The Portable Neuromodulation Stimulator (PoNS) is authorised for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Helius Medical Technologies, a neurotech company focused on neurological wellness, today announced that it has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNSTM) device and reported preliminary financial results for the second quarter and six months ended June 30, 2020.
The PoNS device was granted Breakthrough Designation by FDA on May 7, 2020.
“Helius is excited to announce the submission of our request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age,” said Philippe Deschamps, Helius’ President, CEO and Chairman. “The achievement of this important milestone reflects our strong pace of progress since the first quarter of this year, when we made the strategic decision to prioritize an MS indication as the regulatory pathway to pursue our first U.S. breakthrough designation and regulatory clearance. Most importantly, our submission brings us a step closer to making our novel PoNS Treatment available for the 1 million U.S. patients estimated to be living with MS, a disease with a significant unmet medical need, particularly in addressing associated gait dysfunction. We look forward to the FDA’s review of our submission, as we strive to provide patients with gait deficit due to MS symptoms a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk.”
Mr. Deschamps continued: “As anticipated, our second quarter financial performance was impacted by the disruption caused by the COVID-19 pandemic – with our clinics in Canada affected by government mandates enacted to slow the spread of the virus. However, we were pleased by the efforts and progress made by our team, who worked diligently during the quarter to help mitigate the impact of this pandemic on our business and continue pursuing our commercial and regulatory priorities. We remain focused on expanding access to our novel PoNS technology in Canada as efficiently and effectively as possible for the benefit of our patients and shareholders and look forward to discussing our recent progress in more detail on our second quarter earnings call.”
The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy.
The PoNS is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.
Source: Company Press Release