Press Releases & News

Establishment Labs Receives Notice of Allowance for Key U.S. Patent Application Covering Company’s Implant Surface Technology and Announces 510(k) Submission for its Tissue Expander

September 16, 2019

NEW YORK, Sept. 16, 2019 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent application covering its proprietary implant surface technology. Acquired from the University of Manchester, this critical research and patent application was funded with the cooperation of Establishment Labs and is an important component of Motiva Implants®. The University of Manchester’s Institute of Inflammation and Repair is one of the world’s leading innovators of biocompatible surfaces within the human body.

“We are pleased that the USPTO recognized the unique attributes of our SmoothSilk® implant surface technology, which is a key differentiator of our Motiva Implants® relative to others on the market,” said Juan José Chacón-Quirós, Chief Executive Officer of Establishment Labs. “We will continue to strengthen our intellectual property, both in the U.S. and globally, to protect our innovations and pursue new advances in breast aesthetics and reconstruction.”

Additionally, the Company also announced the 510(k) submission for its SmoothSilk® anatomical tissue expander. The Company filed for CE Mark registration of its tissue expander during the fourth quarter of 2018.

“The 510(k) submission for our tissue expander is an important step forward in advancing our product portfolio and global reach and demonstrates our commitment to the breast reconstruction market. Patients undergoing breast reconstruction deserve significant improvement to safety and aesthetic outcomes and we are committed to delivering these results,” Mr. Chacón-Quirós concluded.

About Establishment Labs

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in 75 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit the website for additional information:

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,” “would,” “may” or other similar expressions in this press release, and includes statements related to the Company’s intellectual property portfolio and regulatory activities. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, 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, they are not guarantees of future performance, and some will inevitably prove to be incorrect. As a result, our actual future results may differ from our expectations, and those differences may be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the Company’s annual report on Form 10-K filed on March 20, 2019, quarterly reports on Form 10-Q, 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.

Investor Relations
Jeremy Feffer
LifeSci Advisors, LLC