TORONTO, ON--(Marketwired - March 23, 2017) - Titan Medical Inc. (TSX: TMD) (OTCQX: TITXF), reported today that the first milestone for 2017, finalizing user requirements for the single port robotic surgical system, has been achieved slightly ahead of schedule. The Company also reiterated the development milestones Titan is pursuing for its single-port robotic surgical system for application in minimally invasive surgery (MIS). The milestones and timeline are designed to lead to Titan's 510(k) submission to the US Food & Drug Administration (FDA) for clearance to market.
The remaining 2017 milestones are as follow:
Select and confirm two US and one European strategic facilities for pre-clinical studies
Test and evaluate performance of subsystems of existing engineering verification (EV) units
Complete initial formative human factors studies that follow previous heuristic studies
Initiate design changes based on subsystem performance and human factors evaluation
Implement design changes and retest system and subsystems
Update Design History File and documentation for relevant modules of the Company's Quality Management System ("QMS")
Complete initial requirements and architecture for simulation software and training program design
Complete and report on pre-clinical studies at strategic facilities in US and Europe
Confirm FDA and CE Mark pathways in coordination with regulatory authorities
2018 milestones:
Complete software development, system design and update Design History File for regulatory filings
Complete summative human factors evaluation
Complete simulation software development and training program design
Complete and document pre-clinical studies for FDA submittal
Prepare and submit 510(k) application to FDA and prepare Technical File for CE Mark and submit to European Notified Body
Publish white papers on pre-clinical studies
David McNally, President and Chief Executive Officer, stated, "During the past few weeks, Dr. Perry Genova, our Vice President of Research and Development and our team have carefully reviewed our plan to submit our single port robotic surgical system to the FDA for clearance to market, and apply for the CE Mark with a European Notified Body by the end of 2018. While the execution of the original roadmap was delayed during last year due to funding issues, we believe that the team's experience in advancing innovative and complex medical technologies through the design, development and regulatory review processes will enable Titan to submit its applications in 2018. We still need to raise additional funding of approximately $70 million to meet the 2018 filing objective. However, we believe with the multi-billion dollar opportunity ahead of us, sufficient financing and successful execution by our team, we can create substantial shareholder value."
