Titan Medical Reports First Quarter 2019 Results [Video]
Posted on May 15, 2019 by Medtech[y] Staff
Titan Medical Inc. (TSX: TMD) (NASDAQ: TMDI) , known for their single port robotic system, known as SPORT in the past, announced their financial results for the three months ended March 31, 2019.
As the single port robotic system gets closer to anticipated launch, research and development expenses had a substantial increase to $14.4 million compared to $3.2 million in the corresponding prior-year period. Thus the loss in the quarter was $28.2 million compared to a net loss of $808k for the same period in 2018.
Titan Medical has $33.8 million in cash and cash equivalents.
“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 (GLP) and Summative Human Factors studies. These studies are in preparation for submitting an Investigational Device Exemption (IDE) 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.
Titan Medical Single Port Robotic System
“We are taking the necessary steps to ensure a successful launch, following regulatory clearance,” Mr. McNally added. “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.”
Titan is projecting a 2020 launch for the single-port robotic system.