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Wednesday, October 16, 2019 12:08:50 AM
And my conclusion is that the new near term milestones are minor and so they are just slowing down the burn.
Milestone 8 :
a) Obtain final independent report from validation testing of system safety and usability for the intended users and use environments under simulated robotic manipulation exercises intended to replicate essential surgical tasks -> minor
b) Complete User Manual for robotic system setup by operating room staff and surgeon operation of surgeon workstation, patient cart, instruments and accessories -> fluff
c) Obtain ISO 13485 Certification(3) -> no change
Milestone 9 :
a) Implement and test improvements to instruments and accessories -> what improvements? **
b) Perform biocompatibility testing of instruments at independent lab -> fluff
c) Perform electrical safety testing for surgeon workstations and patient cart, including electromagnetic compatibility (EMC) and electromagnetic interference (EMI) tests at independent lab -> fluff
d) Update application for IDE as additional testing lab data is received and continue preparations for human confirmatory studies -> no change
Milestone 10
a) Launch rebranded product line, including logos with trade-mark pending, literature and presentation templates, product and packaging -> minor
b) Complete system software validation -> not minor if there are bugs but minor if software is stable**
c) Submit IDE application to FDA -> no change
** = can be on critical path
They have really slowed it down but it is basically the same thing
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