Intuitive Surgical CEO Gary Guthart disclosed plans for a fifth-generation da Vinci robot on the company’s quarterly earnings call Tuesday, confirming speculation circulating among analysts.
The robotic surgery leader submitted a 510(k) application for da Vinci 5 to the Food and Drug Administration in August, after completing a multicenter investigational device exemption study, Guthart said. The company is now responding to the FDA’s questions, which he called in line with “normal expectations for a submission of this type.”
When the robot will launch depends on the time required to answer those questions, Guthart said.
“It is our hope that it is a ‘24 launch,” he added. “But I can’t guarantee it.”
The company plans a phased market introduction over the first several quarters after gaining FDA clearance. Intuitive is also in talks with regulators in Japan and Korea on commercializing da Vinci 5, according to Guthart.
As to what new features the robot will offer, Guthart said more details will be shared once the device is cleared. But the system has been designed to provide 10,000 times the processing power of its predecessor, for gathering data, improving sensing, and delivering better digital and analytic performance.
Intuitive is seeking broad indications for the new robot, aiming initially for greater penetration in current surgical categories, followed by expansion into additional areas, Guthart said.
The robot maker preannounced fourth-quarter results earlier this month that beat analysts' expectations, boosted by a 21% rise in da Vinci procedure volumes. The growth was led by procedures within general surgery, particularly cholecystectomy, colon resection and foregut procedures, company executives said on the earnings call. Growth in bariatric surgeries, which has slowed in recent quarters amid the arrival of new GLP-1 weight-loss drugs, moderated into the mid-single digits year over year.
The company maintained its full-year outlook for procedure growth of 13% to 16% for 2024 and said it also expects total system placements to be lower than in 2023. Procedure growth of 22% last year exceeded long-term trends because of the need to address patient backlogs that built up during the COVID-19 pandemic.
Intuitive continues to see delayed tenders and lower system placements in China due to an ongoing government anti-corruption campaign and expects capital spending in the country to remain affected at least through the first half of 2024, company executives said.
The low end of the procedure growth outlook reflects the bariatric surgery weakness and challenges in China from both increasing competition and the anti-corruption effort, they said. Lower system trade-in volumes also are anticipated as customers await the rollout of the new da Vinci robot.
Intuitive CFO Jamie Samath said Intuitive’s operating margins are likely to come under pressure in 2024 due to the upcoming launch of da Vinci 5, but the company sees opportunity for margin expansion once customers begin to upgrade to the new technology.