Allurion Announces Submission of First Three Modules of Premarket Approval Application to the U.S. Food and Drug Administration for the Allurion Balloon

Rhea-AI Summary

Allurion Technologies (NYSE: ALUR) has submitted the first three modules of its premarket approval application (PMA) to the FDA for the Allurion Balloon, with the fourth and final module containing clinical data from the AUDACITY trial expected early next year. The Allurion Balloon is the world's first swallowable, procedureless gastric balloon for weight loss that requires no surgery, endoscopy, or anesthesia. The device can be placed in 15 minutes during an outpatient visit and naturally passes from the body after four months. Over 150,000 patients have been treated with the balloon outside the US. The AUDACITY trial, involving 550 patients across 17 US sites, completed enrollment ahead of schedule and is expected to conclude by end of 2024.

Positive

• Completed enrollment for AUDACITY trial ahead of schedule
• Successfully submitted 3 out of 4 PMA modules to FDA
• Established track record with 150,000+ patients treated internationally

Negative

• Final FDA approval still pending completion of fourth PMA module
• No current revenue stream from US market due to pending approval

Insights

Medical Research Analyst

The submission of three PMA modules for the Allurion Balloon represents significant regulatory progress, though market approval remains contingent on the important fourth module containing clinical trial data. The device's unique procedureless approach addresses key limitations of traditional gastric balloons, eliminating the need for surgery, endoscopy, or anesthesia. With 150,000 patients treated internationally, the established safety profile strengthens the approval outlook.

The AUDACITY trial's ahead-of-schedule enrollment of 550 patients across 17 U.S. sites indicates strong clinical interest and efficient trial execution. The 4-month treatment duration and natural removal process could position this as a compelling option in the $2.8 billion global gastric balloon market. However, investors should note that final FDA approval depends on the clinical data submission expected in early 2024, with trial completion projected for late 2024.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241023889366/en/

Global Media

Cedric Damour

PR Manager

+33 7 84 21 02 20

cdamour@allurion.com

Investor Contact

Mike Cavanaugh, Investor Relations

ICR Westwicke

(617) 877-9641

mike.cavanaugh@westwicke.com

Source: Allurion Technologies, Inc.

FAQ

When will Allurion (ALUR) submit the final PMA module to the FDA?

Allurion plans to submit the fourth and final PMA module containing clinical data from the AUDACITY trial early next year.

How many patients are enrolled in Allurion's (ALUR) AUDACITY trial?

The AUDACITY trial includes 550 patients across 17 sites in the United States.

How many patients have been treated with the Allurion Balloon outside the US?

Over 150,000 patients have been treated with the Allurion Balloon outside the United States.

When is Allurion's (ALUR) AUDACITY trial expected to conclude?

The AUDACITY trial is expected to conclude by the end of 2024.