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    PoNS device

    Any guess on when the Pons device will be available in the U.S.

    Available in Canada and Europe but not the U.S. Been waiting along time to this...
    “No Jesus, No peace; Know Jesus, Know peace.”

    #2
    Originally posted by ScottLand View Post
    Any guess on when the Pons device will be available in the U.S.

    Available in Canada and Europe but not the U.S. Been waiting along time to this...
    Hi ScottLand ~

    From the Helius Medical Technologies website:

    NEWTOWN, PA., September 4, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device.

    https://heliusmedical.com/index.php/...he-pons-device

    Not sure if this is a fast track request, or what it means.

    Take Care
    PPMS for 22 years (dx 1998)
    ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

    Comment


      #3
      For those (like me!) who had never heard of the PoNS device, this link gives some info and has a short video on the device.

      Any first-hand reports from folks that have used it?
      59M / RRMS / Dx1987 / Ocrevus

      Comment


        #4
        Originally posted by Golgotha View Post
        For those (like me!) who had never heard of the PoNS device, this link gives some info and has a short video on the device.

        Any first-hand reports from folks that have used it?
        Thank you Golgotha!

        Very interesting info and video of how the PoNS works.

        Take Care
        PPMS for 22 years (dx 1998)
        ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

        Comment


          #5
          Thanks Golgotha (and OP) for the link.

          This really appears to be a personal hands-on approach!

          I like the idea of employing our brain by extending knowledge of balance / motion into previously under utilized areas or maybe even "piggy-backing" this knowledge to another location (my own perspective, not the manufacturer).

          Appears to have relationship to what a PT or trainer may call "muscle memory." Although they are not the same, working in conjunction may establish a new pathway for the signal, as the video of treadmill workout suggest. Really like this!

          Look forward to additional info! Will post if I hear something too!

          Jer

          Comment


            #6
            Thanks FDA

            The FDA choose to reject the Pons device. Sad move by the FDA. What was the problem? Big pharma not making enough off this device? Device with no side effects, people regaining function... Arrogant move by the FDA.
            “No Jesus, No peace; Know Jesus, Know peace.”

            Comment


              #7
              Originally posted by ScottLand View Post
              What was the problem?
              Thanks for the update Scott.

              I wonder if they're saying that physical therapy was equally effective as the PONS treatment? The PONS treatment group and control group both showed improvements.

              But still, I'm not really sure what the reason is.

              https://heliusmedical.com/index.php/...ease/2019/276-

              "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.

              In the course of its review of the Company’s submission, 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."
              PPMS for 22 years (dx 1998)
              ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

              Comment


                #8
                Really don't know how to respond to this news.

                To me, the body will find a way if at all possible, to resolve any issue. The devise appears to open the brain to establishing, through our own direct efforts, new pathways to accomplish a possibility (walking better!!).

                With no adverse side effects....?

                Really don't know how to respond....

                Comment


                  #9
                  Hopeful news

                  FDA Grants Breakthrough Device Designation to Helius’ PoNS Device

                  The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients.

                  The device, which is meant to be used in combination with therapeutic exercise programs, works by sending mild electrical signals that travel through nerves that connect the tongue — where the device is placed — to the brainstem. The brainstem is a region at the base of the brain that regulates vital functions (e.g., heart rate, respiration), as well as sensory perception and movement.

                  This mild electrical stimulation is thought to increase the brain’s neuroplasticity — the brain’s ability to adapt or rewire itself to preserve function following damage. The stimulation is expected to promote patients’ physical rehabilitation.

                  https://multiplesclerosisnewstoday.c...le-sclerosis/?
                  PPMS for 22 years (dx 1998)
                  ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

                  Comment


                    #10
                    Thanks for the post. This is exciting news for those who have a lesion in the Pons.

                    What has caused most of my symptoms through the years has been a large lesion
                    in the pons/medulla area.

                    My main lesion is a large one in my pons (medulla to be specific) and messes with my breathing, heart rate, and bp. I also have problems walking, but my baclofen pump did a lot for me in that area.

                    The most interesting thing is that they reach the pons through the tongue. My presenting
                    symptom, and the one that has never abated is one sided tongue pain, and tongue sensory
                    issues. My doctors and I have found a couple meds that help, but without the meds, I go
                    right back to tongue pain. Too late to help an "old fogey" like me, but hopefully will help
                    the next generation of MS brainstem lesion patients with their symptoms. Since facial
                    neuralgias (trigeminal or glossopharyngeal) originate in the brainstem (all cranial nerves run through that area) I wonder if it could help those folks also.

                    It's not implantable, so I wonder how they attach it to the tongue, I'll have to look up more
                    about the device.

                    Comment


                      #11
                      Hi rdmc

                      Originally posted by rdmc View Post

                      What has caused most of my symptoms through the years has been a large lesion
                      in the pons/medulla area.

                      My main lesion is a large one in my pons (medulla to be specific) and messes with my breathing, heart rate, and bp. I also have problems walking, but my baclofen pump did a lot for me in that area.

                      The most interesting thing is that they reach the pons through the tongue. My presenting
                      symptom, and the one that has never abated is one sided tongue pain, and tongue sensory
                      issues.
                      It is interesting what you posted about the lesion on your pons, and the tongue issues that you have to deal with. It's so true that lesion location, and not necessarily the number of lesions, is the most important factor concerning MS symptoms.

                      Originally posted by rdmc View Post
                      It's not implantable, so I wonder how they attach it to the tongue, I'll have to look up more about the device.
                      It looks like the mouth piece just rests on the tongue.

                      Scroll down a little bit for the short video.

                      https://heliusmedical.com/index.php/...he-pons-device
                      PPMS for 22 years (dx 1998)
                      ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

                      Comment

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