The Spectranetics Corporation (NASDAQ:SPNC) today announced that
Dr. Prakash Krishnan of Mount Sinai Medical Center, New York, NY
presented the second interim analysis of 12-month data from the
ILLUMENATE Global Study at the New Cardiovascular Horizons annual
conference in New Orleans, Louisiana. The ILLUMENATE Global Study
is a prospective, multicenter, single-arm study designed to assess
the clinical performance of the Stellarex™ drug-coated balloon
(DCB) in the superficial femoral and popliteal arteries.
Interim results from 220 patients (247 lesions) of the 371
patients enrolled demonstrated a primary patency rate of 90.3% at
day 360 and 86.5% at day 365. Primary patency is a key and
objective indicator of clinical effectiveness. Freedom from
clinically-driven TLR was 93.9% at both day 360 and 365. These
interim results, which include a larger number of patients, are
consistent with the initial ILLUMENATE Global 12-month interim
analysis and the ILLUMENATE First-In-Human Study results.
“The patency rates from this interim data are top-tier and
compare well with the highest DCB patency rates in comparable
clinical studies. The fact that these results were achieved with a
low-dose DCB is especially compelling. This analysis supports the
promising data generated in the First-In-Human study, and I look
forward to seeing the randomized data later this year,” said Dr.
Krishnan.
“Spectranetics is committed to providing our customers with
robust, high quality clinical data in a timely manner to facilitate
evidence-based decisions. We are proud to have collaborated with
some of the top opinion leaders in the United States and Europe,
and are pleased that the second interim analysis supports our
top-tier ILLUMENATE First-in-Human Study data,” said Scott Drake,
President and CEO.
The ILLUMENATE Global Study is being conducted with a high level
of rigor including angiographic and duplex ultrasound core lab
assessments, as well as an independent clinical events committee
(CEC) to adjudicate adverse events.
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 ILLUMENATE Global Study
The ILLUMENATE Global Study is a prospective, single-arm,
multicenter study that enrolled 371 patients at 37 centers in
Europe, Australia and New Zealand. This study is being conducted
with a high level of rigor to ensure data is unbiased and accurate.
Oversight includes review by angiographic and duplex ultrasound
core laboratories, monitoring of all data and oversight by a
clinical events committee and a data safety monitoring board.
Follow-up assessments include a duplex ultrasound for patency
assessment, functional outcome questionnaires (EQ-5D and WIQ), an
ABI and RCC assessment, and adverse event evaluations. Patients
will be followed for up to five years.
About ILLUMENATE Clinical Trials
There are five clinical studies evaluating the safety and
effectiveness of the Stellarex DCB platform and support United
States and Canadian regulatory filings. There are four ILLUMENATE
clinical studies in addition to the ILLUMENATE Global Study
described above:
- The ILLUMENATE First-In-Human (FIH) Study was a non-randomized,
multicenter study that enrolled 80 patients. In the pre-dilatation
arm (n=50), the primary patency rate at 12 months was 89.5% and
80.3% at 24 months. The freedom from clinically driven target
lesion revascularization rate at 12 months was 90.0% and 85.8% 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, multicenter 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 European Randomized Trial is a prospective,
randomized controlled, multicenter trial with 328 patients enrolled
at 18 sites. Results are expected to be released later this
year.
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 news 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 news release. 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, 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 March 31, 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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