Company Overview - Allurion Technologies, Inc. (ALUR) has submitted the first three modules of its premarket approval application (PMA) to the FDA for the Allurion Balloon, utilizing the FDA's modular submission program to enhance application efficiency. The final module, containing clinical data from the AUDACITY trial, is expected to be filed early next year [1] - The Allurion Gastric Balloon is the first swallowable, procedureless gastric balloon designed for weight loss, which can be placed without surgery, endoscopy, or anesthesia, taking approximately 15 minutes during an outpatient visit [2][3] Product Details - The Allurion Balloon helps control appetite by filling space in the stomach and is designed to empty naturally after approximately four months through a time-activated release valve. It is made from polyurethane, ensuring comfort and a snug fit [3] - The AUDACITY trial, a pivotal controlled study involving 550 patients across 17 sites in the U.S., completed enrollment in fall 2023 and is expected to conclude by the end of 2024 [3] Clinical Data and Efficacy - In a study of 121 individuals treated with two consecutive, four-month courses of Allurion balloon therapy, participants lost an average of 22.1% of their body weight after one year, outperforming traditional endoscopic intragastric balloon therapy, which resulted in weight losses of 15.4% and 16.2% [4] - The Allurion Balloon has shown a lower intolerance rate compared to 12-month endoscopic balloons, with a significantly lower overall serious adverse event rate [4][5] Market Potential - The global weight management market was valued at $142.6 billion in 2022 and is projected to grow at a rate of 9.9% from 2023 to 2030, driven by increasing bariatric surgeries, online weight loss program adoption, and rising obesity rates [6] - Allurion's gastric balloon technology is positioned to capitalize on this market growth, potentially boosting the company's business and revenue [6]
ALUR Stock Declines Despite Submitting PMA for Allurion Balloon