November 11, 2025 — Leads & Copy — Allurion Technologies, Inc. (NYSE: ALUR) announced it has achieved significant milestones in the U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) process for its Allurion Smart Capsule.
The company also announced an agreement for a debt exchange with its creditor. All outstanding debt and obligations under its Revenue Interest Financing Agreements will be exchanged for shares of a newly created Series B Convertible Preferred Stock. These shares will be convertible into common stock under certain conditions, referred to as the Exchange Transaction.
Allurion further announced the completion of a $5 million private placement financing. New and existing stockholders, along with a strategic partner possessing expertise in obesity, participated in the financing. This significantly bolsters Allurion’s financial stability as it pursues FDA approval for the Allurion Smart Capsule.
In June 2025, Allurion submitted the fourth and final module of its PMA for the Allurion Smart Capsule to the FDA.
In July 2025, the FDA completed its Acceptance and Filing Reviews process and advanced to the Substantive Review phase.
In August 2025, the company successfully completed the FDA’s pre-approval inspection. The inspection, designed to assess the company’s systems, methods, and procedures to ensure that the quality management system is effectively established, resulted in zero findings, with no observations raised and no Form 483 issued. The inspection focused on compliance with regulatory requirements, process quality, and documentation standards.
In October 2025, Allurion underwent a Bioresearch Monitoring (BIMO) inspection by the FDA. The BIMO inspection, which assesses a company’s clinical trial systems, methods, and procedures to ensure data integrity, again resulted in no observations raised and no Form 483 issued.
Also in October 2025, the company held its Day-100 Meeting with the FDA, where the FDA provided feedback after reviewing the PMA submission. The FDA did not request additional human clinical data.
Allurion Founder and Chief Executive Officer Dr. Shantanu Gaur said that passing the FDA inspections with no findings and completing the Day-100 Meeting are major milestones for Allurion, and the company believes it is entering the final stages of the review process. Gaur added that the achievement is a testament to Allurion’s commitment to upholding the highest quality standards and is another step towards Allurion serving the U.S. market, pending FDA approval.
The Series B Preferred Stock is initially convertible at $3.37 per share and is subject to certain limitations in the certificate of designations that will govern the Series B Preferred Stock. The Series B Preferred Stock will accrue dividends at an 8.25% rate per annum, payable in kind or in cash, as set forth in the Certificate of Designations.
The completion of the Exchange Transaction is subject to stockholder approval for the issuance of the Series B Preferred Stock and the Conversion Shares, compliance with the listing requirements of the national securities exchange on which the common stock is then listed, and approval for listing of the Conversion Shares by such national securities exchange.
The private placement involved the purchase and sale of 2,994,012 shares of common stock and warrants to purchase up to 2,994,012 shares of common stock at a purchase price of $1.67 per share and accompanying warrant. Roth Capital Partners acted as sole placement agent for the private placement, which is expected to close on November 12, 2025.
The aggregate gross proceeds to Allurion from the private placement are expected to be approximately $5 million, before deducting placement agent’s fees and other offering expenses. Allurion plans to use the net proceeds from the private placement for working capital and general corporate purposes.
For more information related to the Exchange Transaction and the private placement, see Allurion’s Form 8-K to be filed with the U.S. Securities and Exchange Commission.
Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program combines the Allurion Smart Capsule, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan. The Allurion Smart Capsule is an investigational device in the United States.
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc.
Dr. Shantanu Gaur, Founder and Chief Executive Officer of the Company.
Source: Allurion Technologies, Inc.
