Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) has signed an
exclusive international distribution agreement with OrbusNeich to
sell its coronary and peripheral Orbital Atherectomy Systems (OAS)
outside the United States and Japan. OrbusNeich manufactures and
sells an extensive portfolio of coronary and peripheral products
including stents, balloons and microcatheters. The company operates
12 regional sales offices throughout the world and their products
are currently sold in over 60 countries.
Scott Ward, Chairman, President and Chief Executive Officer of
CSI, said, “We are excited to expand our strategic partnership with
OrbusNeich, a globally recognized leader offering an extensive
portfolio of vascular intervention products. OrbusNeich’s large
international sales channel serves Europe, Asia and the Middle East
and greatly accelerates our plans to introduce orbital atherectomy
technology to international markets. In turn, we will focus our
international efforts on physician training and education to
support the expanded use of orbital atherectomy.”
Said David Chien, Chairman and Chief Executive Officer of
OrbusNeich, “Our experienced sales force is eager to extend CSI’s
market leadership in peripheral and coronary atherectomy to new
international markets. We intend to introduce CSI’s orbital
atherectomy systems in multiple countries in Europe and Southeast
Asia in calendar 2018 – focusing initially on those countries that
recognize U.S. approvals in addition to European markets where CSI
has CE Mark approval for its peripheral technology.”
CSI management will provide more details on this distribution
agreement on July 31st at its Analyst Day meeting. To access the
live webcast on the day of the meeting click on this link
https://edge.media-server.com/m6/p/c5hxddy7. A webcast replay will
be available beginning at approximately 2:00 p.m. CT the same
day.
In January 2018, CSI announced that it was the exclusive U.S.
distributor for OrbusNeich balloon products. Ultimately, CSI will
offer a full line of semi-compliant, non-compliant and specialty
balloons for both coronary and peripheral vascular procedures.
OrbusNeich PCI balloons include the Sapphire™ II Pro, the first and
only 1.0mm coronary balloon available in the United States.
Currently, CSI offers both the 1.0-4.0mm Sapphire II Pro and the
2.0-4.0mm Sapphire NC Plus coronary balloons.
In November 2016, CSI announced that Medikit, Co., Ltd. signed
an exclusive distribution agreement to sell its coronary and
peripheral OAS in Japan.
About Peripheral Artery Disease (PAD)As many as 18
million Americans, most over age 65, suffer from PAD, which is
caused by the accumulation of plaque in peripheral arteries
reducing blood flow. Symptoms include leg pain when walking or at
rest. Left untreated, PAD can lead to severe pain, immobility,
non-healing wounds and eventually limb amputation. With risk
factors such as diabetes and obesity on the rise, the prevalence of
PAD is growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with
orbital atherectomy utilizing the Stealth 360® and Diamondback 360®
Peripheral Orbital Atherectomy Systems, minimally invasive catheter
systems developed and manufactured by CSI. These systems use a
diamond-coated crown, attached to an orbiting shaft, which sands
away plaque while preserving healthy vessel tissue — a critical
factor in preventing reoccurrences. Balloon angioplasty and stents
have significant shortcomings in treating hard, calcified lesions.
Stents are prone to fractures and high recurrence rates, and
treatment of hard, calcified lesions often leads to vessel damage
and suboptimal results.
About Coronary Artery Disease (CAD)CAD is a
life-threatening condition and a leading cause of death in men and
women in the United States. CAD occurs when a fatty material called
plaque builds up on the walls of arteries that supply blood to the
heart. The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 40% of
patients undergoing a percutaneous coronary intervention (PCI).
Significant calcium contributes to poor outcomes and higher
treatment costs in coronary interventions when traditional
therapies are used, including a significantly higher occurrence of
death and major adverse cardiac events (MACE).
About Cardiovascular Systems, Inc.Cardiovascular Systems,
Inc., based in St. Paul, Minn., is a medical device company focused
on developing and commercializing innovative solutions for treating
vascular and coronary disease. The company’s Orbital Atherectomy
Systems treat calcified and fibrotic plaque in arterial vessels
throughout the leg and heart in a few minutes of treatment time,
and address many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. The
U.S. FDA granted 510(k) clearance for the use of the Diamondback
Orbital Atherectomy System in peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the use of
the Diamondback Orbital Atherectomy System in coronary arteries.
The Stealth 360® Peripheral Orbital Atherectomy System (OAS)
received CE Mark in October 2014. In March 2017, the company
received PMDA approval in Japan for the Diamondback 360® Coronary
OAS Micro Crown and reimbursement approval effective February 2018.
To date, over 373,000 of CSI’s devices have been sold to leading
institutions across the United States and Japan. For more
information, visit the company’s website at www.csi360.com.
