NATICK, Mass.--(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.
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.
Forward-Looking Statements
This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the completion of the Company’s AUDACITY trial and submission of the company’s PMA following data readout. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the VCS, in the United States and abroad, (ii) the timing of, and results from, our clinical studies and trials and submission of such results to regulatory authorities, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the conflict in the Middle East on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the Allurion Program and VCS platform, and (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 (as subsequently amended) and other documents filed by Allurion from time to time with the U.S. Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.
