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Helius Medical Plunges After FDA Declines Request For Approval Of PoNS Device

Shares of Helius Medical Technologies Inc. (HSDT) dropped about 57% in Wednesday pre-market trading, after the company said the U.S. Food and Drug Administration has declined its request for De Novo classification and clearance of its Portable Neuromodulation Stimulator device or PoNS.

In reaching its conclusion, the Agency noted that it did not have sufficient information to discern the relative independent contributions of the PoNS Device and physical therapy on the improvements from baseline in the effectiveness endpoints observed in the Company's clinical studies. The FDA noted that the Company could generate additional data to address its concerns and resubmit its application.

The company noted that the Agency recognized that there were no device-related serious adverse events in either of the Company's two clinical trials, and that patients in both the treatment and the sham control arms demonstrated improvements from baseline for all the pre-specified clinical endpoints, including the primary endpoint of responder rate based on Sensory Organization Test score.   

"We are understandably disappointed by the Agency's decision to decline our request for De Novo classification and 510(k) clearance, but Helius remains committed to generating the data to pursue a De Novo classification and 510(k) clearance of our PoNS device in the future for the treatment of patients with chronic balance deficit due to mmTBI, in order to bring our innovative therapy to more than 1.5 million Americans suffering from this condition," said Philippe Deschamps, Chief Executive Officer of Helius.

"In addition to working on generating this new data, we will continue to focus on expanding our commercial efforts and treating patients in Canada, where we do currently have regulatory clearance," said Deschamps.

The Portable Neuromodulation Stimulator is a licensed class II, noninvasive, medical device in Canada indicated for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury when used in conjunction with physical therapy. The PoNS is an investigational medical device in the United States and the European Union, and it is currently under review for clearance by the EU Notified Body. PoNS Treatment is currently not commercially available in the United States or the European Union.

In Wednesday pre-Market trade, HSDT is trading at $2.65, down $3.56 or 57.33 percent.

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