Monday, March 02, 2020 10:17:09 AM
They have since added 7 more clinics covering 9 more locations (no details on where), and will be requesting clearance in Canada for Multiple Sclerosis indication, in addition to mmTBI (the only official indication today).
They also said they will submit FDA de-novo for MS later this year based on an existing body of evidence. Hopefully their discussions with FDA are well informed enough that they don't expect the same rejection they got for mmTBI.
Still, encouraging progress out of Canada. I would still love to see more official statements from the PT community or patients about their results. My last post about the MS patient was very encouraging. There should be dozens more like it if the results are real.
Still largely sitting on the sidelines here, ready to jump in if things look very positive.
Recent HSDT News
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