Allurion Technologies is relaunching the Allurion Balloon in France after the Agence nationale de sécurité du médicament et des produits de santé (ANSM), the French regulatory authority, cleared Allurion to resume sales.
“We are thrilled the Allurion Balloon will once again serve French patients as a clinically proven treatment for obesity,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “Historically, France has been our top performing market representing approximately 15% of our revenue, and we are looking forward to ramping back up in the coming quarters. “In parallel, as we expand our clinical research pipeline, we are also exploring with French clinics a trial to demonstrate how the Allurion Balloon may be combined with GLP-1s to solve one of the biggest problems in obesity: how to take GLP-1s without losing muscle mass. A successful trial could lead to the development of a gold-standard obesity treatment that counters one of the biggest side effects of GLP-1 therapies.”
According to a recent study, the prevalence of excess weight and obesity in France is approximately 47% and 17%, respectively. While current-generation GLP-1s have now launched in France, their use has primarily been indicated as a second-line treatment in patients with a body mass index (BMI) of greater than or equal to 35 with careful attention to side effect management. Previous studies in patients undergoing GLP-1 therapy have demonstrated reductions in lean mass of approximately 40% as a proportion of total weight lost.
In contrast, in previous studies, patients treated with the Allurion Balloon in combination with the Allurion Virtual Care Suite have demonstrated strong patient outcomes in which patients lose weight while maintaining, and in some cases, increasing, muscle mass. In one study of 571 patients, patients treated with the Allurion Balloon gained 5.6% in lean body mass while losing 14% of their total body weight over four months.4 In another study of 167 patients, patients treated with the Allurion Balloon experienced a weight reduction of 15.7% with no change in muscle mass.
“We intend to initiate clinical trials designed to assess whether the Allurion Balloon combined with GLP-1s offers superior outcomes to GLP-1 therapies alone,” continued Gaur. “We intend for our first clinical trials to study muscle mass in a combination approach, but we expect to announce other clinical trials in the future that will study dose reduction of GLP-1s as a means to reduce side effects and increase adherence.”
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