Helius’ PoNS Device Gets Breakthrough Designation for Poststroke Gait and Balance Deficits


The innovative nonsurgical device has previously received market authorization to treat gait deficit due to mild-to-moderate symptoms from multiple sclerosis.

Dane Andreeff

Dane Andreeff

Helius Medical Technologies’ Portable Neuromodulation Stimulator (PoNS) device has received FDA breakthrough designation as a temporary treatment of dynamic gait and balance deficits due to symptoms of stroke, according to an announcement from the company. The system is to be used adjunct to a supervised therapeutic exercise program for patients 22 years of age and older.1

The PoNS is an innovative nonsurgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. It is currently indicated for us in the US as a short-term treatment for patients with multiple sclerosis (MS) who experience gait as part of their mild-to-moderate symptoms.

"We are very pleased to announce the receipt of breakthrough designation for our PoNS device to treat stroke-induced gait and balance deficits,” Dane Andreeff, chief executive officer, Helius, said in a statement.1 "Strokes are a large and growing cause of long-term disability in the United States. An estimated 7 million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.”

The device is also authorized for sale in Canada as a class 2, nonimplantable medical device, but is currently an investigational medical device in the US, EU, and Australia. PoNS is also intended as a treatment for chronic balance deficit in conjunction with physical therapy for mild-to-moderate traumatic brain injury (mmTBI).

READ MORE: Implementation of Regional Prehospital Stroke Protocol Increases Rates of EVT

"Obtaining breakthrough designation represents an important milestone in our path to providing this underserved patient population with a non-drug, non-implantable treatment option that has the potential to significantly improve their gait and balance, their ability to walk and perform daily tasks," Andreeff added. "We look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate our pursuit of US regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA."

The Breakthrough Devices Program is a voluntary program intended for specific medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Helius requested de novo classification for the PoNS device to treat gait deficit due to MS symptoms on August 4, 2020, and the FDA’s review was put on hold pending their request for additional information in October 2020. The company then submitted its response to the FDA’s request for additional information in January 2021 and received market authorization 2 months later.2,3

In January 2019, Helius was awarded the Pioneer Technology Development Award for the PoNS device, presented by the Brain Mapping Foundation and Society for Brain Mapping and Therapeutics, given to trailblazing technology companies and their CEOs and presidents who have facilitated the development of pioneering technologies through interdisciplinary approaches that have impacted diagnostics, treatment, and healthcare delivery in unprecedented ways.3

1. Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke. News release. August 17, 2021. Accessed August 19, 2021. https://www.biospace.com/article/releases/helius-medical-technologies-inc-announces-fda-breakthrough-device-designation-for-the-treatment-of-dynamic-gait-and-balance-deficits-following-a-stroke/
2. Helius Medical Technologies, Inc. submits response to U.S. FDA in pursuit of de novo classification and clearance of the PoNS™ Device for the treatment of gait deficit due to symptoms of Multiple Sclerosis: Submits formal response to the U.S. Food and Drug Administration’s request for additional information. News release. January 11, 2021. Accessed January 15, 2021. https://www.globenewswire.com/news-release/2021/01/11/2156134/0/en/Helius-Medical-Technologies-Inc-Submits-Response-to-U-S-FDA-in-Pursuit-of-De-Novo-Classification-and-Clearance-of-the-PoNS-Device-for-the-Treatment-of-Gait-Deficit-Due-to-Symptoms-.html
3. Helius Medical, Inc recieves US marketing authorization for the PoNS device. News release. March 29, 2021. Accessed August 19, 2021. https://heliusmedical.com/index.php/newsroom/news-release/2021/471-eliusedicalnceceivesarketinguthorizationf20210329103000
4. Global Neurorehabilitation Device Market 2019-2028. Triton Market Research. 2020.
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