clinical research cited by Helius has shown that electrical stimulation of the tongue activates two major cranial nerves—the trigeminal and facial nerves—creating a flow of neural impulses that are then delivered directly into the brain stem and cerebellum. Combined with PoNS therapy, the device treats balance disorder in patients with mild to moderate traumatic brain injury. Additional trials in multiple sclerosis, stroke and cerebral palsy have shown promising results and provide support for pursuing additional indications for use, said the company in a press release.
The commercial design of the PoNS will be manufactured and assembled at Key Tronic’s facilities located in Oakdale, MN. Key Tronic is a full-service contract manufacturer with decades of experience in manufacturing medical devices and a 1.6-million-square-foot global manufacturing footprint at facilities in the United States, Mexico and China. Offering value-added electronics manufacturing to an array of industries, Key Tronics is equipped with 80 injection molding machines ranging in size from 30 to 880 tons. In addition to providing single-shot, multi-material and liquid injection molding and blowmolding services, the company also offers tool building at its Spokane headquarters and in China and tool maintenance at its Mexico facility.
Helius and Key Tronic have developed a partnership over several years, and in that time it “has proven to be a reliable supplier during previous phases of PoNS’ product development and clinical manufacturing, as [it was a] subcontractor for the clinical mouthpiece builds,” said Joyce LaViscount, CFO/COO of Helius, in a prepared statement. “Key Tronic has also played an integral role in planning and transferring the company’s scaled manufacturing efforts over the previous six months and we are confident in their ability to lead commercial manufacturing, balancing our company’s need for quality and cost control,” said LaViscount.
Key Tronic specializes in printed circuit board 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.