Titan Medical has affirmed its regulatory filing timeline with a 510(k) submission expected by the end of 2019 as a result of discussions with the US 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.
Titan Medical president and CEO David McNally said: “We are encouraged by the collaborative nature of our correspondence and conversations with the FDA, and are confident that with their guidance, our confirmatory studies will be designed and executed to meet their standards.
“Under the leadership of Curtis Jensen, our Vice President of Quality and Regulatory Affairs, and with expert guidance from trusted surgeon advisors, planning meetings have already been held with qualified hospitals in preparation for our IDE study.”
“Based on our close interaction with regulatory bodies in the U.S. and the EU during 2018, we believe we have a clear understanding of the requirements to support our respective regulatory submissions.
“In parallel with planning for our IDE study in the U.S., we are preparing to complete the necessary audit and required documentation for the CE mark. We are well positioned to execute on a sound regulatory plan for our initial target markets.”
Mr. McNally added, “During the past year, we have significantly improved the capabilities and performance of our product platform. The focus in the first half of 2019 will be on completing verification and validation testing along with meeting ISO 13485 requirements for certification in support of the regulatory filings.
“Our efforts in the second half of 2019 will be directed toward preparing and implementing the IDE study and filing our 510(k) submission by the end of the year. We remain confident in our highly experienced team to meet our aggressive timeline, just as they have been doing during the past two years.”
Titan Medical is focused on computer-assisted robotic surgical technologies for application in minimally invasive surgery.
The Company is developing the SPORT Surgical System, a single-port robotic surgical system comprised of a surgeon-controlled patient cart that includes a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures, and a surgeon workstation that provides an advanced ergonomic interface to the patient cart and a 3D endoscopic view inside the patient’s body.
Source: Company Press Release