The Spectranetics Corporation (NASDAQ:SPNC) announced today that it
has submitted to the Food & Drug Administration (FDA) its
Pre-Market Approval (PMA) application for the Stellarex drug-coated
angioplasty balloon (DCB). Stellarex is designed to restore and
maintain blood flow to the superficial femoral and popliteal
arteries in patients with peripheral arterial disease (PAD).
“The Stellarex DCB has been studied extensively in two
randomized controlled trials as part of the rigorous ILLUMENATE
series that enrolled more than 1,100 patients,” said Amanda
Johnson, Vice President of Regulatory and Medical Affairs. “Key
opinion leaders have called the results reported to date
‘remarkable,’ especially in light of Stellarex’s low drug
concentration. This PMA application marks a unique and important
milestone in the future landscape of treating patients with
PAD.”
President and CEO Scott Drake said, “Stellarex has been called a
no-compromise solution with its low drug dosage and top-tier
efficacy. The PMA application embodies our commitment to leading
the way in clinical science by providing proven treatment
algorithms backed by robust clinical evidence. We are preparing
diligently for our launch into the United States market, which we
anticipate in the second half of 2017, and are looking forward to
improving patient care with this next-generation device.”
Spectranetics launched Stellarex in Europe in January 2015.
Stellarex uses EnduraCoat™ technology, a durable, uniform coating
designed to prevent drug loss during transit and facilitate
controlled, efficient drug delivery to the treatment site. It is
not for sale in the United States.
Stellarex enhances Spectranetics’ diversified suite of clinical
solutions to treat complex cardiovascular conditions and expands
its market opportunity in the projected $1 billion global DCB
market.
About the ILLUMENATE Clinical Program
There are five ILLUMENATE clinical studies evaluating the safety
and efficacy of the Stellarex DCB platform and support United
States and Canadian regulatory filings.
- The ILLUMENATE First-In-Human (FIH) Study was a non-randomized,
multi-center study that enrolled 80 patients. In the pre-dilatation
arm (n=50), the primary patency rate at was 89.5% at 12 months and
80.3% at 24 months.
- The ILLUMENATE Pharmacokinetic Study measured the Paclitaxel
drug levels in the blood of 25 patients enrolled at two sites.
- The ILLUMENATE EU Randomized Trial is a prospective, randomized
controlled, multi-center trial with 328 patients enrolled at 18
sites. The primary safety and effectiveness endpoints were met and
superiority over PTA was demonstrated in both. The 12-month primary
patency rate was 89.0% vs. 65.0% in the PTA arm (p<0.001).
- The ILLUMENATE Global study is a prospective, multi-center,
single-arm study with 371 patients enrolled. Interim data on the
first 220 subjects showed a primary patency rate of 86.5% at 12
months.
- The ILLUMENATE Pivotal Study is a prospective, randomized
controlled, multi-center trial with 300 patients enrolled at 43
sites to support U.S. FDA approval.
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. 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 prospects for the Stellarex Drug-coated
Balloon, 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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