Allurion saw its shares jump roughly 60% on Monday, Feb. 23, as the FDA signed off on the medtech’s premarket approval application for its weight loss device.
Allurion’s gastric balloon system, featuring the company’s smart capsule, works like this: A patient in a doctor’s office swallows a capsule with the deflated balloon that’s attached to a thin tube.
An X-ray confirms it’s in the right place, then the balloon is inflated using liquid via the catheter tube. The tube is then removed, and the patient can go home. Around four months after placement, a time-activated valve opens, allowing the balloon to deflate, and it then passes through the digestive system.
The idea is that the device makes a patient feel full and helps reduce overeating. Allurion says this has benefits over medication or other devices, as it does not require invasive interventions like surgery and is administered once in four months.
Allurion also markets the device as being safe and potentially more effective over the long run than the blockbuster GLP-1 obesity medicines from Novo Nordisk and Eli Lilly, which can have unpleasant side effects that in turn can see patients come off their prescriptions and lead to them to regain the weight they had lost.
Allurion’s product has been approved for use in Europe for about a decade, but the device has encountered some issues. France in 2024 temporarily banned its use due to a lack of monitoring of balloon placement, a lack of training for complication management and breaches of advertising regulations.
The country just several months later lifted the ban, a boon for Allurion, which said France accounts for around 15% of its revenue.
Related
In the U.S., the device is now indicated for adults ages 22 to 65 with a BMI over 30 but less than 40 who have had at least one unsuccessful attempt at a weight loss program.
Analysts at Jefferies said in a note to clients that this new approval opens the medtech up to about 80 million potential users. The team sees the initial rollout as being “focused on targeted cohorts of bariatric surgeons, where adoption can be low‑cost, measurable, and help offset practice volume declines following the rise of GLP‑1s.”
“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” Shantanu Gaur, M.D., founder and CEO of Allurion, said in a release.
“Our goal is to deliver patients metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle,” Gaur continued. “The Allurion Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery, and it should become a standard tool in the comprehensive treatment of obesity in the United States.”
