The Spectranetics Corporation (Nasdaq:SPNC) today announced it has
completed the acquisition of Covidien's Stellarex™ drug coated
balloon angioplasty (DCB) platform. The transaction closed after
the acquisition of Covidien by Medtronic.
The Stellarex DCB platform received European CE mark approval in
December 2014. Spectranetics launched the product in Europe today,
with U.S. commercialization anticipated in the 2017 timeframe,
following FDA approval.
"This transaction meaningfully enhances Spectranetics'
portfolio," said Scott Drake, President and CEO, Spectranetics.
"Stellarex is an ideal strategic fit, complementing our suite of
highly differentiated cardiovascular clinical solutions designed to
enable physicians to cross, prepare and treat the most complex
vascular disease. We are excited to have the Stellarex team become
part of SPNC. They are an incredible asset and we are proud to
advance their work as we continue with the ILLUMENATE clinical
trials and product launch."
About the Stellarex DCB Platform
The Stellarex DCB platform is designed to treat peripheral
arterial disease. 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. The Stellarex DCB platform received CE mark to be marketed in
the European Union in December 2014. It is not approved in the
United States, and is currently limited to investigational use.
About ILLUMENATE First-in-Human (FIH) Study
Data from the ILLUMENATE FIH Study was reported at the EuroPCR
Scientific Congress in May 2014. The ILLUMENATE FIH Study is a
prospective, multi-center, single-arm study designed to assess the
clinical performance of the Stellarex DCB. In the study, 58
superficial femoral and/or popliteal lesions (up to 15 cm in
length) in 50 patients were pre-dilated with an uncoated
angioplasty balloon, followed by treatment with the Stellarex DCB.
Clinical events were adjudicated by independent angiographic and
sonographic core laboratories. The study found the Stellarex DCB to
be safe, with durable results to 12 months, including:
- Primary patency (defined as the treated artery remaining open
without further treatment required or renewed blockage detected by
ultrasound scanning) was 89.5 percent at 12 months.
- Freedom from clinically driven target lesion revascularization
through 12-month follow-up was 87.9 percent.
- No amputations or cardiovascular deaths were reported.
About ILLUMENATE Clinical Trials
The Stellarex DCB platform is being studied in an active
Investigational Device Exemption (IDE) trial in the United States
and internationally. There are four active ILLUMENATE clinical
trials in addition to the First-in-Human ILLUMENATE trial,
described above:
- ILLUMENATE Pharmacokinetic Study – to evaluate the drug levels
in the blood; 25 patients to be enrolled at up to two sites
- ILLUMENATE Pivotal Trial – randomized trial to support PMA in
the United States; up to 360 patients to be enrolled at 45
sites
- ILLUMENATE European Randomized Trial – similar to the U.S.
Pivotal Trial; up to 360 patients to be enrolled at 30 sites
- ILLUMENATE Global Registry – non-randomized; up to 500 patients
to be enrolled at 65 sites
These five clinical trials will be used to evaluate the safety
and effectiveness of the Stellarex DCB platform and support United
States and Canada regulatory approval.
About Spectranetics
SPNC develops, manufactures, markets and distributes single-use
medical devices used in minimally invasive procedures within the
cardiovascular system. The Company's products are sold 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 as well as the AngioSculpt® scoring
balloon used in both peripheral and coronary procedures. 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.
Spectranetics' Cautionary Statement Regarding
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and 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, regulatory or competitive
environments, our intellectual property and product development.
These forward-looking statements include, but are not limited to,
statements regarding our expectation of continued growth and
strength and the reasons for that growth, growth rates, strength,
and outlook including projected revenue, net loss and Adjusted
EBITDA. 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 the
Stellarex platform into our business, market acceptance of excimer
laser atherectomy technology and our vascular intervention and lead
removal products, market acceptance of drug coated balloon
technology, 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, 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 approval to market
new products or applications and the timeliness of any 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 2013 Annual Report on Form 10-K and our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2014. 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.
CONTACT: The Spectranetics Corporation
Guy Childs, Chief Financial Officer
(719) 633-8333
guy.childs@spnc.com
Westwicke Partners
Lynn Pieper
(415) 202-5678
lynn.pieper@westwicke.com
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