Establishment Labs Launches Motiva Flora Tissue Expander in Europe and Other CE Mark Countries

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) officially launched its Motiva Flora® tissue expander in Europe during a symposium at the London Breast Meeting on September 2, 2021. This RFID-enabled device aims to enhance post-mastectomy reconstruction, improving patient comfort through advanced biocompatibility and MRI imaging capabilities. CEO Juan José Chacón-Quirós highlighted the significance of Flora in capturing a substantial market share in breast reconstruction, projecting improved outcomes for women. Motiva Flora is not yet approved for distribution in the U.S.

Positive

• Launch of Motiva Flora® tissue expander in Europe, marking a significant innovation in breast reconstruction technology.
• Expected to capture a substantial share of the breast implant market, which represents 20% or more of the breast reconstruction segment in Europe.

Negative

• Motiva Flora is not yet approved for commercial distribution in the United States.

SANTA BARBARA, Calif.--(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, held a symposium at the London Breast Meeting on Thursday, September 2, 2021, marking the official launch of the company’s Motiva Flora^® tissue expander in Europe and other CE Mark countries.

The symposium’s moderator Professor Jian Farhadi, Chair of the London Breast Meeting, commented, “The early clinical experience with Flora shows that this RFID-enabled device can make a meaningful difference in how women are treated during post-mastectomy reconstruction and importantly, in women’s comfort during and after treatment. The surface biocompatibility, the ability to image with MRI, and the possibilities that a non-ferrous construction open up in oncology treatment put Flora ahead of any other tissue expander currently available.” Other participants on the panel included reconstructive surgeons with experience using Motiva Flora and members of the medical and scientific advisory boards of Establishment Labs.

“In Europe, breast reconstruction represents 20% or more of the breast implant market,” added Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “Flora is a significant advancement in tissue expander technology, and we expect to take significant market share as we have in the past: by commercializing real innovation that makes a significant difference in women’s lives. With new options that can lead to better outcomes, we expect to expand the global market for reconstruction.

“This is the foundation of Aesthetic Breast Recon^®,” Chacón-Quirós continued, “where we offer tools and techniques that allow women to receive a reconstruction with an aesthetic result on par with a breast augmentation procedure. We believe that our innovations, in partnership with breast reconstruction surgeons, can create new standards in patient outcomes.”

The Motiva Flora symposium was part of the official program of the 2021 London Breast Meeting. A recording of the event will be posted to Establishment Labs’ investor relations website.

The Motiva Flora tissue expander offers several notable innovations, including Establishment Labs’ patented SmoothSilk^® surface technology as well as an RFID-enabled, non-magnetic integrated port, that offer potential improvements in imaging, treatment, and overall clinical outcomes and patient satisfaction. The Motiva Flora tissue expander is currently not approved for commercial distribution 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. 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 1.6 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. 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. 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, 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 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 15, 2021, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210902005737/en/

Investor/Media Contact:

Raj Denhoy

415-828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What is the significance of the Motiva Flora launch for Establishment Labs (ESTA)?

The Motiva Flora launch represents a major advancement in breast reconstruction technology, expected to capture significant market share in Europe.

When was the Motiva Flora tissue expander officially launched?

The Motiva Flora tissue expander was officially launched on September 2, 2021.

Is the Motiva Flora tissue expander approved for use in the U.S.?

No, the Motiva Flora tissue expander is currently not approved for commercial distribution in the United States.