Titan Medical has warned that factors outside its control could prevent it filing for clearance to sell its robotic surgical system by the end of the year.
Titan said it remains committed to that timeline but it is also managing expectations by advising investors that the schedule is "very tight" and "not completely within [its] control."
Timeline uncertainty stems from the lack of slack in the schedule for following up with patients in an upcoming clinical trial and compiling the data from the study.
Over the past year, Titan has hit a series of milestones in developing its single-port robotic surgical system. The technology, called the Sport Surgical System, is designed to enable surgeons to perform image-guided, minimally invasive procedures, putting Titan on turf currently dominated by Intuitive Surgical.
Titan recently advanced its efforts by completing the surgeries associated with its good laboratory practice studies. Titan is now compiling the follow-up documentation for an FDA Investigational Device Exemption (IDE) filing.
The timing puts Titan on track to hit its goal of submitting an IDE application in the third quarter. After that, the schedule becomes less certain. Titan hopes to receive the clearances needed to start its IDE trial of Sport in the third quarter and complete the study in time to use the resulting data in CE mark and 510(k) filings by the end of the year. But the company said it may miss its goal.
In a letter to investors, CEO David McNally said one of the uncertainties was the inability to predict when FDA and the Institutional Review Board will sign off on the start of the IDE trial. In addition, Titan faces a race to gather the data needed to file for FDA clearance to sell Sport.
"The schedule for completing patient follow-up and compiling data for the 510(k) submission in December is very tight and not completely within our control; however, our team remains committed to the goal of filing this submission and filing for CE mark in Europe by year-end," McNally wrote.
Titan is putting infrastructure in place to support the planned launch of Sport. McNally expects Titan to lease a facility in North Carolina in the coming months, giving the Canadian company a U.S. base. Titan will house the team that manages tasks including manufacturing and commercialization at the facility. The facility will feature a lab capable of hosting post-launch surgeon training.