Establishment Labs Presents New Breast Tissue Preservation Data and Expands Minimally Invasive Platform at WSEI
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on advancing women’s health and wellness, particularly in breast aesthetics and reconstruction, has announced new clinical and scientific findings supporting its Breast Tissue Preservation approach and Minimally Invasive Platform. The company also revealed product line extensions for its Mia® and Preservé™ platforms, including new sizes and additional supporting tools designed to expand the range of patients who may be considered for minimally invasive breast procedures.
The announcements were made during the 11th World Symposium on Ergonomic Implants (WSEI), held in Istanbul, Turkey. The international scientific meeting brought together more than 1,000 plastic surgeons representing 57 countries and featured 127 individual scientific presentations and educational sessions.
The program focused on developments across breast aesthetics, breast reconstruction, minimally invasive surgical techniques and the science surrounding preservation of breast tissue. Establishment Labs used the meeting to highlight clinical evidence supporting its approach and to present research intended to further establish the scientific foundations of Breast Tissue Preservation.
A major component of the scientific program was the recently published Breast Tissue Preservation Building Blocks Supplement in the Aesthetic Surgery Journal (ASJ). The peer-reviewed supplement represents a multidisciplinary effort involving more than 25 authors from around the world, including board-certified plastic and reconstructive surgeons, anatomists, pathologists and researchers affiliated with leading academic and surgical institutions.
The publication brings together research addressing breast anatomy, tissue preservation principles and the scientific rationale behind minimally invasive approaches. It also includes early- and mid-term clinical findings related to Establishment Labs’ Minimally Invasive Platform, including the first published U.S. multicenter clinical experience involving Preservé.
Advancing Breast Tissue Preservation
Breast Tissue Preservation is centered on approaches intended to maintain breast anatomy and minimize disruption to surrounding tissues during procedures. Establishment Labs said the scientific work presented at WSEI is designed to contribute to a standardized framework for surgeons interested in techniques that reduce tissue disruption while pursuing breast augmentation and related procedures.
The company described the publication as an important multidisciplinary effort bringing together anatomical, scientific and clinical perspectives. Rather than focusing solely on implant technology, the research examines the broader surgical principles that may support tissue-preserving procedures.
The Breast Tissue Preservation supplement addresses the underlying anatomy and scientific rationale required to develop minimally invasive approaches. It also incorporates clinical experience designed to help characterize how these techniques are being applied in practice.
The research is particularly relevant as minimally invasive approaches continue to receive attention within aesthetic and reconstructive breast surgery. Establishment Labs is positioning its Minimally Invasive Platform as part of a broader effort to provide surgeons with additional options for performing breast procedures while seeking to preserve native tissue structures.
Dr. Troy Pittman, a board-certified plastic surgeon and author involved in the publication, emphasized the importance of developing evidence and standardized principles as Breast Tissue Preservation continues to evolve.
According to Pittman, the emergence of tissue preservation as an academic and commercial area requires data, standardization and scientific validation. He described the publication as a foundation for the continued development of breast augmentation and said Preservé and the principles underlying Breast Tissue Preservation have influenced his clinical practice and approach to surgery.
New Data on the Minimally Invasive Platform
During WSEI, lead authors of the research presented findings from the Breast Tissue Preservation supplement, covering topics ranging from breast anatomy to the scientific basis for preserving tissue during surgical procedures.
The presentations also included early- and mid-term clinical data from Establishment Labs’ Minimally Invasive Platform. A key component was a review of the first published U.S. multicenter clinical experience with Preservé.
The presentation of multicenter experience provides additional clinical context for the use of the Preservé platform across multiple surgical settings. Multicenter clinical experience can also contribute to the broader understanding of how new surgical technologies and approaches perform across different patient populations and clinical environments.
Establishment Labs said the WSEI presentations collectively reinforce the scientific and clinical framework surrounding its minimally invasive technologies.
The company is developing the platform around the concept that breast augmentation and other breast procedures can potentially be performed through approaches designed to minimize tissue disruption. The scientific publications and clinical experience presented at the symposium are intended to support further understanding of these techniques.
Mia and Preservé Product Extensions
In addition to presenting scientific and clinical data, Establishment Labs announced extensions to both its Mia® and Preservé™ product lines.
