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Thread: News: Has InVivo Therapeutics Developed A New Standard Of Spinal Cord Care?

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    Senior Member Moe's Avatar
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    News: Has InVivo Therapeutics Developed A New Standard Of Spinal Cord Care?

    News: Has InVivo Therapeutics Developed A New Standard Of Spinal Cord Care?
    By Steven Goldman, Aug.22.16:

    Summary

    -5 out of 8 patients paralyzed with spinal-cord injuries showed substantial improvement after being surgically implanted with InVivo's Neuro-Spinal Scaffold. Likely to become a new standard of care.

    -The 5 out of 8 patients in NVIV's INSPIRE study improved at least one ASIA grade after Scaffold implant: a 62.5% success rate.

    -FDA approved Inspire Study only requires Objective Performance Criterion in 25% or more of patients to meet primary endpoints set by FDA out of 20 patients.

    -FDA accepted Humanitarian Device Exemption (HDE) modular shell and review process for the Neuro-Spinal Scaffold. HDE filing in 2017 with approval and first commercial sales possible in 2018.

    -HDE authorizes marketing of the Humanitarian Use Device (HUD) in facilities that approved the device and established institutional review boards (currently 23 clinical sites, with up to 40 sites).


    (Cont..... 11 pages LINK) may require registration of news site to read full article... I'll try to find the article elsewhere.... -Moe
    Last edited by Moe; 08-22-2016 at 02:08 PM.

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    Senior Member lynnifer's Avatar
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    I have a problem with, "Likely to become a new standard of care," from a bio-market journalist. I know those times are off too ... won't be on the market by 2018.
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

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    They're just trying to drive share price. That 62.5% number is based on 8 subjects with no control group. Statistically it's way too soon to declare victory.

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