ESTA Establishment Labs Holdings Inc

The campaign is the first-of-its-kind partnership and follows the US FDA approval of Motiva Implants^® 

NEW YORK, March 6, 2025 /PRNewswire/ -- 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 a partnership with GRAMMY Award-winning hitmaker Meghan Trainor. Meghan recently received Motiva Implants^® after careful consideration and research.

"Self-confidence and body positivity are so important to me. After losing a bunch of weight and having two kids, I have always struggled loving my breasts because they were never even. I've been dreaming about getting this done for so many years. Once I learned about the recent FDA approval of Motiva Implants^®, I knew this was the perfect time for me," Meghan shared. "I did my research, consulted with several plastic surgeons, and chose Motiva Implants^® because they offered the look, the smooth silk feel, and the safety I was looking for. There is just such a difference with these new generation implants. I'm absolutely in love with the results — they feel so soft and natural and I'm more confident than ever. I can't wait to get back on stage with so many new outfit choices."

Motiva Implants^® represent state-of-the-art innovation in plastic surgery. These implants, available to patients in the US since October 2024, feature the patented SmoothSilk^® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation¹. This surface not only helps the tissue around the implant to stay soft¹, but also has led to an industry low 0.5% capsular contracture rate². Motiva SmoothSilk Ergonomix^® implants are unique as their shape adapts as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up^3,4,5. Motiva SmoothSilk^® Round implants provide increased upper breast fullness and softness^3,4,6 while keeping a round full form regardless of position. Both the Motiva SmoothSilk Ergonomix^® and the Motiva SmoothSilk^® Round implants were designed to provide the look and natural feel women want with the safety profile they deserve. Motiva^® devices, through FDA clinical studies, have reported less than 1% device related complications², and above 97% patient and surgeon satisfaction rates⁷. 

"We could not be more thrilled to partner with Meghan Trainor, an artist who echoes the sentiments we hear from millions of women around the world who choose Motiva^® for their breast augmentation," commented Juan José Chacón-Quirós, Founder of Establishment Labs. "It is an exciting time for the organization as we are finally able to bring Motiva^® to women in the United States. These implants were designed to ensure women's health and well-being. Motiva^® enables plastic surgeons to perform the surgeries they want and women to get the results they deserve. This is real innovation leading to better patient outcomes. Top plastic surgeons around the US are adopting Motiva Implants^® rapidly, and many women, like Meghan, are choosing and embracing both the technology and the natural results."

Since first becoming commercially available in 2010, over four million Motiva^® devices have been delivered to plastic and reconstructive surgeons in over 90 countries globally⁸. The company's technologies and products are covered by over 200 patent applications in 20 separate patent families worldwide and are supported by over 100 clinical and scientific studies and peer reviewed publications⁹.

"When Meghan came to me, I was excited to offer her Motiva Implants^®. These implants are so much better than anything that has been available on the US market. They are designed not only to achieve my patients' aesthetic goals but also to ensure the highest quality and safety, backed by years of research and scientific data that show some of the lowest complication rates," said Payman Danielpour, MD, a board-certified plastic surgeon in Beverly Hills, CA. "Since their approval, I've been using Motiva Implants^® almost exclusively and couldn't be more pleased with the results. Motiva^® is a new generation of implants and I'm thrilled that Meghan, and women across the US, now have access to such an advanced device. I've already seen their incredible impact on many patients in my practice."

To learn more, visit MotivaUSA.com/Meghan

References:

1. Doloff JC, Veiseh O, de Mezerville R, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nature Biomedical Engineering. 2021. doi:10.1038/s41551-021-00739-4
2. Establishment Labs^® Holdings Corp. Establishment Labs^® Notes Presentation of 4-Year Results from Motiva^® U.S. IDE Study at The Aesthetic Meeting 2024. https://investors.establishmentlabs.com/press-releases/pressreleasesdetails/2024/Establishment-Labs-Notes-Presentation-of-4-Year-Results-from-Motiva-U.S.-IDEStudy-at-The-Aesthetic-Meeting-2024/default.aspx. Published May 2nd, 2024. Accessed May 28th, 2024.
3. Aitzetmuller-Kleitz ML, Yang S, Wiebinghaus P, Wellenbrock S, Ozturk M, Kuckelhaus M et al. Complication rates after breast surgery with the Motiva SmoothSilk Surface silicone gel implants - A systematic review and meta-analysis. Clin. Med. 2023, 12,1881. doi: 10.3390/jcm12051881
4. Establishment Labs, TR-001038: Rheological analysis of silicone filling gels of Motiva Implants^® and other brands' silicone filling gels using the BTC-2000. Data on File.
5. Establishment Labs, DDD-002: Device Description Document for Sterile Silicone Breast Implants Motiva Implants^®  Ergonomix^®  Round SmoothSilk^® /SilkSurface^®. Data on File.
6. Establishment Labs, DDD-001: Device Description Document Sterile Silicone Breast Implants Motiva Implants^®  Round SmoothSilk^® /SilkSurface^®  Plus. Data on File.
7. Caroline Glicksman, Andrew Wolfe, Patricia McGuire, The Study of the Safety and Effectiveness of Motiva SmoothSilk^®  Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data, Aesthetic Surgery Journal, 2024;, sjae134, https://doi.org/10.1093/asj/sjae134
8. Establishment Labs^®, Post-Market Surveillance Preliminary Results Q4 2024. Internal Data on File.
9. LIS001100: Motiva Publications List of Safety and Performance. Internal 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 ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "expects," "anticipates," "estimates," "intends," "plans," "intends to," "would," "will," "may" or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company's performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company's annual report on Form 10-K filed on March 4, 2024 and discussed in the company's quarterly report on Form 10-Q filed on November 12, 2024, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

Media Contact
Motiva@EvolveMKD.com
646-517-4220

Investor Relations
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