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NATICK, Mass. - Allurion Technologies, Inc. (NYSE:ALUR), a medical device company with a market capitalization of $18.72 million and impressive gross profit margins of 66%, announced Monday it has submitted the fourth and final module of its Pre-Market Approval (PMA) application to the FDA for its swallowable gastric balloon weight loss device. According to InvestingPro analysis, the company currently appears undervalued based on its Fair Value metrics.
The company also reported additional analyses from its AUDACITY Study that it says meet both pre-specified co-primary endpoints. While previously announced topline results showed the study met its first co-primary endpoint related to responder rate at 48 weeks, the second endpoint initially fell short of the required 3% super-superiority margin. InvestingPro data reveals the company faces significant cash burn challenges, with a negative EBITDA of $40.26 million in the last twelve months.
Using imputation methods to account for higher-than-expected weight loss in the control group, Allurion now reports the mean difference between treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% margin (p = .0142).
At 40 weeks, the difference was even more pronounced at 4.90% with a 3.75% super-superiority margin (p = .0006).
"We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon," said Dr. Shantanu Gaur, Founder and CEO of Allurion, in the press release statement.
The AUDACITY Study randomized 550 subjects to either two cycles of the Allurion Balloon or a control group receiving moderate intensity lifestyle therapy. The Allurion Balloon is designed to be swallowed without requiring endoscopy or anesthesia, remaining in the stomach for approximately 16 weeks before passing naturally.
The Allurion Gastric Balloon remains an investigational device in the United States, though the company markets its weight loss platform in other countries. With analyst price targets ranging from $2.50 to $18.00, investors seeking deeper insights can access comprehensive financial analysis and 14 additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, Allurion Technologies reported a significant decline in revenue for the first quarter of 2025, with figures dropping to $5.6 million from $9.4 million in the same period last year. Despite this decrease, the company achieved a gross margin improvement to 75% from 73% and reduced its adjusted loss from operations by 48%. The earnings call highlighted that Allurion is preparing for FDA approval of its combination therapy, which has bolstered investor confidence. The company has set a full-year revenue guidance of approximately $30 million and anticipates a 50% reduction in operating expenses compared to 2024. Allurion is also focused on expanding its market presence with a new commercial plan and has completed a pre-PMA meeting with the FDA, receiving positive feedback on additional analyses. The company’s strategic initiatives, including product development and market expansion, seem to have been well-received by investors.
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