The Spectranetics Corporation (Nasdaq:SPNC) today announced it is
accelerating investments in the Stellarex drug-coated balloon
angioplasty (DCB) platform for treatment of Below the Knee (BTK)
peripheral artery disease. The Company estimates this will
represent a $150 million market opportunity by 2020.
"Our team and global thought leaders believe the Stellarex DCB
platform is ideally suited to treat BTK disease," said Scott Drake,
President and CEO. "Accelerating this investment amplifies and
elongates the impact of our powerful DCB program. Stellarex, in
combination with our crossing solutions and laser atherectomy,
establishes a comprehensive portfolio to treat peripheral artery
disease (PAD) generally and critical limb ischemia (CLI) patients
specifically."
Spectranetics estimates that treatment of BTK disease will
become a meaningful segment of the global market for drug-coated
balloons, representing a potential market opportunity of $150
million. The Company anticipates the global market for DCBs to
reach between $700 million and $1 billion over the next seven
years. Spectranetics is targeting CE mark approval for the
Stellarex DCB BTK platform in the second half of 2016.
"Wound healing is always a concern in the treatment of BTK
disease. Robust patency and coating stability with minimal flaking
is critical in those situations," said William Gray, MD, Columbia
University Medical Center, New York. "The Stellarex DCB was
designed to optimize drug delivery to the treatment site while
minimizing downstream drug loss through the unique coating formula
and manufacturing process. The unique coating coupled with the
strong clinical data on the Stellarex DCB platform set the stage
for an ideal application in treatment of BTK disease."
The acceleration of the investment in the BTK program is
expected to represent an incremental $5 to $6 million of product
development, regulatory and clinical expense in 2015. The Company
expects to commence enrollment in an Investigational Device
Exemption (IDE) clinical trial in the US in mid-2016. The
commencement of the IDE trial is conditioned upon receipt of
regulatory approval from the FDA.
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. It is not approved for use in the United States.
About Spectranetics
SPNC develops, manufactures, markets and distributes 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(R) 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.
Safe Harbor Statement
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 and net loss. 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
inability to compete with larger companies in our highly
competitive industry, inability to successfully penetrate our
target markets and develop new products for those markets,
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, inability to
meet projected development or commercialization goals, inability to
return to profitability, significant costs related to the
acquisitions of AngioScore and the Stellarex platform, 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 2014 Annual Report
on Form 10-K. 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: COMPANY CONTACT
The Spectranetics Corporation
Guy Childs, Chief Financial Officer
(719) 633-8333
INVESTOR CONTACT
Westwicke Partners
Lynn Pieper
(415) 202-5678
lynn.pieper@westwicke.com
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