Establishment Labs Holdings Inc. operates as a medical technology company.
The company focuses on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. The company’s line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of its medical technology platform. The company’s post-market surveillance data (which was not generated in connection with a United States Food and Drug Administration, or FDA, pre-ma...
Establishment Labs Holdings Inc. operates as a medical technology company.
The company focuses on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. The company’s line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of its medical technology platform. The company’s post-market surveillance data (which was not generated in connection with a United States Food and Drug Administration, or FDA, pre-market approval, or PMA, study collected at defined follow-ups, but was patient or practitioner reported) and published third-party registries and data indicate that Motiva Implants has low rates of adverse events (including rupture, capsular contracture, and safety related reoperations) that compare favorably with those of its competitors.
As of December 31, 2024, the company’s Motiva Implants are registered to be sold in 94 countries, including, most recently, in the United States. The company sells its products via exclusive distributors or the company’s direct sales force and has introduced five generations of Motiva Implants. The company commercially sells five product families: Round and Ergonomix Round, Ergonomix Oval, Anatomical TrueFixation, Ergonomix2 Round and Ergonomix2 Diamond and Flora Tissue Expander. The company’s products incorporate first of-its-kind safety features including SmoothSilk / SilkSurface (an optimized biocompatible advanced smooth surface that is designed to reduce capsular contracture), Qid RFID technology and ZEN (a non-invasive, electronically readable serial number that enables product identification and enhances safety and patient peace of mind), BluSeal visual barrier layer (a proprietary indicator that allows for verification of complete barrier layer presence) and TrueMonobloc gel-shell-patch configuration (a highly durable, easy-to-insert performance shell, gel and patch system that allows for smaller incisions and smaller scars).
In September 2024, the company received FDA approval to sell Motiva Implants in the United States.
In February 2025, the company launched Preserve, a minimally invasive breast tissue-preserving technology for breast augmentation, revision augmentation and mastopexy augmentation.
In September 2024, the company received pre-market approval (PMA) approval from the United States Food and Drug Administration (FDA) for its Motiva Implants.
In January 2024, the company announced the commercial launch of Motiva Implants in China and the completion of the first procedure with the Motiva Flora SmoothSilk Tissue Expander in the United States.
Strategy
The key elements of the company's strategy are to expand revenues in existing markets; optimize patient conversion through sales and marketing programs; and seek out and pursue strategic acquisitions.
Products and Technologies
The Motiva breast implants are a Class III Medical Device indicated for breast augmentation and breast reconstruction, including revision surgeries to correct or improve the result of a previous breast implant surgery. The company launched Motiva Implants commercially in October 2010, and as of December 31, 2024, it has sold close to 4 million units. The company’s latest generation of Motiva Implants utilizes its proprietary Gravity Sensitive Ergonomix design, with a round base implant that responds to gravity by shifting its maximum point of projection, offering the more ‘natural’ projection of a shaped implant without the malposition and rotation issues frequently associated with shaped implants. The company’s catalog includes over 1,000 product variations, with round, oval and anatomical shapes, two different surfaces, SmoothSilk and VelvetSurface, and volumes ranging from 95cc to 1060cc, resulting in a wider range of options than those offered by its major competitors.
Ergonomix2 incorporates the latest innovations, including the company’s most advanced ultra-high purity chemistries for enhanced device safety mechanical properties and improved patient ergonomics. Ergonomix2 also features the company’s patented SmoothSilk surface technology, which is the basis of Motiva Implants’ low inflammatory characteristics that has contributed to the lowest capsular contracture rates in the industry. Ergonomix2 was CE marked in December 2020 and labeled for use in both aesthetic and reconstruction procedures.
Shell Surface: SmoothSilk
The surface topography of the breast implant shell surface varies between commercially available breast implants. The company’s SmoothSilk surface on all Motiva Implants was designed to reduce the inflammatory process caused by the immune response, enhancing product biocompatibility. The controlled manufacturing process provides the same surface topography around the entire implant for the benefit of patients.
