Establishment Labs Announces National Medical Products Administration Approval for Motiva Implants in China
10 November 2023 - 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 received National Medical Products
Administration (NMPA) approval in China for Motiva® Implants.
“Our approval in China marks Establishment Labs’ entry into the
second largest global and most dynamic market for breast aesthetics
in the world,” said Juan José Chacón-Quirós, Chief Executive
Officer. “This is the first breast implant technology approved in
China in more than a decade. Many Chinese plastic surgeons are
familiar with Motiva Implants from other Asian countries where we
have leading market shares, and we expect they will adopt our
technology as their first choice."
“We transformed the breast aesthetics market in South Korea with
Motiva, and we are excited to replicate that success in China,”
added John Lim, Founder and CEO of Motiva China Ltd., Establishment
Labs exclusive distribution partner in the market. “Three years
after launching in Korea in 2016, we became the market leader.
Today, Motiva is far and away the most chosen and most recognized
brand in Korea. Most importantly, we changed the perception of our
industry. Chinese plastic surgeons and consumers are highly attuned
to the latest innovations in science and technology, and, just like
the Koreans, we expect they will recognize Motiva as truly
innovative and differentiated.”
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.
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
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 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231109738556/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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