Establishment Labs Announces Hani Zeini has Joined the Company as Exclusive Advisor in Anticipation of US Launch

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a leader in women's health technology, has secured Hani Zeini for a multiyear advisory role as it prepares for its US market launch. Zeini, with over 30 years in aesthetics, previously founded Sientra. His expertise will drive the company's strategy to introduce innovative breast aesthetics solutions, including the Motiva Implant product suite. With 2.0 million implants distributed globally, Establishment Labs is on track to enhance its market presence.

Positive

• Appointment of industry veteran Hani Zeini as advisor may enhance market entry strategy for US launch.
• Establishment Labs aims to lead the US market in breast aesthetics with innovative products.

Negative

• None.

Hani Zeini is a 20+ year executive in the breast aesthetics industry, including as CEO and Founder of Sientra

SANTA BARBARA, Calif.--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that it has retained Hani Zeini to an exclusive, multiyear advisory contract in anticipation of its US commercial launch.

“I have known Hani for many years and can think of no one better to help our team enter the US market,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “His experience will be invaluable as we seek to lead the US market and access new groups of consumers with our differentiated and disruptive solutions in breast aesthetics and reconstruction.”

Hani Zeini founded Sientra in 2006 and has over 30 years of experience in the Pharmaceutical and Medical Device industries, including more than two decades in Aesthetics and Plastic Surgery. Prior to Sientra, he served as Executive Vice President of Inamed and Head of Aesthetics (now part of Abbvie/Allergan Medical) where he was responsible for both the Breast Aesthetics and Facial Aesthetics businesses. In 2017, Mr. Zeini founded a boutique advisory firm, Elissar Advisors, focused on providing commercial expertise in aesthetics medicine. Mr. Zeini holds a Bachelor of Science degree in Electrical and Computer Engineering from the University of Miami in Coral Gables, Florida. He also completed the Stanford Executive Program at Stanford University Graduate School of Business.

“With our launch in the US drawing closer, we have considered a variety of approaches to enter the market. In the end, we decided that to remake the perceptions of our industry, we have to build our business in the US from the ground up. Hani’s experience and wisdom will be vital to those efforts,” said Dr. Heather Brennan, Global Head of Markets at Establishment Labs.

“I am beyond excited to help Establishment Labs usher in a new era in plastic surgery, something to which I have dedicated my career,” said Hani Zeini. “Establishment Labs has created the most advanced technologies in breast aesthetics and reconstruction and the company is transforming these markets with a platform that empowers women to take full control of their choices. The US clinical data that was released in April 2022 and over a decade of data from the international market shows how superior the Motiva Implant product suite truly is. Mía Femtech^® and Aesthetic BreastRecon^® are game changing opportunities that can expand these markets by offering new and vastly improved options to women and plastic surgeons. Bringing disruptive new technologies to market for breast augmentation and reconstruction has been my passion for decades, and I look forward to supporting the growth of Establishment Labs for many years.”

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness. The company’s initial focus is breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants® that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, over 2.0 million Motiva Implants^® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under development a number of related products and technologies, including the Motiva Flora® tissue expander and Mía Femtech^®, the company’s minimally invasive breast enhancement procedure. In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant® and began a clinical trial to support regulatory approval in the United States. Motiva Implants® are manufactured at the company’s two facilities in Costa Rica, which are 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, our liquidity and anticipated cash plans; 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 press release, 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 cash requirements and ability to generate positive cash flow from operations; 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; the effect on our business of the current Russia-Ukraine conflict; the impact of foreign currency exchange rates; the impact on our business of an economic downturn or deterioration of general macroeconomic conditions, including slower growth or recession, inflation or decreases in consumer spending power or confidence; other economic and competitive factors; and the other risks and uncertainties discussed in Item 1A, Risk Factors, in the company’s annual report on Form 10-K filed on March 1, 2022, as such risks and uncertainties will be updated in the company's quarterly report on Form 10-Q for the three months ended June 30, 2022, which is expected to be filed with the SEC on August 9, 2022. These and other factors that could cause or contribute to actual results differing materially from our expectations may also be amended, updated or superseded from time to time 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/20220911005072/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What is the significance of Hani Zeini's appointment for Establishment Labs (ESTA)?

Hani Zeini's appointment as an advisor is crucial for Establishment Labs as it prepares to enter the US market, leveraging his extensive experience in the breast aesthetics industry.

What products does Establishment Labs (ESTA) aim to launch in the US?

Establishment Labs plans to launch its advanced breast aesthetics solutions, including the Motiva Implant product suite, in the US market.

How many Motiva Implants has Establishment Labs (ESTA) distributed globally?

Since its launch in 2010, Establishment Labs has delivered over 2.0 million Motiva Implants to plastic surgeons in more than 80 countries.

What market strategy is Establishment Labs (ESTA) pursuing for its US launch?

Establishment Labs is building its business in the US from the ground up, focusing on reshaping industry perceptions and expanding consumer access.