Allurion Technologies Inc. (NYSE:ALUR) shares soared 10.9% in premarket trading Tuesday after the metabolic health company announced major progress in its U.S. regulatory process and a debt exchange agreement that would eliminate all of its outstanding debt.
The company said it has achieved key milestones in the FDA Pre-Market Approval (PMA) process for its Allurion Smart Capsule, a non-surgical weight loss device. In recent months, Allurion successfully completed FDA pre-approval and Bioresearch Monitoring inspections with zero findings and held its Day-100 Meeting with the FDA, where regulators did not request any additional human clinical data.
“Passing these FDA inspections with no findings and completing the Day-100 Meeting are major milestones for Allurion, and we believe we are now entering the final stages of the review process,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer of Allurion.
In addition to regulatory progress, Allurion unveiled a debt-for-equity exchange in which all existing debt will be converted into new Series B Convertible Preferred Stock. The preferred shares will convert at an initial price of $3.37 per share and accrue dividends at 8.25% per year. The transaction is subject to shareholder approval and standard closing conditions.
Allurion also raised $5 million through a private placement, attracting participation from new and existing investors, including a strategic partner in obesity care. The financing involved the sale of approximately 3 million shares and accompanying warrants at $1.67 per share.
The company submitted the final module of its PMA application in June 2025, with the FDA completing the Acceptance and Filing Reviews the following month before entering the Substantive Review phase. With these milestones reached, Allurion said it is financially and operationally preparing for a potential U.S. launch of its Smart Capsule technology, pending final FDA approval.