Helius Medical Technologies Clarifies: Pivotal Study Successful; FDA Submission Next Up

pons deviceHelius Medical Technologies (T:HSM), developer of a device that shows significant promise of improving the conditions of those with traumatic brain injuries and brain diseases, wants to set the record straight: The results of their most recent clinical trials were decidedly positive, not a failure. Next up: The FDA.

Investors and others interested in the company’s breakthrough device have flooded Helius with calls asking for clarification of the trial outcomes after a puzzling report by an investment analyst that the “pivotal trial failed.” The analyst, Andre Uddin, head of the healthcare practice at Mackie Research, also terminated coverage of the stock.

Helius’ device is an outgrowth of research at the University of Wisconsin in Madison that led to development of the Portable Neuromodulation Stimulator, or PoNS. The device is placed in the mouth of patients and stimulates cranial nerves in the tongue – which is a key pathway to the brain’s learning centers. Combined with cognitive or physical exercise, it is a safe, non-invasive and effective way to prompt the brain to learn certain functions.

What made Uddin’s report confusing was not just that it was directly counter to his previous recommendations. Earlier this year, he said Helius was undervalued in keeping a “speculative buy” rating. It was that his report was issued 15 minutes before the company held a Nov. 9 conference call to present the outcomes of that “pivotal” study. And “failure” was not a term Helius used to describe them.

Helius has conducted several significant trials of the PoNS device. Its 2016 pilot study was conducted among children in Russia, aged 3 to 14, with cerebral palsy, and returned statistically significant improvements in terms of spasticity, balance and gross motor function. The most recent studies in question were registrational and long-term treatment clinical trials.

In the company’s follow up clarification, CEO Philippe Deschamps pointed to decidedly positive outcomes. “The data showed participants who received PoNS Therapy experienced average SOT (sensory organization test) score improvements double to triple the increase that would be expected with physical therapy alone in a much shorter timeframe,” he said.

Moreover, Helius expects to discuss the study data with the FDA as it moves forward to secure marketing clearance with the agency. Also underway is design verification to ensure commercial manufacturing standards are met. Its application to the FDA is expected to be submitted in the first half of 2018, with clearance anticipated in the second.

In addition to confusion over the conflicting takes on the outcomes of the clinical trials of the PoNS device, Uddin’s report caused considerable dismay among people who are pinning a lot of hopes on its commercialization.

Writing on Medium, Laura McGrath, whose young son has severe cerebral palsy and a limited life expectancy as a result, sees Helius’ PoNS device as his best hope for improved function, quality of life and life expectancy. And she believes it’s a realistic hope at that.

But she questioned the basis for the Mackie analyst’s report and worried over the “millions whose chances at brain injury rehabilitation have just been capriciously jeopardized by Mr. Uddin’s piece.”

 

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Author: HEDGE

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