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8-K - 8-K - SPECTRANETICS CORP | a2017stellarexpma8k.htm |
FOR IMMEDIATE RELEASE
Spectranetics Announces FDA Approval of Stellarex™
Drug-Coated Balloon
Stellarex produces top-tier clinical outcomes with a low drug dosage
COLORADO SPRINGS, Colo., July 26, 2017 (GLOBE NEWSWIRE) -- 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 Michaella Gallina
Investor.relations@spnc.com Investor.relations@spnc.com
719-447-2292 719-447-2417