Natick Massachusetts–based Allurion develops the AI-powered gastric balloon for weight loss. The swallowable balloon requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying and passing out naturally.
Last summer, the company agreed to suspend balloon sales following a request from the National Medicines Safety Agency (ANSM) in France. ANSM requested a plan aimed at reducing certain risks linked to communication, follow-up and adverse events associated with the balloon.
“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.”
The company plans to initiate clinical trials to assess the balloon combined with GLP-1s compared to GLP-1s alone. It wants to look at muscle mass but expects to eventually evaluate dose reduction of GLP-1s to combat side effects and increase adherence. Meanwhile, the company awaits an FDA decision on a premarket approval submission made for the balloon last fall.