The company's retrospective implant data shows that Motiva Implants has a lower rate of capsular contracture and seromas when compared to published data from competitors. The company’s proprietary shell surfaces have an average roughness of 4 microns and exhibit more regular surface features than those of its primary competitors, based on several studies using methods such as scanning electron microscopy, profilometry testing, and statistical parameters comparisons.
ProgressiveGel Family
The proprietary silicone chemistries that consist of the company’s ProgressiveGel family allow for a high degree of viscoelasticity and strength but add characteristics such as softness and high ductility that enable movement dynamics more like that of natural breast tissue.
In addition to the anticipated safety advantages, the company’s ProgressiveGel family provides for movement characteristics that resemble natural breast tissue. The company’s later generation Ergonomix products further mimic natural tissue, with a maximum point of projection that shifts lower to create a natural human breast shape when a patient is standing. This allows the company’s Motiva Implants to provide the more natural aesthetics of ‘shaped’ or ‘teardrop’ implants without the risk of associated drawbacks such as breast deformation from rotation and unnaturally hard tactile feel.
TrueMonobloc
The company’s TrueMonobloc technology, which is incorporated into all generations of Motiva Implants sold, combines proprietary chemistry with its proprietary manufacturing techniques to create a shell, gel and other components that are tightly bound to one another. This results in an implant that is more homogeneously elastic and resistant to separation of the gel from the shell, addressing one type of implant failure that can lead to shell ruptures and silicone leaks. This also enables Motiva Implants to be stretched and squeezed to a more significant degree, which enables breast augmentation through incision sizes smaller than one inch, compared with the published industry norm of approximately two inches. A surgical technique that the company has developed, which it calls Minimally Invasive Aesthetics, or Mia Femtech, utilizes the company’s next-generation Ergonomix2 Diamond implant to take advantage of these physical properties to enable a less-invasive procedure for the patient.
Radio-Frequency Identification Platform (RFID) Technology
The company offers a Radio-Frequency Identification Device microtransponder (also referred to as Qid, or the latest generation, ZEN) that is placed in the filling gel as an optional feature for all implant styles. This microtransponder provides each device with a unique electronic serial number for traceability purposes.
The microtransponder contains only a unique 15-digit code that identifies the product and does not contain any patient information. This microtransponder can be read with a simple pass from the company’s non-invasive and inexpensive reading device, the Qid Safety Technology Reader, and the serial number corresponds with related information in its MotivaImagine database such as implant type, size and other characteristics. Patients can create a secure account, register the products and include applicable patient information either through the MotivaImagine application or the company’s website, to access their implant information. The MotivaImagine application and Motiva Implants website also allow the patient to access the implant warranty information. This traceability is intended to give patients comfort that any future recalls can be positively identified as applying, or not applying, to that patient’s particular implant. This addresses a key concern that often discourages women who are otherwise interested in implants from making the choice to move forward with the surgery. Motiva Implants are the only breast implants on the international market with Qid Safety Technology.
Each implant’s unique electronic serial number is encoded into the RFID circuitry as part of a three-point authentication system: the microtransponder, the reader and the database. This authentication system prevents unauthorized access to any personal information of the patient and is compliant with FDA regulations.
In October 2023, the company announced Zen, which is part of its next generation Zensor RFID platform. The new Zen technology has all the previous benefits of Qid but is entirely non-ferromagnetic. In 2023, the Motiva Ergonomix2 Diamond implants used in the Mia Femtech system feature Zen and are available in select geographies with Motiva Ergonomix2 Round Implants in programs like the JOY program.
BluSeal
The Motiva Implant shell is constructed of successive layers of silicone elastomer and a low diffusion barrier layer. The key function of the low diffusion barrier layer is to prevent diffusion of low molecular weight siloxane species from the implant to the tissues. This barrier layer embeds the company’s BluSeal indicator technology, which is a key feature used during the manufacturing process to verify that the barrier is present in a uniform way around the entire shell. It is also used as a visual quality control and safety measure to minimize potential gel diffusion. This patented manufacturing innovation is intended to highlight any imperfections in the barrier layer coverage with a distinct color. The company’s BluSeal indicator technology also provides the plastic surgeon with the ability to verify whether the barrier layer has coverage defects or other imperfections before implantation that might lead to post- implantation shell rupture or gel bleed.
