Titan Medical pushes FDA submission back to 2019, looks to US stock market cross listing

Titan Medical (TSX:TMD) leadership today spoke on the future of the company and its Sport single-port robotic surgery platform, saying it expects to begin submission of clinical data in pursuit of FDA approval by 2019, up from a previously expected submission in late 2018, and that it is exploring eligibility for a cross listing on a US stock exchange.

CEO David McNally, head of the Toronto-based company, said Titan Medical has already begun its conversation with the FDA and that it met with a qualified European notified body for CE Mark approval as they set out in pursuit of regulatory clearance in both markets.

The FDA reportedly informed the company that it can pursue a 510(k) pathway for the system, but Titan said it is still looking to confirm the “most likely predicate devices that would lead to the least burdensome pathway for clearance to market,” according to McNally.

That data won’t begin rolling in until the company has a perfected Sport model, however, pushing a previously set timeline for submission during the third quarter of this year back into 2019.

“Based on what we have learned form these preclinical studies, I don’t believe that that is realistic now. What we have learned from these studies has been incredibly valuable in terms of the granularity of the engineering tasks ahead. We know what we have to do, but to do this right we know that we have to have a product that is in its final form before we would proceed with gathering the data for regulatory submittals. So I expect those activities will roll into 2019,” McNally said in a conference call.

When asked about the company’s commitment to holding its timeline and previous delays, McNally said that the company is “doing everything we can to compress the timeline.”

“Recognizing that we cannot budge on the performance and quality and safety of the system. But with that in mind, management is keenly aware of the history of the company. I can say that over this past 12 months we’ve taken a deeper dive with a – I’ll say, the most highly qualified product development team this company has ever had – to understand what the pathway is looking forward. But, certainly as the CEO of 13 months now […] I’m extremely sensitive to timelines and am certainly proud of what the team accomplished last year, but this team recognizes that we have to make up for lost time,” McNally said.

For the current year, McNally said he sees it as one of “intense product development from manufacturing, including hardware and software at all levels – involving the workstation, patient cart, instruments, camera and light source and disposable components that facilitate successful surgery.”

On the funding front, McNally touted that the company had raised more than $40 million in 2017, saying that the capital would take the company into the third quarter of 2018.

For future funding, McNally added that the company was exploring cross-listing options with a US-based exchange.

“Based on our capital needs, we intend to explore our eligibility for a cross listing on a recognized US-based stock exchange this year in order to gain access to US institutional capital. The timing of this will be dependent on a number of factors, including market conditions,” McNally said. “We will simultaneously be pursuing non-dilutive sources of capital, such as strategic investments.”

The company was hush-hush on its partnerships with contract development partners and supplies, with McNally saying that keeping the information confidential “can potentially support our competitive position when we come to market.”

In December, Titan Medical said it installed a Sport robotic surgical system at the Institut Hospitalo-Universitaire de Strasbourg, marking the 1st installation of the system in Europe and the final planned installation for the company’s feasibility and validation studies.

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