ALLURION TECHNOLOGIES Stock Price, News & Analysis

Allurion Technologies, Inc. (NYSE: ALUR) is a medical device company focused on metabolically healthy weight loss. According to company disclosures and press releases, Allurion has developed the Allurion Program, a weight-loss platform built around the Allurion Smart Capsule, described as the world’s first and only swallowable, Procedureless™ gastric balloon for weight loss. The company states that the Smart Capsule is designed to be swallowed during a brief outpatient visit, filled once in the stomach, and pass naturally after four months.

Allurion’s approach combines this device-based therapy with digital tools and clinical support. The Allurion Program integrates the Smart Capsule with the Allurion Virtual Care Suite, which includes the Allurion Mobile App for consumers, Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. Company materials explain that the Virtual Care Suite can also be offered separately from the full program to help providers customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan.

Business focus and weight-loss platform

Allurion describes itself as a pioneer in metabolically healthy weight loss. Its disclosures emphasize a focus on losing weight, keeping it off, and maintaining muscle mass. The Allurion Program is positioned as a platform that combines a swallowable gastric balloon with remote monitoring and behavior change support. Company communications note that patients using the program can receive digital support and remote monitoring aimed at changing behaviors and improving outcomes.

The Smart Capsule and associated gastric balloon are characterized by the company as procedure-less, meaning they are administered under the guidance of a healthcare provider without surgery, endoscopy, or anesthesia. Press releases further indicate that the Smart Capsule is an investigational device in the United States and that Allurion has pursued a Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA), including submission of PMA modules, completion of Acceptance and Filing Reviews, and entry into Substantive Review.

Digital tools and AI-enabled virtual care

Allurion highlights the role of its Virtual Care Suite in supporting both patients and clinicians. The suite includes:

• Allurion Mobile App for consumers, which is used as part of the Allurion Program.
• Allurion Insights for healthcare providers, which incorporates the Iris AI Platform.
• Allurion Connected Scale, which is used alongside the program to track progress.

Company statements describe the Virtual Care Suite as AI-powered and used to follow patients, customize therapy, and monitor progress during and after Smart Capsule treatment. In clinical case series disclosed by Allurion, patients were followed using this AI-powered virtual care as part of the Allurion Program, and the company indicates that the suite can be deployed independently of the Smart Capsule to support various weight-loss therapies.

Clinical evidence and research emphasis

Allurion frequently references peer-reviewed publications and clinical data related to the Allurion Smart Capsule. Press releases report:

• A multicenter, retrospective study across multiple countries on consecutive Smart Capsule use in adults with overweight and obesity, with company communications highlighting average total body weight loss above 20% and no serious device-related adverse events.
• A case-controlled study in over one thousand patients comparing the Allurion Smart Capsule combined with lifestyle intervention to lifestyle intervention alone, with reported higher weight reduction, fat mass loss, and visceral fat loss in the Smart Capsule group and favorable body composition changes.
• Initial results from combining the Allurion Program and Smart Capsule with low-dose GLP-1 therapies such as tirzepatide, with company materials emphasizing adherence and changes in lean body mass in the reported case series.

Allurion’s communications state that there are over 30 peer-reviewed publications on the Allurion Smart Capsule and that these data contribute to an extensive evidence base on its safety and efficacy. The company also references its pivotal AUDACITY trial in connection with its PMA submission to the FDA.

Regulatory and strategic initiatives

In its public updates and SEC filings, Allurion has described several regulatory and strategic milestones. The company reports:

• Submission of the fourth and final PMA module for the Allurion Smart Capsule to the FDA.
• Completion of FDA Acceptance and Filing Reviews and entry into Substantive Review.
• Successful completion of an FDA pre-approval inspection and a Bioresearch Monitoring (BIMO) inspection with no observations and no Form 483 issued.
• Holding a Day-100 Meeting with the FDA as part of the PMA review process.

Allurion has also discussed a strategic pivot toward a commercial strategy focused on combination therapy with low-dose GLP-1 medications, muscle mass maintenance, and U.S. market entry. Company updates mention transitions to distribution partners with access to physician networks prescribing GLP-1 therapy and exploration of next-generation research and development, including a potential drug-eluting intragastric device in collaboration with a strategic partner.

Capital markets and corporate governance

Allurion’s common stock and certain warrants are listed on the New York Stock Exchange under the symbols ALUR and ALUR WS, respectively, as noted in its SEC filings. The company has reported entering into:

• A private placement of common stock and accompanying warrants, with aggregate gross proceeds described in company filings.
• An exchange agreement to convert outstanding debt and obligations under revenue interest financing agreements into shares of Series B convertible preferred stock, subject to stockholder approval and exchange listing requirements.

