Allurion Technologies, LLC

Company purpose and core offering

• Develops and sells the Allurion Program, a metabolically focused weight-loss platform.
• Core components:
  • Allurion Smart Capsule: a swallowable, procedureless intragastric balloon for weight loss (placement requires no surgery, endoscopy, or anesthesia).
  • Allurion Virtual Care Suite (VCS): remote patient monitoring, digital behavior-change programming, secure messaging, and video telehealth.
  • Allurion App: patient-facing app that integrates data from the connected scale and wearables, supports secure communication with care teams, and delivers behavior-change content and Coach Iris, an AI health coach.
  • Allurion Connected Scale: part of the patient monitoring ecosystem.
  • Allurion Insights: provider-facing clinic dashboard for remote monitoring and analytics, including a Success Predictor.

Market footprint and reach

• Treated more than 200,000 patients with the Allurion Smart Capsule across 50+ countries (outside the U.S.).
• FDA PMA approval for the Allurion Gastric Balloon System (AGBS), which includes the Allurion Smart Capsule, granted February 20, 2026, enabling U.S. market entry.
• Currently selling in over 50 countries outside the United States; U.S. commercialization follows PMA approval.

Intellectual property and brand protection

• Patents (as of December 31, 2025):
  • U.S.: 23 issued patents and 4 pending applications.
  • Outside the U.S.: 43 issued patents and 4 pending applications.
  • Total issued patents cited: 66.
• Trademarks: 65 registered trademarks across 40 jurisdictions (as of December 31, 2025); ongoing maintenance and selective expansion planned.
• Proprietary elements include swallowable balloon design, self-deflating/release mechanisms, valve technologies, and related delivery systems.

Product features and platform capabilities

• Allurion Smart Capsule:
  • Swallowed as a capsule, filled to roughly 550 mL in the stomach, and designed to deflate and pass naturally in about 4–8 months depending on country; endoscopic or surgical removal is rare.
  • Innovations include a dissolvable capsule, a flexible polyurethane film-based balloon with two valves (fill valve and ReleaseValve), and a radiopaque marker for imaging.
  • Next-generation capsule (2024) improved capsule size, catheter radiopacity, and fill valve performance.
• VCS ecosystem:
  • Patient side: app available in 15 languages; integrates data from the connected scale and wearables; supports secure messaging and video telehealth; includes a library of 100 weight-loss actions and Coach Iris AI coach.
  • Provider side: Allurion Insights offers real-time data, analytics, 1:1 video visits, secure messaging, and clinic-level metrics; includes onboarding and Treatment Tracking features.
  • Onboarding and tracking: Treatment Tracking and Clinic-Led Onboarding introduced in 2022 and expanded to the U.S. in 2024 for non-balloon treatments (e.g., anti-obesity medications and bariatric surgery).

Clinical evidence

• Commercial-setting experience outside the U.S. shows meaningful weight loss with the Allurion Program and maintenance after balloon passage.
• Early studies and case series indicate enhanced weight loss and improvements in co-morbidities when the Allurion Program is combined with GLP-1 therapies such as semaglutide and tirzepatide.

Manufacturing

• In-house manufacturing at a 10,000 sq ft ISO 13485-certified facility in Natick, Massachusetts.
• Involves in-house assembly of the Allurion Smart Capsule using components and sub-assemblies; several critical suppliers provide film, catheter components, scales, and related items.

Regulatory status and compliance

• U.S. PMA approval for the AGBS granted February 20, 2026.
• Operations subject to extensive regulatory and post-market requirements, including FDA QSR, EU MDR, data privacy (GDPR/UK GDPR), telehealth regulations, advertising and false claims laws, and other jurisdictional rules.

Business model and go-to-market

• Business model: B2B2C. Primary customers are healthcare providers and clinics; products are sold through direct sales and distributors.
• Payment model: goods are sold primarily as cash-pay weight-loss solutions; selective third-party reimbursement has occurred in a few markets (for example, the UK and Saudi Arabia).
• Delivery model: office-visit placement (about 15 minutes) with follow-up supported via the VCS.

Sales organization and workforce

• Sales and marketing: approximately 18 employees/consultants (as of December 31, 2025).
• Total employees: 41 (38 full-time) as of December 31, 2025; 31 located in the U.S.
• Restructuring in August 2025 reduced approximately 70 roles (about 65% of the workforce), with most changes completed in Q3–Q4 2025.

Growth strategy

• Expand outcomes for metabolically healthy weight loss, with emphasis on maintenance and muscle mass preservation.
• Deepen global presence and scale U.S. commercialization after FDA approval.
• Advance R&D and clinical strategy, including combination therapies with GLP-1s and potential platform extensions such as drug-delivery applications.
• Improve profitability through cost reductions and disciplined capital allocation.

Financial and recent corporate actions

• The company has incurred net operating losses to date and expects to incur losses in the foreseeable future.
• Capital transactions:
  • November 11, 2025: Securities Purchase Agreement to issue approximately 2,994,012 shares of common stock and up to 2,994,012 warrants for about $5.0 million at $1.67 per share.
  • December 18, 2025: Stockholder approval for issuance of Series B Preferred Stock in connection with an exchange involving RTW-related notes and RIFAs (subject to listing requirements).
• Market status:
  • In March 2026, NYSE delisting proceedings were initiated due to non-compliance with market capitalization standards; NYSE trading was suspended and the company plans to list on OTC markets (ALUR and ALUR WS).

Risks and regulatory considerations

• Key risks include the need to maintain regulatory compliance across jurisdictions, potential IP litigation or challenges, scaling manufacturing, dependence on distributors and provider adoption, competition from GLP-1 drugs and other weight-loss modalities, data privacy and security exposure, and broader macroeconomic factors.

One-paragraph summary

Allurion builds a weight-management platform centered on a swallowable, procedureless intragastric balloon (the Allurion Smart Capsule) paired with a digital health suite (Allurion Virtual Care Suite) that provides remote monitoring, behavior-change programming, and clinician analytics. The company operates in over 50 non-U.S. markets with more than 200,000 patients treated, and entered the U.S. market after FDA PMA approval for the Allurion Gastric Balloon System on February 20, 2026. Allurion maintains an extensive IP portfolio (66 issued patents globally as of December 31, 2025), in-house manufacturing in Natick, MA, a global trademark footprint, and a B2B2C commercial model supported by direct sales and distributors, while advancing R&D and combination-therapy strategies.