Establishment Labs Announces Commercial Launch of Motiva Implants in China
23 January 2024 - 12:00AM
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,
today announced it has launched Motiva® Implants in China.
“China is the second largest market globally, but has the
opportunity to be much larger,” commented Juan José Chacón-Quirós,
Establishment Labs Founder and Chief Executive Officer.
“Establishment Labs was founded to make profound changes to our
industry, and our growth reflects that. The Chinese market is
unique in that the size of the opportunity is matched by both an
appreciation among consumers for innovative technologies and a
large segment willing to pay a premium for such products. Not only
do we expect China to quickly become one of the largest and fastest
growing segments for our company, we also expect to expand the
market in China as women are introduced to new standards and
possibilities.”
Dr. Chen Yuzhe, a senior plastic surgeon at BCC Beijing added,
“We all look forward to Motiva’s brilliant performance here in
China and it will inject new vitality into the development of our
plastic surgery and beauty industry.”
The commercial launch coincided with the Motiva China
International Academic Conference that was held in Hainan, China;
events also took place in Shanghai, Guangzhou, and Shenzhen.
Establishment Labs received National Medical Products
Administration (NMPA) approval in China for Motiva® Implants in
November 2023.
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 MR
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.
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.
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
expectations regarding the private placement, such as its closing
date and use of proceeds, as well as the Company’s projections of
our future financial or operating 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 1, 2023 and
discussed in the Company's quarterly report on Form 10-Q filed on
November 8, 2023, which risks and uncertainties may be updated in
the future in other filings made by the company with the SEC. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240122047124/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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