Establishment Labs Publishes 2024 Post Market Surveillance Report

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on women's health and wellness in breast aesthetics and reconstruction, has published its 2024 Post Market Surveillance (PMS) Report. The report highlights the company's Motiva Implants, which show device-related complication rates of less than 1% after 14 years in the market.

CEO Juan José Chacón-Quirós noted the strong market demand for Motiva as they begin shipping across the United States. Rosalyn Cole d´Incelli, SVP of Clinical, Medical & U.S. Regulatory Affairs, emphasized the consistent performance of Motiva implants across various sources, including internal registries, warranty claims, international registries, peer-reviewed publications, and a US FDA study.

Establishment Labs has delivered nearly four million Motiva devices to plastic and reconstructive surgeons since 2010, setting a new standard for safety and patient satisfaction in over 85 countries.

Positive

• Motiva Implants show device-related complication rates of less than 1% after 14 years in the market
• Strong market demand for Motiva Implants in the United States
• Nearly four million Motiva devices delivered since 2010
• Motiva Implants available in over 85 countries
• Consistent positive results across multiple sources, including FDA study

Negative

• None.

Insights

Medical Research Analyst

The release of Establishment Labs' 2024 Post Market Surveillance (PMS) Report is a significant development for the company and the breast implant industry. The report highlights exceptionally low device-related complication rates of less than 1% after 14 years in the market, which is a remarkable achievement in medical device safety.

This data is particularly impactful as it coincides with Motiva Implants' broad launch in the United States, a important market for breast aesthetics. The strong market demand mentioned by the CEO suggests potential for rapid market share gains, which could significantly boost ESTA's revenue and market position.

The consistency of positive results across multiple sources, including FDA studies and independent publications, adds credibility to Motiva's safety profile. This could lead to increased adoption by surgeons and patients, potentially driving long-term growth for Establishment Labs. Investors should monitor how this translates into sales figures and market share in the coming quarters, especially in the newly entered U.S. market.

Market Research Analyst

Establishment Labs' entry into the U.S. market with Motiva Implants represents a significant business opportunity. The CEO's statement about strong market demand and surgeons actively promoting Motiva on social media indicates a potentially successful product launch. This could lead to rapid market penetration in a lucrative market that has seen little innovation in over a decade.

The company's global market leadership in several countries bodes well for its U.S. prospects. If Motiva can replicate this success in the U.S., it could substantially increase ESTA's revenue and market cap. Investors should watch for early adoption rates and sales figures in the coming quarters.

The emphasis on safety and low complication rates could be a key differentiator in a market where patient safety is paramount. This may lead to premium pricing and higher profit margins. Long-term, if Motiva becomes the preferred choice for surgeons and patients, it could reshape the competitive landscape of the breast implant market, potentially leading to significant value creation for ESTA shareholders.

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 that it has published its 2024 Post Market Surveillance (PMS) Report.

“It is fitting that as we publish our 2024 PMS report, we begin broadly shipping across the United States,” said Juan José Chacón-Quirós, Establishment Labs CEO and Founder. “Dozens of plastic surgeons will perform their first Motiva surgery in the coming days, and they are actively talking about the advantages of Motiva Implants on social media. Many women are responding, accepting only Motiva Implants for their surgery. Not surprisingly, after well over a decade without any innovation, the market demand for Motiva is very strong and, while early, we couldn’t be happier with the launch. The PMS amasses a body of clinical and scientific evidence unrivaled in our industry, and this foundation has enabled Motiva to become the market share leader in many countries around the world — I expect no less in the United States.”

Rosalyn Cole d´Incelli, SVP of Clinical, Medical & U.S. Regulatory Affairs added, “Motiva implants continue to show unmatched performance, with device-related complication rates of less than 1% after 14 years in the market. This is reported in our internal registries and warranty claims, international registries, independent and peer-reviewed publications, and now from the gold standard of a US FDA study — all of which are included in the 2024 Post Market Surveillance Report we published this week. The consistency of these results across many years and many sources confirms that we have truly set a new standard for what plastic surgeons and women should expect from the implants they choose.”

Establishment Labs’ Post Market Surveillance Report can be found on the company’s website at: https://establishmentlabs.com/science-based-innovation/pms-report/.

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/20241015685312/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What are the complication rates for Motiva Implants according to the 2024 PMS Report?

According to the 2024 Post Market Surveillance Report, Motiva Implants show device-related complication rates of less than 1% after 14 years in the market.

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 since 2010.

In how many countries are Motiva Implants available?

Motiva Implants are available in over 85 countries worldwide.

What is the market response to Motiva Implants in the United States?

According to the CEO, the market demand for Motiva Implants in the United States is very strong, with many women accepting only Motiva Implants for their surgery.