Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said late yesterday that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year.
The news came as part of the Toronto-based company’s 2018 earnings report, with the robotic surgical company saying that it is hopeful it will finish verification and validation testing followed by design freeze and animal and cadaver studies to support regulatory clearance filings during the first half of 2019.
Following that testing, Titan Medical said it hopes to submit an IDE study application to the FDA during the first half of this year, with a study launch following during the fourth quarter. The company added that it hopes to submit both a 510(k) premarket notification and technical files to support CE Mark approval in the European Union by the end of the year.
In its earnings report, Titan Medical saw losses shrink 32.6% from approximately $33.6 million in 2017 to approximately $22.6 million in 2018. Research and development expenses ballooned, however, rising 60.7% from approximately $12.9 million in 2017 to approximately $32.9 million in 2018.
“2018 was an exceptionally busy and productive year for Titan Medical as we achieved all milestones related to the development of our Sport single-port robotic surgery system. I want to congratulate the Titan Medical team and our business partners for their dedication as we continue our important work toward commercialization. By our internal estimates, we believe there is an opportunity for us to access an unaddressed U.S. market that potentially may include more than $12 billion in capital equipment revenue and more than $3 billion in associated annual recurring revenue, including smaller hospitals and the underserved ambulatory surgery center market segment. During the fourth quarter we completed the system engineering confidence build for our next-generation SPORT Surgical System, including a new camera system and design enhancements to the surgeon workstation and the patient cart, the two primary components of the system. The enhancements reflect our preclinical experience with expert robotic surgeons. We ended the year gaining clarity from the U.S. Food and Drug Administration on the regulatory pathway for the Sport system. During the second quarter, we expect to begin conducting the requisite animal studies that precede human studies. During the second half of 2019 we plan to complete the required human confirmatory studies under an Investigational Device Exemption, or IDE, in support of a 510(k) filing by the end of the year. We also expect to file for the CE mark by year-end 2019,” CEO David McNally said in a press release.
Last month, Titan Medical said that it completed an initial build of its Sport single-port robotic surgery system, paving the way for future development of the platform.