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 ImplantsÂŽ, the centerpiece of the MotivaImagineÂŽ platform. Motiva ImplantsÂŽ are produced at the Companyâs 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 ImplantÂŽ clinical trial in the United States. In addition to Motiva ImplantsÂŽ, Establishment Labsâ product and technologies portfolio includes DivinaÂŽ 3D Simulation System, Puregraft, and MotivaImagineÂŽ Centers.
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