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Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval, page-6

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  1. 4,213 Posts.
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    Here is a timeline for you to consider;

    Study to start within 6 months - Jan 2020
    If there is to be about 100 patients to be enrolled then it usually takes about 12 months - Jan 2021
    6 months of follow up of last patient - July 2021
    Approval maybe Dec 2021

    The best part of this announcement is that surgeons will be able to apply for an exemption to use it.
 
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