Establishment Labs’ Adaptive Study on Gluteal Augmentation: Key Insights for Investors

Establishment Labs Holdings ((ESTA)) announced an update on their ongoing clinical study.

Study Overview: Establishment Labs Holdings is conducting an adaptive study titled ‘Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement.’ This study aims to evaluate the safety and performance of various Motiva devices used in minimally invasive gluteal augmentation for 120 healthy female participants. The significance lies in understanding the potential side effects, device functionality, and satisfaction levels of both surgeons and participants.

Intervention/Treatment: The study tests several devices, including the Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator. These devices are intended to enhance the buttocks through minimally invasive procedures.

Study Design: This is an interventional study with a single-group model. It is prospective, open-label, and adaptive, focusing on device safety and performance without any masking. The primary purpose is to assess the safety and functioning of the devices.

Study Timeline: The study began on December 2, 2024, with the latest update submitted on August 20, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.

Market Implications: This study could significantly impact Establishment Labs’ stock performance and investor sentiment by potentially validating the safety and effectiveness of their devices. As the company operates in a competitive market, positive results could enhance their market position and influence industry trends.

The study is currently recruiting, with further details available on the ClinicalTrials portal.