Helius Medical Technologies Authorized by Health Canada to Market PoNS Device
The neurotechnology company Helius Medical Technologies has received authorization from Health Canada to market its portable neuromodulation stimulator (PoNS) device to treat gait deficit in patients with mild-to-moderate multiple sclerosis (MS).
The symptoms and severity of MS differ between patients, although functional limitations such as gait dysfunction (difficulty walking) are common. Gait difficulties often result from fatigue, muscle weakness, muscle tightness (spasticity), loss of balance, and a deficit in sensory nerve impulses.
PoNS is a non-invasive (non-implantable) medical device that delivers neurostimulation through the tongue. The device is based on the concept that the tongue is connected to the brainstem — a control center for functions such as sensory perception and movement — by two major cranial nerves.
By sending gentle electrical stimulation through the cranial nerves connected to the tongue, the PoNS device enhances neuroplasticity of the brain — a process through which the brain is able to restructure or relearn in response to new experiences. Neuroplasticity allows the activation, or reactivation, of neurons and structures in the brain, which is key for brain processes of learning, training, and rehabilitation.
A previous study showed that the combined use of PoNS device with physical therapy improved the quality of life, and physical and cognitive abilities of patients with advanced MS. Another study reported improved balance and cognitive abilities in MS patients that used PoNS alongside physical and cognitive rehabilitation training.
“Given the chronic and progressive nature of this potentially debilitating neurodegenerative disease, we feel that there is a strong clinical need for novel therapies such as our PoNS Treatment,” Philippe Deschamps, CEO of Helius, said in a press release.
With Health Canada’s approval, the PoNS device will be available for short-term, 14-week treatments of gait deficit in patients with mild and moderate MS symptoms. Use of the device must be combined with physical therapy.
“We are proud to provide MS patients with a treatment option that has the potential to improve or restore their gait function, or in other words their ability to walk,” Deschamps said.
The PoNS device will be available in authorized treatment centers throughout Canada. A list of those authorized centers can be found at www.ponstreatment.ca.
“We are very pleased to receive regulatory clearance to market our PoNS Treatment to the approximately 93,500 patients in Canada who suffer from MS,” Deschamps said.
The PoNS device also was approved by Health Canada for short-term, 14-week treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury. The device also should be used alongside physical therapy in these patients.
Currently, PoNS is an investigational medical device in the United States, the European Union, and Australia, and is not yet available commercially. In Australia, the device is under review for clearance by the Therapeutic Goods Administration.