Motiva Flora Tissue Expander
The Motiva Flora Tissue Expander is used in breast reconstruction surgery for temporary implantation (less than six months) to gradually expand the breast tissue prior to the placement of a long-term breast implant. After implantation, the device is periodically filled with saline solution via an injection port to increase its volume to stretch the skin and create a pocket for breast implant placement. The injection port is dome-shaped and includes an RFID coil, which can be accurately located utilizing the port locator. The Motiva Flora Tissue Expander is the first MRI Conditional expander and is the only tissue expander in the market with an integrated RFID port with no magnets, allowing for use of the expander safely alongside MRI (1.5 and 3 Tesla) scanning. The Motiva Flora received CE mark in June 2020 and 510(k) clearance from the FDA in October 2023 and has been registered in 70 countries. The company’s catalog includes 15 variations, including three different heights, and a range of volumes from 260 to 995 cc.
Minimally Invasive Aesthetics: Preserve and Mia Femtech
In February 2025, the company introduced Preserve, a minimally invasive breast tissue-preserving technology designed for breast augmentation, revision augmentation, and mastopexy augmentation. This innovative solution aims to maintain the structural anatomy and function of the breast during aesthetic surgery, resulting in more stable and natural outcomes compared to traditional methods. Preserve utilizes the company’s proprietary minimally invasive surgical tools along with Ergonomix2 implants, which feature the patented SmoothSilk surface for improved biocompatibility and softness. These implants are unique in the industry, adapting their shape as the body changes position. Preserve is suitable for primary augmentations of up to four cups, hybrid augmentations, and mastopexy augmentations. The initial commercial launch occurred in Brazil, with further launches anticipated in other countries throughout 2025.
In April 2023, the company launched Mia Femtech — a patient centric procedure designed to allow breast augmentation to be performed under local anesthesia rather than general anesthesia, through smaller incisions, with faster recovery times and a resulting reduction in surgical complications. The Mia Femtech system includes the specially designed Ergonomix2 Diamond implant, which received CE mark in December 2020, and its proprietary tools, including the Motiva Inflatable Balloon and the Motiva Injector.
In December 2020, the company received a CE mark for its Motiva Ergonomix2 Diamond breast implant, the implant used in the Mia Femtech procedure. In early 2021, it completed enrollment in its one hundred patient Mia Femtech case series in Costa Rica. In October 2024, the company published the three-year results of the Motiva Femtech Clinical Study. The study, which had a three-year follow-up compliance rate of 93%, found no reports of capsular contracture (Baker Grade III/IV), ruptures (suspected or confirmed), bleeding, hematoma, or seroma requiring intervention in the study.
The company offers Mia Femtech in multiple countries across the world with plastic surgeons fully certified to provide the Mia experience.
Clinical Data
14-Year Safety Post-Market Surveillance Data
Dating from the commercial launch of Motiva Implants in October 2010 through December 2024, the company has sold close to 4 million breast implants in various countries. The company maintains a Quality Management System database to track and report complaints received from patients or physicians. From October 2010 through December 2024, a total of 5,901 complaints has been reported, investigated and processed, representing approximately 0.1% of the total Motiva Implants sold through December 2024. There were no reported cases of double capsule formation or breast-implant associated anaplastic large-cell lymphoma, or BIA- ALCL, in this data set, and there were 81 cases of early seroma and 13 case of late seroma.
Independent Clinical Experience
Beginning in March of 2014, the company started supplying its products to Dolan Park under a series of long-term supply agreements with Dolan Park’s affiliated companies. The last supply agreement expired in July of 2019.
