Establishment Labs Notes Publication of Mia Femtech 3-Year Prospective Study Results in Aesthetic Surgery Journal
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, noted the publication of "The 3-Year Results of a 100-Patient Prospective Study of Safety and Effectiveness of Mia Femtech" in the Aesthetic Surgery Journal.
The study showed a very low rate of complications, with no reports of capsular contracture (Baker Grade III/IV), implant rupture (including a 33-patient MRI cohort), nipple or breast sensitivity loss, incision-related complications, infection, seroma, rippling, hematoma, or BIA-ALCL; the reoperation rate at 3 years was 1%. Patient and surgeon satisfaction was high, with patients reporting an 87% increase in breast satisfaction at 3 years and 90% of surgeons ‘very satisfied' with their overall experience and none ‘dissatisfied'. Patient follow-up was 93%. The manuscript can be accessed on the Aesthetic Surgery Journal website.
"Breast tissue preservation made possible by our minimally invasive platform is the future of breast augmentation," said Peter Caldini, Establishment Labs' Chief Executive Officer. "We expect our minimally invasive platform will generate at least $30 million in revenue in 2026, and it is accelerating TAM expansion on both a dollar and procedure basis. We continue to increase market share in our traditional breast implant business as well as create a new market for women interested in a procedure that offers real differentiation from standard breast augmentation."
Mia Femtech® and Preservé® comprise Establishment Labs' minimally invasive platform. The breast tissue-preserving procedures can be done without the need for general anesthesia1 and offer fast recovery*. Mia Femtech utilizes patented tools and technologies, including the Motiva Ergonomix2 Diamond® implant — the first and only injectable and biocompatible implant2 — and delivers natural results with no visible scars on the breast. Preservé uses many of the advances pioneered with Mia, but can be used in a wider cross section of cases and allows for larger sizes.
"This study has tremendous implications for patients and the market. Not only are the outcomes outstanding, but the high follow-up rate gives us the highest confidence in the data," added Steven Teitelbaum, MD, FACS, Associate Clinical Professor of Plastic Surgery at the UCLA School of Medicine and in private practice in Santa Monica, California. "I have been talking about preserving breast tissue through precise surgery for years, and the Establishment Labs' method takes that principle to an even higher level, with the lowest-ever complication rate and natural outcomes. Patients are talking about it and are coming into my office specifically asking for it. In 30 years of practice, I've never seen this kind of demand for anything. With the smaller incision, reduced anesthesia, faster recovery — and the Motiva implants themselves — this innovation is already interesting a whole new group of patients in breast augmentation."
Mia Femtech and Ergonomix2 Diamond implants are available in international markets but are not cleared for sale in the United States; Preservé is available in international markets, including in limited release in the United States.
* As compared to traditional breast augmentation.
1. Establishment Labs, CLINR-001035. Fifth progress report for Minimally Invasive Breast Augmentation Traditional Feasibility Study (CLINP-001007). Data on file.
2. Establishment Labs. DDD-006: Device Description Document for MotivaImplants®Ergonomix2®. December 2023. Data on file.
Important Safety Information
The Motiva SmoothSilk® Round and SmoothSilk Ergonomix® Silicone Gel Breast Implants are indicated for breast augmentation for women of at least 22 years old. Breast augmentation includes primary breast surgery to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation). Breast Implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have not received sufficient treatment for those conditions, or who are currently pregnant or nursing. Adequate studies have not been performed to confirm the safety of breast implant surgery in women with these conditions or under these circumstances; therefore, if you have any of the conditions or circumstances listed above, breast augmentation surgery with implants should not be performed at this time. Failure to take into consideration these contraindications may increase the risks involved with breast implant surgery and have the potential to cause harm. Patients should be advised that key complications have historically been associated with silicone gel breast surgery and implantation of silicone gel breast implants including, but not limited to, capsular contracture, implant removal, reoperation, infection, and rupture. Further, breast implants are not lifetime devices and patients should visit their healthcare professional, as recommended. For more detailed information about the benefits and risks of Motiva SmoothSilk® Round and SmoothSilk Ergonomix® Silicone Gel Breast Implants, please visit: www.motivausa.com or call Motiva at 1-800-924-5072.
The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Motiva USA.
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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