Titan Medical (TSX:TMD;OTC:TITFX) today pushed back the timeline on its Sport robot-assisted surgery device, saying it now expects to file for 510(k) clearance from the FDA next year, sending its share prices down in New York and Toronto.
With a successful human factors evaluation of the single-port device under its belt, the Toronto-based company said it expects to file for an investigational device exemption from the federal safety watchdog during the fourth quarter. The full 510(k) filing is slated for the first half of 2020, not by the end of this year as previously expected, Titan said.
“We have now successfully completed all [good laboratory practice] and HFE studies, which have further demonstrated our single-port system’s best in-class potential,” CEO David McNally said in prepared remarks. “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.”
“In the short time I have worked at Titan Medical I have become ever more excited about the potential for our single-port robotic surgical system, once it is fully developed, to compete successfully in a very large market,” added chief commercial officer Chad Zaring. “I have already met with a number of experienced robotic surgeons and hospital administrators, and based on their feedback I believe the single-port market has the potential to develop rapidly. I also believe Titan Medical can deliver a product with differentiated features of value to the surgeons who utilize it, ultimately benefitting their patients.”
TITFX shares were down -2.4% to $2.01 apiece today in mid-morning trading in New York City; TMD shares were off -1.8% to C$2.68 today in Toronto.