Natick, Massachusetts-based Allurion expects to file the fourth and final module of the PMA early next year. That module contains clinical data from the company’s AUDACITY trial.
AUDACITY evaluates the balloon in 550 patients across 17 U.S. sites. The randomized, pivotal, controlled trial completed enrollment in fall 2023, two months ahead of schedule. Allurion expects the trial to conclude by the end of 2024.
Allurion develops an AI-powered gastric balloon for weight loss. The swallowable balloon requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying and passing out naturally.
The company recently ran into issues abroad, where it had to pull its balloon from the market in France earlier this month. However, it continues to report positive data on the balloon, including 22% weight loss in patients at one year.
“These submissions are a critical milestone for Allurion, and I commend our team for their efforts,” said Dr. Shantanu Gaur, founder and CEO. “We are pleased to capitalize on the opportunity that the FDA provides through its modular submission program to improve the efficiency of our application process.”