Study to Support a PMA
The company is conducting a prospective IDE clinical trial in the United States on its Motiva Round and Motiva Ergonomix Round product families. The company’s IDE submission was approved by the FDA on March 20, 2018, to perform a single open-label, prospective, multi-center trial, with follow-up visit data reported annually and at the time of filing. The company will continue to monitor patients for ten years post-implantation. The primary endpoints of the trial are safety, effectiveness and patient satisfaction. In general, the company’s trial design and patient enrollment are consistent with prior PMA studies conducted by Allergan, Mentor, and Sientra. In August 2019, the company announced that it was implementing a bifurcated regulatory strategy in the United States, which is designed to allow the company to initiate the rolling submission of data to the FDA from the primary augmentation and revision augmentation cohorts, and then subsequently supplement the company’s PMA with data from the reconstruction cohorts. All the enrollment procedures and the three-year study subject follow-up has been completed in the aesthetics cohort, which includes primary augmentation and revision augmentation, with total enrollment of 451 and 265 subjects, respectively. In the fourth quarter of 2021, the company initiated a modular PMA submission process with the FDA and submitted the first of four expected modules. In April 2022, the company released preliminary results of the two-year patient follow-up data for the primary augmentation cohort of its IDE clinical trial. The second module was submitted in May 2022. In June 2022, full enrollment of the IDE clinical trial was complete, and all surgeries in the primary reconstruction cohort were performed. In August 2022, the third module was submitted to the FDA. The final fourth module was submitted to the FDA in February 2023.
Sales and Marketing
The company primarily derives revenue from sales of its Motiva Implants from two types of customers: medical device distributors and direct sales to physicians, hospitals, and clinics. The company’s products are commercially available in 94 countries through exclusive distributors, except in the United States, Brazil, Argentina and several European countries where it sells through its direct sales force. As of December 31, 2024, the company’s sales organization included 282 employees and contractors. All these sales personnel are supported through a suite of tools, including marketing and training materials, mobile smartphone applications, and access to a robust schedule of physician education events.
Intellectual Property
As of December 31, 2024, the company owned or had rights to 33 issued, one allowed and 15 pending patents in the United States related to various aspects of its Motiva Implants (such as implant barrier layers, surface texture technology, minimally invasive implant delivery systems, minimally invasive and tissue preservation procedures and systems and the company’s Qid Safety Technology or ZEN radio frequency identification devices). In addition, the company owns or has rights to 161 issued, one allowed and 72 pending foreign applications and one pending Patent Cooperation Treaty, or PCT, applications. The company’s owned and licensed patents are expected to expire at various times between February 2025 and February 2039. The company’s owned and licensed pending applications, if granted, likely would expire between September 2033 and December 2044.
Research and Development
The company’s research and development expenses of $19.7 million for the year ended December 31, 2024.
Suppliers
The company obtains NuSil brand medical-grade silicone from Avantor, Inc., or Avantor, which is a sole-source supplier of such products to the majority of the silicone breast implant industry. In May 2022, the company entered into a master supply agreement with Avantor, which provides for specified prices per unit of each relevant component, has an initial term ending on December 31, 2026, and automatically renews for successive terms of one year each for up to five successive renewal terms. The agreement superseded and replaced the previous master supply agreement originally executed in 2016, as amended, that expired on May 13, 2022.
Regulation
While the company’s instruments are cleared as class II devices, breast implants are classified as Class III devices requiring an approved PMA for commercial distribution.
The company’s devices specifically, the FDA’s guidance document ‘Saline, Silicone Gel, and Alternative Breast Implants’ recommends that a core study, which can be a single, open label, multi-center study, be conducted with ten years or more of prospective patient follow-up.
The company’s clinical study sites are additionally subject to possible inspection by the FDA.
The company is subject to various laws governing the privacy and security of health information and other personally identifiable information. The Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, established comprehensive U.S. federal protection for the privacy and security of protected health information.
The company’s activities must also comply with other applicable privacy laws, including the EU General Data Protection Regulation, or EU GDPR, and the UK General Data Protection Regulation, or UK GDPR, or collectively, EU/UK GDPR.
The company is also subject to similar national or local laws and regulations, including, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to health care professionals.
The company is subject to applicable anti-corruption laws, such as the U.S. Foreign Corrupt Practices Act and the UK Bribery Act, and similar anti-corruption laws in the countries in which it distributes its products.
History
Establishment Labs Holdings Inc was founded in 2004. The company was incorporated in 2004.
