ARTICLE SUMMARY:
After years of financial and technological advances and setbacks, and bolstered by the arrival of a new interim president and CEO, Titan Medical is gearing up to launch a pivotal trial of its robotic-assisted single-port access system, with plans to file for FDA de novo review in 2023 and a potential launch in 2024, in a fast-growing but increasingly competitive sector. A video interview with interim president and CEO Paul Cataford and VP Chris Seibert.
Titan Medical is betting on the high quality of its technology to capture the robotic single-port access opportunities, which are an emerging area of robotic surgery. While a multiport robotic system requires four incisions, including a camera and three instruments, a single port incision procedure delivers a camera with a light source and two highly functional, multi-articulating arms simultaneously. The benefits are the potential to reduce trauma and speed recovery.
So far, the only robotic single-port access system on the market is Intuitive Surgical’s da vinci SP platform, which was launched in 2018 for urological indications. As of the end of 2021, Intuitive Surgical reported 99 placements. If all goes well, Titan Medical’s Enos system could be the second to come to market.
The key to single-port incision is instruments that allow a high-level dexterity and advances in camera technology that enable 3D visualization. Titan’s IP revolves around its unique dual-view camera technology, which includes a 10-millimeter in diameter dual-camera system built into an cannula, which is steered by the surgeon, similar to a trocar with viewing capacity. This delivers an initial 2D view of the target anatomy, followed by delivery of a steerable 3D high-definition camera, all from the same incision, so the surgeon can visualize the target anatomy from the moment the incision is made. The instrumentation has uniquely designed end effectors, which grasp and cut tissue. The plan is to file an IDE in 2023, and, if all goes well, this is to be followed by a clinical trial launch in 2024, submission of a de novo FDA application for review in 2024, and a market launch in 2025. [Editor’s note: these projections were updated post-publication.]
Subscribers can view our conversation with Titan execs Paul Cataford, interim president & CEO and Chris Seibert, VP, below.
