Corindus Announces FDA Submission for Neurovascular Intervention Indication for CorPath® GRX Vascular Robotic System
Expansion of CorPath GRX into neurovascular intervention could mark first step in revolutionizing stroke treatment
WALTHAM, Mass.--(BUSINESS WIRE)-- 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.
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.
Source: Corindus Vascular Robotics, Inc.