Allurion Announces Landmark Peer-Reviewed Publication on Consecutive Use of the Allurion Smart Capsule Showing More Than 20% Weight Loss
Multicenter study across six countries demonstrates safety and efficacy of two consecutive treatments in adults with obesity
Weight loss of greater than 20% on par with bariatric surgery and high dose GLP-1 therapy
Allurion Technologies, Inc. (NYSE:ALUR), a pioneer in metabolically healthy weight loss, today announced the publication of the first peer-reviewed study on the consecutive use of the Allurion Smart Capsule, a first of its kind, swallowable, procedure-less weight-loss device.
Published in Obesity Surgery, a leading international journal dedicated to the treatment of obesity and metabolic disease, the multicenter, retrospective study demonstrates that two consecutive treatments can achieve average total body weight loss of 22.1% (19.3 kg), results comparable to bariatric surgery and high-dose GLP-1 therapy.
The study included 121 overweight adults (BMI of 25 to 30) and adults with obesity (BMI of 30 and above) across 11 international sites. No serious device-related adverse events were reported.
"This study provides robust evidence that consecutive use of the Allurion Smart Capsule is both safe and effective," said Dr. Roberta Ienca, the Senior Author of the study and Medical Doctor at Nuova Villa Claudia Clinic in Rome, Italy. "What excites me most is that it shows patients can achieve weight loss of over 20% without surgery. Consecutive treatment broadens what is possible in obesity care, as a flexible, scalable tool that could meet the needs of patients at different stages of their weight-loss journey."
The study design mirrors the approach used in AUDACITY, the company's FDA pivotal study, reinforcing the potential of consecutive Smart Capsule use as a first-line therapy for higher BMI patients who require more than 20% weight loss but are unwilling or ineligible to undergo surgery.
Based on the results of the AUDACITY trial, Allurion submitted the fourth and final module of the Pre-Market Approval (PMA) application to the FDA earlier this year.
The publication of this peer-reviewed study further bolsters an extensive data set on the safety and efficacy of the Allurion Smart Capsule.
"This is a milestone for Allurion, but more importantly, for patients. The data show that a non-surgical, swallowable device can deliver weight-loss outcomes once thought possible only with surgery or high-dose drugs. As we continue to build the evidence base, our goal is to redefine what is possible in non-surgical weight loss and set a new benchmark for innovation in the field," said Dr. Shantanu Gaur, Founder and CEO of Allurion. "This is another step toward creating a new standard of care that we expect to be both scalable and accessible. By broadening the range of effective options, we seek to empower more patients and clinicians to find solutions that fit their needs and circumstances."
The Allurion Smart Capsule is designed to be swallowed during a brief outpatient visit, filled once in the stomach, and pass naturally after four months. When combined with Allurion's Virtual Care Suite, patients also receive digital support and remote monitoring aimed to change behaviors and improve outcomes.
About Allurion
Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the Allurion Smart Capsule, the world's first and only swallowable, ProcedurelessTM gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the 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. The Allurion Smart Capsule 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 contains forward-looking statements that reflect Allurion's beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this release, these statements involve risks and uncertainties that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
Forward-looking statements in this press release include, but are not limited to, statements regarding: establishing a new standard for weight loss; the scalibility and accessibility of Allurion's product; combination of the Allurion Smart Capsule with other treatments; choosing appropriate strategic, distribution, or other partners; pioneering in healthy weight loss and maintenance of muscle mass; the uniqueness of Allurion's product and service offerings, including the Allurion Program; the status of the U.S. FDA's review of the Company's PMA application for the Allurion Smart Capsule and Allurion Balloon; expectations regarding entry into the U.S. market; and other statements about future events that reflect the current beliefs and assumptions of Allurion's management based on information currently available to management.
Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program, including the Allurion Smart Capsule and Allurion Balloon; the timing of, and results from, Allurion's clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Balloon; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; a changing regulatory landscape in the highly competitive industry in which Allurion competes; the impact of the imposition of current and potential tariffs and trade negotiations, and those factors discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 27, 2025, and updated from time to time by its other filings with the SEC, and its Quarterly Report on Form 10-Q filed with the SEC on May 15, 2025. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law.
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