Sientra® Issues Statement in Response to FDA Post-Approval Study Warning Letter
March 20 2019 - 4:26PM
Sientra, Inc. (NASDAQ: SIEN), a medical aesthetics company
(“Sientra" or the “Company”), today announced it has provided an
initial response to the U.S. Food and Drug Administration (“FDA”)
related to a post-approval study Warning Letter issued on March 19,
2019 and will provide a comprehensive plan for compliance to FDA
within 15 days. The Company also issued the following statement:
Sientra takes this matter seriously and will take all necessary
steps to address the topic of the Warning Letter issued by the FDA
for one of the Company’s post-approval studies. We are working to
fully address the points noted with our study’s participant
retention, including patient questionnaire completion and
additional follow-up office visits. We have employed numerous
methods to encourage patient participation and look forward to
continuing to work collaboratively with the FDA for a prompt
resolution.
Our primary focus has always been, and continues to be,
upholding the highest levels of patient safety. Importantly, the
totality of our clinical and real-world data, including our 10-year
Post-Approval Cohort Study (PACS) which included almost 1,800
participants and fully met FDA’s compliance requirements, has
confirmed the long-term safety and effectiveness of our products.
Our peer-reviewed, open-label PACS study is the largest silicone
gel breast implant pivotal trial that has occurred in our industry
to date.
Sientra looks forward to discussing its plans to achieve
compliance at the FDA’s General and Plastic Surgery Devices Panel
meeting scheduled for March 25-26, 2019.
As a clinically-driven company, Sientra continues to be a
leading contributor of physician education and awareness around
breast implant safety, and the Company’s mission is to provide
board-certified plastic surgeons, patients and regulatory officials
with balanced, evidence-based information.
The Company noted it believes this matter will not have an
adverse impact on its ongoing business or operations.
About SientraHeadquartered 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, comprises
its miraDry® system, which is approved for sale in over 40
international markets, and is the only non-invasive FDA-cleared
device for the permanent reduction of underarm sweat, odor and hair
of all colors.____________________(*) 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 include, but are not limited to, statements regarding
the Company’s ability to fully address the topics raised in the
FDA’s Warning Letter, the Company’s plans to achieve compliance
with the topics raised in the FDA’s Warning Letter, and the impact
of the FDA’s Warning Letter on the Company’s ongoing business or
operations. Such statements are subject to risks and uncertainties,
including the dependence on conclusion of the audit procedures for
the year ended December 31, 2018 by the Company’s independent
auditors, positive reaction from plastic surgeons and their
patients to Sientra’s Breast Products, the ability to meet consumer
demand, the acceptance and growth of its miraDry segment.
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,’’ 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. 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.
Investor Contact: Neil
Bhalodkar805-679-8845ir@sientra.com
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