Titan medical this week updated investors’ efforts to bring robotic surgery systems to the U.S. and European markets.
The company spent $14.4 million on R & D in the first quarter, resulting in a net loss of $28.2 million, but remained ready to apply for the CE mark and 510 (k) customs clearance at the end of the financial year. Titan expects its R & D team to continue burning cash at a similar rate in the coming quarters, which means it needs to raise $35 million to continue for a year.
Titan is developing a sports surgery system. The single port robotic surgery system includes a cart that displays images captured from the patient’s body, as well as the control that the doctor can use to guide the instrument during minimally invasive surgery. If Titan brings the system to market, it will enter the field dominated by intuitive surgical and be composed of fast-growing challengers, including industry giants such as Medtronic and Johnson & Johnson.
Titan said that by collecting surgeons’ investment in the sport development process, it has gained an advantage in the competition, thus forming a system that claims to have a more ergonomic user interface and higher instrument flexibility, rather than competitors’ technology. The company also seeks to minimize the cost of each procedure by developing reusable instruments that can be paired with disposable effectors.
So far, 12 surgeons have used the system to study 43 living animals and 2 human cadavers. In order for sport to enter the U.S. market, Titan will need to conduct further live animal and cadaver studies before it can test human systems under the exemption of research equipment.
Titan is expected to submit ide applications in the third quarter and 510 (k) licenses and CE marks in the fourth quarter. Titan plans to spend about $15 million on R & D every quarter. After the first quarter ended with $34 million in liquid assets, the R & D spending plan will force Titan to raise funds in the near future.
Investors injected nearly $29 million into the business in the first quarter, and Titan plans to raise another $35 million to support its entry into the market. Strategic partnerships, private placements and debt are all under consideration. The $35 million will see Titan reach the end of the first quarter of 2020, when it may be preparing to commercialize sport.
“This includes the estimated capital resources required for a company to file a 510 (k) application with the FDA and apply for the CE mark,” the SEC filing said. “If these efforts succeed, the company will continue its early commercialization activities in the United States in 2020.”