Helius Medical Technologies has announced that its Portable Neuromodulation Stimulator (PoNS) device, for multiple sclerosis sufferers, has received marketing authorisation from the US Food and Drug Administration (FDA).
According to a company press release, the device is indicated for use as a short–term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise programme in patients 22 years of age and over by prescription only.
“With the receipt of FDA marketing authorisation, Helius is proud to announce that our PoNS device is now the first, and only, medical device cleared in the USA for this indication,” said Dane Andreeff, interim president and chief executive officer of Helius. “This milestone represents the most important achievement of our organisation since its inception, and I would like to thank our dedicated employees, our shareholders, and the people who participated in the research for making it possible. MS is a chronic, degenerative and often debilitating disease that is estimated to affect approximately one million patients in the USA. Many of these patients experience problems with their gait, or walking, as a result of MS, which can severely restrict their mobility and daily activities. Our aim in obtaining marketing authorisation is to provide MS patients suffering from gait deficit with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk, and potentially enhance their safety and quality of life as a result.”
Andreeff continued: “For this vastly underserved population of MS patients with a clear medical need and few viable treatments, our innovative PoNS device and treatment represents a new therapeutic option with demonstrated results. Specifically, its safety and efficacy has been demonstrated in two clinical studies and a retrospective analysis of real-world data which were submitted to, and assessed by, the FDA as part of our request for marketing authorisation. The receipt of FDA marketing authorisation represents an important validation of both the strength and quality of this supporting data, and ultimately the safety and efficacy of our PoNS device.”
Andreeff concluded: “Looking ahead, Helius remains committed to providing our PoNS treatment to patients as efficiently and effectively as possible. We are focused on preparing to commercialise our PoNS treatment in the USA, which we expect to begin in the first quarter of 2022. As part of our pre-commercial activities, we will continue to work with the Centers for Medicaid and Medicare with the goal of obtaining reimbursement coverage under the Medicare Coverage of Innovative Technology (MCIT) pathway for FDA–cleared and designated breakthrough devices. Longer term, we also intend to pursue additional indications for our PoNS device to expand access to our platform technology in order to help as many patients as possible.”