Johnson & Johnson’s OTTAVA Robotic Surgery System Targets Long-Term Growth

Key Points

• Johnson & Johnson received FDA De Novo authorization for OTTAVA and plans a disciplined U.S. launch targeting high-volume hospitals and established robotic-surgery programs, with international expansion to follow.
• The table-integrated system is designed to use 30% to 50% less operating-room space than boom- or cart-mounted platforms, while features such as Twin Motion and automated procedure poses aim to improve workflow and enable robotics in more operating rooms.
• Initial clinical results showed 100% procedural completion across 30 patients, and J&J plans to expand OTTAVA from gastric bypass and hernia repair into urology, gynecology and other procedures; however, the company has not disclosed placement, pricing or revenue targets.

Johnson & Johnson NYSE: JNJ outlined its commercialization plans for the OTTAVA robotic surgical system after receiving U.S. Food and Drug Administration De Novo authorization, positioning the table-integrated platform as a long-term growth initiative in surgical robotics.

The company said it will begin with a disciplined U.S. launch focused on early adopters and established robotic surgery programs, including academic and non-academic hospitals with high procedural volumes. Johnson & Johnson plans to use initial placements to gather feedback, build clinical evidence and expand the system’s capabilities, indications and geographic reach over time.

“OTTAVA is not simply a new system,” Rocco De Bernardis, Global President of the OTTAVA program, said during the investor call. “It is something we have built with purpose, persistence, and in partnership with surgeons and hospitals.”

Table-Integrated Design and Operating Room Footprint

OTTAVA is designed as a soft-tissue robotic surgery system with surgical arms integrated into a standard-size operating table, rather than using booms or carts. De Bernardis said the system occupies 30% to 50% less space than leading boom- and cart-mounted systems, which could enable hospitals to deploy robotics in operating rooms that may not have accommodated conventional robotic platforms.

Johnson & Johnson said five of six sites in its initial clinical trials used OTTAVA in operating rooms that had not previously been used for robotic procedures. One of those rooms measured 243 square feet, according to the company.

The design is intended to improve patient access, staff movement and visibility around the operating room while potentially allowing hospitals to expand robotic surgery capacity without major infrastructure changes. During the call, executives emphasized that the company sees the platform as a way to make robotic surgery compatible with more operating rooms rather than requiring facilities to dedicate specific rooms to robotics.

Hani Abouhalka, Company Group Chairman of Surgery, said U.S. robotic surgery penetration remains “in the high 20s” and that Johnson & Johnson believes OTTAVA can help expand the market. He said the company intends to bring the system to international markets after the U.S. launch.

Twin Motion and Automation Features

A central feature of the system is “Twin Motion,” which synchronizes movement between the operating table and robotic arms. Neda Cvijetic, Global Head of Research and Development for Robotics and Digital, said the feature allows clinicians to reposition the patient and table while maintaining the remote center of motion, leaving instruments unaffected and allowing a procedure to continue without undocking and repositioning the system.

Dr. Dominic Papandrea, Global Head of Medical Affairs for OTTAVA, said the need for repositioning varies by procedure but can be greater in operations that move across multiple abdominal quadrants.

OTTAVA will also include automation at launch through automated procedure poses. With a button press, the system’s motorized arms can deploy from beneath the table into a procedure position or be stored out of the way for patient preparation and transfer. Johnson & Johnson said the automation is intended to make setup and teardown more repeatable for surgical teams.

Cvijetic said the architecture provides a foundation for continued automation, software and digital development, while emphasizing that the company’s approach is intended to keep surgeons and care teams in control.

Clinical Results and Instrument Strategy

Johnson & Johnson reported that its FORTE trial met its primary safety and effectiveness endpoints and achieved 100% procedural completion without conversion to a non-robotic approach across 30 patients. The company also cited an early-experience survey in which all responding surgeons and surgical staff agreed that OTTAVA could create opportunities to free space or convert rooms into robotic operating rooms; 95% agreed it creates efficiencies, and 90% agreed it increases operating-room visibility.

The company plans to launch the system with next-generation instruments designed specifically for robotics. Executives highlighted a two-in-one needle driver with separate surgeon-activated cutting and suturing-only modes, as well as monopolar curved scissors engineered for consistent cuts.

Abouhalka said Johnson & Johnson intends to offer advanced instruments exclusively on OTTAVA and expects a regular cadence of 510(k) submissions to expand the instrument portfolio, including products in stapling and energy.

Commercial Expansion and Global Ambitions

Johnson & Johnson said it selected Roux-en-Y gastric bypass as an initial procedure because it is a complex, multi-step operation involving multiple abdominal quadrants. Papandrea said the procedure was intended to demonstrate performance and safety while supporting multiple general surgery indications.

The company said an investigational device exemption study in inguinal hernia repair is ongoing. Tim Schmid, Executive Vice President and Worldwide Chairman of MedTech, said Johnson & Johnson expects to subsequently expand into areas including urology and gynecology and ultimately make the system available for the majority of surgical procedures.

Executives said the company is pursuing registrations in Western Europe and Japan in parallel with its U.S. commercialization efforts. Schmid said fewer than 8% of relevant soft-tissue procedures globally are currently performed robotically and called OTTAVA a global program with potential to be financially material for Johnson & Johnson by the end of the decade.

Johnson & Johnson did not provide specific placement, pricing or revenue targets. The company said it expects to discuss its expectations for OTTAVA and its broader robotics strategy at its Enterprise Business Review on Dec. 8.

About Johnson & Johnson (NYSE:JNJ)

Johnson & Johnson is a multinational healthcare company headquartered in New Brunswick, New Jersey, that develops, manufactures and markets a broad range of products across pharmaceuticals, medical devices and previously consumer health. Founded in 1886 by the Johnson family, the company has grown into a global healthcare organization with operations and sales in many countries around the world.

The company's pharmaceuticals business, organized largely under its Janssen research and development organization, focuses on prescription medicines across therapeutic areas such as immunology, infectious disease, oncology and neuroscience.

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