• Less than 1% device-related complication rates reported in post market surveillance data over 12+ years.

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 that it has surpassed three million Motiva^® devices in market.

“Since its founding, Establishment Labs has been guided by one core principle: putting women at the center of everything we do,” said Juan José Chacón-Quirós, Establishment Labs CEO and Founder. “We let science, engineering, and evidence drive our research and development, and this is reflected in the outstanding performance of our portfolio of solutions for breast aesthetics and reconstruction. By leading with innovation for over twelve years now, we have transformed the future of this industry.”

“The superior performance of Motiva is seen in our internal registries and warranty claims, as well as from independent registries and peer-reviewed publications, all of which are referenced in our annual Post Market Surveillance report,” said Dr. Heather Brennan, General Manager, Global Markets. “Our expectations for continued growth are clear: with our new Sulàyöm Campus, which is opening in July, we are more than doubling our manufacturing capacity to address the growing demand for Motiva. We believe that by setting new standards in safety and clinical performance, we will expand markets in breast aesthetics and reconstruction.”

Establishment Labs’ 2022 Post Market Surveillance Report is available at: Motiva PMS Report. Motiva Implants are undergoing an IDE clinical trial and are not approved for sale in 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 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 establishmentlabs.com.

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