The Spectranetics Corporation (NASDAQ:SPNC) today announced receipt
of U.S. Food and Drug Administration (FDA) Pre-Market Approval
(PMA) of the Stellarex™ drug-coated balloon (DCB), designed to
restore and maintain blood flow to the superficial femoral and
popliteal arteries in patients with peripheral arterial disease
(PAD).
“The Stellarex DCB has shown safety and efficacy in a cohort of
patients which included a higher preponderance of diabetics and
core-lab defined severely calcified lesions in the US IDE trial.
These results, in combination with the cohort of patients studied
in the European Randomized Controlled Trial, demonstrate the
Stellarex DCB is safe and effective in diverse patient populations
when addressing symptomatic femoropopliteal disease,” stated Dr.
Prakash Krishnan, ILLUMENATE Pivotal Trial’s Co-Principal
Investigator, Mount Sinai in New York.
Dr. Sean Lyden, ILLUMENATE Pivotal Trial’s Co-Principal
Investigator, Cleveland Clinic, Cleveland, Ohio added, “The
ILLUMENATE Pivotal Trial treated a challenging patient population
with a low paclitaxel drug dose. When considering options, I
think most clinicians would prefer to use a lower drug dose if they
can also achieve great patency results.”
Throughout the ILLUMENATE Trial Series, Stellarex DCB’s
EnduraCoat™ Technology demonstrates both safety and efficacy with
consistently high patency rates and low clinically driven target
lesion revascularization rates in a range of lesion complexities
and patient co-morbidities. The device offers both hybrid
paclitaxel crystallinity and a durable excipient to provide
efficient drug transfer, effective drug residency with high coating
durability and minimal particulate loss.
“The Stellarex DCB delivers top-tier clinical results for common
to complex patients. As the only commercially available DCB with
two reported randomized controlled trials, Stellarex has
demonstrated durability with consistently high patency rates in a
wide range of patients," said Scott Drake, President and CEO,
Spectranetics. "Our customers refer to Stellarex as a no-compromise
solution. This next generation DCB provides proven treatment backed
by robust clinical evidence.”
“Spectranetics is a provider of proven solutions to manage the
challenges of crossing lesions, preparing vessels, and treating
even the most complex coronary and peripheral lesion morphologies.
We are always focused on better patient care, and with today’s FDA
approval, the Stellarex DCB becomes a formidable competitor in the
drug-coated balloon market, and a proven solution for those
suffering with PAD,” said Scott Hutton, Sr. Vice President &
General Manager, Spectranetics.
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 ILLUMENATE Clinical
Program
There are five ILLUMENATE clinical studies evaluating the safety
and efficacy of the Stellarex DCB platform and supporting United
States regulatory filings:
- The ILLUMENATE EU Randomized Study is a prospective, randomized
controlled, multi-center trial with 328 patients. The primary
safety and effectiveness endpoints at 12 months were met and
superiority over PTA was demonstrated in both. The 12-month
primary patency rate was 83.9% (188/224) in the Stellarex arm vs.
60.6% (40/66) in the PTA arm (P<0.001), per Kaplan Meier (KM)
estimate the patency rate at day 365 was 89.0% vs. 65.0%,
respectively (log-rank p<0.001).
- The ILLUMENATE Pivotal Study is a prospective, randomized
controlled, multi-center trial with 300 patients enrolled.
The cohorts were well match and included a preponderance of
patients with diabetes (50%) and severely calcified lesions (44%).
The primary safety and effectiveness endpoints at 12 months were
met and superiority over PTA was demonstrated in both. The
primary patency rate was significantly higher in the Stellarex
group at 76.3% (135/177) vs. 57.6% (53/92) for PTA (p=0.003). The
12-month primary patency rate, per KM estimate at day 365 was 82.3%
in the DCB arm vs. 70.9% in the PTA arm (p=0.002).
- The ILLUMENATE Global Study is a prospective, multi-center,
single-arm study with 371 patients enrolled. The 12-month primary
patency rate was 81.4% per KM estimate.
- 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 per KM estimate 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 and showed all patients had
detectable paclitaxel levels after DCB deployment that declined
rapidly within the first hour (54.4±116.9 ng/mL to 1.4±1.0
ng/mL).
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. 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, including
the Bridge™ Occlusion Balloon.
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,” “see,” “enable,”
“potential,” and other words and terms of similar meaning in
connection with any discussion of, among other things, future
operating or financial performance including the performance of the
Stellarex DCB, the pending Philips Transaction, 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 innovation
and development, and commercialization schedule, expectation of
continued growth and the reasons for that growth, growth rates,
strength, integration and product launches, regulatory approvals,
and 2017 outlook and projected results including projected revenue
and expenses, gross margin, net loss and loss per share. 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; our need to comply with
complex and evolving laws and regulations; intense and increasing
competition and consolidation in our industry; the impact of rapid
technological change; slower revenue growth and continued losses;
the inaccuracy of our assumptions regarding AngioScore and
Stellarex; market acceptance of our technology and products,
including the Stellarex DCB 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 from healthcare reform and related legislation and
regulations, including changes in reimbursements and the impact of
fraud and abuse and information privacy laws and regulations;
adverse conditions in the general domestic and global economic
markets and volatility and disruption of the credit markets or
other factors that prevent us from obtaining funding; our inability
to protect our intellectual property and intellectual property
claims of third parties; availability of inventory and components
from suppliers, including sole source 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; interruptions of
our manufacturing operations and other events that affect our
ability to manufacture sufficient volumes to fulfill customer
demand; our dependence on third party vendors, suppliers,
consultants and physicians; risks associated with international
operations, including international sales using distributors and
the impact of “Brexit” on our European sales and operations; risks
associated with any future acquisitions; our ability to use net
operating loss carryovers and potential impairment charges; 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 2016 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.
Investor Relations Contacts
Zach Stassen
Investor.relations@spnc.com
719-447-2292
Michaella Gallina
Investor.relations@spnc.com
719-447-2417
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