Titan Medical Inc (TMDIF)

[chillout]

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Development Milestone
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Estimated Cost (in U.S. $)
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Schedule for Milestone Completion
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Comments
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Alpha commercial prototype design complete
(Design of prototype suitable for ongoing tissue testing)
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Q1 2014
Completed
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Alpha commercial prototype built
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-
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Q2 2014
Completed
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Tissue testing complete
(Testing performance of individual features and functionality)
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-
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Q2 2014
Completed
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Design and test of feasibility prototype complete
(Demonstrate feasibility for next generation console and advanced instruments)
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$11 million
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Q1 2015
Expected
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Proves feasibility to build and reflects expanded use of SPORTTM Surgical System
Units built and ready for engineering verification
(Prototype is formally tested to meet previously defined specifications)
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$17 million
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Q4 2015
Expected
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Prototype units enable validation of expanded use (not previously disclosed as discreet milestone)
Early human feasibility report complete
(Human clinical cases utilizing units are tested under engineering verification)
Audit for CE Mark approval commenced
$10 million (2 milestones)
Q2 2016
Expected
Q2 2016
Expected
First “in human” studies confirm capabilities of SPORTTM Surgical System for expanded use
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Pivotal Human clinical trial commenced
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$3 million
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Q3 2016
Expected
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Pivotal Human clinical trial completed and 510(k) application submitted to FDA
Outside U.S. commercial launch
(Pending CE Mark approval)
U.S. commercial launch
(Pending 510(k) market clearance)
$3 million (3 milestones)
Q4 2016
Expected
Q4 2016
Expected
Mid-2017
Expected
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TOTAL
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$44 million
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