Intuitive Surgical (NYSE: ISRG) has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot.
The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.
“We are submitted and in the back-and-forth with the FDA. It is our hope for a 2024 launch, but they are ultimately the arbiters of when we get clearance,” CEO Gary Guthart said yesterday evening during an earnings call with analysts.
ISGR shares were up more than 6% to $395 apiece in after-hours trading. But the next day, the stock was down more than 2% to about $364 per share. MassDevice‘s MedTech 100 Index was down slightly.
News of Intuitive moving forward with a next-generation da Vinci system has been much anticipated. Intuitive officials had previously stayed quiet on the timing, especially after the company’s stock took a temporary hit a year ago when Guthart mentioned there would not be a new multiport system launch in 2023.
During the earnings call, Guthart announced that Intuitive has completed a comprehensive multicenter IDE trial for the da Vinci 5. The trial finished accruing patients in May 2023, with Intuitive submitting for 510(k) clearance in August 2023. The company is responding to the FDA’s questions, which Guthart described as falling within normal expectations.
In addition, Intuitive has initiated conversations about da Vinci 5 with regulators in Japan and South Korea, according to Guthart.
Intuitive Surgical CFO Jamie Samath outlined how Intuitive is gearing up for da Vinci 5 manufacturing. The company has already transferred X system production to its East Coast hub near Atlanta. This year, Xi system production will move to Atlanta, too.
Over the next 18 months, the company will open new manufacturing facilities in California for the da Vinci 5 and Ion, he said. It will also complete line transfers for Ion and SP to Mexicali, Mexico.
“We believe these activities will position Intuitive to serve our customers with best-in-class supply availability, product quality and product cost,” Samath said.
Guthart and other Intuitive officials promised more details about the da Vinci 5’s features and benefits after the company receives FDA clearance. He said the next-gen system underwent hundreds of design changes to respond to input from surgeons and care teams.
He mentioned that the da Vinci 5 has four orders of greater magnitude processing power than Intuitive’s fourth-generation systems. “That means 10,000 times the processing power to gather data, improve sensing, and deliver better digital and analytic performance.”
Guthart later added: “We think that having a portfolio of choices makes a ton of sense for hospitals, and this will be a part of that portfolio.”
Intuitive had additional positive news to report
On top of the da Vinci 5 news, Intuitive reported today that da Vinci SP has received a CE mark in the European Union, further expanding the company’s market reach.
The company’s fourth-quarter 2023 results exceeded the consensus of Wall Street analysts. Revenue was up 17% year-over-year to $1.93 billion. Net income was $606 million, or $1.69 per share, compared with $325 million, or 91¢ per share, in Q4 2022.
Adjusted to exclude one-time items, Intuitive’s EPS was $1.60. The result was 12¢ ahead of The Street, where analysts expected EPS of $1.48 and revenue of $1.89 billion.
Worldwide da Vinci procedures grew roughly 21% compared with the fourth quarter of 2022, and the install base was up 14% — to 8,606 systems — from a year ago.
Analysts Brandon Vazquez and Justin Lin at William Blair sounded positive about 2024 in their report, saying that procedure guidance remains achievable if not conservative for Intuitive. They expect Intuitive to start seeing meaningful procedure growth from da Vinci 5 in mid-2025 and beyond. Plus, the new system will solidify Intuitive’s competitive moat as medtech companies large and small seek to take on the robotic surgery pioneer.
This story originally ran on the evening of Tuesday, Jan. 23, 2024. Updated on Jan. 24 with next-day stock price and analyst comment.