Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women's health and wellness, principally in breast aesthetics and reconstruction, announced the presentation of three-year clinical results with Mia Femtech at the 9th Annual World Symposium on Ergonomic Implants (WSEI) being held this week in Barcelona, Spain.
The Mia Femtech Clinical Study is an IRB-approved prospective study that enrolled 100 subjects between December 2020 and April 2021. In the preliminary three-year analysis of key complications, there were no reports of capsular contracture (Baker Grade III/IV) and no ruptures (suspected or confirmed). There were also no reports of infection, hematoma, or seroma requiring intervention in the study and no reports of changes in nipple or breast sensation. The follow-up compliance rate at three years was 93%.
"The 9th Annual World Symposium on Ergonomic Implants will bring together over 500 plastic surgeons, researchers and commercial partners to share best practices and the latest scientific and clinical data on Establishment Labs' growing portfolio of technologies, focusing this year on breast tissue preservation," said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. "The Mia results being shown this week are among the best breast implant data reported at three years and prove again that minimally invasive is the future of breast aesthetics. Demand for Mia in our current markets, from both women and clinic partners that launched over the past year, is reaching an inflection point and with the recent FDA approval of Motiva implants, we have already begun the process to bring this revolutionary technology to the United States."
The World Symposium on Ergonomic Implants is being held October 31 to November 2 in Barcelona, Spain.
Primary Augmentation Primary Congenital | 3-year (N=100), 95% CI | |
Capsular contracture (Baker Grade III/IV) | 0.0% | |
Rupture, suspected or confirmed* | 0.0% | |
Infection | 0.0% | |
Seroma | 0.0% | |
Hematoma | 0.0% | |
Changes in Nipple Sensation | 0.0% | |
Changes in Breast Sensation | 0.0% | |
Malposition/Displacement** | 1.0% | |
Inferior malposition | 0.0% | |
Any reoperation | 1.0% |
*Includes overall and MRI cohort (33 subjects/ 66 implants) combined
** One patient had an implant malposition and underwent implant reposition; no implant exchange
All data presented is preliminary follow-up data and does not reflect the complete study results nor establish the ultimate safety or effectiveness of the Mia Femtech procedure.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women's health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech, Establishment Lab's unique minimally invasive experience for breast harmony, is the Company's most recent breakthrough innovation. These solutions are supported by over 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 ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com.
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Contacts:
Investor/Media Contact:
Raj Denhoy
415 828-1044
rdenhoy@establishmentlabs.com
