The Spectranetics Corporation (NASDAQ:SPNC) today announced that
Professor Marianne Brodmann of Medical University Graz, Austria,
presented the final 12-month results of the Stellarex Drug-coated
Balloon ILLUMENATE European Randomized Clinical Trial (EU RCT) at
the Amputation Prevention Symposium (AMP) in Chicago, Illinois. The
EU RCT Trial enrolled 328 patients, 295 of whom were randomized to
treatment with the Stellarex drug-coated balloon (DCB) or a
percutaneous transluminal angioplasty (PTA). The key results
at day 365 include:
- Primary patency, per Kaplan-Meier survival estimates, was 89.0%
for the DCB group and 65.0% for the PTA group. Primary
patency means a restoration of adequate blood flow through the
treated segment of the diseased artery.
- Freedom from clinically-driven target lesion revascularization
(CD-TLR), per Kaplan-Meier survival estimates, was 94.8% for the
DCB group and 85.3% for the PTA group. Freedom from CD-TLR is a
measure of repeat procedures due to loss of adequate blood flow and
recurrent symptoms related to the treated lesion.
Dr. Henrik Schöder, the trial’s National Principal Investigator
from Jewish Hospital in Berlin, Germany, said, “The Stellarex DCB
produced outstanding results in this rigorous trial, validating its
earlier First-in-Human and interim ILLUMENATE Global studies. These
consistent, high quality outcomes are achieved with a low dose drug
balloon, making this device especially compelling. Physicians now
have a powerful tool to prevent restenosis and improve their
patients’ quality of life.”
The EU RCT Study was conducted with the highest level of rigor
to ensure accuracy and reliability of the data. Independent,
blinded third parties included a clinical events committee and
angiographic and duplex ultrasound core laboratories to assess
diagnostic images and outcomes.
“While results clearly show a highly significant gain compared
to PTA, they favorably match the highest rates of primary patency
with a low drug dose,” said Professor Brodmann. “It is very
encouraging for us physicians to observe such a tremendous
evolution in DCB technologies and appreciate how low-dose and
highly stable coatings such as Stellarex can achieve and beat such
high clinical performance benchmarks while offering excellent
deliverability and tractability.”
Scott Drake, President and CEO, stated, “Spectranetics is
committed to leading the way in clinical science to provide
patients and customers with proven treatment algorithms. We are
pleased that the Stellarex DCB achieved top-tier results in its
first randomized trial, and value our customer and key opinion
leader feedback that Stellarex is a next generation device.”
The Stellarex DCB is designed to restore and maintain blood flow
to the superficial femoral and popliteal arteries in patients with
peripheral arterial disease. Spectranetics launched the device in
Europe in January 2015, with U.S. commercialization anticipated in
the 2017 timeframe.
About the Stellarex Drug-coated Balloon
Platform
The Stellarex drug-coated balloon (DCB) platform is designed to
treat peripheral arterial disease. The Stellarex DCB uses
EnduraCoat™ technology, a durable, uniform coating designed to
prevent drug loss during transit and facilitate controlled,
efficient drug delivery to the treatment site. The Stellarex DCB
platform received CE mark to be marketed in the European Union in
December 2014. It is not for sale in the United States.
Spectranetics looks forward to releasing additional analysis on the
Stellarex DCB later this year.
About the ILLUMENATE Clinical Program
There are five clinical studies evaluating the safety and
efficacy of the Stellarex DCB platform and support United States
and Canadian regulatory filings. There are four ILLUMENATE clinical
studies in addition to the ILLUMENATE EU RCT Trial described
above:
- 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 Pivotal Study is a prospective, randomized
controlled, multi-center trial with 300 patients enrolled at 43
sites to support U.S. FDA approval. Results are expected to be
released later this year.
- 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. Final data are expected to be released in early
2017.
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
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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
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inspections, including FDA warning letters and any remediation
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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
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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
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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 June 30, 2016. We
disclaim any intention or obligation to update or revise any
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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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