Still would love to see the AGM video get posted soon. I don't remember it taking this long last year.
Meanwhile, I will summarize the schedule from the Short Form Prospectus on SEDAR from last week:
Finalize User Requirements, Q1 2017, Complete.
Select/Confirm facilities for pre-clinical studies, Q2 2017, Identified, in contract phase.
Test/Evaluate Performance of sub-systems in EV units, Q2 2017, Complete.
Complete Initial Formative Human Factors studies, q@ 2017, Complete.
Initiate design changes based on the last two items above, Q2 2017, Initiated on schedule; design changes in progress.
Complete and verify system design
architecture, including performance testing in
laboratory environment and design of
surgeon simulation training modules
- Implement design changes and retest
system and subsystems
- Update Design History File and
documentation for relevant modules of
Company Quality Management
Systems (“QMS”)
- Complete initial requirements and
architecture for surgeon simulation
software and training program design,
as required in preparation for FDA
submittal Q3 2017.
Verify system performance in pre-clinical
(live animal labs, swine), while establishing
clear regulatory pathways for US and Europe
- Complete and report on pre-clinical
live animal (swine) studies at strategic
facilities in US and Europe
- Confirm FDA and CE Mark pathways
in coordination with regulatory
authorities Q4 2017.
Complete software development, system
design and update Design History File for
regulatory filing applications Q1 2018.
Verify production system operation with
clinical experts under rigorous formal
(summative) human factors evaluation under
simulated robotic manipulation exercises, and
exercise completed surgeon simulation
software and training program Q2 2018.
Complete and document pre-clinical live
animal (swine) surgery studies that are representative of anticipated human surgeries for FDA submittal Q3 2018
Prepare and submit 510(k) application to
FDA and prepare technical file for CE Mark
and submit to European Notified Body Q4 2018
Anticipated receipt of FDA 510(k) clearance
and CE Mark H1 2019
The SEDAR filing also has cost estimates for most of these items.
AI
