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Re: Flenderson post# 81508

Tuesday, 02/05/2019 1:16:46 PM

Tuesday, February 05, 2019 1:16:46 PM

Post# of 140474
Mc was unclear about the mid section but he starts with a intra Q1 event, followed by a bunch of "then"s, and ends with an intra Q4 event, meaning that the precedent events should occur before the "within Q4 event. Theres nothing here that specifies exactly mid year, rather before Q4 as Mc implies...

2019 will be an incredibly busy year. During the first quarter, we expect to document the results of testing the confidence build of our next-generation robotic system. We then expect to proceed to design freeze and the verification of system operation with rigorous human factors evaluation under simulated robotic manipulation exercises. We then plan to proceed to preclinical animal and human cadaver studies in support of our 510(k) submission. Based on preparations that are already underway, we're planning for the first human surgeries to be performed with our single-port surgical system during the fourth quarter of 2019 under an Investigational Device Exemption from the FDA. [B]Upon successful completion of those studies, we expect to file our 510(k) application with the FDA by year-end.