Allurion Technologies announced that it has achieved several significant milestones in the U.S. Food and Drug Administration Pre-Market Approval process for the Allurion Smart Capsule, signaling continued progress toward potential approval in the United States. The company has also entered into an agreement that would eliminate all of its outstanding debt through an exchange transaction, along with completing a $5 million private placement financing that includes participation from new and existing stockholders, as well as a strategic investor with expertise in obesity.
The company submitted the fourth and final module of its PMA in June 2025, followed by the Acceptance and Filing Reviews in July 2025, which advanced the submission into Substantive Review. In August 2025, Allurion passed the FDA’s pre-approval inspection with zero findings, confirming that the company’s quality systems and procedures met required standards. The company later underwent a Bioresearch Monitoring inspection in October 2025, which also resulted in no observations and no Form 483 issued. The Day-100 Meeting with the FDA was also completed in October 2025 without requests for additional human clinical data.
Allurion also announced a transaction to exchange all outstanding debt under its Revenue Interest Financing Agreements for shares of newly created Series B Convertible Preferred Stock. If completed, the exchange would result in the company becoming debt-free. The Series B Preferred Stock will be convertible into common shares for $3.37 per share and will accrue an annual dividend of 8.25 percent, payable in cash or in kind. The completion of the exchange is subject to stockholder approval and compliance with listing requirements.
Alongside the debt exchange, the company completed a private placement financing totaling approximately $5 million through the sale of 2,994,012 shares of common stock and accompanying warrants. Roth Capital Partners acted as the sole placement agent. The proceeds will be used for working capital and general corporate purposes as the company prepares for the potential U.S. commercialization of the Allurion Smart Capsule.
The company stated that these steps support its strategic focus on entering the U.S. market, pending FDA approval, while solidifying its financial position. Allurion continues to market its broader program internationally, which includes its swallowable Smart Capsule gastric balloon, the Allurion Virtual Care Suite, and connected health tools. The Smart Capsule remains an investigational device in the United States until formal approval.
KEY QUOTES:
“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. This achievement is a testament to our commitment to upholding the highest quality standards across our entire company and is another step towards Allurion serving the U.S. market, pending FDA approval.”
“As we pursue FDA approval and a potential U.S. launch of the Allurion Smart Capsule, we wanted to have a clear path to being debt-free, and this transaction provides that path.”
Dr. Shantanu Gaur, Founder and Chief Executive Officer
