FDA Approval Process Milestones
Allurion passed several critical milestones towards FDA approval for the Allurion Smart Capsule, including the completion of the substantive review phase with no observations or Form 483 issued, indicating readiness for the U.S. market.
Restructuring Success
Operating expenses decreased by 29%, and operating loss narrowed by 22% compared to the prior year, reflecting improved efficiencies from restructuring efforts.
Debt Restructuring and Financial Position
Allurion entered a transaction to exchange all outstanding debt for convertible preferred equity, along with a $5 million private placement financing, strengthening the financial position and providing a path to being debt-free.
R&D and Manufacturing Innovations
Exploration of a drug-eluting balloon in collaboration with a strategic partner, with potential to revolutionize obesity therapy by addressing adherence challenges.