USA – Johnson & Johnson (J&J) has submitted an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) for its Ottava surgical robot.
This marks a major milestone as the company prepares to launch clinical trials for the much-anticipated device.
J&J announced this achievement during the release of its Q3 2024 financial results, delivering on its prior commitment to submit the IDE in the second half of 2024.
CEO Joaquin Duato confirmed the submission, stating, “We are proud to submit the Ottava surgical robot for FDA investigational device exemption as we look toward advancing surgical innovation.”
Ottava’s development and unique design
Johnson & Johnson first introduced its Ottava surgical robot nearly three years ago, highlighting its potential to revolutionize robotic-assisted surgery.
Unlike other systems, Ottava features a unique six-arm design integrated directly into the surgical table, promising surgeons unparalleled flexibility and control.
Over the years, the platform has undergone design refinements, with the most recent update in November 2023 revealing four robotic arms that can be stowed beneath the table when not in use.
According to J&J, this innovative design is meant to “eliminate barriers to movement and collaboration” in the operating room, while offering surgical teams the ability to adapt workflows to meet the specific needs of each patient.
The road to clinical trials
Ottava’s development has faced delays due to the COVID-19 pandemic and technical challenges. Initially, J&J had aimed to begin clinical trials in 2022.
However, the timeline was pushed back, and now with the FDA IDE submission, the company hopes to start trials in the near future.
Speaking about the competitive landscape, Hani Abouhalka, group chair for Robotics & Digital at J&J MedTech, noted during a December 2023 event, “This market is ready for competition and choice.
Based on our timeline and our confidence to deliver, we expect Ottava to contribute meaningful revenue towards the end of the decade.”
Growing market and competitive pressure
The global surgical robotics market is booming, driven by increasing demand for precision in surgeries.
According to GlobalData, the market for surgical robots was valued at US $8.6 billion in 2022 and is expected to reach US $10 billion by the end of 2024.
With its entry, J&J aims to challenge industry leader Intuitive, whose Da Vinci robot has dominated the field since 2000.
As of March 2024, Intuitive had installed more than 8,600 units globally, capturing 60% of the market.
Other competitors include Medtronic, which entered the market in 2021 with its Hugo soft tissue robot, and several companies, including Vitestro and Ronovo Surgical, currently conducting clinical trials for their robotic systems.
Financial highlights from Q3 2024
Alongside the Ottava IDE submission, J&J reported its financial results for the third quarter of 2024, showing mixed performance.
The company recorded profits of US$2.7 billion, equivalent to US $1.11 per share, on sales of US $22.47 billion.
Despite a 37.5% year-over-year drop in profits, sales increased by 5.2%. Adjusted earnings per share came in at US $2.42, surpassing Wall Street’s expectations.
Johnson & Johnson MedTech’s performance was particularly strong, with a 6.4% rise in sales to US $7.9 billion.
Growth was driven by the company’s electrophysiology products, Abiomed in its Cardiovascular unit, and wound closure products in General Surgery.
Looking ahead, J&J raised its 2024 revenue guidance to between US $88.4 billion and US $88.8 billion.
CEO Joaquin Duato remarked, “Our strong results in the third quarter reflect the unique breadth of our business and our commitment to delivering the next wave of healthcare innovation.”
“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.”
