Allurion Technologies Wins FDA's PMA Approval For Allurion Gastric Balloon System, Stock Soars

(RTTNews) - Allurion Technologies Inc. (ALUR), Monday announced that the U.S. Food and Drug Administration has approved the pre-market approval application for the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule.

The innovative Capsule could be swallowed during a 15-minute office visit. Once it reaches the stomach, it will be filled with fluid, and reside inside for approximately four months. During that time, it occupies space within the stomach, helping patients feel full and eat less. After approximately four months, the patented Release Valve opens, and it passes out of the body naturally.

The company stated that the data from the AUDACITY trial along with the real-world experience outside the United States demonstrate the product's safety and efficacy, offering an option to individuals struggling with weight loss issues.

Dr. Jaime Ponce, President and Medical Director of the Weight Loss Center of Chattanooga and former President of the American Society for Metabolic and Bariatric Surgery, commented, "For patients with a BMI between 30 and 40 seeking meaningful health improvements, the Allurion Smart Capsule could be an attractive option, especially for those seeking a structured alternative to medications or surgery."

ALUR is currently soaring 57.13 percent, to $1.71 on the New York Stock Exchange. The stock opened at $1.50 and has climbed as high as $1.97 so far in today's session. Over the past year, it has traded in a range of $0.95 to $4.18.