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 510k-clearance for the Company’s
novel, patented1 AlloX2 Pro Tissue Expander. Building upon the
proprietary dual port technology of the Company’s ground-breaking
AlloX2® tissue expander, the AlloX2 Pro expands this platform by
removing 95% of the metal traditionally associated with tissue
expander ports. This innovation allows the AlloX2 Pro to be labeled
as MRI-conditional, making it the only tissue expander cleared in
the United States for exposure to magnetic resonance imaging, an
important screening tool for breast reconstruction
patients. Other innovative features of the AlloX2 Pro
include minimal interference with radiation therapy for
post-mastectomy patients,2 faster port filling and drainage, and a
softer drain for enhanced patient comfort.
“I am extremely proud to have partnered with
Sientra to bring the AlloX2 Pro to market,” commented Dr. Thomas
McClellan, a board-certified plastic surgeon in West Virginia and
inventor of AlloX2. “Sientra’s commitment to women’s health and
technological development in breast reconstruction made them the
natural choice to make this important innovation in the treatment
of post-mastectomy women a reality.”
“AlloX2 Pro is a remarkable and differentiating
advancement in tissue expander technology. The AlloX2 Pro will
significantly improve reconstructive approach with both dual ports
and MRI-compatibility. These combined features will allow for
better and safer treatment options and even allow use expanders in
situations where we could not before,” said Dr. Thomas Davenport, a
leading board-certified plastic surgeon specializing in
reconstruction at Long Island Plastic Surgery. “Reconstructive
surgery enhances the lives of our breast cancer patients by
restoring their confidence and quality of life. AlloX2 Pro is a
game changing innovation which will allow us to deliver the best
and safest care to our patients.”
“The FDA clearance of
AlloX2 Pro tissue expander represents another significant
achievement for Sientra, and is a testament to our unwavering
commitment to women’s health, innovation and leadership in
reconstruction,” commented Ron Menezes, President and CEO of
Sientra. “This is the third new product cleared or approved by the
FDA in the past 12 months, setting Sientra apart from the
competition and showing that Sientra continues to lead the way
offering the most innovative solutions for plastic surgeons and
their patients. We are excited to offer this ground-breaking new
technology to our customers, and continue our market share gains in
reconstruction where we have already reached an all-time high of
23% at the end of Q1.3”
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
AlloX2 Pro™ product into its existing operations, the clinical
performance of the Company’s products, 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
_________________________________________1 U.S.
Patent No. 11,039,8982 Ramos-Méndez J, Park C, Sharma M.,
“Dosimetric characterization of single- and dual-port temporary
tissue expanders for postmastectomy radiotherapy using Monte Carlo
methods,” Front Oncol. 2023 Apr 18;13:1124838. doi:
10.3389/fonc.2023.1124838. 3 IQVIA, SMART-Medical Device
Supply Edition, Gel Implants & Breast Expander Purchases.
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