Corindus Announces Regulatory Approval of CorPath GRX for Neurovascular Intervention in Australia and New Zealand
Expanded indication provides access to robotic technology in vascular procedures from head to toe
WALTHAM, Mass.--(BUSINESS WIRE)-- 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.
Source: Corindus Vascular Robotics, Inc.