Establishment Labs Holdings Inc. (NASDAQ:ESTA), a global medical technology company dedicated to improving women's health and wellness in breast aesthetics and reconstruction, announced it has launched Preservé™ in Brazil, the first country in its global rollout. Preservé is the second product in the Company's minimally invasive platform, building upon the technologies and techniques developed with Mia Femtech®, Establishment Labs' minimally invasive experience.
"These are not small innovations, this is an entirely new era for aesthetic breast surgery," said Juan José Chacón-Quirós, Founder and CEO of Establishment Labs. "Whereas Mia® made minimally invasive breast aesthetics possible for women looking for a one to two cup enhancement, Preservé allows less invasive breast surgery for the day-to-day breast augmentation patient."
"Historically, many women have not been convinced by traditional methods and legacy techniques," Mr. Chacón-Quirós continued. "With Mia and Preservé, we have solutions that address these concerns. The technology platform of breast tissue preservation allows plastic surgeons to create natural results with less disruption of the patient's breast tissue. By improving safety profiles, recovery times, and achieving the breast aesthetic patients are looking for, breast augmentation may now be possible for women that otherwise never would have considered it — as well as making the decision easier for many who were already considering. After Brazil, Preservé will rollout globally over the next few years, and this should contribute to top line growth and profitability."
Preservé was designed to preserve breast tissue during aesthetic breast surgery, maintaining the structural anatomy and function of the breast for more stable and natural outcomes when compared to traditional breast augmentation. Preservé leverages Establishment Labs' proprietary minimally invasive surgical tools coupled with the Ergonomix2 implants, which feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and softness, and which are unique in the industry as their shape adapts as the body changes position. Preservé is intended for primary augmentations up to four cups, hybrid augmentations, and mastopexy augmentations.
"Breast tissue preservation is a new paradigm in breast aesthetics. With less invasive breast procedures made possible by technology pioneered by Establishment Labs, we can address many of the complications that lead to reoperations," said Dr Kamakshi Zeidler, San Francisco plastic surgeon and head of the Femtech board of Establishment Labs. "Preservé is an incredible new choice for women considering breast augmentation because it speaks to many of their aspirations, including smaller scars, quicker recovery, maintaining breast sensation, and avoiding unnecessary reoperations."
The commercial launch of Preservé took place last weekend at the Brazilian Breast Meeting in Rio de Janeiro with over 300 surgeons in attendance and included live surgery and academic sessions. This year additional launches of Preservé are planned around the world.
The medical devices used in Preservé are not yet approved for commercial distribution in the United States.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women's health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The Company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 90 countries. With over four million Motiva ® devices delivered to plastic and reconstructive surgeons since 2010, the Company's products have created a new standard for safety and patient satisfaction. The company's minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for breast augmentation, revision augmentation and mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company's first biosensor Zenº™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patents applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com.
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