Establishment Labs Announces Appointment of Jeff Ehrhardt as General Manager of North America

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announces the appointment of Jeff Ehrhardt as the General Manager of North America. Mr. Ehrhardt brings over 25 years of experience from Allergan Aesthetics, with the responsibility of launching Motiva implants in the U.S. to set new standards in breast aesthetics and reconstruction. The move signifies a significant step for Establishment Labs in expanding its global presence and enhancing women's health and wellness.

Positive

• Appointment of highly experienced Jeff Ehrhardt as General Manager of North America will bring valuable expertise to Establishment Labs.

• Anticipated launch of Motiva implants in the U.S. under Mr. Ehrhardt's leadership is expected to set new standards in breast aesthetics and reconstruction.

• Establishment Labs is dedicated to improving women's health and wellness globally through its innovative technologies and solutions.

Negative

• Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States, undergoing PMA clinical investigation.

• The lack of FDA approval for Motiva implants in the U.S. may pose challenges in expanding the Company's market presence and revenue streams.

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 Jeff Ehrhardt has joined the company as General Manager of North America. After having spent over 25 years at Allergan Aesthetics, an Abbvie Company, Mr. Ehrhardt joins Establishment Labs with responsibilities including the anticipated launch of Motiva implants in the U.S. later this year.

“Jeff is the ideal person to introduce Motiva to the United States,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs. “Just as we have changed the standard for breast augmentation and reconstruction around the world for more than a decade, we will establish a new standard for women and plastic surgeons in the United States. With Jeff leading our efforts, we expect to become the leading technology not only in the U.S., but globally."

Mr. Ehrhardt was most recently General Manager for Plastic Surgery & Regenerative Medicine at Allergan Aesthetics. In his most recent role, Jeff was responsible for the company’s portfolio of implants and related technologies in breast augmentation and reconstruction, including developing and executing the group’s commercial strategy and managing the U.S. sales and marketing organizations. He has held a number of other positions at Allergan, including vice president of U.S. operations, vice president of sales, regional sales director, marketing director, sales training director, sales rep, and roles in business development. Prior to Allergan, Mr. Ehrhardt also worked at American Cyanamid and Johnson & Johnson. Mr. Ehrhardt received his bachelor’s degree in business from the University of Cincinnati and his MBA from Xavier University.

"Joining Establishment Labs is in many ways the culmination of the last 25 years of my career,” said Jeff Ehrhardt. “I’ve seen firsthand the diminished importance of science and data in the U.S. market. The lack of innovation has left plastic surgeons with few, if any, real choices for technologies that can improve the outcomes of their breast procedures. Establishment Labs is different. The quality of the science and the outcomes achieved with Motiva implants are unprecedented. We will not only take share, but also have the potential to grow these markets as we show what can be achieved when a company puts women at the center of everything that it does.”

Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. The Company’s implants are undergoing PMA clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.

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 over three 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 25 separate patent families worldwide and over 50 scientific 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. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. 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, 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/20240501035044/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

Who has Establishment Labs appointed as the General Manager of North America?

Establishment Labs has appointed Jeff Ehrhardt as the General Manager of North America.

What is the stock symbol of Establishment Labs?

The stock symbol of Establishment Labs is NASDAQ: ESTA.

What is the focus of Establishment Labs in terms of medical technology?

Establishment Labs focuses on improving women's health and wellness primarily in breast aesthetics and reconstruction.

Where are Establishment Labs' Motiva implants currently undergoing clinical investigation?

Establishment Labs' Motiva implants are undergoing PMA clinical investigation in the United States.

What is the unique feature of Motiva Flora tissue expander from Establishment Labs?

Motiva Flora tissue expander is the only regulatory-approved expander with an integrated port using radio-frequency technology that is MRI conditional.