Sientra Announces FDA-Clearance of Novel Portfinder™ Technology
May 17 2023 - 8:30AM
Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a
medical aesthetics company focused on enhancing lives by advancing
the art of plastic surgery, announced that the Food and Drug
Administration (FDA) has granted a 510(k) clearance for the
Company’s novel Portfinder™ technology. Portfinder™ is an
electronic handheld device that allows for the subcutaneous
location of ports in Sientra’s Dermaspan® and AlloX2® Pro tissue
expanders. This new technology replaces the traditional dangle
magnet mechanism and provides a more accurate port location with
improved useability for clinicians.
“Portfinder™’s state-of-the-art proprietary technology improves
the user experience during tissue expander filling sessions,
allowing for more precision and confidence in the port location.
The Portfinder™’s unique interactive screen guides the user towards
the center of the ports and allows for precise identification and
marking of both fill and drain ports in Dermaspan® and AlloX2® Pro
expanders, making it a very versatile device”, said Dr. Denise
Dajles, Sientra’s Chief Technical Officer.
“The FDA’s clearance of Portfinder™ marks another first for
Sientra and reflects our ongoing commitment to innovation and
improvement of the patient experience in reconstruction cases,”
said Ron Menezes, President and CEO of Sientra. “We look forward to
commercializing this product and putting it in the hands of the
most skilled plastic surgeons, our customers.”
About Sientra
Headquartered in Irvine, California, Sientra is a medical
aesthetics company exclusively focused on plastic surgery. The
Company mission is to offer proprietary innovations and
unparalleled partnerships that radically advance how plastic
surgeons think, work and care for their patients. 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 product
portfolio includes its Sientra round and shaped 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, the Viality™ with AuraClens™ enhanced viability fat
transfer system, the SimpliDerm® Human Acellular Dermal Matrix, and
BIOCORNEUM® the #1 performing, preferred and recommended scar gel
of plastic surgeons (*).
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.
(*) Data on file
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
possible or assumed future results of operations, including
descriptions of the Company’s revenues, profitability, outlook, and
overall business strategy, the Company’s ability and timing to
successfully integrate the Portfinder™ product into its existing
operations, the reception of plastic surgeons to the Company’s
products, and the Company’s ability to capture additional market
share and customer accounts in the plastic surgery market. Such
statements are subject to risks and uncertainties, including the
positive reaction from plastic surgeons and their patients to the
Company’s products, the ability to meet consumer demand, including
any potential supply issues resulting from the COVID-19 pandemic or
the war in Ukraine, the growth of the plastic surgery market and
breast procedures, and the ability of the Company to execute on its
commercial, marketing, research and development and regulatory
plans. 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. 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. 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.
Investor Relations Contact
Aman R. Patel, CFA
aman.patel@westwicke.com
Sientra (NASDAQ:SIEN)
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