ALl you Naysayers do your Dd!!.
Titan Medical’s path to commercializing Enos
Titan Medical expects its Enos System to be first-to-market as a single-access, robotic-assisted surgical system, the company said this week in an investor presentation.
The presentation touted the value of its IP and its Enos system, saying Titan Medical’s partnership with Medtronic contributed to the second-generation prototype.
Titan Medical previously hoped to submit Enos for FDA investigational device exemption (IDE) in mid-2023 and commercialize the robotic surgery system in 2025. The company withdrew its Enos timeline in December when announcing the cost cuts, but said the IDE filing would remain a top priority along with the strategic review.
In this week’s presentation to investors, Titan Medical offered a new timeline to market, though the fine print says it’s only for information purposes and doesn’t depict actual target dates.
When the company resumes normal operations, it estimates Enos would need two months for the transfer to manufacturing and system delivery, eight months for safety and verification testing, 11 months for IDE application, FDA review and IDE study, and five months for the commercial launch.
A 12-month process to obtain CE marking would likely start sometime within the 11-month FDA process, the presentation said.
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FILED UNDER: BLOG, BUSINESS/FINANCIAL NEWS, FEATURED, GYNECOLOGICAL, MERGERS & ACQUISITIONS, NEWS WELL, ROBOTICS, SURGICAL
TAGGED WITH: FDA, MEDTRONIC, ROBOTIC SURGERY, SURGICAL ROBOTICS, SURGICAL ROBOTICS PLATFORMS, TITAN MEDICAL
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About Jim Hammerand
Jim Hammerand is the managing editor of Medical Design & Outsourcing. He has more than 15 years of professional journalism experience spanning newspapers, magazines, websites and broadcast news. For nearly a decade, he reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then managing editor of the Puget Sound Business Journal in Seattle. He holds a bachelor’s degree in journalism from the University of Minnesota. He is based near Seattle in Edmonds, Washington, where he and his family live. Connect with him on LinkedIn or by email at jimhammerand@wtwhmedia.com.
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