Titan Medical updated investors this week on its efforts to bring a robotic surgical system to market in the U.S. and Europe.
The company spent $14.4 million on R&D in the first quarter, resulting in a net loss of $28.2 million but keeping it on track to file for a CE mark and 510(k) clearance by the end of the fiscal year.
Titan expects its R&D team will continue burning through cash at a similar rate in the coming quarters, meaning it will need to raise $35 million to keep going for another year.
Titan is developing the Sport Surgical System. This single-port robotic surgical system consists of a cart that displays images captured from inside the patient and controls the physician can use to guide instruments while performing minimally-invasive procedures.
If Titan brings the system to market, it will enter a field dominated by Intuitive Surgical and populated by a fast-growing number of challengers, including industry giants such as Medtronic and Johnson & Johnson.
Titan said it has gained an edge over the competition by gathering input from surgeons during the development of Sport, resulting in a system it claims has a more ergonomic user interface and greater instrument dexterity than rival technologies. The company is also seeking to minimize the cost per procedure by developing reusable instruments that pair to single-use effectors.
To date, 12 surgeons have used the system to work on 43 live animals and two human cadavers. To get Sport to market in the U.S., Titan will need to perform further live animal and cadaver studies before filing to test the system in humans under an investigational device exemption.
Titan expects to submit an IDE application in the third quarter and file for 510(k) clearance and a CE mark in the fourth quarter. Titan plans to spend around $15 million a quarter on R&D. Having ended the first quarter with $34 million in current assets, the R&D spending plan will force Titan to raise money in the near future.
Investors pumped almost $29 million into the business in the first quarter and Titan plans to raise another $35 million to support its path to market. Strategic partnerships, private placements and debt are all under consideration. The $35 million will see Titan through to the end of the first quarter of 2020, by which time it could be gearing up to commercialize Sport.
"This includes projected capital resources necessary for the Company to submit its 510(k) application to the FDA and apply for CE Marking," an SEC filing states. "If successful with those efforts, the Company then expects to proceed with early commercialization activities in the U.S. in 2020."