Establishment Labs Announces First Mia Femtech™ Partners in Europe and Second Partner Chain in Japan

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) has announced partnerships with four clinics in Europe and one in Japan for its Mia Femtech™ product. This rollout marks a significant step for the company as it seeks to expand its innovative breast aesthetics offerings. Clinics in Sweden, Switzerland, and Spain are among the new partners, highlighting strong interest in the Mia brand. The CEO expressed optimism about further partnerships and market potential. However, it's important to note that Mia Femtech is not commercially available in the EU or the US at this time.

Positive

• Partnerships with prestigious clinics in Europe and Japan enhance market access.
• Mia Femtech™ introduces a minimally invasive breast aesthetic solution, potentially attracting new consumers.

Negative

• Mia Femtech is not yet commercially available in the European Union and the United States.

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 it has entered into agreements with four partners in Europe and a second partner chain in Japan for Mia Femtech™ (“Mia®”).

“Our global rollout of Mia Femtech continues, and we are pleased to announce our first European partners in Sweden, Switzerland, and Spain, as well as an additional chain in Japan,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer. “We expect to partner with many more centers with a focus on creating premium experiences with broad appeal. Mia is opening breast aesthetics to a new group of consumers and the strong interest in partnering with us demonstrates the potential of Mia to dramatically expand our markets. We look forward to many more announcements on Mia over the coming weeks and months.”

In Stockholm, Sweden, Establishment Labs is partnering with Nordiska Kliniken, one of Scandinavia’s leading clinics in plastic surgery and aesthetic treatments. In Switzerland, the Company is working with Leman Aesthetic Clinic in Geneva and Clinic Utoquai in Zurich, which are both internationally recognized and well-established leaders in aesthetics. In Barcelona, Spain, Clínica Planas is well-known as a provider of premium services and outcomes in plastic surgery. Joe Clinic is a high-end medical aesthetics chain in Japan that will begin initially by offering Mia at its Tokyo and Osaka locations.

“Mia Femtech will define a new premium aesthetic category with great potential for expanding the market,” said Javier Planas, CEO of Clínica Planas. “Clínica Planas has been a pioneer in aesthetics since 1971, and we are excited to once again be at the forefront of innovation and excellence.”

“As leaders in plastic surgery, we are proud to introduce Mia Femtech as the coming evolution in breast aesthetics. Building Nordiska Kliniken has always been about innovating and this is the next natural step in our journey of being market leaders,” said Sam Besara, CEO of Nordiska Kliniken.

Mia Femtech is Establishment Labs’ breakthrough minimally invasive breast aesthetics experience. The patented technologies used with Mia can shape the breast up 1 to 2 cups in a 15-minute procedure without the need for general anesthesia.

Mia Femtech is not yet commercially available in the European Union and the United States.

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 2.5 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 www.establishmentlabs.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s quarterly report and annual reports, and other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230323005283/en/

Investor/Media Contact:

Raj Denhoy

415-828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What is Mia Femtech by ESTA?

Mia Femtech is Establishment Labs' breakthrough minimally invasive breast aesthetics experience, designed to enhance breast appearance without general anesthesia.

What partnerships has ESTA recently announced?

Establishment Labs has entered into partnerships with clinics in Sweden, Switzerland, Spain, and Japan for Mia Femtech.

Where is Mia Femtech available?

Mia Femtech is currently available through select clinics in Europe and Japan, but not in the EU or the US.

What is the significance of the recent press release for ESTA's stock?

The announcement of new partnerships may positively impact ESTA's market potential and investor interest.

When can we expect Mia Femtech to be available in the US?

The press release does not specify a timeline for when Mia Femtech will become available in the US.