SANTA BARBARA, Calif.--(BUSINESS WIRE)--
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 it will host a virtual investor event on Feb. 9, 2021 to discuss its Motiva Mia® system for minimally invasive augmentation, which includes the Motiva Ergonomix2 Diamond® breast implant.
The Motiva Mia system is designed to offer a minimally invasive breast enhancement procedure in less time, with faster recovery and less pain, and without the need for general anesthesia compared to a traditional breast surgery procedure. During the event, members of the Company’s management team will discuss this innovative technology, as well as the potential market opportunity and proposed commercialization timeline. The event will also feature the participation of Charles Randquist, MD; Prof. Marcos Sforza, MD and Jeffry Fassero, MD, who will share their experiences from the recently completed 30-patient Motiva Mia series in the Company’s IRB approved study.
Event Details
Date: Tuesday, Feb. 9, 2021
Time: 1:00 – 2:30 pm EST
To register:
After the conclusion of the program, there will be a question and answer session for investors and analysts. A recording of the event will be archived on the Company’s website.
The Motiva Mia® system is currently not approved for commercial distribution. Motiva Implants® are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.
About Establishment Labs
Establishment Labs Holdings Inc. 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 at .
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 our ongoing clinical trials and our ability to commercialize Motiva Ergonomix implants. 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 related to the performance of the Motiva Mia system and commercial timelines and plans 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 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.
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