Approval gives Allurion access to about 80 million obese Americans
NATICK, Massachusetts – Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolic healthy weight loss, announced today that the U.S. Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application for the Allurion Gastric Balloon System, including the Allurion Smart Capsule.
“Today’s approval marks a milestone for Allurion and for the treatment of obesity in the United States,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer. “Our goal is to support patients in metabolic healthy weight loss: lose weight, maintain weight loss while maintaining muscle mass. The Allurion Smart Capsule offers a safe and effective alternative to GLP-1 medication and bariatric surgery and should become a standard part of comprehensive obesity treatment in the United States.”
The Allurion Smart Capsule is an advanced innovation protected by more than fifty patents worldwide. The capsule is swallowed during a fifteen-minute consultation in the practice, without surgery, endoscopy or anesthesia. Once in the stomach, the capsule is filled with liquid and remains in place for approximately four months. During this time, the capsule occupies space in the stomach, creating a feeling of satiety and reducing food intake. After about four months, a patented drain valve opens and the capsule leaves the body naturally. Two months after leaving the first capsule, a new Smart Capsule can be taken. Unlike medication that must be administered daily or injected weekly, Allurion’s approach offers a treatment duration of approximately four months after a single administration.
In the United States, more than 100 million people are obese, about 80 million of whom have a body mass index (BMI) between 30 and 40 kg/m², the approved indication for treatment with the Allurion Smart Capsule. It is estimated that about 20 million Americans have now started and discontinued GLP-1 medication; this number is expected to increase to 40 million by 2027. Previous studies show that 65% of patients discontinue GLP-1 therapy within the first year, primarily because of side effects, which are often followed by rapid weight gain.
“Obesity is an urgent health problem in the United States and many patients are seeking alternatives or additional treatment options to existing options, including GLP-1 medication,” said Dr. Shelby Sullivan, Professor of Medicine at Dartmouth University’s Geisel School of Medicine and principal investigator of the AUDACITY FDA registration study. “The results of the AUDACITY study, combined with real-world experience outside the United States, underscore both the safety and efficacy of this product. The solution offers a treatment option that many people need. The capsule temporarily resides in the body, can be applied repeatedly if needed, and does not require long-term use of medication for weight loss. As a stand-alone or complementary intervention within obesity care, Allurion can play an important role for both patients and caregivers.”
Outside the United States, the Allurion Smart Capsule has now been used in more than 200,000 patients. Results have been described in more than 30 peer-reviewed medical publications. In a commercial setting outside the United States, data show that when treatment is combined with the Allurion Virtual Care Suite – including the AI-driven behavior change program and personalized guidance from the treatment team – patients lose an average of 14% total body weight and more than 20% at two treatment cycles. Combined with low-dose GLP-1 medication and the Allurion Virtual Care Suite, a total weight loss of more than 20% is achieved, with favorable improvements in muscle mass.
“Allurion’s innovative solution is a valuable tool within the continuum of obesity care,” said Dr. Jaime Ponce, President and Medical Director of the Weight Loss Center of Chattanooga and past president of the American Society for Metabolic and Bariatric Surgery (ASMBS). “For patients with a BMI between 30 and 40 seeking significant health improvements, the Allurion Smart Capsule may be an attractive option, especially for those seeking a structured alternative to medication or surgery.”
About Allurion
Allurion is a pioneer in metabolic healthy weight loss. The Allurion Program is an integrated weight reduction platform that combines the FDA Premarket Approval (PMA) approved Allurion Gastric Balloon System, including the Allurion Smart Capsule, with the Allurion Virtual Care Suite. This digital care environment includes the Allurion Mobile App for consumers with the Iris AI platform, Allurion Insights for healthcare providers and the Allurion Connected Scale.
In the United States, the Allurion Gastric Balloon System (AGBS) is indicated to promote short-term, limited weight loss in obese adults aged 22 to 65 years, with a body mass index (BMI) of ≥30 kg/m² and ≤40 kg/m², who have made at least one previous, unsuccessful weight loss attempt. The length of stay of each balloon varies, with an average observed length of stay of 15.3 weeks. The AGBS should be used in conjunction with a lifestyle intervention program of moderate intensity. The system consists of up to two Allurion balloons placed within a 10-month period.
Are you considering a gastric balloon yourself? Don’t wait any longer. Take the first step toward a healthier life today.
Request your free intake consultation or Take the test to see if gastric ballooning is right for you.
