Allurion Announces Submission of First Three Modules of Premarket Approval Application to the U.S. Food and Drug Administration for the Allurion Balloon
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NATICK, Mass., October 23, 2024--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the submission of the first three modules of its premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for the Allurion Balloon. The Company expects to file the fourth and final module of the PMA containing the clinical data from its AUDACITY trial early next year.
"These submissions are a critical milestone for Allurion, and I commend our team for their efforts," said Dr. Shantanu Gaur, Allurion’s 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."
In a traditional PMA application, the applicant submits all PMA data at the same time, and the FDA begins its PMA review only upon receipt of all of the required information. In a modular PMA application, the FDA allows applicants to submit discrete sections of the application for review to improve the efficiency of the process.
The Allurion Gastric Balloon is the world’s first and only swallowable, procedureless? gastric balloon for weight loss and was designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and placed 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 naturally1. Over 150,000 patients have already been treated with the Allurion Balloon outside the United States.
The Allurion Balloon is being evaluated in AUDACITY, a randomized, pivotal controlled trial in 550 patients at 17 sites in the United States. The trial completed enrollment in the fall of 2023, two months ahead of schedule. The company expects the trial to conclude by the end of 2024.
| Source: 1. Jense, M.T., Palm-Meinders, I.H., Sanders, B. et al. The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity. OBES SURG 33, 1668–1675 (2023). https://doi.org/10.1007/s11695-023-06573-8 |
About Allurion
Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, Procedure-less? intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.