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 Companys 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 Companys 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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