In the 30-patient cohort, the study met its primary safety and performance endpoints through 30 days post-procedure, and investigators completed all procedures robotically on OTTAVA™ without conversion to a non-robotic approach. Average weight loss by 30 days after surgery was 30 pounds. These clinical data, together with preclinical testing, were used to support an application to the U.S. Food and Drug Administration (FDA) for De Novo classification targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as 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, UTHealth Houston, Director of Bariatric Surgery, 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."