Helius Medical Technologies Inc.
Shares of Helius Medical Technologies Inc.(OTCMKTS:HSDT) fell 25.33% despite the company reporting positive results from its Registration Clinical trial for Traumatic Brain Injury (TBI). The company’s Portable Neuromodulator Stimulation (PoNS), being evaluated in patients with chronic balance deficits, met its primary and secondary endpoints.
PoNS Trial Results
According to the medical technology company, the low-frequency device demonstrated statistical improvements in composite SOT scores, compared to baseline. The device also successfully met its primary and secondary safer endpoints as measured by a decrease in falls and headaches in both groups. There were no serious device-related adverse events.
“We are very pleased with the findings from our registration trial that demonstrate that PoNS™ Therapy, deployed independently across our seven study sites, produced statistically significant improvements in balance from baseline, on average over three times the clinically significant amount,” said Helius’ Chief Medical Officer, Dr. Jonathan Sackier.
Helius Medical Technologies Inc. (OTCMKTS:HSDT) plans to submit an application for clearance with the U.S. Food and Drug Administrations (FDA) and other foreign regulatory bodies following the positive trial results. TBI is a serious public health condition with limited treatment options. Available treatments are minimally ineffective and focus on teaching patients on how to deal with deficits rather than improving symptoms.
It is still unclear why investors pushed the stock lower following the positive PoNS trial results. The stock faces the risk of dropping further after breaking a key support level and failing to rise above $3.90 on two attempts. However, Helius Medical technologies has outperformed the overall industry after rising by more than 80% since the start of the year.
Separately, Helius Medical Technologies Inc. (OTCMKTS:HSDT), through its wholly-owned subsidiary NeuroHabilitation has extended its Cooperative Research and Development Agreement with the U.S Army. The agreement will run through 2018 and extends the commercialization deadline of PoNS therapy through December 31, 2021.
The cooperation is for the development and commercialization of the non-invasive brain stimulation device currently being developed for the treatment of traumatic brain injury. The partnership also seeks to support the development of other potential indications of the device, relevant to injured service members.
“We are encouraged with the progress to date on our TBI trial as all study subjects have completed their treatment; an important milestone as we work towards FDA clearance forecasted for the first half of 2018. We continue to appreciate the US Army as our development partner,” said Philippe Deschamps, CEO of Helius Medical Technologies Inc. (OTCMKTS:HSDT).
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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