First U.S. Women Successfully Receive Breast Augmentation with New FDA Approved Motiva Implants

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced the first successful breast augmentations in the United States using Motiva® Implants, following recent FDA approval. The company reports high demand from surgeons and patients, with over 400 plastic surgeons engaged post-announcement. Establishment Labs has doubled its U.S. sales team to 25 representatives.

Motiva Implants feature the SmoothSilk® surface, designed for enhanced biocompatibility and low inflammation. Two styles are offered: Motiva® SmoothSilk® Ergonomix®, which adapts its shape based on body position, and Motiva® SmoothSilk® Round implants for increased upper breast fullness. Surgeons performing the first procedures noted the implants' potential to enhance aesthetic outcomes and reduce complication rates.

Positive

• FDA approval of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants
• High demand reported from surgeons and patients
• Sales team doubled to 25 representatives across the United States
• Implants designed for enhanced biocompatibility and low inflammation
• Potential for improved aesthetic outcomes and lower complication rates

Negative

• None.

Insights

Medical Research Analyst

The FDA approval of Motiva® Implants marks a significant milestone in breast aesthetics. These 6th generation implants offer two key innovations:

• SmoothSilk® surface designed for enhanced biocompatibility and lower inflammation
• Ergonomix® design that adapts to body position, mimicking natural breast tissue movement

Clinical data suggests lower complication rates and higher patient satisfaction compared to existing options. The rapid uptake by surgeons (over 400 contacted post-announcement) indicates strong market potential. With 4 million devices delivered globally since 2010, Motiva has established a track record in 85% of countries worldwide.

For investors, this represents a significant market opportunity in the $1.1 billion U.S. breast implant market. The doubling of the sales force to 25 reps suggests aggressive growth plans. However, competition from established players and potential long-term safety concerns should be monitored closely.

Financial Analyst

This FDA approval positions Establishment Labs (ESTA) for potential significant revenue growth in the lucrative U.S. market. Key financial implications include:

• Expanded addressable market: Entry into the $1.1 billion U.S. breast implant market
• Increased sales capacity: Doubling of U.S. sales force indicates expectations of strong demand
• Potential market share gains: Innovative features may drive adoption and market share from competitors

With a market cap of $1.13 billion, ESTA's valuation could see upside if U.S. market penetration is successful. Investors should monitor quarterly reports for revenue growth rates, gross margins and operating expenses as the U.S. launch progresses. The company's ability to scale production and maintain quality will be critical factors in capitalizing on this opportunity.

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 today that the first patients in the United States have successfully undergone breast augmentation with Motiva^® Implants.

“With the FDA approval last week, we are experiencing high demand for Motiva Implants — both from surgeons and patients,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “The FDA approval came as we were attending the annual conference of the American Society of Plastic Surgeons. The response was overwhelming, and our team has already talked to more than 400 plastic surgeons post announcement. Since approval, we have already doubled our team to 25 sales reps across the United States, and our story of real innovation, backed by science and data, is resonating strongly. Everything we are seeing suggests that we can be the implant of choice in the United States.”

M. Bradley Calobrace, MD, Kentucky-based board-certified plastic surgeon, and Caroline A. Glicksman, MD, New Jersey-based board-certified plastic surgeon, performed the first surgeries following the U.S. Food and Drug Administration (FDA) approval of Motiva^® SmoothSilk^® Ergonomix^® and Motiva^® SmoothSilk^® Round breast implants in primary and revision breast augmentation.

“I have many patients that have been waiting a long time for Motiva approval, in some cases, for years,” said Dr. Calobrace. “I was delighted to perform one of the first Motiva breast augmentations in the United States. The innovation in these devices not only enhances aesthetics outcomes, but also significantly lowers the rates of the complications we see with other devices. Motiva implants are a game changer.”

Motiva Implants feature the SmoothSilk^® surface, which is designed for enhanced biocompatibility and scientifically shown to promote low inflammation. These 6th generation implants are offered in two distinct implant styles. Motiva^® SmoothSilk^® Ergonomix^® is the first breast implant in the world that embodies the science of ergonomics, as it is designed to react, feel, and move like natural breast tissue. Motiva^® SmoothSilk^® Ergonomix^® implants are unique as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. Motiva^® SmoothSilk^® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position.

“The plastic surgery community has waited more than a decade to offer breast augmentation patients in the United States something truly new,” said Dr. Glicksman, Medical Director of the Motiva U.S. IDE Study and a clinical trial investigator. “Now, we can confidently offer our patients implants that have consistently shown low complication rates and high patient satisfaction.”

More information about Motiva breast implants can be found at motivausa.com.

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/20241002297313/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) recently get FDA approval for?

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

How many sales representatives does Establishment Labs (ESTA) now have in the United States?

Establishment Labs (ESTA) has doubled its sales team to 25 representatives across the United States following FDA approval of Motiva Implants.

What is unique about the Motiva® SmoothSilk® Ergonomix® implants from Establishment Labs (ESTA)?

Motiva® SmoothSilk® Ergonomix® implants are designed to adapt their shape based on body position, maintaining a round shape when lying down and a teardrop shape when standing up.

How many plastic surgeons has Establishment Labs (ESTA) engaged since the FDA approval of Motiva Implants?

Establishment Labs (ESTA) reports engaging with over 400 plastic surgeons since the FDA approval announcement for Motiva Implants.