Establishment Labs Launches Preservé™
Establishment Labs Holdings Inc. (NASDAQ: ESTA) has launched Preservé™ in Brazil, marking the first country in its global rollout. Preservé is the company's second minimally invasive platform product, following Mia Femtech®. The technology is designed to preserve breast tissue during aesthetic breast surgery, maintaining structural anatomy and function for more natural outcomes compared to traditional augmentation.
Preservé combines proprietary minimally invasive surgical tools with Ergonomix2 implants featuring patented SmoothSilk® surface. It is intended for primary augmentations up to four cups, hybrid augmentations, and mastopexy augmentations. The launch took place at the Brazilian Breast Meeting in Rio de Janeiro with over 300 surgeons attending, featuring live surgery and academic sessions. Additional global launches are planned throughout the year, though the medical devices are not yet approved for commercial distribution in the United States.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) ha lanciato Preservé™ in Brasile, segnando il primo paese nel suo rollout globale. Preservé è il secondo prodotto della piattaforma minimamente invasiva dell'azienda, dopo Mia Femtech®. La tecnologia è progettata per preservare il tessuto mammario durante la chirurgia estetica del seno, mantenendo l'anatomia strutturale e la funzione per risultati più naturali rispetto all'aumento tradizionale.
Preservé combina strumenti chirurgici minimamente invasivi proprietari con impianti Ergonomix2 dotati di superficie brevettata SmoothSilk®. È destinato ad aumenti primari fino a quattro coppe, aumenti ibridi e aumenti di mastopessi. Il lancio si è svolto al Brazilian Breast Meeting a Rio de Janeiro con oltre 300 chirurghi presenti, che hanno assistito a interventi chirurgici dal vivo e sessioni accademiche. Ulteriori lanci globali sono previsti nel corso dell'anno, anche se i dispositivi medici non sono ancora approvati per la distribuzione commerciale negli Stati Uniti.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) ha lanzado Preservé™ en Brasil, marcando el primer país en su despliegue global. Preservé es el segundo producto de la plataforma mínimamente invasiva de la compañía, después de Mia Femtech®. La tecnología está diseñada para preservar el tejido mamario durante la cirugía estética de senos, manteniendo la anatomía estructural y la función para resultados más naturales en comparación con el aumento tradicional.
Preservé combina herramientas quirúrgicas mínimamente invasivas patentadas con implantes Ergonomix2 que cuentan con una superficie SmoothSilk® patentada. Está destinado a aumentos primarios de hasta cuatro copas, aumentos híbridos y aumentos de mastopexia. El lanzamiento tuvo lugar en el Brazilian Breast Meeting en Río de Janeiro, con más de 300 cirujanos presentes, con cirugía en vivo y sesiones académicas. Se prevén lanzamientos globales adicionales a lo largo del año, aunque los dispositivos médicos aún no están aprobados para distribución comercial en los Estados Unidos.
Establishment Labs Holdings Inc. (NASDAQ: ESTA)는 브라질에서 Preservé™를 출시하며 글로벌 롤아웃의 첫 번째 국가로 삼았습니다. Preservé는 Mia Femtech®에 이어 회사의 두 번째 최소 침습 플랫폼 제품입니다. 이 기술은 미용 유방 수술 중 유방 조직을 보존하도록 설계되어, 전통적인 확대술에 비해 보다 자연스러운 결과를 유지합니다.
Preservé는 독점적인 최소 침습 수술 도구와 특허받은 SmoothSilk® 표면을 가진 Ergonomix2 임플란트를 결합합니다. 이는 최대 네 컵까지의 1차 확대, 하이브리드 확대 및 유방 거상 수술에 사용됩니다. 이 출시는 리우데자네이루에서 열린 Brazilian Breast Meeting에서 이루어졌으며 300명 이상의 외과의사가 참석하여 라이브 수술과 학술 세션을 진행했습니다. 연중 추가적인 글로벌 출시가 계획되어 있지만, 의료 기기는 아직 미국에서 상업 배급 승인을 받지 못했습니다.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) a lancé Preservé™ au Brésil, marquant le premier pays de son déploiement mondial. Preservé est le deuxième produit de la plateforme peu invasive de l'entreprise, après Mia Femtech®. La technologie est conçue pour préserver le tissu mammaire lors de la chirurgie esthétique du sein, maintenant l'anatomie structurelle et la fonction pour des résultats plus naturels par rapport à l'augmentation traditionnelle.
