Titan Medical Inc. affirmed its regulatory filing timeline with a 510(k) submission expected by the end of 2019 as a result of discussions with the U.S. Food and Drug Administration (“FDA”). The Company plans to complete the required human confirmatory studies under an Investigational Device Exemption (‘IDE’) during the second half of 2019 in support of its 510(k) filing. Additionally, the Company confirms that it also expects to file for the CE mark by year-end 2019. Based on the timing of anticipated approvals, Titan plans to commence commercialization of its single-port robotic system in the U.S. and Europe in 2020, as previously announced.