Establishment Labs Holdings, Inc. is a technology company, which engages in the design, development, manufacture, and marketing of silicone breast implants. It generates income from customers in Europe, the Middle East, Latin America, and Asia. The firm's products include Motiva Implants, Motiva Flora Tissue Expander, Motiva Ergonomix, and Motiva Ergonomix2. The company was founded by Juan Jose Chacon-Quiros in 2004 and is headquartered in Alajuela, Costa Rica.
Clinical Trials
8
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
4
50.0%
Enrolling By Invitation
1
12.5%
Recruiting
3
37.5%
No approval data available
- Conexeu Sciences has launched a preclinical development program for its B.R.E.A.S.T.™ 3D-bioprinted matrix at the Wake Forest Institute for Regenerative Medicine, one of the world's largest regenerative medicine research centers. - The program will evaluate durability, host tissue integration, and resorbability of the CXU™ platform's 3D-printed matrix using WFIRM's advanced Integrated Tissue-Organ Printing System (iTOPS). - Conexeu's CXU™ is an extracellular matrix–based platform targeting multiple markets including wound care, aesthetics, and breast reconstruction, with a 510(k) submission anticipated in early 2027. - The regenerative medicine market is projected to grow from approximately $47.4 billion in 2025 to roughly $230.4 billion by 2034, reflecting a compound annual growth rate of 19.2%.
- Establishment Labs has received FDA approval for its Motiva SmoothSilk Ergonomix and Round breast implants for primary and revision augmentation. - The Motiva implants feature a patented SmoothSilk surface, designed to enhance biocompatibility and promote low inflammation. - Clinical trials showed less than 1% rates of capsular contracture and rupture with Motiva implants, demonstrating their safety and effectiveness. - Nearly four million Motiva devices have been delivered globally since 2010, marking a significant milestone for Establishment Labs.
