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Helius Medical Technologies Inc HSDT

Helius Medical Technologies, Inc. is a neurotech company in the medical device field. It is focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms enhancing the lives of people dealing with neurologic diseases. It develops, licenses, or acquires non-implantable technologies targeted at reducing symptoms of neurological disease or trauma. Its product Portable Neuromodulation Stimulator (PoNS) is a non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit. PoNS Therapy is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS neuromodulation stimulator. PoNS is used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.


NDAQ:HSDT - Post by User

Post by Mcburnzon Nov 09, 2017 12:03pm
150 Views
Post# 26933558

Update on action from fabrice

Update on action from fabriceThere is a lot of confusion this morning about Helius clinical data. The company believes the results are very positive, with but one analyst who covers it didnt agree, arguing that the company didnt meet its endpoints and discontinuing coverage of the stock. That would have triggered a lot of selling. This is a quote from the release: Primary effectiveness endpoint demonstrated a trend toward a higher responder rate in the high frequency PoNS Therapy group (75.4%) than in the low frequency PoNS Therapy group (60.7%), p<0.081 primary="" effectiveness="" endpoint="" was="" not="" reached="" because="" low="" frequency="" pulse="" treatment="" had="" a="" significant="" therapeutic="" effect="" secondary="" effectiveness="" endpoints="" demonstrated="" statistically="" and="" clinically="" significant="" increases="" (at="" least="" 8="" points)="" in="" composite="" sot="" scores:="" the="" mean="" improvement="" at="" 2="" weeks="" for="" combined-arms="" was="" 18.3="" points,=""><0.0005 the="" mean="" improvement="" at="" 5="" weeks="" for="" combined-arms="" was="" 24.6="" points,=""><0.0005in other words, he says that difference between using the pons device and nothing is not st its that second sentence thats causing the debate. the study didnt reach its primary effectiveness endpoint because while the high-frequency group (the patients getting the true treatment) showed excellent results, those in the low-frequency group (the sham group) also saw a big improvement, so the company cant claim that the normal treatment regimen is behind the improvement. however, the low-frequency group did receive a form of the therapy, but at a lower frequency. (the patients had to receive some stimulation or they would know they were in the sham group.) ceo phil deschamps told me this morning that this is excellent news because he believes even a lower frequency version of the treatment shows very good results. he is completely puzzled as to how the analyst could reach the conclusion he came to. the company has been preparing for this potential outcome for two years, and phil had mentioned this possibility to me on more than one occasion but not with dread, rather with excitement. management is very pleased with the results and highly optimistic about the business. helius is planning to rebut the report, so its probably a good idea to wait for that before acting. other="" words,="" he="" says="" that="" difference="" between="" using="" the="" pons="" device="" and="" nothing="" is="" not="" st="" its="" that="" second="" sentence="" thats="" causing="" the="" debate.="" the="" study="" didnt="" reach="" its="" primary="" effectiveness="" endpoint="" because="" while="" the="" high-frequency="" group="" (the="" patients="" getting="" the="" true="" treatment)="" showed="" excellent="" results,="" those="" in="" the="" low-frequency="" group="" (the="" sham="" group)="" also="" saw="" a="" big="" improvement,="" so="" the="" company="" cant="" claim="" that="" the="" normal="" treatment="" regimen="" is="" behind="" the="" improvement.="" however,="" the="" low-frequency="" group="" did="" receive="" a="" form="" of="" the="" therapy,="" but="" at="" a="" lower="" frequency.="" (the="" patients="" had="" to="" receive="" some="" stimulation="" or="" they="" would="" know="" they="" were="" in="" the="" sham="" group.)="" ceo="" phil="" deschamps="" told="" me="" this="" morning="" that="" this="" is="" excellent="" news="" because="" he="" believes="" even="" a="" lower="" frequency="" version="" of="" the="" treatment="" shows="" very="" good="" results.="" he="" is="" completely="" puzzled="" as="" to="" how="" the="" analyst="" could="" reach="" the="" conclusion="" he="" came="" to.="" the="" company="" has="" been="" preparing="" for="" this="" potential="" outcome="" for="" two="" years,="" and="" phil="" had="" mentioned="" this="" possibility="" to="" me="" on="" more="" than="" one="" occasion="" but="" not="" with="" dread,="" rather="" with="" excitement.="" management="" is="" very="" pleased="" with="" the="" results="" and="" highly="" optimistic="" about="" the="" business.="" helius="" is="" planning="" to="" rebut="" the="" report,="" so="" its="" probably="" a="" good="" idea="" to="" wait="" for="" that="" before="">
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