Titan Medical Inc (TMDIF)

[was CUIN2]

Please confirm, but I believe their may be a slight change to the Timeline Outline at the Titan Medical Website. See below. In particular, 2nd half of 2015 below indicates •Final phase of FDA approval process completed•Limited commercial product launch in U.S. undertaken


Initiation of Bench and Pre-Clinical Tissue Testing (2H 2013)
•Tissue testing initiated
•Technical feasibility and integrated testing continues

Initiation of Pre-clinical and Clinical Planning Process with FDA (1H 2014)
•Alpha commercial prototype design completed
•Alpha commercial prototype built
•Tissue testing continues

Initiation of Outside U.S. Approval Process (1H 2015)
•Tissue validation study completed
•Product design and design verification completed

Initiation of Outside U.S. Initial Commercial Launch Process (1H 2015)
•Application for CE Mark to European regulatory agencies submitted
•CE Mark approval from European regulators obtained
•Limited commercial launch in Europe undertaken
•Human trials in U.S. and final FDA approval submission process commence

Initiation of FDA 510(K) Clearance Process (2H 2015)
•Final phase of FDA approval process completed
•Limited commercial product launch in U.S. undertaken
•Shift to high volume manufacturing initiated