SANTA BARBARA, Calif.–(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 it has entered into an agreement with Seishin Plastic and Aesthetic Surgery Clinic in Japan for Mia Femtech™ (“Mia®”).
“Seishin is one of the leading plastic surgery practices in Japan, and we are delighted to announce them as our first clinic partner in the global rollout of Mia Femtech,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer. “The Japanese market was the original inspiration for Mia. A significant number of Japanese women are simply not satisfied with their current options for breast aesthetics and our research shows that this new category will increase the breast aesthetics market manyfold.”
“We are thrilled to be the first launch partner of Mia,” said Dr. Tatsuro Kamakura, Chief Medical Officer of Seishin Plastic and Aesthetic Surgery Clinic. “Mia is very important for patients, but it is also very important for the future of breast aesthetics. This procedure increases our productivity, and we expect the Mia experience to attract new patients that we would not have otherwise seen.”
Seishin Plastic and Aesthetic Surgery Clinic was founded in 1993 and operates 10 premium plastic surgery clinics in Japan. Mia will be first available at Seishin’s main Tokyo clinic in Roppongi and at their newest clinic in Ginza.
“While the inspiration came from Japan, Mia has appeal for women around the world,” continued Mr. Chacón-Quirós. “Mia is defining a new category of breast aesthetics, offering women a premium experience that is far more accessible. This should be the first announcement of many regarding Mia that we make this year, and we look forward to launching in a number of markets in the first half of 2023.”
Mia Femtech is Establishment Labs’ breakthrough minimally invasive breast aesthetics experience. The patented technologies used with Mia can increase breast shape by 1 to 2 cups in a 15-minute procedure without the need for general anesthesia.
Motiva Implants and Mia Femtech are currently not approved for commercial distribution in the United States. Motiva Implants are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness. The company’s initial focus is breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants® that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, over 2.5 million Motiva Implants® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under development a number of related products and technologies, including the Motiva Flora® tissue expander and Mia Femtech™, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant® and began a clinical trial to support regulatory approval in the United States. Motiva Implants® are manufactured at the company’s two facilities in Costa Rica, which are 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.