The Spectranetics Corporation (NASDAQ:SPNC) today announced that
Dr. Sean Lyden presented the final 12-month results of the
Stellarex Drug-coated Balloon (DCB) ILLUMENATE Pivotal Trial at the
Transcatheter Cardiovascular Therapeutics (TCT) conference in
Washington, D.C. The ILLUMENATE Pivotal Trial’s Co-Principal
Investigators are Dr. Lyden, of the Cleveland Clinic, and Dr.
Prakash Krishnan of Mount Sinai in New York.
Dr. Krishnan stated, “First-generation drug-coated balloons
forced us to make a choice between top-tier clinical outcomes and
the potential safety advantages of a lower drug dose. Based on the
compelling Stellarex DCB study results, we no longer need to
compromise. In the most challenging patient population studied in a
DCB Investigational Device Exemption trial, the next-generation
Stellarex DCB achieved remarkable clinical outcomes. I am very
excited these results could be obtained given the high proportion
of severely calcified lesions and co-morbidities.”
The ILLUMENATE Pivotal Trial enrolled 300 patients, all of whom
were randomized to treatment with the Stellarex DCB or a
percutaneous transluminal angioplasty (PTA). This patient cohort
represents the most complex patient population studied in a DCB IDE
trial, when considering co-morbidities for the DCB arm included
high rates of severe calcification (43.9%), diabetes (49.5%), renal
insufficiency (18.0%), and cardiovascular disease (45.0%). The key
results, per Kaplan-Meier survival estimates, at day 365
include:
- Primary patency was 82.3% for the DCB group and 70.9% for the
PTA group.
- Freedom from clinically-driven target lesion revascularization
(CD-TLR) was 93.6% for the DCB group and 87.3% for the PTA
group.
- The trial met its primary safety and effectiveness endpoints
and demonstrated superiority to PTA on both.
The ILLUMENATE Pivotal Trial is the second randomized controlled
trial to study the Stellarex DCB. The ILLUMENATE European
Randomized Control Trial reported a 12-month Kaplan-Meier primary
patency rate of 89.0% for the DCB arm vs. 65.0% in the PTA arm.
When the DCB cohort data from both randomized trials is pooled, the
Kaplan-Meier primary patency rate is 86.0% and the CD-TLR rate is
94.2%.
“Severe calcification has been viewed as the Achilles heel of
drug-coated balloons. Our U.S. Pivotal Trial data provides
compelling evidence that Stellarex achieves top-tier patency even
in very complex patients. These outcomes are a significant step
forward in our effort to improve patient care and lead the way in
clinical science,” said Scott Drake, President and CEO.
The ILLUMENATE Pivotal Trial 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.
As previously announced, the company will host a webcast to
discuss the study results with Dr. Krishnan and Dr. Lyden at 10 am
Eastern Standard Time today. You may view the webcast via the
investor relations portion of Spectranetics’ website at
http://www.spectranetics.com/investor-relations/investor-events.
About the Stellarex Drug-coated Balloon
Platform
The Stellarex 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. Spectranetics launched the device in Europe in
January 2015. It is not available for sale in the U.S.
Commercialization in the U.S. is anticipated in the second half of
2017.
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. There are four ILLUMENATE
clinical studies in addition to the ILLUMENATE Pivotal 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 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.
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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