Market ExpansionThe Allurion Balloon has been cleared to resume sales in France, which historically accounted for ~15% of sales, potentially providing a meaningful tailwind to ALUR's growth trajectory.
Product EfficacyThe study succeeded in the responder rate co-primary endpoint, with 58% of Allurion balloon patients losing more than 5% of their total body weight, a statistically significant result.
Regulatory ApprovalThe Audacity findings are considered sufficiently strong to support US approval, with an anticipated approval following a one-year regulatory review.