ok,heres the part I was looking for...bummer I was hoping this was the year !!
of Costs and Timelines
The results achieved by surgeons in operating prototypes in animal and cadaver studies during 2017 validated the
potential for single incision surgeries to be performed with the SPORT Surgical System. However, the studies also
confirmed that improvements to the system would be necessary before proceeding toward regulatory clearance and
commercialization. The planning for engineering activities has already commenced, but the execution of those
activities will increase the cost of product development and extend the timeline to commercialization. The Company
anticipates that 2018 will be a year of intense product development in preparation for manufacturing, including
hardware and software at all levels, involving the workstation, patient cart, camera and light source, instruments, and
disposable components that facilitate successful surgery. This work must be completed before design freeze and
proceeding with summative evaluation usability tests with the final product and validation studies required for
regulatory filings. Based on the scope of product development ahead, the Company expects these tests and studies to
take place in 2019, with the system in its final configuration and with training programs in place for new surgeon
users.
The amounts and timing of the Company’s actual expenditures will depend upon numerous factors, including the
status of its development and commercialization efforts and the amount of capital raised through equity financings
and warrant and option exercises.
Previously, FDA guidance was issued in 2016 that recommended additional/increased Human Factors Evaluation
requirements for medical device companies. This has caused, and will continue to cause the Company to incur
substantial expenses related to heuristic, formative and summative human factors evaluations in preparation for FDA
510(k) clearance submittal in 2019.
The rapidly evolving competitive market in surgical robotics requires a higher-performance product than originally
envisioned by the Company at its inception. This has required the re-assessment of user requirements in
consideration of competitors and in turn, driven further design changes. Specifically, the market leader, Intuitive
Surgical, has since revealed and begun clinical evaluation of its da Vinci SP Surgical System, a single port robotic
surgical system, in select hospital sites. In addition, competitor Medrobotics has announced the expansion of
applications for its Flex Robotic System beyond ENT surgery, and into abdominal surgery. Resulting design
changes to the Company’s product include instrument control mechanisms and software, as well as the visualization
system, including 3D camera and optics,
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