Allurion Balloon Reintroduced in France

With French regulatory authority ANSM’s blessing, Allurion Technologies Inc. has relaunched the Allurion Balloon in France, roughly half a year after the company suspended its sales amid safety concerns.

“We are thrilled the Allurion Balloon will once again serve French patients as a clinically proven treatment for obesity,” Allurion Founder/CEO Dr. Shantanu Gaur said. “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.”

A recent study cited the prevalence of excess weight and obesity in France at approximately 47% and 17%, respectively.¹ While current-generation GLP-1s are now available 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.² Previous studies in patients undergoing GLP-1 therapy have demonstrated reductions in lean mass of approximately 40% as a proportion of total weight lost.³

Related: Allurion Technologies Touts Positive Study Results for its Weight Loss Balloon

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 a 571-patient study, participants 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 167-patient trial, subjects treated with the Allurion Balloon experienced a 15.7% weight reduction 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,” Gaur stated. “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.”

The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less 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.

References
¹ Fontbonne et al. J. Clin. Med. 2023, 12(3), 925; https://doi.org/10.3390/jcm12030925
² https://ansm.sante.fr/actualites/analogues-du-glp-1-et-obesite-nous-prenons-des-mesures-pour-securiser-leur-utilisation-en-france?
³ Wilding et al. NEJM. 2021, 384, 989-1002; 10.1056/NEJMoa2032183
⁴ Dejeu et al. Clin. Pract. 2024, 14(3), 765-778; https://doi.org/10.3390/clinpract14030061