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Home » Johnson & Johnson submits Ottava for FDA IDE, beats Street in Q3

Johnson & Johnson submits Ottava for FDA IDE, beats Street in Q3

October 15, 2024 By Sean Whooley

This is the logo of Johnson & Johnson.

Johnson & Johnson (NYSE: JNJ) shares dipped slightly before hours today on third-quarter financial results and an update on its surgical robot platform.

Shares of JNJ fell 1.1% to $159.78 apiece in pre-market trading today. They ticked up after the market opened, rising 1% to $163.10 apiece.

In a news release, Joaquin Duato, J&J’s chair and CEO, said the company submitted its Ottava surgical robot for FDA investigational device exemption (IDE). The company had said last year that it planned for a second-half IDE submission for the much-anticipated surgical robot.

Johnson & Johnson first shared details on the Ottava surgical robotic platform nearly three years ago. It highlighted the potential for unrivaled flexibility and control compared to the rest of the market.

Since that day in November 2020, Johnson & Johnson MedTech has remained quiet on the topic, though. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors. J&J initially expected to begin the verification and validation processes for Ottava in 2021. The company planned for enrollment in clinical trials for the device in 2022 to follow.

In the initial unveiling of Ottava, the company highlighted its six-armed approach. It aimed to provide more control and flexibility in surgery, while those arms will be integrated into the operating table. A November 2023 update shed more light on Ottava and some changes in its look over the past three years. The company said Ottava incorporates four robotic arms into a standard-size surgical table. Its unified architecture allows for an invisible design, J&J says. The robotic arms are available when needed and stowed beneath the surgical table when not.

Johnson & Johnson MedTech said the design removes barriers to movement and collaboration in robotic operating rooms. It also offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualize patient needs.

“This market is ready for competition and choice,” Hani Abouhalka, J&J MedTech company group chair for Robotics & Digital, said during a December 2023 investor event. “Based on our timeline and our confidence to deliver, we expect Ottava to contribute meaningful revenue towards the end of the decade.”

The rest of the Johnson & Johnson third-quarter results

J&J reported third-quarter financial results that topped the consensus forecast on Wall Street.

The New Brunswick, New Jersey-based medtech giant reported profits of $2.7 billion. That equals $1.11 per share on sales of $22.47 billion for the three months ended Sept. 30, 2024.

Johnson & Johnson recorded a 37.5% bottom-line slide on a sales increase of 5.2%.

Adjusted to exclude one-time items, earnings per share came in at $2.42. That landed 21¢ ahead of expectations on Wall Street. Sales also topped the forecast as experts estimated $22.16 billion in revenue.

Johnson & Johnson MedTech recorded $7.9 billion in sales, marking a 6.4% increase from the same period last year. Net acquisitions and divestitures impacted growth by 2.7%, according to a news release. The company attributed growth to sales for its electrophysiology products and for Abiomed in the Cardiovascular unit. Other growth drivers included contact lenses in Vision and wound closure products in General Surgery. Endocutter products in Advanced Surgery partially offset growth.

J&J updated its 2024 guidance with expectations for stronger revenue and adjusted EPS, albeit offset slightly by its $1.7 billion acquisition of V-Wave. The company increased its adjusted EPS projection from $10.05 to $10.15 pre-M&A, with post-M&A expectations coming in at $9.91. It expects sales between $88.4 billion and $88.8 billion, rising from a range of $88 billion to $88.4 billion.

“Johnson & Johnson’s strong results in the third quarter reflect the unique breadth of our business and commitment to delivering the next wave of healthcare innovation,” said Duato. “During the quarter, we advanced our pipeline with regulatory approvals for TREMFYA and RYBREVANT, submitted an IDE for our general surgery robotic system, Ottava, and launched Velys Spine and Shockwave E8 IVL catheter, further strengthening our confidence in our near-and long-term growth targets.”

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Regulatory/Compliance, Robotic-Assisted, Surgical, Surgical Robotics, Wall Street Beat Tagged With: Johnson & Johnson, Johnson & Johnson MedTech

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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