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Corindus Announces Pharmaceutical and Medical Device Agency (PMDA) Approval of CorPath GRX System in Japan

2018年06月08日 PM10:00
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WALTHAM, Mass.

Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, announced today that it received Pharmaceutical and Medical Device Agency (PMDA) Approval for commercialization of its CorPath® GRX System in Japan. Japan is one of the largest markets in the world for percutaneous coronary interventions (PCI) with approximately 250,0001 PCI procedures performed annually.

Corindus is actively pursuing reimbursement for robotic PCI through the Japanese insurance system and plans a post-market study of CorPath GRX. In early 2017, Corindus announced a strategic relationship with Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. (subsidiary of Mitsubishi Corporation), to become the exclusive distributor of Corindus products in Japan, bringing robotic precision and control to the large and growing PCI segment of the Japanese healthcare market.

“There is strong demand for robotic-assisted intervention from Key Opinion Leaders (KOLs) and the broad clinical community in Japan. PMDA approval of CorPath GRX in Japan represents a significant step in our ongoing effort to bring cutting-edge vascular robotics to global markets,” stated Mark Toland, President and Chief Executive Officer. “We believe robotics has the potential to enhance patient care in Japan by offering the benefits of robotic precision and advanced tools for physicians to perform these life-saving procedures.”

“I look forward to offering CorPath GRX to my patients during PCI, especially in complex procedures where precision and procedural control are extremely valuable,” said Takafumi Ueno, MD, PhD, Director of Interventional Cardiology, Center of Cardiovascular Disease, Kurume University Hospital. “We are pleased to be one of the first Asia-Pacific countries to adopt this new and innovative technology.”

About Corindus Vascular Robotics, Inc.

Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company’s CorPath® System is the first FDA-cleared medical device to bring robotic precision to percutaneous coronary and percutaneous vascular procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance guide catheters, stents, and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. CorPath GRX is the second generation robotic-assisted PCI 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. With the CorPath System, Corindus Vascular Robotics brings robotic precision to interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement during manual procedures. Corindus stands behind its product with its unique $1,000 hospital credit “One Stent Program.” 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 is actively pursuing reimbursement for robotic PCI through the Japanese insurance system and plans a post-market study of CorPath GRX;
  • the strong demand for robotic-assisted intervention from KOLs and the broad clinical community in Japan;
  • the PDMA approval of CorPath GRX representing a significant step in Corindus’ ongoing effort to bring cutting-edge vascular robotics to global markets; and
  • robotics having the potential to enhance patient care in Japan.

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: 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.

__________________________
1 © 2015 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180608005167/en/

CONTACT

Corindus Vascular Robotics, Inc.
Media Contact:
Kate
Stanton, 508-653-3335 ext. 200
kate.stanton@corindus.com
or
Investor
Relations Contact:

Lynn Pieper Lewis, 415-937-5402
ir@corindus.com

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