Titan Medical, a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that multiple disruptions have resulted in an updated Investigational Device Exemption (IDE) submission timeline for the Enos™ robotic single access surgery system. The company now expects the IDE submission to occur mid-year 2023 instead of the first quarter of 2023. Pending successful regulatory review and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system remains 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. 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,” said Paul Cataford, Interim President and CEO.
The Enos project timeline has been impacted by several factors including:
- Supply of certain key components and materials has affected the production of instruments and camera systems and the delivery of capital equipment resulting 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.
- Delayed procurement of disposable and consumable components resulted in delays in cleaning and disinfection testing and the GLP study required for the IDE submission.
“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.
Source: Titan Medical.