Establishment Labs Receives U.S. FDA Approval for Motiva Implants

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) has received U.S. FDA approval for Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation. These implants feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and low inflammation. The Ergonomix® device adapts to body position, maintaining a round shape when lying down and a teardrop shape when standing up.

The Motiva U.S. IDE Study, conducted at 35 centers, showed exceptional results with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort. At three years post-implantation, the Kaplan-Meier risk rates for primary augmentation patients (N=451) were: Capsular Contracture: 0.5%; Rupture: 0.6%; Breast Pain: 0.7%; Infection: 0.9%. Any reoperation was reported at 6.1% and any complication at 8.4%.

Positive

• FDA approval for Motiva® SmoothSilk® Ergonomix® and Round breast implants
• Low complication rates in clinical trials (< 1% for capsular contracture and rupture)
• High patient compliance (92.4%) in the primary augmentation cohort
• Nearly 4 million Motiva® devices delivered in over 85 countries since 2010
• Strong intellectual property portfolio with over 200 patent applications

Negative

• None.

Insights

Medical Research Analyst

The FDA approval of Motiva® SmoothSilk® Ergonomix® and Round breast implants represents a significant milestone for Establishment Labs and the breast aesthetics industry. Key points:

• First new breast implant PMA approved by the FDA since 2013, indicating a major technological advancement
• Exceptionally low complication rates in clinical trials: 0.5% capsular contracture and 0.6% rupture rate at 3 years
• Unique Ergonomix® design adapts to body position, mimicking natural breast tissue movement
• SmoothSilk® surface designed for enhanced biocompatibility and low inflammation
• Strong market presence with nearly 4 million devices delivered in over 85 countries

This approval opens up the lucrative U.S. market for Establishment Labs, potentially driving significant revenue growth and market share gains in the breast implant sector. The company's focus on women's health and innovative "Femtech" approach could resonate well with consumers and surgeons alike.

Financial Analyst

The FDA approval of Motiva implants is a game-changer for Establishment Labs (ESTA), potentially transforming its financial outlook:

• Expands addressable market to include the U.S., the world's largest breast implant market
• Likely to drive significant revenue growth and market share gains
• Strong intellectual property portfolio with over 200 patent applications provides competitive advantage
• Existing global presence in 85+ countries demonstrates scalability and manufacturing capabilities
• Potential for premium pricing due to advanced technology and lower complication rates

With a current market cap of $1.16 billion, ESTA's valuation could see substantial upside as the company penetrates the U.S. market. Investors should monitor initial adoption rates, pricing strategies and the company's ability to scale production to meet increased demand. This approval could be a catalyst for both short-term stock price appreciation and long-term value creation.

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, announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva^® SmoothSilk^® Ergonomix^® and Motiva^® SmoothSilk^® Round breast implants in primary and revision breast augmentation.

“Today’s approval is transformative for breast aesthetics in the United States. This is a new era, in which women now have a choice of highly differentiated technology that is backed by rigorous scientific and clinical research,” commented Juan José Chacón-Quirós, Founder and Chief Executive Officer. “Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals. We have never wavered in our commitment to women’s health and our entire organization is ready to bring this passion and technology to the United States.”

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.

“The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results, with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort,” said board-certified plastic surgeon Dr. Caroline A. Glicksman. “As the Medical Director of the Motiva study and an investigator, I am proud of the quality of the data and the patient follow-up rates of this study. Motiva implants were designed to reduce device related complications, and they will be welcomed by the plastic surgery community and women seeking breast augmentation in the United States.”

The Motiva U.S. IDE Study was conducted at 32 centers in the U.S. and three centers in Western Europe. At the study endpoint of three years post-implantation, patient compliance in the primary augmentation cohort of the trial was 92.4%. The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort (N=451) were as follows: Capsular Contracture: 0.5%; Rupture, Confirmed or Suspected: 0.6% (MRI Cohort N=176); Breast Pain: 0.7%; Infection: 0.9%. Any reoperation, including an implant size change, was reported at 6.1% and any complication, including reoperations, was reported at 8.4%.

“There has been a real lack of innovation in the U.S. breast implant market for well over a decade,” added board-certified plastic surgeon and study investigator Dr. M. Bradley Calobrace. “Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients. A safer, next generation viscoelastic implant with a uniquely designed low inflammatory surface will undoubtedly improve clinical and aesthetic outcomes. I am pleased to finally be able to offer Motiva implants to my patients in the United States.”

Since first becoming commercially available in 2010, nearly four million Motiva^® devices have been delivered to plastic and reconstructive surgeons in over 85 countries. 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 publications. The Motiva^® Implant approval announced today is the first new breast implant PMA approved by the U.S. FDA since 2013.

“Motiva is the first and only implant purposefully designed for women and their lifestyles,” said Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of the Establishment Labs Femtech Advisory Board. “These implants move and feel like natural breast tissue. The rates of complications in the clinical trial were also much lower than we have seen with any other implant in a U.S. PMA study. This is true Femtech. I could not be happier that women in the United States now have access to this revolutionary technology.”

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva^® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora^® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. 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 under the MDSAP program. 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 will be discussed in the company's quarterly report on Form 10-Q filed on August 7, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240926359459/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What breast implants did Establishment Labs (ESTA) receive FDA approval for?

Establishment Labs received FDA approval for Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation.

What were the complication rates for Motiva implants in the U.S. IDE Study?

In the primary augmentation cohort, the 3-year Kaplan-Meier risk rates were: Capsular Contracture: 0.5%; Rupture: 0.6%; Breast Pain: 0.7%; Infection: 0.9%. Any reoperation was 6.1% and any complication was 8.4%.

How many Motiva devices has Establishment Labs (ESTA) delivered since 2010?

Establishment Labs has delivered nearly four million Motiva® devices to plastic and reconstructive surgeons in over 85 countries since 2010.

What is unique about the Motiva® SmoothSilk Ergonomix® implants?

Motiva® SmoothSilk Ergonomix® implants adapt to body position, maintaining a round shape when lying down and a teardrop shape when standing up, designed to mimic natural breast tissue movement.