Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the completion of patient enrollment in its AUDACITY trial. AUDACITY is a randomized, pivotal controlled trial designed to support U.S. Food and Drug Administration (FDA) approval of the Allurion Balloon. The trial enrolled 550 patients at 17 sites and completed enrollment two months ahead of schedule.
“I believe the brisk enrollment in the AUDACITY trial reflects the broad appeal of a novel, completely reversible weight loss device,” said Shelby Sullivan, M.D., Director of the Gastroenterology Metabolic and Bariatric Program at the University of Colorado School of Medicine and Principal Investigator of the AUDACITY trial. “As the obesity epidemic worsens in the United States, I expect options like the Allurion Balloon will be attractive to a large segment of the population.”
The AUDACITY trial website received 78,106 unique visitors of whom over half or 39,947 completed a pre-screen questionnaire.
“We were pleased to see such a high level of interest in the Allurion Balloon in the United States,” said Jay Donosky, Vice President of Clinical Affairs for Allurion. “As interest in weight loss grows in the United States with the rise of GLP-1 drug therapy, we believe our robust enrollment is indicative of a strong desire for alternative first-line options.”
The Allurion Balloon is the world’s first and only swallowable, procedure-less gastric balloon for weight loss and was designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and filled under the guidance of a health care provider without surgery, endoscopy, or anesthesia. The placement takes approximately 15 minutes during an outpatient visit. Approximately four months later, a patented ReleaseValve™ opens, allowing the balloon to empty and pass out of the body naturally. The patient does not need to return to the doctor to have the balloon removed.
“We are delighted to bring the Allurion Balloon one step closer to commercialization in the United States,” said Dr. Ram Chuttani, Chief Medical Officer for Allurion. “We are looking forward to building off the experience we have acquired in treating over 130,000 patients outside of the United States.”
