Sientra Announces Preliminary Results from Clinical Study and The First Shipment of Viality™ Fat Transfer System
March 01 2023 - 8:32AM
Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a
medical aesthetics company uniquely focused on plastic surgeons,
today announced that it has begun commercial shipping of its
Viality™ with AuraClens™ fat transfer system. The Company also
announced the release of preliminary results from its on-going,
multi-center, long-term volume retention clinical study with
Viality. These preliminary results show over 80% volume retention
at both the 3- and 6-month timepoints, making Viality the first,
and only, system to have clinically demonstrated such high levels
of retention.
“The promising results showcased in this preliminary data
mirrors what I am seeing clinically with the patients I have
treated with Viality to-date,” said board-certified plastic surgeon
and clinical study investigator, Dr. Sachin M. Shridharani, MD,
FACS. “Fat transfer has been gaining popularity for the past
decade, and with Viality, Sientra has not only contributed to an
unmet market need though superior fat retention rates, but allows
me to offer my patients predictable outcomes, with the natural
results they are looking for.”
Based on the preliminary results, with 68 patients* enrolled,
the clinical study shows over 80% volume retention at both 3- and
6-months post breast augmentation and reconstruction. In addition,
volume changes from 3 to 6 months were on average only 3.59%,
indicating the long-term viability of fat transfer when using
Viality.
“Sientra is known for elevating industry standards through
innovation and unmatched product quality,” said Ron Menezes,
President and CEO of Sientra. “This research allows us to best
equip surgeons with what they need to generate the best outcomes
for their patients. We have experienced a significant demand for
the product in presales alone, and look forward to putting Viality
in the hands of our plastic surgeon customers as we commence
commercial shipping. We anticipate that when the study is
completed, the results of this first-of-its-kind study will
establish a new standard for evidence in fat transfer.”
The full preliminary results are now available on our website
and Sientra will continue to develop the data within the ongoing
clinical study.
*Not all patients in the study had reached 3 and 6 month
timepoints when preliminary results were released
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(*).
(*) 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. 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 the long-term results of the Company’s
clinical study, the anticipated outcomes of the Company’s clinical
study, the Company's anticipated sales of Viality, the demand of
Sientra’s customers and patients for the Viality system, and the
expected results of the Viality system once commercially launched.
Such statements are subject to risks and uncertainties, including
the positive reaction from plastic surgeons and their patients to
the Viality system, the Company's ability to successfully convert
accounts to purchase the Viality system, the long-term clinical
results of the Viality system, and the Company's ability to
execute on its commercial, sales and marketing plans, 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.
Sientra Contact:
Investor RelationsAman
Patelaman.patel@westwicke.com
MediaEvolveMKDsientra@evolvemkd.com
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