Through its definitive proxy statement and related filings, Allurion has outlined proposals for stockholders, including amendments to its stock option and incentive plan, repricing of certain stock options, approval of preferred share and warrant share issuances, and a potential reverse stock split within a specified ratio range. These filings also describe the company’s use of virtual annual meetings and its governance processes.

Use cases and target patients

Based on the clinical studies and case series described in Allurion’s press releases, the Allurion Smart Capsule and Program have been used in adults with a body mass index (BMI) at or above thresholds such as 25 kg/m² and 30 kg/m². The company’s communications reference use in patients with overweight and obesity and emphasize goals of significant weight reduction, improved body composition, and maintenance or increase of lean body mass.

Allurion’s combination of a swallowable gastric balloon, AI-enabled virtual care, and behavior change support is presented as a non-surgical option for individuals seeking weight loss and for healthcare providers offering obesity care. The company’s materials also indicate interest in combination approaches with GLP-1 medications, with a focus on adherence and long-term outcomes.

Risk disclosures and financial reporting

In SEC filings, Allurion has disclosed restatements of certain prior financial statements related to accounting for a revenue interest financing agreement and convertible senior secured notes, noting that these matters affect non-cash items such as Other Comprehensive Income (Loss) and Other Income (Expense). The company has stated that these corrections are not expected to affect revenue, gross margin, operating expenses, or cash. It has also described material weaknesses in internal control over financial reporting and efforts to address them.

Allurion’s periodic reports and press releases discuss operating expenses, operating loss, and changes in revenue over time, as well as initiatives to reduce expenses and refine its commercial strategy. The company has cautioned that forward-looking statements in its communications are subject to risks and uncertainties, referencing risk factors in its Annual Report on Form 10-K and other SEC filings.

FAQs about Allurion Technologies, Inc. (ALUR)

• What does Allurion Technologies, Inc. do?
  Allurion Technologies, Inc. is a medical device company focused on metabolically healthy weight loss. It has developed the Allurion Program, a weight-loss platform that combines the Allurion Smart Capsule, a swallowable, Procedureless™ gastric balloon for weight loss, with the Allurion Virtual Care Suite, including a mobile app, provider-facing tools with the Iris AI Platform, and the Allurion Connected Scale.
• What is the Allurion Smart Capsule?
  Company materials describe the Allurion Smart Capsule as the world’s first and only swallowable, Procedureless™ gastric balloon for weight loss. It is designed to be swallowed during a brief outpatient visit, filled once in the stomach, and pass naturally after four months, under the guidance of a healthcare provider and without surgery, endoscopy, or anesthesia.
• What is included in the Allurion Virtual Care Suite?
  According to Allurion, the Virtual Care Suite includes the Allurion Mobile App for consumers, Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. It is used to customize, monitor, and manage weight-loss therapy and can be offered separately from the full Allurion Program.
• How does Allurion describe its approach to weight loss?
  Allurion describes itself as a pioneer in metabolically healthy weight loss, with an approach focused on losing weight, keeping it off, and maintaining muscle mass. Its communications highlight the combination of the Smart Capsule, AI-powered virtual care, and behavior change support.
• Is the Allurion Smart Capsule approved in the United States?
  Allurion states that the Allurion Smart Capsule is an investigational device in the United States. The company has submitted a PMA application to the FDA and reports having completed Acceptance and Filing Reviews, entered Substantive Review, undergone FDA inspections with no observations, and held a Day-100 Meeting, but it also notes that FDA approval is pending.
• What clinical data has Allurion reported?
  Press releases from Allurion describe multiple peer-reviewed studies and case series, including a multicenter study on consecutive Smart Capsule use in adults with overweight and obesity, a large case-controlled study comparing Smart Capsule plus lifestyle intervention to lifestyle intervention alone, and initial results from combining the Allurion Program with low-dose GLP-1 therapies. These reports emphasize weight reduction, changes in body composition, and adherence in the studied populations.
• How is Allurion’s stock traded?
  According to its SEC filings, Allurion’s common stock is listed on the New York Stock Exchange under the symbol ALUR. Warrants to purchase a fraction of a share of common stock at a specified exercise price are listed under the symbol ALUR WS.
• What financial reporting issues has Allurion disclosed?
  Allurion has disclosed errors in the accounting for the fair value of a revenue interest financing agreement and convertible senior secured notes, leading to restatements of certain prior financial statements. The company has indicated that these misstatements affect non-cash items and are not expected to change revenue, gross margin, operating expenses, or cash, and it has reported material weaknesses in internal control over financial reporting.