Sientra Receives Regulatory Approval to Market OPUS® Breast Implants in Japan
August 25 2020 - 8:00AM
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 self-esteem, 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 StatementsThis 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 forward-looking 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
ContactInvestor Relations805-679-8885
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