The goal is to commercially launch Enos in early 2025 after securing a De Novo market authorization from the FDA, the Toronto-based robotic surgery company said during its second-quarter earnings report today.
Titan Medical officials said they have an ongoing dialogue with FDA through the agency’s Q-Submission program. Its regulatory timeline includes filing an application for an investigational device exemption (IDE) in mid-year 2023 for its initial target indication for benign gynecologic surgical procedures, followed by an FDA response in the second half of 2023. After the IDE approval, the next step would be to complete a clinical study in time for a De Novo submission in 2024.
During the second quarter, Titan Medical focused on completing product development and transferring substantially all of the Enos system’s components to its external manufacturing partner. As of June 30, 2022, Titan had cash and cash equivalents of $20.2 million, compared to $32.3 million six months before.
“Our technical partnerships, our relationships with surgeons and the dedication of our employees support our efforts in submitting an IDE application, designing forthcoming clinical trials and planning our commercialization strategy for the U.S. market,” Titan’s recently appointed CEO Cary Vance said in a news release.
“Setting Titan apart is our innovative, ergonomic platform design derived from extensive surgeon input. We believe this will set the stage for the next generation of single-access RAS to advance patient care. The capability of the Enos system to operate robust, small-scale, and dexterous instruments through a minimal incision should improve patient outcomes and change the paradigm for surgeons and patients.”
Other news from Titan Medical includes an agreement with Nissha Medical Technologies for the manufacture of surgical consumables. The single-use surgical components will be used for verification and validation testing, as well as pre-clinical and clinical studies of Titan’s Enos system.
Bill Fahey, who has held executive-level engineering positions at Precision Spine/Spinal USA and Orthofix/Blackstone Medical, has joined Titan Medical as its VP of manufacturing and operations.