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Titan Medical Inc. Message Board

  • fitasafiddle99 fitasafiddle99 Mar 12, 2014 9:09 AM Flag

    MILESTONES we can look for....

    Development Milestone
    Anticipated Schedule
    for Milestone

     Completion of the functional prototype -
    Q3, 2013

     Alpha commercial prototype design complete
    (design of prototype suitable for ongoing tissue testing)
    $4.0 million Q1, 2014
    Completion of Clinical/Commercial Prototype
     Alpha commercial prototype built $3.0 million Q2, 2014
     Tissue testing complete
    (testing performance of individual features and functionality)
    $1.5 million Q2, 2014
     Tissue validation study complete
    (formal statistically relevant study intended to demonstrate
    safe and effective completion of surgical procedure)
    $4.0 million Q4, 2014
     Product design completion and design verification
    (building production equivalent product and confirming
    product meets previously established specifications)
    $4.0 million Q1, 2015
     Human clinical trials and regulatory submissions
    (prepare for and conduct human trials, prepare for and submit
    regulatory submissions)
    $12.0 million Q2-Q4, 2015

     Outside U.S. approval process
    (prepare and deliver submission packages to outside U.S.
    regulatory agencies)
    $2.0 million Q2, 2015

     Outside U.S. limited commercial launch
    (technology transfer, manufacturing ramp up and launch)
    $4.0 million Q2, 2015

     Process to shift to high volume manufacturing
    (transfer of manufacturing processes and procedure, ramp up
    of manufacturing)
    $2.5 million Q3, 2015

     U.S. limited commercial product launch $2.0 million Q4, 2015

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