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

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.

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