SANTA CLARA, CA
Johnson & Johnson announced results from the first clinical study of its investigational OTTAVA™ Robotic Surgical System, marking a key milestone in the development of the company’s soft-tissue surgical robotics platform.
The prospective, multicenter clinical study evaluated the safety and performance of OTTAVA™ in Roux-en-Y gastric bypass procedures. Results were presented at the 2026 American Society for Metabolic and Bariatric Surgery Annual Meeting in San Antonio, Texas.
In a 30-patient cohort, the study met its primary safety and performance endpoints through 30 days after surgery. Investigators completed all procedures robotically using OTTAVA™ without conversion to a non-robotic approach. Patients in the cohort recorded an average weight loss of 30 pounds within 30 days after surgery.
Johnson & Johnson said the clinical data, together with preclinical testing, were used to support an application to the U.S. Food and Drug Administration for De Novo classification. The proposed indication would cover multiple upper-abdominal general surgery procedures, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
“The data show encouraging evidence regarding the safety and performance of the OTTAVA™ Robotic Surgical System in Roux-en-Y gastric bypass procedures,” said Erik Wilson, M.D., chief of minimally invasive and elective general surgery at UTHealth Houston, director of bariatric surgery at Memorial Hermann-Texas Medical Center, and lead investigator for the clinical study. “Continued innovation in bariatric surgery is important to patient care, and I am pleased to present these initial clinical results.”
OTTAVA™ is designed as a multi-specialty soft-tissue robotic surgical system. Its architecture incorporates four robotic arms into a standard-size surgical table, eliminating the need for separate robotic carts or booms. Johnson & Johnson said the design may help support robotic procedures in operating rooms where space constraints have traditionally limited adoption.
During the study, (NYSE: JNJ) OTTAVA™ was installed and used across six participating hospitals. Operating room sizes ranged from approximately 243 to 694 square feet. In five of the six sites, procedures were performed in rooms that had not previously been used for robotic surgery.
“This is an exciting milestone for our program as we share the role of OTTAVA™ as a robotic surgical system with a novel architecture supporting patient treatment during the clinical trial,” said Hani Abouhalka, company group chair, surgery, MedTech, Johnson & Johnson. “This work also underscores our long-term commitment to bariatric surgeons and to equipping clinicians with a broad portfolio of surgical technologies to address the complexity of obesity care.”
The study, known as FORTE, is a single-arm, open-label clinical trial conducted across six U.S. study sites. It was designed to evaluate the safety and performance of OTTAVA™ through 30 days after Roux-en-Y gastric bypass surgery.
The OTTAVA™ Robotic Surgical System remains under development and is not authorized to be marketed or sold in any market.
About Johnson & Johnson MedTech
Johnson & Johnson MedTech develops surgical, cardiovascular, orthopaedic and vision solutions designed to address complex healthcare challenges. Its surgical portfolio includes technologies across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions.
About Johnson & Johnson
Johnson & Johnson is a global healthcare company focused on Innovative Medicine and MedTech. The company works across healthcare sectors to develop solutions aimed at preventing, treating and curing complex diseases while supporting less invasive and more personalized care.