NEWTOWN, Pa., Nov. 17, 2017 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (TSX:HSM) (OTCQB:HSDT) ("Helius" or the "Company"), a medical technology company focused on neurological wellness, has received numerous inquiries asking for clarification on the results of the registrational and long-term treatment clinical trials reported on November 9, 2017 (http://heliusmedical.com/index.php/newsroom/news-release/2017/204). In response to those inquiries, Helius wishes to clarify the observations from the two trials previously reported and its plans to include the data in an application for marketing authorization by FDA.
Philippe Deschamps, Chief Executive Officer of Helius, stated, “The data showed participants who received PoNS Therapy experienced average SOT score improvements double to triple the increase that would be expected with physical therapy alone in a much shorter timeframe. The company is excited to finalize and submit its regulatory dossier to the FDA.”
Registrational TBI Trial
- Sensory Organization Test (SOT) was the measurement tool used in the trial to assess balance. It is a reliable, reproducible, referenced metric and recognized as a measure of clinically significant changes in trials measuring balance.
- SOT Composite Score is a 0 to 100-point scale where zero means the patient cannot balance unaided and 100 implies perfect balance.
- An average SOT score for a neurologically intact adult is 70 – 80 and a change in score of 8 points is considered clinically significant. The mean baseline score for subjects in the trials was about 40, representing a population with a profound loss of balance.
- According to medical literature, subjects with chronic balance disorders caused by mild to moderate TBI have historically demonstrated limited response to physical therapy alone, with typical increases in SOT scores of 8-13 points over a 6-9 month period of time.
- The registrational trial was a randomized, double blind, multicenter clinical study designed to determine if a high frequency pulse (HFP) version of the investigational PoNS™ Therapy was superior to a low frequency pulse (LFP) version of the PoNS™ Therapy, that was intended in the trial design to be non-therapeutic. The LFP stimulus was detectable and was used to maintain blinding of study subjects and investigators.
• Had suffered a mild to moderate TBI and had a chronic balance disorder.
• Were at least one-year post injury and would, therefore, be unlikely to spontaneously recover their balance.
• Had all completed balance rehabilitation therapy, documented by a healthcare professional to no longer provide benefit. Therefore, if they responded to investigational PoNS™ Therapy with either HFP or LFP, it would likely be due to the intervention of the PoNS™ Therapy.
- The primary effectiveness endpoint in the trial was a responder analysis, comparing the HFP group to the LFP group. A responder was defined as a participant whose SOT score increased by more than 15 points, which is twice what is considered clinically significant and above what is typically seen in patients treated with PT alone.
- The secondary effectiveness endpoint in the trial was the mean change in composite SOT score at 2 and 5 weeks, compared to baseline.
Our prospective statistical analysis plan contemplated the scenario where the LFP PoNS™ Therapy was observed to be therapeutically active in the trial which would make it more difficult to reach statistical significance in the between-group comparison for our primary endpoint. The statistical analysis plan also provided for combining the data for HFP and LFP into a single group to assess the secondary endpoints of mean increase in SOT scores from baseline to the score at 2 and 5 weeks post PoNS™ Therapy.
Results of Registrational Trial:
- The response rates in this study showed that 75.4% (HFP) and 60.7% (LFP) of participants had at least a 15-point change in SOT, having previously plateaued on PT alone. There was a trend to higher response rate in the HFP group when compared to the LFP group, but as between the groups, both groups showed a strong response. The p value was = 0.081. Of note, the increase in SOT score in each group, 27.6 for HFP and 23.6 for LFP are markedly above what has been established for PT alone (8 - 13 points), a therapy all participants had previously undergone with no further benefit. Given this outcome, the next step of our statistical analysis plan was to combine the results for the two groups to ascertain if the mean change in the combined group would be significantly different from zero at the end of two weeks and five weeks of treatment. This would statistically assess whether the interventions in the HFP and LFP groups were positively therapeutic or not. The mean change was +18.3 at the two-week measurement point and +24.6 at week 5. Both measurements were statistically significant, p value <0.0005.
- We assessed the change in SOT scores for each of the HFP and LFP groups and observed a statistically significant change p<0.025 when comparing the increase in SOT scores in both the week 2 and week 5 measurement points in both the HFP and LFP groups compared to the baseline scores.
- The study met the primary and secondary safety endpoints. At baseline and post-PoNS™ therapy, the primary safety endpoint assessed falls and the secondary safety endpoint assessed headaches.
- We did not observe any device related serious adverse events.
Figures associated with registrational trial data are available at
Long-Term Treatment Trial
The long-term treatment trial was performed at the University of Wisconsin-Madison. It was designed to investigate what happens when subjects in both HFP and LFP PoNS™ Therapy groups discontinued treatment for 12 weeks after receiving 14 weeks of therapy.
- The results of the long-term trial were very similar to the results of the registrational trial.
- There were no statistical differences between the HFP and LFP groups.
- This study demonstrated that PoNS™ Therapy could help bring balance from profoundly disabled participants, to the normal range in 14 weeks of treatment and that this result was sustained without further therapy for another 12 weeks without any kind of prescribed therapy.
- There were no device related serious adverse events in the long-term treatment trial.
Figures associated with long-term treatment trial data are available at
Plans for FDA Submission for Marketing Authorization
First, it is critical to note that the planned route to market for the PoNS™ Therapy is as a class II medical device via the de novo classification process. This is novel technology for which there are currently no substantially equivalent devices being marketed in the US. During the pre-submission meeting with FDA, it was established that the investigational PoNS™ Therapy study to address balance symptoms in participants with mild to moderate TBI was a “Non-Significant Risk” device study.
FDA will evaluate the probable benefit to health from the use of the device against any probable injury based upon a reasonable assurance of safety and effectiveness. There is a reasonable assurance that a device is effective when it can be determined by FDA, based upon valid scientific evidence, that in a significant portion of the target population, the intended use of the device will provide clinically significant results. We believe we have met this standard in the results of the two clinical trials reported on in this communication in participants that had significant balance disorder associated with their mild to moderate TBI.
Second, the treatment of balance disorder after TBI is a significant health issue and represents an unmet medical need. We believe the results of these two clinical trials indicate that the investigational PoNS™ Therapy represents a promising opportunity to help patients and address a recognized unmet medical need.
Helius also has accomplished the following steps to securing marketing authorization:
- Proven Quality Management Systems. The company obtained ISO 13485 certification in October 2016 (http://heliusmedical.com/index.php/newsroom/news-release/2016/117-helius-medical-technologies-to-receive-iso-13485-certificate-precursor-certification-for-regulatory-applications-in-europe-canada-and-australia) and in September, 2017 passed their annual audit with no issues. Helius has therefore satisfied this element.
- Design Verification: The company is engaged in a battery of tests to ensure the investigational PoNS™ device can be manufactured to the required quality. These tests, once successfully completed, will accompany submission to FDA.
We look forward to discussing the data with FDA to secure marketing clearance for the device. We now anticipate that our 510(K) application to the US FDA will be submitted in the first half of 2018, with clearance expected in the second half of 2018. The timing on our submission is based on our decision to use devices from our scale manufacturing line for our submission for clearance to enhance the quality and reliability of our commercial devices at launch.
About PoNS™ Therapy
The Portable Neuromodulation Stimulator (PoNS™) is an investigational non-invasive device designed to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the device with physical therapy and is currently being evaluated in a multicenter clinical trial for the treatment of balance disorder for subjects with mild to moderate traumatic brain injury.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
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