Establishment Labs Reaches Two Million Motiva Implants Milestone
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, announced that it has surpassed two million Motiva Implants® in market.
“Our journey to transform breast aesthetics and reconstruction has always been guided by putting women at the center of all of our efforts and by making innovation, science, and research the foundation of all of our products,” said Juan José Chacón-Quirós, Establishment Labs CEO and Founder. “Having over two million Motiva implants now in the market is a testament to those efforts.”
“In the nine years from when we first commercialized Motiva, we delivered one million implants and now, just two years later, we have surpassed two million,” said Dr. Heather Brennan, Head of US Commercial Operations. “Our commitment to women, ongoing development efforts, and advanced technologies have allowed us to win share as we expand our markets. I want to thank the entire Establishment Labs team and the growing group of surgeons who use our products for their support and partnership in helping us to achieve this important commercial milestone.”
Rosalyn Cole d´Incelli, Head of Clinical and Medical Affairs added, “Motiva implants have shown unsurpassed safety performance, with device-related clinical complication rates that remain less than 1%. Our eleven-year Post Market Surveillance Report, which includes all data from our internal registries and warranty claims as well as from international registries and peer-reviewed publications, consistently validates that we have raised the standard for what women should expect from the implants they choose.”
Motiva Implants are part of Establishment Labs’ comprehensive portfolio of advanced smooth implants that are available in more than 80 countries. The Motiva portfolio includes Motiva Round, Ergonomix®, and Ergonomix2® implants, the latter of which are available as part of the JOY™ program; Motiva MIA®, the company’s minimally invasive breast enhancement offering; and the Motiva Flora® tissue expander. Motiva Implants are undergoing an IDE clinical trial and are not approved for sale in the United States. Establishment Labs’ eleven-year Post Market Surveillance Report is available at ESTA 2021 PMS Report.
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, more than 2.0 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 Motiva MIA®, 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.
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 on Form 10-Q filed on November 9, 2021, 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.
Contacts
Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com
