Commercial Sale of U.S.-Manufactured OPUS™
Branded Breast Implants to Begin Immediately
Sientra, Inc. (NASDAQ:SIEN) (“Sientra” or the “Company”), a medical
aesthetics company, today announced U.S. Food and Drug
Administration (FDA) approval of the Company’s PMA supplement
allowing commercialization of its OPUS-branded breast implant
products manufactured by Vesta, a Lubrizol LifeSciences company, at
Vesta’s Wisconsin-based manufacturing facility.
Jeffrey M. Nugent, Chairman and Chief Executive
Officer of Sientra, commented, “This FDA approval allows us to
commercialize our OPUS-branded breast implants with an improved
manufacturing process and represents a critical milestone for
Sientra. The approval culminates over two years of successful
collaboration between the Sientra and Vesta teams. We now
once again have access to a supply of implants to support our plan
to regain and grow share in the U.S. breast implant market for both
augmentation and reconstruction. Our decision to manufacture
finished goods product prior to approval has positively positioned
us to begin meeting customer demand immediately. We will
continue our precision-controlled selling strategy through the
first half of 2018 as the new Vesta facility scales its
manufacturing to full supply capabilities, which we anticipate will
occur during the second half of this year."
Mr. Nugent added, “As Sientra continues to
expand into categories beyond breast surgery, we decided to rebrand
our breast products with a name that symbolizes what they
represent. We chose the name Sientra OPUS, the only brand of
silicone gel breast implants and tissue expanders marketed
exclusively to board-certified plastic
surgeons. OPUS signifies an artist’s best body of work and
for our brand, the name evokes excellence, quality, performance and
artistry. We believe our OPUS products provide the true
artists with the best tools available to achieve optimal
results.”
Mr. Nugent concluded, “Since October 2015, the
entire Sientra team has been determined to overcome each successive
challenge stemming from our former Brazilian manufacturer. With
today’s FDA approval, we have closed the final chapter of our
transition and positioned the Company with a diversified portfolio
of differentiated products to capitalize on significant market
opportunities for each of our two core businesses. Overall,
we are now poised to continue executing an integrated commercial
aesthetics strategy. In the immediate term, we will be
leveraging the American Society for Aesthetic Plastic Surgery
(ASAPS) annual meetings held later this month to showcase each of
our brands. Looking further ahead, we expect 2018 to be another
pivotal year in which we deliver meaningful incremental value to
our customers, patients, and shareholders.”
With this FDA approval, Sientra has gained
access to an additional $10.0 million tranche of term debt under
its credit facility with MidCap Financial Services and Silicon
Valley Bank.
About Sientra
Headquartered in Santa Barbara, California,
Sientra is a medical aesthetics company committed to making a
difference in patients’ lives by enhancing their body image,
growing their self-esteem and restoring their confidence. The
Company was founded to provide greater choice to board-certified
plastic surgeons and patients in need of medical aesthetics
products. The Company has developed a broad portfolio of products
with technologically differentiated characteristics, supported by
independent laboratory testing and strong clinical trial outcomes.
The Company sells its OPUS™ brand of breast implants and breast
tissue expanders exclusively to board-certified and
board-admissible plastic surgeons and tailors its customer service
offerings to their specific needs. The Company also offers a
range of other aesthetic and specialty products including
BIOCORNEUM®, the professional choice in scar management, and
miraDry®, the only FDA-cleared device to reduce underarm sweat,
odor and permanently reduce hair of all colors.
About MidCap Financial
MidCap Financial is a middle market-focused,
specialty finance firm that provides senior debt solutions to
businesses across all industries. The firm’s years of experience,
strong balance sheet, and flexibility make it a lender of choice
for companies across all stages of growth and complexity. MidCap
Financial’s debt solutions focus in five areas: (i) General and
Healthcare Asset-Based working capital loans collateralized by
third-party accounts receivable and other assets, (ii) Leveraged
loans to companies backed by private equity sponsors, (iii) Life
Sciences loans to VC-backed and public pharmaceutical, biotech, and
medical device companies, (iv) Real Estate loans on all types of
commercial properties, medical office buildings, various types of
senior housing and skilled nursing properties, and (v) Lender
Finance term loans or revolvers provided across the consumer and
commercial finance sectors. Additional information about MidCap
Financial can be found at www.midcapfinancial.com.
About Silicon
Valley Bank
For more than 30 years, Silicon Valley
Bank (SVB) has helped innovative companies and their investors
move bold ideas forward, fast. SVB provides targeted financial
services and expertise through its offices in innovation centers
around the world. With commercial, international and private
banking services, SVB helps address the unique needs of innovators.
Learn more at svb.com.
Forward Looking StatementsThis
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 regain share in
the U.S. breast implant market, the Company’s ability to meet
customer demand, the timing for relaunch of the Company’s breast
implants, the expected growth of the Company’s current customer
base and acquisition of new customers, the Company’s ability to
deliver value and become a world class, diversified aesthetics
organization, and the Company’s ability to finance its near and
long-term strategic growth initiatives. Such statements are subject
to risks and uncertainties, including positive reaction from
plastic surgeons and their patients to Sientra’s breast products,
risks associated with contracting with any third-party manufacturer
and supplier, including uncertainties that such parties will be
able to meet consumer demand, that the integration of recently
acquired product lines will not achieve the anticipated benefits,
and the ability to obtain additional capital on acceptable
terms. 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 Annual Report on
Form 10-K for the year ended December 31, 2017. 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 Contacts:
Patrick F. WilliamsSientra, Chief Financial
Officer (619) 675-1047patrick.williams@sientra.com
Tram Bui / Brian JohnstonThe Ruth Group(646)
536-7035 / (646) 536-7028IR@sientra.com
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