Corindus Announces Regulatory Approval of CorPath GRX for Neurovascular Intervention in Australia and New Zealand
17 7월 2019 - 7:45PM
Business Wire
Expanded indication provides access to robotic
technology in vascular procedures from head to toe
Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a
leading developer of precision vascular robotics, announced today
that it received approval from the Australian Therapeutic Goods
Administration to commercialize its CorPath® GRX System for
neurovascular interventions in Australia and New Zealand. The
CorPath GRX System is already approved for percutaneous coronary
and peripheral vascular interventions in the region.
In March 2019, Corindus received CE mark to commercialize
CorPath GRX for neurovascular interventions in 33 countries in
Europe and the Company plans to initiate clinical cases with select
partners in Europe as early as this summer.
“Approval of CorPath GRX for an expanded indication for
neurovascular procedures in Australia and New Zealand represents a
significant step in expanding the application of vascular robotics
in global markets,” stated Mark Toland, President and Chief
Executive Officer of Corindus. “The significant need for expanding
access to care has fueled considerable clinical interest in
vascular robotics. This new indication offers more patients the
benefits of robotic precision while allowing physicians to gain
valuable experience with vascular robotics to prepare for a future
treatment paradigm, including telerobotic stroke treatment,” added
Toland.
The CorPath GRX System is distributed in Australia and New
Zealand by LifeHealthcare, a leading medical devices distributor in
the region.
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:
- The Company plans to initiate clinical cases with select
partners in Europe as early as this summer.
- The significant need for expanding access to care has fueled
clinical interest in vascular robotics.
- This new indication will offer patients the benefits of robotic
precision and allow physicians to gain valuable experience with
vascular robotics.
- The future treatment paradigm includes telerobotic stroke
treatment.
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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version on businesswire.com: https://www.businesswire.com/news/home/20190717005240/en/
Media Contact: Matter for Corindus Jessica Wolter 617-391-9896
corindus@matternow.com
Investor Contact: In-Site Communications, Inc. Lisa Wilson T:
917-543-9932 ir@corindus.com
Corindus Vascular Robotics (AMEX:CVRS)
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Corindus Vascular Robotics (AMEX:CVRS)
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