Establishment Labs® (NASDAQ:ESTA) is a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market by designing, developing, manufacturing, and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform.
Motiva Implants® are produced at two FDA-compliant state-of-the-art facilities in Costa Rica and are currently approved for commercial distribution in over 70 countries through exclusive distributors or a direct salesforce.
In March 2018, Establishment Labs® received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implants® clinical trial in the United States.