Yesterday, David McNally, CEO of Titan Medical Inc., told shareholders that the company must raise $85 million to finish developing its Sport robot-assisted surgery device and file for clearance by the U.S. Food and Drug Administration.
The Toronto-based medical device company is considering raising that money through equity or debt, licensing, merger, or acquisition.
In August 2019, Titan Medical announced that it was delaying its submission of Sport to the FDA to further refine the system.
Titan Medical lost nearly half its value in October 2019 after suspending the timeline for bringing the device to market due to lack of funds. In November, the company put its research and development work on hold while it looked for funding.
In December, Aspire Capital Fund agreed to purchase up to $35 million of Titan’s common shares through June 23, 2022.
In the letter to shareholders, McNally spelled out the 12-year-old company’s strategy beyond paying its bills. Titan’s board of directors established a special committee of independent directors in January to oversee the search for financing, McNally said.
Titan Medical explains strategy
“If we are successful in securing sufficient financing, our planned next steps will be to restart and complete product development, proceed to product verification and validation, and submit an Investigative Device Exemption (IDE) application to the FDA to begin human confirmatory studies,” said McNally. “Preparation for IDE submission includes extensive planning for these studies, which is already in advanced stages having identified four hospitals and the key opinion-leading surgeons who will perform the studies.”
“We believe that the magnitude of the market opportunity justifies the investment of substantial human and financial capital to improve patient outcomes through single-port robotic surgery,” he added. “We remain committed to our search for the capital necessary to pursue our vision of delivering both patient and physician satisfaction through a product that, upon completion, we expect will be able to reduce trauma and deliver virtually scar-free surgery.”