Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction

Key Terms

u.s. food and drug administration (fda) regulatory

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

ide study regulatory

An IDE study is a regulated clinical trial that allows a medical device to be tested in people under an Investigational Device Exemption from the U.S. Food and Drug Administration, so firms can gather safety and effectiveness data before full market approval. For investors, an IDE study is like a controlled test drive and safety inspection: positive results move a device closer to commercial sales and can boost a company’s value, while setbacks can sharply reduce its prospects.

mri-conditional medical

A device labeled "MRI-conditional" means it can be exposed to magnetic resonance imaging only under specific, tested conditions (such as certain magnet strength, body location, or scan settings). For investors, this matters because it affects how widely the device can be used, the size of its market, and potential liability: a broader, well-documented MRI-conditional claim is like a product rated safe for more weather conditions, making it more attractive to hospitals and patients.

tissue expander medical

A tissue expander is a temporary medical implant, often like a small balloon placed under the skin and gradually filled with fluid to gently stretch tissue and create extra space for later reconstructive surgery. Investors track them because their approval status, safety record, manufacturing supply and insurance reimbursement directly affect a medical device maker’s sales, regulatory risk and potential legal exposure — factors that influence a company’s revenue and valuation.

radio-frequency technology technical

Radio-frequency technology uses invisible radio waves to send, receive, or heat energy for communication, sensing, or medical and industrial procedures — think of it as sending ripples through the air or tissue to carry signals or produce controlled effects. Investors watch it because its performance, regulatory approvals, patents and compatibility with standards determine product adoption, recurring revenue and competitive advantage, much like a highway that enables new businesses to reach customers.

rfid technology technical

RFID technology uses tiny tags and radio signals to identify and track items without needing a direct line of sight, like an electronic name tag that can be read from a short distance. It matters to investors because it can cut inventory errors and theft, speed up logistics, and provide real-time data that boosts efficiency and reduces costs—factors that can improve revenue, margins, and competitive advantage.

iso13485:2016 regulatory

ISO 13485:2016 is an international standard that specifies what a company must do to manage quality for medical devices and related services — think of it as a detailed recipe and checklist to make sure devices are designed, made and controlled consistently and safely. For investors, certification signals lower regulatory and operational risk, smoother market access and a reduced chance of costly recalls or compliance fines, which can protect revenue and company value.

fda 21 cfr 820 regulatory

FDA 21 CFR 820 is the U.S. regulatory rule that sets required quality-management practices for medical device makers, covering design, manufacturing, testing, record-keeping and corrective actions. For investors it matters because compliance is like a building code for devices: it affects a maker’s ability to sell products, avoid recalls or fines, and predict manufacturing costs and reliability, all of which influence revenue risk and company valuation.

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NEW YORK--(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, today announced that it has submitted Motiva^® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on September 27, 2024.

“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” said Jeff Ehrhardt, Senior Vice President and Establishment Labs’ General Manager of North America. “Breast reconstruction has seen little innovation for more than a decade, despite these patients often needing improved and more advanced technology. This milestone brings us closer to offering the benefits of Motiva to women after mastectomy, providing the same proven technology that has seen rapid adoption in breast augmentation.”

The Motiva U.S. IDE Study was conducted at 17 centers in the U.S. and one center in Western Europe and included 274 post-mastectomy reconstruction patients, including 220 primary and 54 revision patients. Motiva^® SmoothSilk^® Round and Ergonomix^® Implants represent state-of-the-art innovation in plastic surgery. These devices feature the patented SmoothSilk^® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva^® SmoothSilk Ergonomix^® device is the first breast implant in the world that embodies the science of ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva^® SmoothSilk^® Ergonomix^® implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva^® SmoothSilk^® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position. Since approval for breast augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.

“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” said Mark Clemens, MD, MBA, FACS, and Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center. “While surgical techniques have advanced significantly, innovation in reconstructive devices has been more gradual, making technologies that address real clinical limitations especially important. In my experience, the ability to safely image patients with MRI during the expansion process and to improve precision during radiation planning has made MRI-conditional tissue expanders, like Motiva Flora, a valuable addition to reconstructive care. The availability of a reconstruction indication for Motiva implants expands our options further, allowing surgeons to thoughtfully incorporate device characteristics such as unique surface design and clinical performance data into individualized reconstructive planning.”

The Motiva Flora^® tissue expander was cleared for use in the United States in 2023 and is in use at over 200 cancer centers for breast reconstruction following breast cancer. Flora is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional.

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 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 ISO13485:2016 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20251229658937/en/

Investor/Media Contact:
Raj Denhoy
415 828-1044
rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.