The FDA previously declined to approve de novo classification in April 2019.
Helius Technologies recently submitted its response to the FDA’s request for additional information and that followed the company’s request for de novo classification and clearance of its Portable Neuromodulation Stimulator (PoNS) device for the short-term treatment (up to 14 weeks) of gait deficit due to mild-to-moderate multiple sclerosis (MS) symptoms.1
The PoNS device is authorized for sale in Canada as a class 2, non-implantable, 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).
Dane Andreeff, interim president, chief executive officer, Helius Technologies, said in a statement that “looking ahead, we expect that the FDA’s receipt of our response will enable the FDA to resume its review of our request for de novo classification and clearance. We remain committed to our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms as expeditiously as possible, and hope to receive the FDA’s decision on our request for de novo classification and clearance during the first half of this year.”
Helius Technologies requested de novo classification for the PoNS device in August 4, 2020, and the FDA’s review was put on hold pending their request for additional information in October 2020. The PoNS device was granted breakthrough device designation on May 12, 2020.2
When the device was granted that designation, then-chief executive officer Philippe Deschamps (who left the company in August 2020), said in a statement that the company has “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.”
Triton Market Research named Helius Technologies as a competitive player in its Global Neurorehabilitation Device Market 2019-2028 research report. The basis of this is grounded in the belief that the market for neurorehabilitation devices will continue to grow as neurological diseases become prevalent around the world and technology and robotics continue to advance.3
A feasibility study published in 2017 demonstrated that patients stimulated with the PoNS device showed significant improvement from baseline (P = .046) on the Sensory Organization Test (SOT). FMRI also revealed significant blood oxygen level-dependent signal changes in the left primary motor cortex for the active group. The control group had increased activity in bilateral premotor cortices, but only the treatment group showed increased dorsolateral prefrontal cortex activity in the working memory assessments. Investigators concluded that the results suggest that stimulation by the PoNS device drives neuroplasticity and can enhance motor performance and working memory.4