NEW YORK--(BUSINESS WIRE)--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, today announced the launch of Mia Femtech� (�Mia��) in Japan, marking the beginning of a new era in breast aesthetics.
�In 2013, we recognized that traditional breast augmentation was not meeting the needs of most women in Japan. Now, a decade later, we are providing a solution. Our launch of Mia Femtech through our partner clinics is focused on delivering an empowering experience in breast aesthetics that overcomes the reservations women may have while matching the ideals to which they aspire,� said Juan Jos� Chac�n-Quir�s, Founder and Chief Executive Officer. �The potential for Mia Femtech in Japan is many times larger than the current breast augmentation market. In creating a solution for Japanese women, we have also created a vibrant new category for women worldwide.�
Mia Femtech is Establishment Labs� breakthrough breast aesthetics experience. The patented technologies used with Mia can shape the breast in a 15-minute minimally invasive procedure without the need for general anesthesia. The result is natural and discreet, with a one to two cup proportionate result. The procedure requires minimal downtime with a return to most activities the same day.
�With close to 30 years of practice around the world, I have come to appreciate that many women are not satisfied with their breast shape but are unwilling to explore traditional breast procedures, either because of the perceived stigma or because of reservations about the procedure itself,� added Dr. Charles Randquist, plastic surgeon and medical educator from Victoriakliniken in Stockholm, Sweden. �Many more women than are currently in the category of breast aesthetics are looking for safe alternatives but are not finding solutions that speak to them. With Mia, we have developed an experience that brings balance and harmony while removing many of the obstacles of a traditional breast augmentation. I believe this is the future of breast aesthetics.�
The premium and personalized Mia Femtech experience is being launched at two clinic chains in Japan. Seishin Plastic and Aesthetic Surgery Clinic operates 10 premium plastic surgery clinics with Mia Femtech now available at their main Tokyo clinic in Roppongi and at their newest clinic in Ginza. Joe Clinic is a high-end medical aesthetics chain in Japan that will offer Mia Femtech initially at its Tokyo and Osaka locations. More information can be found at www.miafemtech.com.
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 over three 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 the only regulatory-approved expander in the world with an integrated port that is MRI conditional and is used to improve outcomes in breast reconstruction following breast cancer. 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 25 separate patent families worldwide and over 50 scientific 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. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants� and began a clinical trial to support regulatory approval in the United States. Please visit our website for additional information at https://establishmentlabs.com/.
Establishment Labs' implants are currently not approved for commercial distribution in the United States. The Company�s Motiva implants are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.
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