Helius Medical Technologies announced today that its Portable Neuromodulation Stimulator (PoNS) device, a short-term treatment for gait deficit due to mild and moderate symptoms of multiple sclerosis (MS) used in conjunction with supervised physical therapy, has received a breakthrough designation by the FDA.1
The PoNS is currently authorized for sale in Canada as a class II, non-implantable medical device, where it is also indicated as a short-term, 14-week treatment for chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI). It is still an investigational medical device in the United States, Europe, and Australia.
“We are extremely pleased to receive this designation for our PoNS device,” said Philippe Deschamps, CEO, Helius Medical Technologies, in a statement. “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.”
In January, 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.2
This designation is somewhat of a shift from the FDA’s previous decisions regarding the PoNS device. In April 2019, it declined to approve a de novo classification as well as a 510(k) clearance submission from Helius, with the agency noting that it did not have sufficient information to determine the relative independent contributions of the PoNS Device and physical therapy on the improvements from baseline in the efficacy end points observed in its clinical development. The application included findings from 2 double-blind, randomized controlled clinical trials with a total of 163 participants. The FDA did, however, inform Helius that it could generate additional data to address its concerns and resubmit its application at that time.3
In a feasibility study published in the Multiple Sclerosis Journal—Experimental, Translational and Clinical in February 2017, which included 14 patients with MS randomized to an active (n = 7) and a sham stimulation (n = 7) group. Participants received intensive physical therapy and working memory training for 14 weeks, and investigators used functional magnetic resonance imaging (fMRI) with motor imagery and working-memory tasks completed prior to and following therapy, as well as Sensory Organization Test (SOT), motor performance measures, and neuropsychological assessment.4
On the SOT, the active group showed significant improvement from baseline (P = .046), and fMRI revealed significant blood oxygen level-dependent signal changes in the left primary motor cortex for the active group, while the sham group had increased activity in bilateral premotor cortices. Only the active group showed increased dorsolateral prefrontal cortex activity in the working memory assessments. Altogether, the investigators concluded that the results suggest that PoNS stimulation can enhance motor performance and working memory while also driving neuroplasticity.
In addition to MS, the treatment device has also been assessed for TBI. In December 2019, data were published in the Archives of Rehabilitation Research and Clinical Translation from a 26-week double-blind phase 1/2 study (NCT02158494) in those with chronic symptoms due to mild-to-moderate TBI, with 3 consecutive treatment stages: in-clinic, at-home, and no treatment.5
The trial randomized 44 participants in a 1:1 fashion to either high-frequency pulse (HFP; n = 22) or low-frequency pulse (LFP; n = 22) translingual neurostimulation with the PoNS device. Participants received stimulation plus physical therapy for a total of 14 weeks (2 weeks in-clinic and 12 weeks at home), twice daily, followed by 12 weeks without treatment. The primary end point was the change in SOT composite score from baseline to Week 14, and secondary variables—Dynamic Gait Index (DGI) and 6-minute walk test (6MWT)—were also collected.
The results of that assessment showed a significant improvement in SOT scores from baseline at Weeks 2, 5, 14, and 26 for both arms (P <.0001), without significant differences between the groups. The HFP group ultimately improved from 42.77 (±17.54) at baseline to 21.0 at Week 2 assessment, 26.0 at Week 5 assessment, 29.8 at Week 14 assessment, and 33.8 at Week 26 assessment. At the same time points, the LFP group improved from 36.24 (±16.09) at baseline to 25.3, 28.5, 35.0, and 33.8, respectively.
Additionally, there were significant improvements in both groups for DGI scores in the HFP (Week 2: P <.01; Week 5, 14, and 26: P <.001) and LFP groups (Week 2 and 5: P <.01; Week 14 and 26: P <.001) compared to baseline. 6MWT evaluations were significant after 2 weeks, and there were no treatment-related serious adverse events (AEs).
1. Helius Medical Technologies, Inc. Announces FDA Has Granted the PoNS Device Breakthrough Device Designation for the Treatment of Gait Deficits Due to Symptoms of Multiple Sclerosis [press release]. Newtown, PA: Helius; Published May 12, 2020. Accessed May 12, 2020. globenewswire.com/news-release/2020/05/12/2031783/0/en/Helius-Medical-Technologies-Inc-Announces-FDA-Has-Granted-the-PoNS-Device-Breakthrough-Device-Designation-for-the-Treatment-of-Gait-Deficits-Due-to-Symptoms-of-Multiple-Sclerosis.html
2. Helius Medical Technologies Awarded Pioneer Technology Development AwardBrain Mapping Foundation and Society for Brain Mapping Therapeutics name the Portable Neuromodulation Stimulator ( PoNS™) device a trailblazing technology [press release]. Newtown, PA: Helius; Published January 10, 2020. Accessed May 12, 2020. biospace.com/article/releases/helius-medical-technologies-awarded-pioneer-technology-development-awardbrain-mapping-foundation-and-society-for-brain-mapping-therapeutics-name-the-portable-neuromodulation-stimulator-pons-device-a-trailblazing-technology
3. Helius Medical Technologies, Inc. Provides Update on FDA’s Review of its Request for De Novo Classification and 510(k) Clearance of the PoNS™ Device [press release]. Newtown, PA: Helius; Published April 10, 2019. Accessed May 12, 2020. heliusmedical.com/index.php/newsroom/news-release/2019/276-
4. Leonard G, Lapierre Y, Chen JK, et al. Noninvasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplastic changes in patients with multiple sclerosis: A multimodal neuroimaging study. Mult Scler J Exp Transl Clin. Published online February 1, 2017. doi: 10.1177/2055217317690561
5. Tyler M, Skinner K, Prabhakaran V, Kaczmarek K, Danilov Y. Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury. ARRCT. 2019;1(3-4):100026. doi: 10.1016/j.arrct.2019.100026