Marks First Regulatory approval of Sientra Breast Implants Outside of the U.S.
Santa Barbara, CA – August 25, 2020 – Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”),
a diversified global medical aesthetics company, announced today that it has received approval from
Japan’s Pharmaceutical and Medical Device Agency (”PDMA”) to market the Company’s entire
OPUS line of breast implants in Japan.
Sientra will market the complete portfolio of OPUS breast implants in Japan through its local partner
Medical U&A, Inc. (“Medical U&A”), a leading provider of surgical and medical devices in the fields of
plastic and reconstructive surgery. Medical U&A will sell Sientra’s implants through a dedicated sales
force to over 2,000 hospitals and clinics across Japan.
Jeff Nugent, Chairman and Chief Executive Officer of Sientra, said, “The approval of our OPUS line
of implants in Japan represents a major milestone for Sientra, representing our first approval for our
breast products outside of the U.S. With this approval, Sientra’s implants will be one of only two
breast implants approved by the PDMA, which reinforces our clinically proven safety profile.”
Jeff continued, “In an era when safety and trust are paramount, Sientra upholds the highest
standards for both patients and providers. With our latest generation of clinically supported and
FDA approved implants sold only to highly qualified surgeons in the U.S. and now Japan, we
believe Sientra consistently provides patients with safe and beautiful outcomes.”
Shojiro Matsuda, Chief Executive Officer of Medical U&A, said “Many patients in Japan have long awaited
Sientra's breast implants. In response to the demands of patients and healthcare professionals, and
with the full cooperation of Sientra, we submitted the regulatory application and obtained approval in
only six months. We are very pleased to be able to distribute these highly differentiated Sientra products
that contribute to the quality of life of Japanese patients.”
About Sientra
Headquartered in Santa Barbara, California, Sientra is a diversified global medical aesthetics
company and a leading partner to aesthetic physicians. The Company offers a suite of products
designed to make a difference in patients' lives by enhancing their body image, growing their selfesteem,
and restoring their confidence. Sientra has developed a broad portfolio of products with
technologically differentiated characteristics, supported by independent laboratory testing and strong
clinical trial outcomes. The Company’s Breast Products Segment includes its OPUS® breast
implants, the first fifth generation breast implants approved by the FDA for sale in the United States,
its ground-breaking Allox2® breast tissue expander with patented dual-port and integral drain
technology, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic
surgeons(*). The Company’s miraDry Segment, comprised of its miraDry® system, is approved for
sale in over 56 international markets and is the only non-surgical, FDA-cleared device indicated for
the permanent reduction of underarm sweat and hair and may also reduce odor.
Sientra uses its investor relations website to publish important information about the Company,
including information that may be deemed material to investors. Financial and other information
about Sientra is routinely posted and is accessible on the Company’s investor relations website
at www.sientra.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, based on management’s current assumptions and expectations of future events and
trends, which affect or may affect the Company’s business, strategy, operations or financial
performance, and actual results may differ materially from those expressed or implied in such
statements due to numerous risks and uncertainties. Forward-looking statements are made only as
of the date of this release. The words ‘‘believe,’’ ‘‘may,’’ ‘‘might,’’ ‘‘could,’’ ‘‘will,’’ ‘‘aim,’’ ‘‘estimate,’’
‘‘continue, ‘‘anticipate,’’ ‘‘intend,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘position,” or the negative of those terms, and
similar expressions that convey uncertainty of future events or outcomes are intended to identify
estimates, projections and other forward-looking statements. Forward-looking statements may
include information concerning the Company’s sales of its OPUS breast implant products in Japan.
Such statements are subject to risks and uncertainties, including positive reaction from plastic
surgeons and their patients to Sientra’s Breast Products and the ability to meet consumer demand.
Additional factors that could cause actual results to differ materially from those contemplated in this
press release can be found in the “Risk Factors” section of Sientra’s public filings with the Securities
and Exchange Commission. All statements other than statements of historical fact are forwardlooking
statements. You are cautioned not to place undue reliance on these forward-looking statements, and
such estimates, projections and other forward-looking statements speak only as of the date they were
made, and, except to the extent required by law, the Company undertakes no obligation to update or
review any estimate, projection or forward-looking statement. Actual results may differ from those set
forth in this press release due to the risks and uncertainties inherent in the Company’s business.
(*) Data on file
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Investor Relations
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