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Thread: Epidural Stimulation Future Trials and Commercial Planning

  1. #101
    Quote Originally Posted by lynnifer View Post
    Totally agree. Talk about temper excitement. Today he said it was difficult to answer my questions which I read as, 'Don't bother me.'
    Why would Dr. Fehlings even have the answer to those questions? He wasn't involved in the original Harkema epi stim trial. He did not design the study and had no input as to the outcome measures they measured. That's why it's hard for him to answer your questions...he has no idea because he wasn't involved.

    The reason the info on BB&S return is only anecdotal is because Harkema et. al couldn't have predicted those functions would return, and therefore did not evaluate them. That is why the next "Big idea" trial is focusing solely on measuring the return of BBS and autonomic functions. You will have your answers when that trial is complete.

  2. #102
    Quote Originally Posted by Curt Leatherbee View Post
    Oh ya, I'm sure they do want incompletes, you can make the results looks a lot better with incompletes. My Original doc told me the nerves were dead never to be reborn at the site of my injury and that kind of stuck with me, he was right.
    Getting an implant to market costs $120 million.

    Getting the "transcutaneous" to market can help offset the cost of the $120 million, so thats what we are trying to do. The transcutaneous itself is $5. That?s what we need. We need $2 million to development for the implantable, and another $70 to get it to market.

  3. #103
    Quote Originally Posted by paolocipolla View Post
    I am not sure how she worked things out. I believe she is not part of the trial, but I could be wrong. Paolo
    Probably going to Bieke in China...

  4. #104
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    Quote Originally Posted by tomsonite View Post

    The reason the info on BB&S return is only anecdotal is because Harkema et. al couldn't have predicted those functions would return, and therefore did not evaluate them. That is why the next "Big idea" trial is focusing solely on measuring the return of BBS and autonomic functions. You will have your answers when that trial is complete.
    That's my understanding, too. There will be six parameters studied in the Big Idea: cardio, sexual function, bowel, bladder, voluntary movement, and temperature regulation.

    I asked Reggie straight up: do the four guys have orgasm back? I could hardly believe it when he said he wasn't exactly sure, until I remembered that this wasn't his project. He did say that he knows for certain that all of them have stopped using viagra. LOL, doesn't he realize what we're all dying to know?

    You've probably all seen this, but here's the pitch to get the Big Idea funded. Share it, for god's sake. We need this to happen, and it's not going to if there's no $$.

  5. #105
    Quote Originally Posted by GRAMMY View Post
    Probably going to Bieke in China...
    No, not China.

    As you know the stimulators have been used for long time for neuropathic pain and is just a medical device, so it is not difficult to get the approval of medical autorities to use them for a different indication.
    Reggie and Harkema do not have the exclusive.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  6. #106
    Quote Originally Posted by GRAMMY View Post
    Getting an implant to market costs $120 million.

    Getting the "transcutaneous" to market can help offset the cost of the $120 million, so thats what we are trying to do. The transcutaneous itself is $5. That?s what we need. We need $2 million to development for the implantable, and another $70 to get it to market.
    Will epistim reduce the cost of care? If yes, how much (more or less)?

    That is what insurance companies want to know to decide if cover the cost or not.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  7. #107
    They should send out everybody letters who has SCI with results thus far, heck if it is something that really is promising I would donate a grand and if everybody donated some they could raise that money easily. I'm just not convinced as much as I would like to be that it's going to be anything that is going to help us.

    Quote Originally Posted by GRAMMY View Post
    Getting an implant to market costs $120 million.

    Getting the "transcutaneous" to market can help offset the cost of the $120 million, so thats what we are trying to do. The transcutaneous itself is $5. That?s what we need. We need $2 million to development for the implantable, and another $70 to get it to market.
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  8. #108
    Quote Originally Posted by Barrington314mx View Post
    Have they got the 36 participants ready or will that come after complete funding is reached?
    Do they plan to have near all of the patients at once? Or is that 36 spread out over a certain time period?
    Quote Originally Posted by GRAMMY View Post
    I'm not sure if they have to wait for all the funding or not. I can ask on that. I believe they have 5 million already before this campaign. They have a link here to register for participation in the trial at University of Louisville...I'll find out as much as I can at the end of the week.

    http://www.reevebigidea.org/the-research
    Have you heard any more info on this side of the discussion? Do they plan to take on all 36 individuals in Louisville or I wonder if they have considered other locations as well?

  9. #109
    I believe the 5 year project will all be held in Louisville. If you space the 36 out, that one facility would have all their proposed data by working with 7 patients per year. This pdf file gives a pretty good flavor of what they're wanting to work on. I don't think it will entail a whole lot of step training since they're wanting to check out the other things that happened with their preliminary 4 guys concerning quality of life issues. From what I'm reading here, they want all of the funds for the proposed projects by spring of 2015 and paid for by Dec 2015.

    http://www.reevebigidea.org/assets/p..._Sept_2014.pdf

    Test the hypothesis that epidural stimulation can be used to promote recovery of autonomic control in patients who have been diagnosed as completely paralyzed.
    __________________________________________________ __________________________________________________ _____________________________

    The NeuroEnabling Technologies Inc. clinical trials for the testing of the actual transcutaneous devices listed at clinical trial.gov site are different than what is happening on the big idea project being promoted by Reeve for discovery work at Louisville .
    Last edited by GRAMMY; 11-06-2014 at 02:25 AM.

  10. #110
    Quote Originally Posted by paolocipolla View Post
    No, not China.

    As you know the stimulators have been used for long time for neuropathic pain and is just a medical device, so it is not difficult to get the approval of medical autorities to use them for a different indication.
    Reggie and Harkema do not have the exclusive.

    Paolo
    Wrong. Currently there are no spinal cord stimulators approved to restore function from paralysis by any medical authority including the FDA. There are large medical device companies developing and commercializing implantable neurostimulation devices to treat chronic pain. Others are being developed for migraine, epilepsy and gastro-esophageal reflux. If there wasn't difficulty, it obviously would have been done many years ago. NeuroRecovery Technologies Inc. (Monarch Beach, CA) which is developing novel spinal-cord stimulator technology and holds the exclusive license to the IP related to it.

    Last edited by GRAMMY; 11-06-2014 at 03:26 AM.

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