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Intuitive Surgical stated right now that it has submitted for FDA 510(okay) clearance of its next-generation da Vinci 5 multiport surgical robotic. The da Vinci 5 will be part of Intuitive’s current da Vinci robotic surgical system portfolio alongside the multiport X and Xi techniques and the single-port SP. There’s additionally Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy within the lung.
“We’re submitted and within the back-and-forth with the FDA. It’s our hope for a 2024 launch, however they’re in the end the arbiters of once we get clearance,” CEO Gary Guthart stated throughout a night earnings name with analysts.
ISGR shares had been up greater than 6% to $395 apiece on the information.
Information of Intuitive transferring ahead with a next-generation da Vinci system has been a lot anticipated. Intuitive officers had beforehand stayed quiet on the timing, particularly after the corporate’s inventory took a short lived hit a 12 months in the past when Guthart talked about there wouldn’t be a brand new multiport system launch in 2023.
Guthart stated Intuitive has accomplished a complete multicenter IDE trial for the da Vinci 5. The trial completed accruing sufferers in Might 2023, with Intuitive submitting for 510(okay) clearance in August 2023. The corporate is responding to the FDA’s questions, which Guthart described as falling inside regular expectations.
As well as, Intuitive has initiated conversations about da Vinci 5 with regulators in Japan and South Korea, in accordance with Guthart.
Intuitive Surgical CFO Jamie Samath outlined how Intuitive is gearing up for da Vinci 5 manufacturing. The corporate has already transferred X system manufacturing to its East Coast hub close to Atlanta. This 12 months, Xi system manufacturing will transfer to Atlanta, too.
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Over the subsequent 18 months, the corporate will open new manufacturing amenities in California for the da Vinci 5 and Ion, he stated. It’s going to additionally full line transfers for Ion and SP to Mexicali, Mexico.
“We consider these actions will place Intuitive to serve our prospects with best-in-class provide availability, product high quality and product value,” Samath stated.
Guthart and different Intuitive officers promised extra particulars concerning the da Vinci 5’s options and advantages after the corporate receives FDA clearance.
“We predict that having a portfolio of decisions makes a ton of sense for hospitals, and this shall be part of that portfolio,” Guthart stated.
Intuitive’s da Vinci X surgical robotic system. Credit score: Intuitive Surgical
Intuitive had a Avenue-beating This fall
On high of the da Vinci 5 information, Intuitive reported fourth-quarter 2023 outcomes that exceeded the consensus of Wall Avenue analysts. Income was up 17% year-over-year to $1.93 billion. Web revenue was $606 million, or $1.69 per share, in contrast with $325 million, or 91¢ per share, in This fall 2022.
Adjusted to exclude one-time gadgets, Intuitive’s EPS was $1.60. The end result was 12¢ forward of The Avenue, the place analysts anticipated EPS of $1.48 and income of $1.89 billion.
Worldwide da Vinci procedures grew roughly 21% in contrast with the fourth quarter of 2022, and the set up base was up 14% — to eight,606 techniques — from a 12 months in the past.
Editor’s Notice: This text was republished from sister web site MassDevice.