The Toronto-based company reported research and development expenses of approximately $14.4 million, up 340.1% from the approximate $3.3 million it reported during the first quarter of 2018.
Titan Medical posted net and comprehensive loss of approximately $28.3 million, up significantly from the $808,699 in losses it reported during Q1 last year.
“We continued to make steady progress during the first quarter and recent weeks, moving closer to pivotal milestones in the development of our single-port robotic surgical system. Most recently we announced hardware design freeze, which allows us to complete verification and validation activities. We remain on track to conduct preclinical studies this summer under Good Laboratory Practices and summative human factors studies. These studies are in preparation for submitting an Investigational Device Exemption application to the U.S. Food and Drug Administration for human confirmatory studies, which we plan to conduct during the fourth quarter. Based on this schedule and anticipated approval of our IDE application, we expect to file by year-end 2019 our 510(k) application with the FDA and our technical file for the CE mark in Europe. During the first quarter we raised nearly $29 million in the single-largest offering in Titan’s history, which included several U.S. institutions as a result of our Nasdaq listing. We are now capitalized through several of this year’s important milestones ahead,” prez & CEO David McNally said in a press release. “We are taking the necessary steps to ensure a successful launch, following regulatory clearance. We have bolstered our global patent position, which now stands at 35 issued and 73 patents pending. Our agreement with Teleflex for ligation instruments will expand the types of procedures our system will be able to perform in the future. We are also proud to have welcomed our new chairman of the board earlier this month, Charles Federico, a prominent medical technology executive who possesses deep experience and a track record of success in strategic planning, corporate governance, and successful commercialization.”
Shares in Titan Medical are down 1.7% so far today, at $3.50 as of 1:38 p.m. EDT.
Late last month, Titan Medical said that it achieved a design freeze for its single-port Sport robotic surgery platform.