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Establishment Labs 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 the Company’s two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and currently sold in over 60 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 Implant® clinical trial in the United States. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes Divina® 3D Simulation System, Puregraft, and MotivaImagine® Centers.

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