The medical device company, which is focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery, now expects the IDE submission to occur mid-year 2023 instead of in the first quarter of 2023.
Pending successful regulatory review, and upon receipt of marketing authorization, the expected US product launch for the Enos system remains on schedule for early 2025.
By focusing on a single patient access point, Titan Medical expects that patient trauma and scarring can be reduced, and patients may be able to recover faster.
Interim President and CEO Paul Cataford said: “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.
“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.”
The Enos project timeline has been impacted by several factors including:
“We continue to carefully monitor our project plan. 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,” concluded Paul Cataford.