Medikit will be Exclusive Japanese Provider of CSI’s Diamondback
360® Atherectomy Systems;
Agreement Includes $10 million Upfront Payment to CSI
ST. PAUL, Minn.--(BUSINESS WIRE)--
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) has signed an
exclusive distribution agreement with Medikit Co., Ltd. to sell its
Diamondback 360® Coronary and Peripheral Orbital Atherectomy
Systems (OAS) in Japan.
Medikit is one of the world's leading manufacturers in vascular access
and interventional medical devices, especially hemodialysis and other
catheters used by hospitals for coronary and peripheral interventions.
Medikit’s Japanese sales channel includes 120 sales representatives
selling products to over 800 hospitals that perform percutaneous
coronary interventions. To secure exclusive distribution rights, Medikit
will make an upfront payment of $10 million to CSI.
“The presence of severely calcified coronary lesions contributes to both
poor patient outcomes and higher treatment costs,” said Nobufumi Kurita,
President, Medikit Co., Ltd. “We look forward to working with CSI to
bring this important, novel technology, with compelling clinical and
economic evidence, to the Japanese market.”
In June, CSI submitted a Shonin application to Japan’s Pharmaceuticals
and Medical Devices Agency (PMDA) for approval of its Diamondback 360
Coronary OAS Micro Crown to treat severely calcified coronary arteries.
The company anticipates commercialization beginning in calendar 2018.
CSI will also pursue Shonin approval for its Diamondback 360 Peripheral
Orbital Atherectomy System in the near future.
“We’re excited to partner with Medikit, a highly respected distribution
partner with a large sales force in Japan,” said Scott Ward, President
and Chief Executive Officer of CSI. “Japan represents the world’s
second-largest market for coronary interventions, with a large patient
population suffering from calcified artery disease. Physicians in Japan
understand the challenges of treating calcified lesions and they are
seeking novel tools, like orbital atherectomy, to improve clinical
outcomes for their patients.”
CSI submitted its application for Shonin approval of the Coronary OAS
Micro Crown following the completion of the COAST clinical study. COAST
is a Harmonization-By-Doing clinical study conducted in both the United
States and Japan under the regulations of both governments. COAST is a
single-arm, multi-center, global investigational device exemption (IDE)
study to evaluate the safety and efficacy of CSI’s next-generation OAS
in treating patients with severely calcified coronary lesions. The
company completed COAST enrollment of 100 patients, including 74
patients at 12 sites in the United States and 26 patients at five sites
in Japan, in July 2015. At the 2016 Cardiovascular Research Technologies
Conference (CRT), data presented from the study showed a 30-day freedom
from MACE (major adverse cardiac events) rate of 85% and a successful
stent delivery rate of 99%.
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 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
lives 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 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. To date, over
275,000 of CSI’s devices have been sold to leading institutions across
the United States. For more information, visit the company’s website at www.csi360.com.
Safe Harbor
Certain 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) regulatory
approval of CSI’s devices in Japan; (ii) the anticipated
commercialization of the Diamondback 360 Coronary OAS Micro Crown in
Japan, including the anticipated timing thereof; and (iii) CSI’s plans
to seek regulatory approval of and commercialize CSI’s Diamondback 360
Peripheral Orbital Atherectomy System in Japan. These statements involve
risks and uncertainties that could cause results to differ materially
from those projected, including, but not limited to, regulatory
developments in Japan; Japanese clearances and approvals; approval of
our products for distribution in Japan; approval of products for
reimbursement in Japan and the level of reimbursement; 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 Products
The 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 Product
Indications: 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.
Micro Crown OAS
This new system is limited by federal law to
investigational use and is currently not commercially available in the
United States or Japan.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161114005172/en/
Source: Cardiovascular Systems, Inc.