Corindus Announces FDA Submission for Neurovascular Intervention Indication for CorPath® GRX Vascular Robotic System
February 14 2019 - 5:45AM
Business Wire
Expansion of CorPath GRX into neurovascular
intervention could mark first step in revolutionizing stroke
treatment
Corindus Vascular Robotics, Inc. (“Corindus” or
the “Company”) (NYSE American: CVRS), a leading developer of
precision vascular robotics, announced today it is seeking
premarket clearance from the U.S. Food and Drug Administration
(FDA) to use the CorPath GRX System in neurovascular intervention.
CorPath GRX, the second generation robotic platform, received FDA
clearance for percutaneous coronary intervention (PCI) in 2016 and
peripheral vascular intervention (PVI) in 2018. Upon successful FDA
clearance, CorPath GRX would become the world’s first and only
robotic platform indicated for use in PCI, PVI and neurovascular
intervention (NVI).
“An expansion of CorPath GRX to treat neurovascular conditions
would represent a major stepping stone towards our goal of
revolutionizing stroke treatment,” said Mark Toland, President and
Chief Executive Officer of Corindus. “We believe that our current
robotic platform will bring benefits to neurovascular procedures
today and we will leverage our recent achievements in telerobotics
and strong focus on technology development to build a remote stroke
solution to tackle the challenge of access to care. This would
extend the reach of highly-skilled specialists across the globe by
granting remote access to patients suffering from life-altering
diseases where access to care is limited and time to treatment is
paramount,” added Toland.
Corindus established a Physician Steering Committee dedicated to
the Neuroendovascular sector last year and appointed Dr. Aquilla
Turk as the Company’s chief medical officer. Dr. Turk and the
steering committee are tasked with spearheading the Company’s
clinical initiatives, including establishing dedicated
neurovascular programs to expand robotic treatment, extending the
advanced robotic capabilities across the spectrum of vascular
interventions.
“The ability to treat neurovascular disease with CorPath GRX is
the first step for physicians to gain critical experience with
robotics,” said Dr. Turk. “Applying the benefits of robotic
precision to neurovascular intervention, while building a wealth of
clinical knowledge and expertise, are key to preparing for a future
of remote stroke treatment.”
This announcement comes on the heels of Corindus’ announcement
that its technology was successfully used to conduct the
first-in-human Telerobotic Intervention Study. The study was the
world’s first-in-human PCI conducted from a remote location
approximately 20 miles outside of the catheterization lab and
solidifies Corindus’ commitment to providing better patient care to
underserved patient populations with geographic barriers to
treatment.
To learn more about Corindus and CorPath GRX, please visit them
at 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:
- the anticipated FDA clearance of
CorPath GRX for neurovascular treatment
- the potential for CorPath GRX to be the
world's first and only robotic platform indicated for use in PCI,
PVI and NVI;
- that the anticipated expansion of
CorPath GRX to treat neurovascular conditions represents a major
stepping stone toward our goal of revolutionizing stroke
treatment;
- our belief that our current robotic
platform will bring benefits to neurovascular procedures today and
that we will leverage our recent achievements in telerobotics and
strong focus on technology development to build a remote stroke
solution to tackle the challenge of access to care; and
- the advancement of our remote vascular
robotic technology.
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; risks
associated with market acceptance; our ability to enforce our
intellectual property rights; our need for additional funds to
support our operations; factors relating to engineering,
regulatory, manufacturing, sales and customer service challenges;
and potential safety and regulatory issues that could slow or
suspend our sales. 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/20190214005152/en/
Media Contact:Matter for CorindusJessica
Wolter978-518-4536corindus@matternow.comwww.matternow.com
Investor Contact:Lisa WilsonIn-Site Communications, Inc.T:
917-543-9932ir@corindus.com
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