\nTopline results announced previously showed that the AUDACITY Study met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects.<\/p>\n
\nAdditional analyses submitted in the PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p <\/i>= .0142).<\/p>\n
\nAt 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p<\/i> = .0006).<\/p>\n
\n\u201cWe are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon,\u201d said Dr. Shantanu Gaur, Founder and CEO of Allurion. \u201cWe 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.\u201d<\/p>\n
\nThe AUDACITY Study is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. 550 subjects were randomized 1:1 to either two cycles of the Allurion Balloon1<\/sup> or a control group that received moderate intensity lifestyle therapy. Subjects in the treatment group received their first Allurion Balloon at Week 0, which passes at approximately Week 16, and a second Allurion Balloon at Week 24, which passes at approximately Week 40. Co-primary endpoints based on Allurion Balloon subject responders and a comparison of percent total body weight loss between groups were measured at Week 48, approximately eight weeks after the second Allurion Balloon passes at Week 40.<\/p>\n About Allurion<\/b><\/p>\n \nAllurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world\u2019s first and only swallowable, Procedureless\u2122<\/sup> 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 Gastric Balloon is an investigational device in the United States.<\/p>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n 1<\/sup> Subjects received only the Allurion Balloon without the Allurion App, Bluetooth\u00ae<\/sup> Scale, Coach Iris, or access to the Virtual Care Suite.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250707165712\/en\/<\/a><\/span><\/p>\n Media\n
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Allurion Press Office
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Woodrow Communications
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allurion@woodrowcommunications.com<\/a><\/b><\/p>\n
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