The Spectranetics Corporation (NASDAQ:SPNC) today announced that
its Stellarex™ 0.014” Drug-coated Angioplasty Balloon (DCB) has
received the CE mark. The Stellarex 0.014” device is designed to
treat small vessels, below-the-knee disease, and challenging
critical limb ischemia (CLI) in patients. The combination of
the currently available Stellarex 0.035” and the new 0.014” line
available in Europe expands Spectranetics’ comprehensive portfolio
of next generation DCBs to treat complex disease states across the
lower extremities.
CLI afflicts over 3 million people in the United States and
Europe. The critical unmet need of this complex patient population
is inhibition of restenosis, which commonly occurs within three to
six months of treatment and can lead to high rates of non-wound
healing, re-intervention, and amputation.
"Now available on a 0.014” balloon platform, Stellarex
represents a latest generation DCB backed by compelling evidence in
the fem-pop arteries. It holds strong promise to deliver safety and
efficacy in the notoriously challenging infrapopliteal district,”
said Professor Dierk Scheinert of Universitätsklinikum in Leipzig,
Germany.
President and CEO Scott Drake stated, "Spectranetics is
committed to providing specialized and innovative tools and
compelling clinical data to improve our patients’ quality of life.
Stellarex 0.014” exemplifies these important elements and augments
our existing product portfolio, which now includes clinically
differentiated treatment for both above and below the knee disease.
The Stellarex 0.014” DCB is a significant advancement in our effort
to eradicate restenosis and amputation.”
About Spectranetics
The Spectranetics Corporation develops, manufactures, markets
and distributes medical devices used in minimally invasive
procedures within the cardiovascular system. The Company's products
are available in over 65 countries and are used to treat arterial
blockages in the heart and legs and in the removal of pacemaker and
defibrillator leads.
The Company's Vascular Intervention (VI) products include a
range of laser catheters for ablation of blockages in arteries
above and below the knee, the AngioSculpt scoring balloon used in
both peripheral and coronary procedures, and the Stellarex
drug-coated balloon peripheral angioplasty platform, which received
European CE mark approval in December 2014. Stellarex is not
available for sale in the United States. The Company also markets
support catheters to facilitate crossing of peripheral and coronary
arterial blockages, and retrograde access and guidewire retrieval
devices used in the treatment of peripheral arterial blockages,
including chronic total occlusions. The Company markets aspiration
and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser
sheaths, dilator sheaths, mechanical sheaths and accessories for
the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. You can identify these statements
because they do not relate strictly to historical or current facts.
Such statements may include words such as “anticipate,” “will,”
“estimate,” “expect,” “look forward,” “strive,” “project,”
“intend,” “should,” “plan,” “believe,” “hope,” “enable,”
“potential,” and other words and terms of similar meaning in
connection with any discussion of, among other things, future
operating or financial performance, strategic initiatives and
business strategies, clinical trials and regulatory approvals,
regulatory or competitive environments, outcome of litigation, our
intellectual property and product development. These
forward-looking statements include, but are not limited to,
statements regarding our competitive position, product development
and commercialization schedule, expectation of continued growth and
the reasons for that growth, growth rates, strength, integration
and product launches, and 2016 outlook and projected results
including projected revenue and expenses, net loss and gross
margin. Such statements are based on current assumptions that
involve risks and uncertainties that could cause actual outcomes
and results to differ materially. You are cautioned not to place
undue reliance on these forward-looking statements and to note they
speak only as of the date of this presentation. These risks and
uncertainties may include financial results differing from
guidance, increasing competition and consolidation in our industry,
the impact of rapid technological change, slower revenue growth and
losses, inability to successfully integrate AngioScore and
Stellarex into our business and the inaccuracy of our assumptions
regarding AngioScore and Stellarex, market acceptance of our
technology and products, our inability to manage growth, increased
pressure on expense levels resulting from expanded sales,
marketing, product development and clinical activities, uncertain
success of our strategic direction, dependence on new product
development and successful commercialization of new products, loss
of key personnel, uncertain success of or delays in our clinical
trials, costs of and adverse results in any ongoing or future legal
proceedings, adverse impact to our business of healthcare reform
and related legislation and regulations, including changes in
reimbursements, adverse conditions in the general domestic and
global economic markets and volatility and disruption of the credit
markets, our inability to protect our intellectual property and
intellectual property claims of third parties, availability of
inventory and components from suppliers, adverse outcome of FDA
inspections, including FDA warning letters and any remediation
efforts, the receipt of FDA clearance and other regulatory
approvals to market new products or applications and the timeliness
of any clearance and approvals, product defects or recalls and
product liability claims, cybersecurity breaches, ability to
manufacture sufficient volumes to fulfill customer demand, our
dependence on third party vendors, suppliers, consultants and
physicians, unexpected delays or costs associated with any planned
improvements to our manufacturing processes, risks associated with
international operations, lack of cash necessary to satisfy our
cash obligations under our outstanding 2.625% Convertible Senior
Notes due 2034 and our term loan and revolving loan facilities, our
debt adversely affecting our financial health and preventing us
from fulfilling our debt service and other obligations, and share
price volatility due to the initiation or cessation of coverage, or
changes in ratings, by securities analysts. For a further list and
description of such risks and uncertainties that could cause our
actual results, performance or achievements to materially differ
from any anticipated results, performance or achievements, please
see our previously filed SEC reports, including those risks set
forth in our 2015 Annual Report on Form 10-K and our Quarterly
Report on Form 10-Q for the three months ended September 30, 2016.
We disclaim any intention or obligation to update or revise any
financial or other projections or other forward-looking statements,
whether because of new information, future events or otherwise.
Investor Relations Contacts
Zach Stassen
Sr. Director of Finance
zach.stassen@spnc.com
(719) 447-2292
Michaella Gallina
Director of Investor Relations
michaella.gallina@spnc.com
(719) 447-2417
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