NEW YORK, March 25, 2020 (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 U.S. Patent & Trademark Office has issued a patent protecting its proprietary implant surface technology. U.S. Patent No. 10,595,979, which extends protection to March 2035, covers breast implant surface technology associated with increased biocompatibility. The ‘979 patent epitomizes the Company’s dedication to improving patient safety and post-operative outcomes by advancing technology.
“This patent protects the fundamental characteristics of the unique surface technology found in our popular Motiva Implants, currently available to patients in over 80 countries and now being studied in our U.S. clinical trial,” said Juan José Chacón-Quirós, Chief Executive Officer. “We believe this differentiated technology is a key aspect of the exceptional safety profile of Motiva and provides our company with a strong competitive advantage. Our culture of innovation, backed by a strong patent portfolio, will help Establishment Labs to transform this industry with new advances for breast surgery.”
The ‘979 patent was co-invented by Dr. Ardeshir Bayat, Professor at the University of Manchester at the Manchester Institute of Biotechnology in the United Kingdom. With this newly issued patent, the Company owns or has rights to eight issued patents and 17 pending patent applications in the U.S. related to various aspects of its Motiva Implants; four issued patents and 57 pending foreign patent applications; and 6 pending international Patent Cooperation Treaty (PCT) applications.
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 more than 80 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 our website for additional information: www.establishmentlabs.com
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 16, 2020, 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.
David K. Erickson