About Medikit Co., Ltd.Established in 1973 and based in
Tokyo, Medikit Co., Ltd. is a global medical technology company and
is publicly-traded on the JASDAQ exchange (JASDAQ: 7749). Medikit’s
mission is to deliver the highest standards of excellence in
operating as a health care company whose products and services help
to enhance healthy life by minimizing unnecessary suffering and
death from disease. Medikit is a market leader in interventional
products including vascular access devices such as hemodialysis
catheters, intravenous catheters, sheaths and guiding catheters.
Medikit products are sold in Japan, the United States and over 30
other countries. The company has R&D and manufacturing
capabilities in Japan and Vietnam with more than 1,300 consolidated
employees. For more information, visit the company’s website at
www.medikit.co.jp.
About OrbusNeichOrbusNeich is a global pioneer in the
provision of life-changing vascular solutions and offers an
extensive portfolio of products that set industry benchmarks in
vascular intervention. Current products include the world's first
dual therapy stents, the COMBO Plus and COMBO Dual Therapy Stents,
together with stents and balloons marketed under the names of
Azule™, Scoreflex™, Sapphire™ II, Sapphire™ II PRO and Sapphire™ II
NC, as well as products to treat peripheral artery disease: the
Jade™ and Scoreflex™ PTA balloons. OrbusNeich is headquartered in
Hong Kong and has operations in Shenzhen, China; Fort Lauderdale,
Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan.
OrbusNeich supplies medical devices to physicians in more than 60
countries. For more information, visit www.OrbusNeich.com.
Safe HarborCertain statements in this news release are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and are provided under the
protection of the safe harbor for forward-looking statements
provided by that Act. For example, statements in this press release
regarding (i) the anticipated sale of CSI devices outside of the
United States and Japan, including the initial countries for
introduction of CSI’s products and the anticipated timing thereof;
(ii) CSI’s plans to introduce orbital atherectomy technology to
international markets; (iii) CSI’s plans to focus on physician
training and education; (iv) regulatory approvals of CSI’s products
outside of the United States and Japan; (v) the specific OrbusNeich
products to be offered by CSI in the United States; and (vi) the
sale of CSI products in Japan, are forward-looking statements.
These statements involve risks and uncertainties that could cause
results to differ materially from those projected, including, but
not limited to, regulatory developments, clearances and approvals;
approval of our products for distribution in countries outside of
the United States; approval of our products for reimbursement in
and the level of reimbursement; the ability of OrbusNeich to
successfully launch CSI products outside of the United States and
Japan; the experience of physicians regarding the effectiveness and
reliability of CSI’s products; the reluctance of physicians,
hospitals and other organizations to accept new products; the
impact of competitive products and pricing; general economic
conditions; international trade developments; and other factors
detailed from time to time in CSI’s SEC reports, including its most
recent annual report on Form 10-K and subsequent quarterly reports
on Form 10-Q. CSI encourages you to consider all of these risks,
uncertainties and other factors carefully in evaluating the
forward-looking statements contained in this release. As a result
of these matters, changes in facts, assumptions not being realized
or other circumstances, CSI's actual results may differ materially
from the expected results discussed in the forward-looking
statements contained in this release. The forward-looking
statements made in this release are made only as of the date of
this release, and CSI undertakes no obligation to update them to
reflect subsequent events or circumstances.
Product Disclosures:
Peripheral ProductsThe Stealth 360® PAD System and
Diamondback 360® PAD System are percutaneous orbital atherectomy
systems indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and stenotic
material from artificial arteriovenous dialysis fistulae. The
systems are contraindicated for use in coronary arteries, bypass
grafts, stents or where thrombus or dissections are present.
Although the incidence of adverse events is rare, potential events
that can occur with atherectomy include: pain, hypotension,
CVA/TIA, death, dissection, perforation, distal embolization,
thrombus formation, hematuria, abrupt or acute vessel closure, or
arterial spasm.
Coronary ProductIndications: The Diamondback 360®
Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital
atherectomy system indicated to facilitate stent delivery in
patients with coronary artery disease (CAD) who are acceptable
candidates for PTCA or stenting due to de novo, severely calcified
coronary artery lesions.
Contraindications: The OAS is contraindicated when the
ViperWire guide wire cannot pass across the coronary lesion or the
target lesion is within a bypass graft or stent. The OAS is
contraindicated when the patient is not an appropriate candidate
for bypass surgery, angioplasty, or atherectomy therapy, or has
angiographic evidence of thrombus, or has only one open vessel, or
has angiographic evidence of significant dissection at the
treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively
tortuous vessels or bifurcations may result in vessel damage; The
OAS was only evaluated in severely calcified lesions, A temporary
pacing lead may be necessary when treating lesions in the right
coronary and circumflex arteries; On-site surgical back-up should
be included as a clinical consideration; Use in patients with an
ejection fraction (EF) of less than 25% has not been evaluated. See
the instructions for use before performing Diamondback 360 Coronary
OAS procedures for detailed information regarding the procedure,
indications, contraindications, warnings, precautions, and
potential adverse events. For further information call CSI at
1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale
by or on the order of a physician.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180716005570/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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