Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that
develops and commercializes biologic products to improve
compatibility between medical devices and the patients who need
them, and Sientra, Inc. (Nasdaq: SIEN) (“Sientra”), a medical
aesthetics company uniquely focused on plastic surgery, today
announced they have entered into an agreement to expand the
distribution of Aziyo’s SimpliDerm product line. Under the
agreement terms, Aziyo will grant Sientra certain non-exclusive
rights in the United States to market, sell and distribute
SimpliDerm for select use in reconstruction surgery.
“At Aziyo, our mission is to improve
compatibility between medical devices and the patients they serve.
With this partnership, we significantly expand women’s access to
biologic solutions necessary for successful reconstruction
procedures,” said Randy Mills, Ph.D., President and Chief Executive
Officer of Aziyo Biologics. “We are excited to partner with
Sientra, a proven commercial company that brings a
highly-specialized commercial team with reach and relationships to
help drive growth of the SimpliDerm portfolio in reconstructive
surgery. This agreement is intended to help drive meaningful
revenue growth and support our strategy of quickly and profitably
expanding the reach of our proprietary biologics platforms.”
SimpliDerm is a pre-hydrated human
acellular dermal matrix (hADM) that uses a proprietary process to
preserve key growth factors of native dermis that support faster
integration and more rapid revascularization while demonstrating a
lower risk of inflammatory response. Due to this unique process,
SimpliDerm has been able to provide a pliable, conforming matrix in
a ready-to-use format and achieve a sterility assurance level (SAL)
of 10-6.
“At Sientra, we believe that putting the best
products in the hands of the most qualified surgeons leads to the
most optimal results. The partnership with Aziyo allows our
customer to access the innovative SimpliDerm portfolio to provide
the industry’s most compelling reconstruction portfolio,” said Ron
Menezes, President and Chief Executive Officer of Sientra. “The
addition of SimpliDerm to our portfolio fits perfectly with our
strategy of being the leader in reconstruction, while enhancing our
path to profitability.”
SimpliDerm is to be used for the repair or
replacement of damaged or insufficient integumental tissue or for
other homologous uses of human integument.
About Aziyo Biologics
Aziyo develops and commercializes biologic
products to improve compatibility between medical devices and the
patients who need them. With a growing population in need of
implantable technologies, Aziyo’s mission is to humanize medical
devices to improve patient outcomes. For more information, visit
www.Aziyo.com.
About Sientra
Headquartered in Irvine, California, Sientra is
a medical aesthetics company exclusively focused on plastic
surgery. The Company’s 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™ fat transfer system, and
BIOCORNEUM®, the #1 performing, preferred and recommended scar gel
of plastic surgeons(*). For more information, visit
www.sientra.com.
(*) Data on file.
Aziyo 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. Forward-looking statements can be identified
by words such as “projects,” “may,” “will,” “could,” “would,”
“should,” “believes,” “expects,” “anticipates,” “estimates,”
“intends,” “plans,” “potential,” “promise” or similar references to
future periods. All statements contained in this press release that
do not relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
and information concerning the anticipated benefits and financial
results from the partnership with Sientra and the benefits from and
efficacy of SimpliDerm. Forward-looking statements are 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 inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified, and other important
factors that may cause actual results, performance or achievements
to differ materially from those contemplated or implied in this
press release, including, but not limited to, risks regarding the
Company’s operating losses and ability to become profitable;
adverse changes in economic conditions and disruptions in credit
markets; the Company’s ability to continue as a going concern; the
Company’s products and its ability to enhance, expand, develop and
commercialize its product offerings; the impact on the Company’s
business of the recall of a single lot of its FiberCel product and
the discontinuation of its sales by its distribution partner; the
Company’s dependence on its commercial partners; the Company’s
future capital needs and available sources of funding; the adverse
impacts of COVID-19 or adverse changes in economic conditions and
credit markets; physician awareness of the distinctive
characteristics, and acceptance by the medical community, of the
Company’s products; the ability to obtain regulatory approval or
other marketing authorizations; and the Company’s intellectual
property rights, and other important factors which can be found in
the “Risk Factors” section of Aziyo’s public filings with the
Securities and Exchange Commission (“SEC”), including Aziyo’s
Annual Report on Form 10-K for the year ended December 31, 2021, as
such factors may be updated from time to time in Aziyo’s other
filings with the SEC, including, without limitation, Aziyo’s
Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2022, accessible on the SEC’s website at www.sec.gov
and the Investor Relations page of Aziyo’s website at
https://investors.aziyo.com. Because forward-looking statements are
inherently subject to risks and uncertainties, you should not rely
on these forward-looking statements as predictions of future
events. Any forward-looking statement made by Aziyo in this press
release is based only on information currently available and speaks
only as of the date on which it is made. Except as required by
applicable law, Aziyo expressly disclaims any obligations to
publicly update any forward-looking statements, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Sientra 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. All such statements are subject to
certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of the Company, which
could cause actual results to differ materially from those
expressed in, or implied or projected by, the forward-looking
information and statements. Forward-looking statements may include
information concerning Sientra’s launch of the SimpliDerm product,
the Sientra’s ability to promote the SimpliDerm product to its
customers, Sientra’s profitability projections, and Sientra’s
long-term strategic plans. Such statements are subject to risks and
uncertainties, including the positive reaction from plastic
surgeons and their patients to the SimpliDerm product, the
Company’s ability to execute on its commercial, sales and marketing
plans, the regulatory environment related to Sientra’s products, as
well as other risks and uncertainties described under the “Risk
Factors” contained in the Company’s periodic and interim SEC
reports, including but not limited to, the preliminary prospectus
supplement relating to this offering, its Annual Report on Form
10-K for the fiscal year ended December 31, 2021, its Quarterly
Reports on From 10-Q, and its Current Reports on Form 8-K filed
from time to time with the SEC. Readers are cautioned not to place
undue reliance on these forward-looking statements that speak only
as of the date hereof, and the Company does not undertake any
obligation to revise and disseminate forward-looking statements to
reflect events or circumstances after the date hereof, or to
reflect the occurrence of or non-occurrence of any events.
Aziyo Contacts:
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
Media:Courtney GuyerAziyo Biologics, Inc.PR@aziyo.com
Sientra Contacts:
Investors:Aman
Patelaman.patel@westwicke.com
Media:EvolveMKDsientra@evolvemdk.com
INDICATIONS FOR USESimpliDerm® is to be used
for the repair or replacement of damaged or insufficient
integumental tissue. It may also be used for the repair,
reinforcement, or supplemental support of soft tissue defects or
any other homologous use of human integument. Each package of
SimpliDerm® is intended for use in one patient on a single occasion
by a licensed physician.
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