Dive Brief:
- Johnson & Johnson on Tuesday unveiled a timeline to begin clinical trials for its Ottava robotic surgery platform, announcing it intends to file a submission for an investigational device exemption (IDE) with the Food and Drug Administration in the second half of 2024.
- Ottava is J&J’s answer to Intuitive Surgical’s market-dominating da Vinci system for general surgery. The Ottava robot is designed for use with J&J’s Ethicon surgical instruments.
- The progress update on Ottava has been eagerly awaited after J&J announced layoffs earlier this year in its robotics business following delays in the system’s development, with CFO Joe Wolk at the time saying “we have to get better” with the soft tissue robot.
Dive Insight:
Gaining an IDE to start clinical trials for Ottava will put J&J on the path to challenging Intuitive’s da Vinci, which has led the robotic surgery market for more than two decades. Medtronic is also in the race to bring a soft tissue robot system called Hugo to the U.S. market. Its U.S. study is now underway after also facing delays.
J&J is counting on its leadership in surgical devices to drive interest in Ottava, touting its 135-year history as a maker of instruments used in surgical procedures.
The Ottava system is designed to be incorporated into any operating room, with four robotic arms that work with a standard size surgical table and can be stowed beneath the table when not in use, J&J said. The platform also allows for the patient to be repositioned during surgery without interrupting the procedure.
Robot-assisted surgery is a nearly $5 billion market opportunity in the U.S., RBC Capital Markets analyst Shagun Singh said in a research report last month. “We expect JNJ’s industry-leading surgical portfolio to be led by continued procedure volume growth, and a shift towards MIS [minimally invasive surgery] aided by robotics,” Singh wrote.
J&J’s robotic portfolio also includes the Monarch platform for bronchoscopy and urology procedures and the Velys orthopedic system.