Establishment Labs Holdings Inc. noted the presentation of an update on the Motiva US IDE Study, including five-year patient follow-up data for primary augmentation subjects. The results were presented by Dr. Caroline Glicksman at The Aesthetic MEET 2025.
The five-year Kaplan-Meier risk rates for capsular contracture (Baker Grade III/IV) were 0.5%, and for suspected or confirmed rupture in the MRI cohort, they were 0.6%. These low complication rates demonstrate consistency, with no increase in capsular contracture or rupture since the two-year reporting.
Interim CEO Peter Caldini stated that U.S. momentum continues to exceed expectations, driven by differentiated clinical data and a lack of innovation in the market. The company now has over 800 accounts onboard, with more than 550 placing orders, representing a 20% increase in just three weeks.
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