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WALTHAM, Mass.–(BUSINESS WIRE)–Corindus
Vascular Robotics, Inc. (“Corindus” or the “Company”) (NYSE
American: CVRS), a leading developer of precision vascular robotics,
announced today that the first clinical robotic-assisted PCI procedures
in Japan were completed in partnership with Takafumi Ueno, MD, PhD,
Director of Interventional Cardiology, Center of Cardiovascular Disease,
Kurume University Hospital. These procedures mark initial enrollment in
a post-market study of CorPath GRX in Japan. CorPath GRX received
Pharmaceutical and Medical Device Agency (PMDA) approval in 2018 and A1
technical fee reimbursement for Japan in March of this year.
“The acceptance of robotic-assisted PCI in Japan is an important next
step for Corindus to bring this critical medical advancement to
additional markets across the globe. Japan represents one of the largest
markets for PCI globally, with over 1,200 hospitals performing nearly
250,000 PCI procedures annually,” said Mark Toland, President and Chief
Executive Officer of Corindus Vascular Robotics. “We are thrilled to
have partnered with Dr. Ueno, Kurume University Hospital, and Japan
Medicalnext to launch the first vascular robotic program in Japan,
offering these patients the benefits of robotic-assisted PCI.”
This is the first CorPath GRX System placed by the Company’s Japanese
distribution partner, Japan Medicalnext Co., Ltd., a wholly-owned entity
of MC Healthcare, Inc. (a subsidiary of Mitsubishi Corporation),
following the launch of a partnership in 2017.
“After completing the first cases with CorPath GRX, I am impressed with
the capabilities of the system, including the level of precision and
control during complex procedures,” stated Dr. Ueno. “Robotics will
provide Japan with cutting-edge technology in interventional medicine,
and we are pleased to be one of the first facilities in the Asia-Pacific
region to offer this treatment to our patients,” Dr. Ueno added.
To learn more about Corindus and CorPath GRX, please visit www.corindus.com.
About Corindus Vascular Robotics, Inc.
Corindus Vascular Robotics is a global technology leader in
robotic-assisted vascular interventions. The Company’s CorPath® platform
is the first FDA-cleared medical device to bring robotic precision to
percutaneous coronary and vascular procedures. CorPath GRX is the second
generation robotic-assisted technology offering enhancements to the
platform by adding important key upgrades that increase precision,
improve workflow, and extend the capabilities and range of procedures
that can be performed robotically. We are focused on developing
innovative robotic solutions to revolutionize treatment of emergent
conditions by providing specialized and timely medical care to patients
around the world. For additional information, visit www.corindus.com,
and follow @CorindusInc.
Forward Looking Statements
Statements made in this release that are not statements of historical
or current facts are “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements may involve known and unknown risks, uncertainties and other
factors that may cause the actual results, performance or achievements
of Corindus to be materially different from historical results or from
any future results or projections expressed or implied by such
forward-looking statements. Accordingly, readers should not place undue
reliance on any forward-looking statements. In addition to statements
that explicitly describe such risks and uncertainties, readers are urged
to consider statements in the conditional or future tenses or that
includes terms such as “believes,” “belief,” “expects,” “estimates,”
“intends,” “anticipates” or “plans” to be uncertain and forward-looking.
Forward-looking statements may include comments as to Corindus’ beliefs
and expectations as to future events and trends affecting its business
and are necessarily subject to uncertainties, many of which are outside
Corindus’ control.
Examples of such statements include statements regarding or such as:
-
Corindus’ ability to bring robotic-assisted PCI to additional
markets across the globe; and -
that robotics will provide Japan with cutting-edge technology in
interventional medicine.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements are
described in the sections titled “Risk Factors” in the Company’s filings
with the Securities and Exchange Commission, including its most recent
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well
as reports on Form 8-K, including, but not limited to the following: our
ability to expand our technology platform and achieve the advances
necessary for telestenting and remote procedures, including in humans;
our ability to expand our technology platform for use in other segments
of the vascular intervention market, including neurointerventional and
other more complex cardiac interventions; obtaining necessary regulatory
approvals for the use on humans and marketing of our products in the
United States and in other countries, including for stroke and other
neurovascular interventions; the rate of adoption of our CorPath System
and the rate of use of our cassettes; risks associated with market
acceptance, including pricing and reimbursement; our ability to enforce
our intellectual property rights; our need for additional funds to
support our operations; our ability to manage expenses and cash flow;
factors relating to engineering, regulatory, manufacturing, sales and
customer service challenges; potential safety and regulatory issues that
could slow or suspend our sales; and the effect of credit, financial and
economic conditions on capital spending by our potential customers.
Forward looking statements speak only as of the date they are made.
Corindus undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise that occur after that date. More information
is available on Corindus’ website at http://www.corindus.com.
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