Allurion Technologies announced that it has passed critical milestones in the FDA Pre‑Market Approval process for its Smart Capsule, including a successful Day‑100 Meeting and zero‑finding inspections, positioning the company closer to U.S. regulatory approval.
In a separate transaction, the company exchanged all outstanding debt for newly issued Series B Convertible Preferred Stock, a move that will render Allurion debt‑free once the transaction closes. The preferred shares are convertible at $3.37 per share and carry an 8.25% dividend, and the deal is contingent on shareholder approval and other closing conditions.
Allurion also completed a $5 million private placement, selling 2,994,012 shares of common stock and an equal number of warrants at $1.67 per share. The proceeds will support ongoing operations and the company’s strategy to accelerate U.S. market entry.
The company’s recent financials show a sharp decline in revenue, falling to $3.4 million in Q2 2025 from $11.8 million in Q2 2024, and to $5.4 million in Q3 2024 from $18.2 million in Q3 2023. Gross profit margins have fluctuated, ranging from 58% in Q3 2024 to 74% in Q2 2025, reflecting mix shifts and pricing dynamics.
Dr. Shantanu Gaur, founder and CEO, said the FDA milestones and debt‑free path “signal a de‑risking of the regulatory pathway and a strengthening of the balance sheet, positioning Allurion for a potential U.S. launch.” He added that the financing will provide the working capital needed to execute the company’s low‑dose GLP‑1 combination therapy strategy and to support the Smart Capsule’s commercialization.
Investors responded positively to the combined regulatory, financial, and capital‑raising developments, viewing the milestones as a significant step toward U.S. market entry and the debt exchange as a key improvement to the company’s financial health.
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