Establishment Labs Announces Seishin Plastic and Aesthetic Surgery Clinic in Japan as First Clinic Partner in Global Launch of Mia Femtech™

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced a strategic partnership with Seishin Plastic and Aesthetic Surgery Clinic in Japan, launching Mia Femtech, a minimally invasive breast aesthetics procedure. This collaboration aims to address dissatisfaction among Japanese women regarding breast aesthetic options, potentially expanding the market significantly. The Mia procedure can enhance breast shape by 1 to 2 cup sizes in just 15 minutes, without general anesthesia. While currently not approved for commercial distribution in the U.S., this launch represents the first of many anticipated in 2023.

Positive

• Partnership with Seishin Clinic enhances market presence in Japan.
• Mia Femtech targets an unmet need in breast aesthetics, expected to grow the market significantly.
• Mia offers a quick and minimally invasive solution, increasing patient appeal.

Negative

• Mia Femtech not yet approved for distribution in the U.S., limiting market access.
• Current FDA investigation for Motiva Implants may delay broader market entry.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230103005212/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What is the agreement between Establishment Labs and Seishin Clinic?

Establishment Labs has partnered with Seishin Plastic and Aesthetic Surgery Clinic to launch Mia Femtech in Japan.

What is Mia Femtech and its expected impact?

Mia Femtech is a minimally invasive breast aesthetics procedure aiming to significantly expand the breast aesthetics market, particularly in Japan.

What benefits does Mia Femtech offer?

The procedure can increase breast shape by 1 to 2 cup sizes in just 15 minutes, without general anesthesia.

When will Mia Femtech be available?

Mia Femtech will first be available at Seishin's Tokyo and Ginza clinics, with potential expansions planned in 2023.

Is Mia Femtech approved for use in the United States?

No, Mia Femtech is currently not approved for commercial distribution in the U.S.