Helius Medical Technologies Inc (HSDT)

[tykundegex]

That's right.. FDA wanted assurance (that even this latest independent study did not provide) that physical therapy alone was not yielding the same improvement in balance than PT together with the PoNS.

I find it a little far-fetched to suggest PT alone may have been the main factor in the improvements given that all patients had already been undergoing PT in the past and were no longer seeing any improvements. Perhaps the PT regime was very different when done together with PoNS?

Either way, the company is all over this, and unless the new trials that they've agreed with FDA do not yield the same results, I would expect FDA clearance is in the bag. I just won't be very soon. But in the meantime, Canadian market is their litmus test.. if results are strong there, then they really have something unique. More indications and larger markets (US, EU) would be outstanding.