Titan Medical (Nasdaq:TMDI) announced today that it updated the FDA submission timeline for its Enos robotic surgery platform.
“Multiple disruptions” have resulted in an updated FDA investigational device exemption (IDE) submission timeline for the Enos robotic single access surgery system, with the Toronto-based company now expecting the IDE submission to come in mid-2023, rather than the previously slated first quarter of 2023.
Following successful regulatory review and upon receipt of marketing authorization, Titan expects the U.S. product launch for the Enos system to remain on schedule for early 2025.
“We have been fortunate to have avoided and mitigated against many of the issues facing almost all other technology companies over the last few months,” Titan interim President and CEO Paul Cataford said in a news release. “However, we now expect our targeted IDE application date to be pushed out to the summer of 2023. Human clinical trials are still planned to start in 2023 and we expect to receive marketing authorization in the U.S. in early 2025.”
Titan said the project timeline has been impacted by the supply of certain key components and materials, affecting the production of instruments and camera systems and the delivery of capital equipment. That has resulted in delays for verification and validation testing.
Recruitment and resourcing of software engineers and developers has resulted in delays in unit testing procedures and certain documentation activities, Titan said, while the delayed procurement of disposable and consumable components resulted in delays in cleaning and disinfection testing and the good laboratory practices (GLP) study required for IDE submission.
“We continue to carefully monitor our project plan,” Cataford added. “With recent changes, we believe we have the right people, resources and partners in place to execute against our project delivery timeline. This team is committed, engaged and accountable, and we’re excited to bring our vision of single access robotic-assisted surgery to the market.”