The Spectranetics Corporation (NASDAQ:SPNC), (“the Company”) today
announced that Professor Thomas Zeller presented the final 12-month
results of the Stellarex Drug-coated Balloon (DCB) ILLUMENATE
Global Study at the Leipzig Interventional Course (LINC) in
Leipzig, Germany. 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.
“In a real-world setting, ILLUMENATE Global validates the
earlier ILLUMENATE US Pivotal results, achieving best-in-class
12-month primary patency rates in a patient cohort with the highest
rate of severe calcium yet studied. These results are significant
because severe calcium has been one of the greatest challenges in
our DCB practice,” said Professor Zeller.
The ILLUMENATE Global Trial enrolled 371 patients. The treated
lesions were highly complex, including a high proportion of chronic
total occlusions (31%) and severe calcification (41%), as reported
by an independent angiographic core-laboratory. The key results,
per Kaplan-Meier survival estimates at day 365 include:
- Primary patency was 81.4%
- Freedom from clinically-driven target lesion revascularization
(CD-TLR) was 94.8%
Scott Drake, President and CEO, stated, “At Spectranetics we aim
to lead the way in clinical science, and are proud to have the only
DCB with proven results in complex patients. As KOLs have stated,
Stellarex is a next-generation DCB providing top-tier efficacy with
a low drug dose.”
The ILLUMENATE Global Study was conducted with the highest level
of rigor to ensure accuracy and reliability of the data.
The Stellarex DCB enhances Spectranetics’ diversified suite of
clinical solutions to treat complex cardiovascular conditions and
expands its market opportunity in the projected $1 billion DCB
global market.
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 Global Study
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 Pivotal Study is a prospective, randomized
controlled, multicenter trial with 300 patients enrolled at 43
sites to support U.S. FDA approval. The primary safety and
effectiveness endpoints were met and superiority over PTA was
demonstrated in both. With the most complex patient
population ever studied in a DCB SFA IDE trial, the 12-month
primary patency rate was 82.3% at 12 months. 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%).
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 and 2017 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 release. These risks and
uncertainties may include financial results differing from
guidance, inability to successfully integrate AngioScore and
Stellarex into our business, market acceptance of excimer laser
atherectomy technology and our vascular intervention and lead
management products, 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, increasing price
and product competition, 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, loss of key personnel,
uncertain success of or delays in our clinical trials, costs of and
adverse results in any ongoing legal proceeding, or any legal
proceeding in which we may become involved, adverse impact to our
business of the health care reform and related legislation or
regulations, including changes in reimbursements, continued or
worsening adverse conditions in the general domestic and global
economic markets and continued volatility and disruption of the
credit markets, which affects the ability of hospitals and other
health care systems to obtain credit and may impede our access to
capital, intellectual property claims of third parties,
availability of inventory 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, market acceptance of new products
or applications, product defects, ability to manufacture sufficient
volumes to fulfill customer demand, availability of vendor-sourced
components at reasonable prices, unexpected delays or costs
associated with any planned improvements to our manufacturing
processes, 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 Reports on Form 10-Q. 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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