Allurion Technologies (NYSE:ALUR) shares jumped about 40% after the company announced it had received U.S. Food and Drug Administration approval for its Allurion Gastric Balloon System, which includes the Allurion Smart Capsule.
The FDA granted premarket approval for the weight-loss treatment, opening access to an estimated 80 million Americans with obesity who fall within the approved body mass index range of 30 to 40 kg/m², according to the company. Allurion noted that more than 100 million Americans are affected by obesity overall.
The Allurion Smart Capsule is designed to be swallowed during a brief 15-minute office visit without the need for surgery, endoscopy, or anesthesia. Once in the stomach, the capsule is filled with fluid, remaining in place for roughly four months to promote fullness and reduced food intake. After that period, a patented Release Valve allows the device to empty and pass naturally through the body. Patients may begin a second treatment cycle two months after the first capsule exits.
Internationally, the system has already been used by more than 200,000 patients, with outcomes documented in over 30 peer-reviewed medical publications. When paired with the company’s Virtual Care Suite, data indicate average total body weight loss of about 14%, rising above 20% after two treatment cycles.
Allurion estimates that roughly 20 million Americans have started and discontinued GLP-1 weight-loss medications, a figure it expects could reach 40 million by 2027. Prior research cited by the company suggests around 65% of patients stop GLP-1 therapies within the first year, largely due to side effects.
The Allurion Smart Capsule is protected by more than 50 patents worldwide and delivers approximately four months of treatment from a single administration, offering an alternative to daily or weekly drug-based regimens.