Preservé combine des outils chirurgicaux peu invasifs propriétaires avec des implants Ergonomix2 dotés d'une surface SmoothSilk® brevetée. Il est destiné aux augmentations primaires allant jusqu'à quatre tasses, aux augmentations hybrides et aux augmentations de mastopexie. Le lancement a eu lieu lors du Brazilian Breast Meeting à Rio de Janeiro, avec plus de 300 chirurgiens présents, présentant des interventions chirurgicales en direct et des sessions académiques. D'autres lancements mondiaux sont prévus tout au long de l'année, bien que les dispositifs médicaux ne soient pas encore approuvés pour la distribution commerciale aux États-Unis.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) hat Preservé™ in Brasilien eingeführt, was das erste Land in ihrem globalen Rollout markiert. Preservé ist das zweite minimalinvasive Plattformprodukt des Unternehmens, nach Mia Femtech®. Die Technologie ist darauf ausgelegt, Brustgewebe während ästhetischer Brustoperationen zu erhalten, wodurch die strukturelle Anatomie und Funktion für natürlichere Ergebnisse im Vergleich zur traditionellen Vergrößerung beibehalten wird.
Preservé kombiniert proprietäre minimalinvasive chirurgische Werkzeuge mit Ergonomix2-Implantaten, die über eine patentierte SmoothSilk®-Oberfläche verfügen. Es ist für primäre Vergrößerungen von bis zu vier Tassen, hybride Vergrößerungen und Mastopexie-Vergrößerungen gedacht. Der Launch fand beim Brazilian Breast Meeting in Rio de Janeiro statt, an dem über 300 Chirurgen teilnahmen, und beinhaltete Live-Operationen und akademische Sitzungen. Weitere globale Einführungen sind im Laufe des Jahres geplant, obwohl die medizinischen Geräte in den Vereinigten Staaten noch nicht für den kommerziellen Vertrieb zugelassen sind.
- Launch of new product Preservé™ in Brazil, expanding the company's minimally invasive platform
- Technology addresses complications that lead to reoperations, potentially reducing future costs
- Product expected to contribute to top line growth and profitability
- Strong initial market reception with 300 surgeons attending launch event
- Medical devices not yet approved for U.S. commercial distribution, limiting market potential
- Multi-year global rollout timeline suggests delayed revenue recognition
Insights
The launch of Preservé in Brazil represents a strategic milestone for Establishment Labs, introducing a paradigm shift in breast augmentation technology. The Brazilian market, being the second-largest for cosmetic procedures globally, provides an ideal launch platform with significant revenue potential.
The technology's key differentiator lies in its tissue preservation approach, which addresses several critical market needs:
- Reduced tissue disruption and potentially lower reoperation rates, which typically range from
10-20% in traditional procedures - Smaller incisions and faster recovery times, expanding the addressable market to patients previously hesitant about traditional procedures
- Integration with their proprietary Ergonomix2 implants, creating a comprehensive solution that could command premium pricing
The commercial strategy appears well-executed, with the launch event attracting over 300 surgeons and including live surgery demonstrations - important for driving early adoption in the aesthetic surgery community. The planned global rollout over the next few years suggests a measured approach to market expansion, likely prioritizing key markets where regulatory pathways are most favorable.
The technology's potential to reduce complications and reoperations could significantly impact the economics of breast augmentation practices. Lower complication rates typically translate to higher surgeon satisfaction, better patient outcomes, and stronger practice economics. This could drive faster market adoption, particularly among high-volume surgeons seeking to differentiate their practices.
While the U.S. market remains pending regulatory approval, the international rollout provides valuable real-world evidence and surgical experience that could support future FDA submissions. The company's extensive intellectual property portfolio, with over 200 patent applications across 20 families, suggests strong barriers to competition and potential licensing opportunities.
“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
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,
The commercial launch of Preservé took place last weekend at the Brazilian Breast Meeting in
The medical devices used in Preservé are not yet approved for commercial distribution in
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250218369358/en/
Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com
Source: Establishment Labs Holdings Inc.
FAQ
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