Mr. Paul Cataford reports
TITAN MEDICAL PROVIDES UPDATE TO ENOS PROJECT TIMELINE
Multiple disruptions have resulted in an updated investigational device exemption (IDE) submission timeline for Titan Medical Inc.'s Enos robotic single-access surgery system. The company now expects the IDE submission to occur midyear 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 chief executive officer.
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 have 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 (good laboratory practice) 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 Mr. Cataford.
About Titan Medical
Titan Medical, a medical device company headquartered in Toronto, Ont., and with operations in Chapel Hill, N.C., is focused on enhancing robotic-assisted surgery using innovative technology through a single access point. The Enos robotic single-access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multiarticulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
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