Allurion Technologies saw its stock surge 40% after the U.S. Food and Drug Administration granted premarket approval for the Allurion Gastric Balloon System, which incorporates the Allurion Smart Capsule.
The FDA approval authorizes the device for adults who meet the company’s specified treatment range: a body mass index of 30 to 40 kg/m2. Allurion said that range corresponds to access to roughly 80 million Americans with obesity. The company also stated that more than 100 million Americans have obesity.
The Allurion Smart Capsule is designed to be swallowed during a short, roughly 15-minute office visit and does not require surgery, endoscopy, or anesthesia. Once it reaches the stomach the capsule is filled with fluid and remains in place for approximately four months. The presence of the device is intended to help patients feel full and reduce food intake. After about four months a patented Release Valve opens and the capsule exits the body naturally. The company noted that a subsequent Smart Capsule may be taken two months after the first has passed.
Outside the United States the device has been used in the treatment of more than 200,000 patients, and outcomes have been reported in over 30 peer-reviewed medical journal publications. Allurion reported that when the Smart Capsule is used in combination with its Virtual Care Suite, patients have achieved an average total body weight loss of 14% from a single treatment cycle, and greater than 20% weight loss when two cycles are completed.
Allurion also provided context about current trends in weight-management medication use. The company estimated that about 20 million Americans have previously started and later stopped GLP-1 medications, and it expects that number to rise to 40 million by 2027. The company cited prior studies indicating that 65% of patients discontinue GLP-1 therapies within the first year, with side effects cited as the primary reason for discontinuation.
The company emphasized that the Smart Capsule is protected by a portfolio of more than 50 patents worldwide. Unlike daily or weekly medication regimens, a single administration of the capsule is intended to provide roughly four months of treatment.
Key contextual points in the approval and product profile include the non-surgical delivery method, the finite treatment duration per administration, prior international use and peer-reviewed reporting, and the stated patent protections. The FDA clearance expands the device's availability in the U.S. to patients who meet the approved BMI range and aligns the product as an alternative or complement to pharmacologic approaches to weight management described by the company.