The Toronto-based medical device developer has been considering the best options for investors and the company’s Enos surgical robot. Facing delisting of its stock from the Nasdaq exchange due to its low price last year, Titan Medical announced a strategic review in November and furloughed staff in December.
Also this week — and probably not coincidentally — the company released details of a second-generation Enos design with improvements such as an increase in the number of instrument arms to three from two. Learn more about those Enos design improvements, including a new video featuring the latest prototype, at our sister site Medical Design & Outsourcing.
The company did not name individuals or companies with whom they met, but timed their visit for the J.P Morgan Healthcare Conference, which brought some of the biggest names to the Bay Area.
“We are looking forward to meeting with strategic buyers and investors during the conference week and providing a future view into what a three-arm single access robotic-assisted surgery technology could look like,” Titan Medical President and CEO Cary Vance said in a statement when the conference kicked off.
Medtronic CEO Geoff Martha spoke on the first day of the conference. Medtronic (NYSE:MDT) is the world’s largest medical device company and has already worked with Titan Medical. Additionally, Medtronic has developed its own surgical robotics system, called Hugo, and is using it in clinical trials.
Vance was joined in this week’s meetings by CFO Stephen Lemieux, General Counsel and VP of Legal, IP and Strategic Initiatives Jasminder Brar and VP of Investor Relations and Corporate Communications Kristen Galfetti.
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.
