Titan Medical is delaying filing for FDA clearance of its single-port robotic surgical system until the first half of 2020. Previously, the Toronto-based company said it would file its 510 (k) by the end of the year.
The Sport system is comprised of a surgeon-controlled patient cart that includes a 3-D high-definition vision system and multi-articulating instruments for performing minimally invasive surgeries, procedures, and a surgeon workstation that provides an advanced ergonomic interface to the patient cart and a 3-D endoscopic view inside the patient’s body.
Titan Medical also announced the human factors evaluation (HFE) required to support its planned IDE filing with FDA was completed successfully and received a highly favorable assessment from the surgeon investigators.
In a release, David McNally, Titan’s CEO said, “We have now successfully completed all [Good Laboratory Practice Regulations] and HFE studies, which have further demonstrated our single-port system’s best-in-class potential. Having achieved the expected results, we are compiling the associated reports from independent experts in preparation for our IDE submission with the FDA to begin human studies. In addition, we have engaged a top contract research organization to manage our human studies.”
McNally added, “We will now take additional time to perfect our system and implement all planned system and sterile instrument interface components, software enhancements and training tools, in order not only to further de-risk our IDE studies but also to introduce a more refined product in the marketplace. This more measured development schedule will allow us to better manage workflow and associated payments to our contractors, resulting in a reduction of our anticipated third-quarter cash burn and a smoother overall quarterly cash burn through to the filing of our 510(k). By extending our resources and milestones, we can ensure the highest likelihood of success for our single-port robotic system from clinical, regulatory and commercial perspectives, and enable a robust and careful examination of our future funding options, which may include strategic sources.”
Titan Medical’s announcement follows Medtronic giving an update on its surgical robotics system. The Dublin-based company said it will host a preclinical demonstration of the device on September 24 and also reaffirmed plans to launch its surgical robotics platform outside of the U.S. in its FY20.
Medtronic has also experienced delays with its timeline for getting its surgical robotics system to the market.
The robotic systems from both Medtronic and Titan Medical would compete against Intuitive Surgical’s da Vinci platform, which is well-established in the market.
Recently, the Sunnyvale, CA-based company has been making strategic moves to strengthen its portfolio and secure its position when competition finally hits the market. For an undisclosed sum, the company acquired the robotic endoscope portion of Schölly Fiberoptic’s business. Schölly Fiberoptic is a player in the field of visualization systems for minimally invasive diagnostic and surgical applications, headquartered in Germany — and one of Intuitive’s strategic suppliers.