Establishment Labs Marks Motiva Devices Milestone

Establishment Labs Holdings Inc. is celebrating a marketing milestone, having commercialized more than 5 million Motiva devices worldwide.

“Surpassing five million Motiva devices is another milestone for our company, and a clear reflection that our investment in bringing better technology and procedures to market is rewarded by strong consumer adoption,” Establishment Labs CEO Peter Caldini said. “Just three years ago, we announced that we had exceeded 3 million devices, and we continue to gain market share while expanding the category. Our over 25% revenue growth in 2025 has continued into 2026, driven by the successful entry of Motiva in the United States and the global momentum of our minimally invasive platform.”

“Establishment Labs has changed what is possible for our patients,” stated Mark Epstein, M.D., a board-certified plastic surgeon in Hauppauge, N.Y. “By rethinking device design through the lens of science, safety, and the real needs of women, they have provided more than 2.5 million women worldwide with advanced options that are clinically shown to be best in class. I am delivering better patient outcomes, and my practice has more than doubled. In the first quarter of 2026, I had 56 patients choose the Preservé minimally invasive procedure, and in the last six months I have completed 90 cases. Preservé is priced 30% higher than my standard Motiva Breast Augmentation, because patients are willing to spend more for a procedure and technology that avoids general anesthesia, preserves native breast tissue and their chest muscles, and supports faster recovery.”

Establishment Labs Holdings Inc. is a global medical device company improving women’s health and wellness in breast aesthetics and reconstruction through science, engineering, and technology. The company offers solutions for breast health, breast aesthetics, and breast reconstruction in more than 100 countries. With 5 million Motiva devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction, bigwigs claim. The company’s minimally invasive platform consists of Mia Femtech, a minimally invasive experience for breast harmonization, and Preservé, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM is a next-generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB-approved pivotal study. The Motiva Flora tissue expander improves outcomes in breast reconstruction after breast cancer and is reportedly the world’s only regulatory-approved expander with an integrated port using radio-frequency technology that is MRI-conditional. Zensor is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº, currently part of an IRB-approved pivotal study to measure core breast temperature. These solutions are supported by more than 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer-reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica, compliant with all applicable regulatory standards under ISO13485:2024 and U.S. Food and Drug Administration 21 CFR 820.