Business
Motiva Ergonomix2 Platform and Motiva Mia Implant Receive CE Mark
Commercial Launch of Ergonomix2 Planned for 2021Approval Accelerates Path to Europe for Motiva MiaPre-Commercial European Mia Procedures to Begin in Second
About this update from Establishment Labs Holdings Inc.
[{"type":"text","content":"Commercial Launch of Ergonomix2 Planned for 2021Approval Accelerates Path to Europe for Motiva MiaPre-Commercial European Mia Procedures to Begin in Second Half of 2021 SANTA BARBARA, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced it has received a CE mark for its next generation Motiva Ergonomix2® silicone breast implant platform. The CE mark also includes the Motiva Ergonomix2 Diamond® breast implant, which is the implant that will be used in the Motiva Mia® minimally invasive breast augmentation system when it is approved. Ergonomix2 incorporates the latest innovations by Establishment Labs, including its most advanced ultra-high purity chemistries for enhanced device mechanical properties and improved patient ergonomics. Ergonomix2 also features the Company’s patented SmoothSilk® surface technology, which is the basis of Motiva Implants’ low inflammatory characteristics that have contributed to the lowest capsular contracture rates in the industry. Ergonomix2 has CE mark labeling for use in both aesthetic and reconstruction procedures and following its planned commercialization will become Establishment Labs’ most premium implant to date. \"Motiva Ergonomix2 technology is another significant advancement for the breast implant industry,” said Marcos Sforza, MD, UK-based plastic surgeon and member of Establishment Labs’ Medical Advisory Board. “By design, this implant has biomechanical characteristics specifically adapted to the breast anatomy for greater comfort and softness. It is exciting to see Establishment Labs innovate with its advanced ultra-high purity silicone technology for breast implants, which should reduce complications and allow, for the first time, the possibility of a true minimally invasive breast enhancement with Motiva Mia.” “This regulatory approval will enable Establishment Labs to bring the next generation of our best-selling Motiva Ergonomix® implant to Europe in the first half of 2021 followed by a broad commercial launch later in the year,” said founder and chief executive officer Juan José Chacón-Quirós. “Equally important, the inclusion of the Motiva Ergonomix2 Diamond breast implant in this CE mark shortens our European re...