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Titan Medical’s Enos robotic-assisted surgical procedure (RAS) system is supposed to learn hospitals by means of a smaller footprint, straightforward mobility and decrease working prices. | Photos courtesy of Titan Medical
Titan Medical (Nasdaq: TMDI; TSX: TMD) expects manufactured items of the Enos robotic-assisted surgical procedure system might be accessible later this 12 months.
The aim is to commercially launch Enos in early 2025 after securing a De Novo market authorization from the FDA, the Toronto-based robotic surgical procedure firm mentioned throughout its second-quarter earnings report right this moment.
Titan Medical officers mentioned they’ve an ongoing dialogue with FDA by means of the company’s Q-Submission program. Its regulatory timeline contains making use of for an investigational system exemption (IDE) in mid-year 2023 for its preliminary goal indication for benign gynecologic surgical procedures, adopted by an FDA response within the second half of 2023. After the IDE approval, the following step can be to finish a medical research in time for a De Novo submission in 2024.
Throughout the second quarter, Titan Medical centered on finishing product improvement and transferring considerably the entire Enos system’s parts to its exterior manufacturing companion. As of June 30, 2022, Titan had money and money equivalents of $20.2 million, in comparison with $32.3 million six months earlier than.
“Our technical partnerships, {our relationships} with surgeons and the dedication of our staff help our efforts in submitting an IDE software, designing forthcoming medical trials and planning our commercialization technique for the U.S. market,” Titan’s just lately appointed CEO Cary Vance mentioned in a information launch.
“Setting Titan aside is our modern, ergonomic platform design derived from in depth surgeon enter. We imagine it will set the stage for the following era of single-access RAS to advance affected person care. The aptitude of the Enos system to function sturdy, small-scale, and dexterous devices by means of a minimal incision ought to enhance affected person outcomes and alter the paradigm for surgeons and sufferers.”
Different information from Titan Medical contains an settlement with Nissha Medical Applied sciences for the manufacture of surgical consumables. The one-use surgical parts might be used for verification and validation testing, in addition to pre-clinical and medical research of Titan’s Enos system.
Invoice Fahey, who has held executive-level engineering positions at Precision Backbone/Spinal USA and Orthofix/Blackstone Medical, has joined Titan Medical as its VP of producing and operations.