ALUR

Allurion To File Final Module Of Weight Loss Balloon To FDA For Approval Next Month

(RTTNews) - Allurion Technologies, Inc. (ALUR), reported its financial results for the first quarter of 2025 and presented new clinical data at the European Congress on Obesity or ECO in Malaga, Spain, demonstrating the potential of its Allurion Balloon and AI-powered Virtual Care Suite or VCS, both with and without GLP-1 medications.

The Allurion Gastric Balloon is the world's first and only swallowable, procedure-less gastric balloon for weight loss, while the Allurion Virtual Care Suite includes the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform.

The company generates revenue from the sales of the Allurion Balloon in Europe. In the U.S., it is an investigational device.

Q1 performance:

For the quarter ended March 31, 2025, Allurion reported revenue of $5.6 million, compared to $9.4 million during the same period last year.

Operating expenses were $11.4 million, a 37 percent decrease year-over-year, and adjusted operating expenses—excluding $1.4 million in one-time financing costs—came in at $10.1 million.

The net operating loss for the quarter was $7.3 million, compared to $11.4 million in the first quarter 2024, while the adjusted operating loss was $5.9 million.

Net income for the quarter was $7.4 million, or $0.20 per share, compared to net income of $5.6 million, or $2.78 per share, in the year-ago quarter.

Clinical Developments:

Allurion unveiled new clinical data presented in four abstracts at ECO 2025, underscoring the significant potential of combining the Allurion Balloon and its VCS platform with GLP-1 medications.

One study of 60 patients using the Allurion Balloon followed by semaglutide reported an average total body weight loss of 21.2 percent over 10 months, a result approaching the outcomes typically seen with bariatric surgery.

Another study of 138 patients prescribed GLP-1s with normal dose escalation who also used the VCS demonstrated an average increase in lean body mass of 6.1 percent, an increase in muscle mass of 6.4 percent, and a 10.2 percent decrease in fat mass over four months, suggesting that Allurion's AI-driven behavioral support may help preserve muscle mass during GLP-1 therapy.

In a large single-center study involving 2,000 patients treated with the Allurion Program alone (without GLP-1s), patients experienced an average weight loss of 12.4 percent after four months and a 9.8 percent increase in muscle mass after six months.

Additionally, another study showed that patients prescribed GLP-1s who used the VCS lost 17.3 percent of their total body weight over nine months, outperforming comparable U.S. data for GLP-1s alone, where tirzepatide typically yielded a 15.2 percent reduction and semaglutide 7.9 percent over twelve months.

These results highlight the potential of Allurion's platform to enhance both weight loss outcomes and muscle preservation when used in combination with GLP-1 therapies.

The company also announced that it had completed a successful pre-PMA or Premarket Approval meeting with the U.S. Food and Drug Administration and remains on track to submit the final module of its PMA application for the Allurion Balloon by the end of June 2025.

Furthermore, Allurion plans to initiate a prospective clinical trial this year to study the combination of its Program with low-dose GLP-1 medications, with a focus on improving adherence and preserving muscle mass.

The Road Ahead:

Allurion reaffirmed its full-year 2025 revenue guidance of approximately $30 million and reiterated its plan to reduce operating expenses by around 50 percent compared to 2024. Revenue was $32.1 million, and operating expenses were $71.7 million in 2024.

Cash Position:

The company ended the quarter with a cash balance of $20.4 million.

Currently, ALUR is trading at $2.75 up by 16.53 percent on the Nasdaq.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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