The expanded product offerings include new sizes and supporting tools. According to the company, these additions are intended to broaden the applicability of the Minimally Invasive Platform and enable more patients to potentially be considered for minimally invasive breast augmentation.
The expansion follows what Establishment Labs described as growing momentum for its minimally invasive approach. The company said the introduction of additional sizes is part of a broader strategy to expand the platform and increase the range of available options for surgeons.
Peter Caldini, Chief Executive Officer of Establishment Labs, said the company’s experience with the Minimally Invasive Platform has accelerated plans to introduce additional sizes and broaden its minimally invasive portfolio.
Caldini also pointed to growth in the broader breast augmentation market. He referenced recent data from the American Society of Plastic Surgeons showing that the augmentation market had accelerated by 11%, describing the figure as an indication of continued market activity and the potential impact of new technologies and approaches.
The company is continuing to work on additional product launches as it expands its minimally invasive portfolio.
WSEI Highlights International Interest in Breast Surgery Innovation
The 11th WSEI provided an international setting for Establishment Labs to present its latest developments alongside a broad scientific and educational program.
With more than 1,000 plastic surgeons attending from 57 countries, the symposium represented a substantial international gathering of specialists working across breast aesthetics, reconstruction and implant-based procedures.
The 127 scientific presentations and educational sessions covered advances in breast surgery and related fields, providing a platform for discussions about surgical techniques, implant technology and the evolving science of breast tissue preservation.
For Establishment Labs, participation at the event provided an opportunity to connect the development of its products with a wider body of anatomical and clinical research.
The company emphasized that Breast Tissue Preservation is not simply a product-specific concept but a multidisciplinary approach that draws upon anatomy, surgical technique, pathology and clinical evidence. The Aesthetic Surgery Journal supplement reflects this approach by bringing together contributors from multiple specialties and institutions.
Building a Scientific Framework for Minimally Invasive Procedures
One of the central themes emerging from the research is the need for standardized scientific principles as minimally invasive breast procedures develop.
The Breast Tissue Preservation Building Blocks Supplement seeks to establish such a framework by examining the anatomical and scientific foundations behind techniques intended to preserve breast tissue.
For surgeons, a standardized framework can provide a common basis for evaluating new techniques, understanding anatomical considerations and assessing clinical outcomes. Establishment Labs said the research is intended to provide surgeons with scientific resources that can support the application of tissue-preserving approaches.
The early- and mid-term clinical data presented at WSEI add a clinical component to the anatomical and scientific work. The inclusion of the first published U.S. multicenter clinical experience with Preservé further expands the published evidence base surrounding the platform.
The combination of peer-reviewed research and clinical experience represents an important part of Establishment Labs’ strategy as the company continues developing its minimally invasive technologies.
Expanding Options for Patients and Surgeons
The new product extensions for Mia and Preservé are expected to broaden the range of options available through Establishment Labs’ Minimally Invasive Platform. The addition of new sizes and supporting tools is intended to help surgeons consider the approach across a wider range of patient needs.
The company said it is continuing to develop additional products as it seeks to expand its minimally invasive portfolio.
At the same time, the scientific research presented at WSEI reflects a broader effort to establish evidence around Breast Tissue Preservation. Establishment Labs’ strategy combines product development with anatomical research, peer-reviewed publications and clinical data.
As the field of breast aesthetics and reconstruction continues to evolve, minimally invasive techniques and tissue preservation are receiving increasing attention from surgeons and researchers. Establishment Labs is seeking to contribute to this evolution through its Mia and Preservé platforms while expanding the supporting evidence base.
The company’s announcements at WSEI therefore encompass both product development and scientific research. New sizes and tools for Mia and Preservé are intended to broaden the platform’s potential use, while the Breast Tissue Preservation supplement provides a multidisciplinary foundation for understanding the anatomical and clinical principles behind minimally invasive breast procedures.
With further product launches planned and additional clinical experience emerging, Establishment Labs is continuing to develop its Minimally Invasive Platform alongside the broader scientific work supporting Breast Tissue Preservation. The company said the combination of new technologies, peer-reviewed research and clinical evidence will remain central to its efforts to expand minimally invasive options in breast aesthetics and reconstruction.
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 100 countries. With five 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 primary breast augmentation and primary 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 Zen™, currently part of an IRB approved pivotal study to measure core breast temperature.
These solutions are supported by over 200 patent 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.