Allurion Submits Final PMA Module to FDA Following Strong AUDACITY Study Results
Allurion Technologies, Inc., a global leader in innovative, non-surgical weight loss solutions, announced it has officially submitted the final module of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA). This milestone submission includes additional analyses from the pivotal AUDACITY Study, which reinforce the effectiveness of the Allurion Balloon and confirm that the study met both pre-specified co-primary endpoints.
The company’s PMA submission marks a significant step toward securing FDA approval and expanding access to its flagship balloon technology in the United States.
Positive Topline Results Already Reported
Previously released topline results from the AUDACITY Study showed that the first co-primary endpoint—the responder rate at 48 weeks—was successfully met. Patients who received the Balloon demonstrated substantially greater total body weight loss (TBWL) compared to those in the control group, which received moderate-intensity lifestyle therapy.
At the 48-week mark, the mean difference in weight loss between the Allurion and control groups was 3.77%, corresponding to a 2.69% super-superiority margin. However, this fell slightly below the pre-specified 3% super-superiority margin required to meet the second co-primary endpoint, due in part to higher-than-anticipated weight loss among control group participants.
Additional Analyses Strengthen the Case
In response to the unexpectedly high weight loss observed in the control group, it conducted supplementary statistical analyses using advanced imputation methods. These methods more accurately reflect the trends seen in the study population and were included in the PMA submission.
The updated analysis revealed:
- At 48 weeks, the mean weight loss difference increased to 4.34%, resulting in a super-superiority margin of 3.14%, thereby exceeding the 3% threshold for the second co-primary endpoint (p = 0.0142).
- At 40 weeks, the difference in weight loss was even more pronounced, with a 4.90% mean difference and a 3.75% super-superiority margin (p = 0.0006).
These findings offer compelling evidence of the Balloon’s clinical effectiveness and reaffirm the company’s confidence in achieving FDA approval.
“We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of it’s Balloon,” said Dr. Shantanu Gaur, Founder and CEO..
“We believe these analyses are more appropriate for the data trends observed in both the treatment and control groups. With the PMA now submitted, we look forward to working with the FDA to bring our solution to more patients across the U.S.”
AUDACITY Study: A First-of-Its-Kind Clinical Trial
The AUDACITY Study is a landmark investigation in the field of medical weight loss. It is the first FDA pivotal trial for an intragastric balloon to report primary outcomes beyond 9 months, setting a new standard for durability of results in this treatment category.
Key aspects of the study include:
- Design: Open-label, multicenter, randomized, controlled trial
- Enrollment: 550 subjects between the ages of 18 and 65
- Randomization: 1:1 to either the Balloon treatment group or a control group receiving lifestyle therapy
- Duration: 48 weeks total with key evaluation points at Weeks 40 and 48
Subjects in the treatment group received two cycles of the it’s Balloon:
- First balloon: Placed at Week 0 and passed naturally around Week 16
- Second balloon: Placed at Week 24 and passed around Week 40
Both co-primary endpoints were measured at Week 48—approximately 8 weeks after the second balloon had passed.
Advancing Non-Surgical Weight Loss Solutions
It’s balloon-based weight loss program is designed to provide a safe, effective, and non-invasive alternative to bariatric surgery. Unlike traditional intragastric balloons, the Balloon:
- Does not require endoscopy or anesthesia for placement or removal
- Passes naturally through the body, avoiding the need for a removal procedure
- Is part of a comprehensive weight-loss program that includes nutritional coaching, behavior change support, and a connected digital platform
This innovative solution has already been approved and used in over 60 countries, helping thousands of patients worldwide lose weight without surgery.
What’s Next for Allurion?
With the PMA now fully submitted, It enters the review phase with the FDA, a crucial step in potentially bringing the Balloon to the U.S. market. If approved, the device would provide a powerful new tool for physicians looking to address obesity and metabolic health through non-surgical means.
Pending FDA approval, the Balloon could soon offer U.S. patients a highly effective, lower-risk option for significant weight loss and improved health outcomes.
About Allurion
Allurion is a pioneer in metabolically healthy weight loss. The Program is a weight-loss platform that combines the Gastric Balloon, the world’s first and only swallowable, Procedureless™ gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Mobile App for consumers and 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.
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.
