Allurion Submits PMA to FDA, Additional Analyses Meet Both Endpoints

Allurion Technologies submitted its fourth and final PMA module to the FDA for approval. The AUDACITY Study met its first co-primary endpoint and additional analyses showed a mean difference in weight loss between treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%. The company believes these analyses support the effectiveness of the Allurion Balloon and look forward to working with the FDA toward approval.

Allurion Technologies, Inc. (NYSE: ALUR) has submitted its fourth and final module of the Pre-Market Approval (PMA) application to the Food & Drug Administration (FDA) for the Allurion Balloon. The submission includes additional analyses from the AUDACITY Study that meet both pre-specified co-primary endpoints. The company is optimistic about these results and looks forward to working with the FDA towards approval.

The AUDACITY Study, an open-label, multicenter, randomized, controlled trial, reported primary outcomes beyond 9 months, making it the first FDA pivotal trial for an intragastric balloon for weight loss to do so. The study enrolled 550 subjects, who were randomized 1:1 to either two cycles of the Allurion Balloon or a control group receiving moderate-intensity lifestyle therapy. The study's first co-primary endpoint related to responder rate at 48 weeks was met, and Allurion Balloon subjects exhibited greater weight loss compared to control subjects, with a mean difference of 3.77% in total body weight loss at 48 weeks.

However, the initial results did not meet the pre-specified 3% super-superiority margin due to higher-than-expected weight loss in the control group. To address this, additional analyses were conducted using imputation methods to account for variations observed in the control subjects. These analyses showed a mean difference in weight loss between the treatment and control groups at 48 weeks of 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified margin in the second co-primary endpoint (p = .0142). At 40 weeks, the mean difference in weight loss was 4.90% with a super-superiority margin of 3.75%, also exceeding the pre-specified margin (p = .0006).

Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed his enthusiasm about the submission, stating, "We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon. We believe that these analyses are more suitable for the trends observed in both groups in the AUDACITY Study and further strengthen our positive topline data. With the PMA now submitted, we are looking forward to working with the FDA toward an approval."

The Allurion Program combines the Allurion Gastric Balloon, the world’s first and only swallowable, procedureless gastric balloon for weight loss, with a virtual care suite including the Allurion Mobile App and Allurion Insights featuring the Iris AI Platform. The Allurion Virtual Care Suite is also available separately to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan.

Forward-looking statements in this press release include, but are not limited to, statements regarding the timing of the FDA’s review of the Company’s PMA application for the Allurion Balloon, the approval by the FDA of the Company’s PMA application for the Allurion Balloon; the FDA’s willingness to consider the Company’s use of additional, supportive analyses regarding imputation methods with respect to achievement of the second co-primary endpoint; the uniqueness of Allurion’s product and service offerings, including the Allurion Program; 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 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.

References:
[1] https://www.stocktitan.net/news/ALUR/allurion-announces-submission-of-pma-to-fda-and-additional-analyses-9hwdst13nn3j.html
[2] https://www.businesswire.com/news/home/20250707165712/en/Allurion-Announces-Submission-of-PMA-to-FDA-and-Additional-Analyses-From-Pivotal-AUDACITY-Study-That-Meet-Both-Endpoints