Allurion Rebounds, Eyes US Market with Novel Weight Loss Capsule

NATICK, MA – January 12, 2026 – Allurion Technologies, Inc. (NYSE: ALUR), a company aiming to reshape the weight loss landscape, has signaled a significant financial turnaround, posting its first quarter-over-quarter revenue growth in over a year. The company announced preliminary unaudited results for the fourth quarter of 2025, projecting revenues between $3.3 million and $3.7 million, a jump of 22% to 37% from the prior quarter. This positive momentum comes as the company awaits a pivotal decision from the U.S. Food and Drug Administration (FDA) on its flagship product.

The preliminary results, which also include an estimated full-year 2025 revenue of approximately $15 million, point to the early success of a major corporate overhaul. “We are pleased with our results from the fourth quarter, where we grew revenue meaningfully quarter-over-quarter for the first time in more than one year as our new commercial strategy implemented after our strategic pivot in 2025 began to take hold,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer of Allurion.

A Calculated Turnaround

The improved financial outlook marks a crucial turning point for Allurion, which faced headwinds earlier in 2025. The company's Q2 2025 revenue of $3.4 million was a stark decrease from $11.8 million in the same period of 2024. This decline was attributed to strategic distributor transitions and a temporary reduction in sales and marketing investments as the company recalibrated its approach.

That recalibration, termed the 'strategic pivot' by management, involved a multi-pronged effort to stabilize and re-energize the business. A key component was a rigorous focus on operational efficiency. Allurion undertook significant cost-cutting measures, leading to a substantial improvement in operating expenses and a reduced operating loss in the fourth quarter. This leaner operational model, Dr. Gaur noted, has set the company up for “an even more efficient 2026.”

Beyond cost management, the pivot included a revamped commercial strategy. The company shifted to new distribution partners with access to physician networks capable of offering comprehensive obesity care. It also adopted a new business-to-business-to-consumer (B2B2C) commercial plan, which has already shown significant growth in pilot clinics by targeting key geographies with deeper market penetration. This strategic shift was designed not just to reverse declining revenue but to build a more sustainable and scalable business model ahead of its potential U.S. launch.

The 'Procedureless' Prize: FDA Approval Nears

At the heart of Allurion's future is the Allurion Smart Capsule, a technology it bills as the world’s first and only swallowable, “Procedureless” gastric balloon for weight loss. Unlike traditional gastric balloons that require endoscopic procedures for both placement and removal, the Allurion balloon is swallowed in a capsule and, after approximately four months, naturally deflates and passes through the digestive system.

The company is now in the final stages of the rigorous FDA Pre-Market Approval (PMA) process. After submitting the final module of its application in June 2025, Allurion successfully passed two critical FDA inspections later in the year. Both a pre-approval facility inspection in August and a Bioresearch Monitoring (BIMO) inspection of its clinical trial procedures in October concluded with zero findings—a significant achievement indicating high standards of quality and compliance. Following a Day-100 Meeting with the agency, the FDA did not request any additional human clinical data, a positive sign that the review is progressing as anticipated.

This smooth regulatory journey has bolstered confidence within the company. Dr. Gaur stated his belief that a potential FDA approval in 2026 “will be a historic year for Allurion.” Approval would unlock the vast and lucrative U.S. weight loss market, where the Smart Capsule is currently an investigational device.

Navigating the Crowded Weight Loss Market

The timing of Allurion’s potential U.S. entry is notable, as it coincides with the meteoric rise of GLP-1 agonist drugs like Ozempic and Wegovy. Rather than viewing these popular injectables as direct competitors, Allurion's strategic pivot has positioned its program as a complementary or alternative therapy. The company is actively promoting a combination approach, addressing some of the key drawbacks of GLP-1s, such as muscle mass loss, high cost, and poor long-term adherence.

Initial data from a case series of 76 patients has shown promising results. By combining the Allurion Smart Capsule with a low dose of the GLP-1 drug tirzepatide, patients achieved an average total body weight loss of 23% after 12 months, along with a 14% increase in lean body mass. This addresses a major concern with GLP-1-only therapy, which can lead to significant muscle wasting alongside fat loss. The combination therapy also allowed for lower, more tolerable doses of the GLP-1 drug, improving patient adherence.

Recent peer-reviewed studies further support the Allurion Program's efficacy. One study demonstrated that consecutive use of the Smart Capsule could achieve over 20% total body weight loss, a result comparable to bariatric surgery. Another showed an average 20% weight reduction at 36 weeks when combined with lifestyle intervention, suggesting a safety profile superior to surgery and efficacy rivaling high-dose GLP-1s at a substantially lower cost.

Global Track Record Fuels US Ambitions

While Allurion is a new name to many in the United States, it is already a well-established player on the global stage. The Allurion Program is available in over 80 countries, and the company has recorded over 200,000 placements of its balloon worldwide. This extensive international experience provides a wealth of real-world data and a proven track record of safety and efficacy.

A large-scale study presented in late 2024, which analyzed data from over 19,000 patients across 72 countries, found a consistent average weight reduction of 12.2% after the four-month treatment period. The program’s success is built on more than just the device itself; it is a comprehensive platform. The Allurion Virtual Care Suite includes a mobile app, a connected scale, and an AI-powered insights platform for healthcare providers, all designed to support patients with personalized monitoring and coaching.

This established global footprint and integrated care model provide a solid foundation for the company’s U.S. ambitions. The preliminary 2025 financial results serve as the first tangible evidence that its strategic course correction is working. With a leaner operation, a refined commercial strategy, and a mountain of positive clinical and real-world data, Allurion stands at a critical juncture, with its future prospects in the world's largest healthcare market now hinging on the FDA's final verdict.