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Be the first with the news that moves the market- Neurotechnology company Helius Medical Technologies (TSX:HSM) has received a Breakthrough Device designation from the FDA for its PoNS device
- The FDA gives the Breakthrough Device designation to medical devices that provide an effective treatment for life-threatening or irreversibly debilitating diseases or conditions
- The company will gain access to FDA experts to help complete the premarket approval process and its application will be prioritised by the review board
- The PoNS device is designed to help multiple sclerosis sufferers improve their gait and balance, when used in conjunction with physical therapy
- Helius Medical Technologies (HSM) is up 36.67 per cent, with shares trading for C$0.82
Neurotechnology company Helius Medical Technologies (TSX:HSM) has received a Breakthrough Device designation from the FDA for its PoNS device.
The US Food and Drug Administration gives the Breakthrough Device designation to medical products that provide an effective treatment for life-threatening or irreversibly debilitating diseases or conditions.
To help bring these products to the public quicker, the designation is designed to expedite the rest of the approval process.
Toward this end, the company will gain access to FDA experts to help complete the premarket approval process and receive timely feedback. Furthermore, when the application is submitted, products with the designation are prioritised by the review board.
The company was quick to point out that the designation does not ease any of the FDA’s approval standards, all of which will still need to be met before the device can be made available.
The PoNS device, short for Portable Neuromodulation Stimulator, is already for sale in Canada. The medical device is designed to help multiple sclerosis sufferers to improve their gait and balance, when used in conjunction with physical therapy.
The product has also been used to improve walking in people who have received a mild-to-moderate traumatic brain injury.
The product remains under review in the US, as well as in Australia and the EU.
Philippe Deschamps, CEO of Helius, is extremely pleased that the PoNS has been designated as Breakthrough Device.
“We look forward to working with FDA to process our application, with the ultimate goal of bringing our innovative technology to the aid of patients suffering with gait deficit due to MS-related symptoms, by providing them with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk,” he said.
Helius Medical Technologies (HSM) is up 36.67 per cent, with shares trading for C$0.82 at 3:03pm EDT.
