MHLW to grant regulatory approval for KCI to enter Japan market

Sep 9 2009NewsGuard 100/100 Score

Kinetic Concepts, Inc. (NYSE: KCI) announced today that it has been informed by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan that in October the Ministry of Health, Labor and Welfare (MHLW) will grant regulatory approval for KCI to begin market development activities in Japan for its innovative V.A.C.® Therapy product.

“This is exciting news for the medical community and patients in Japan,” said Catherine Burzik, KCI president and CEO. “Our vision is to transform wound care in Japan by delivering advanced healing solutions and clinical know-how in a way that produces unparalleled outcomes.”

The company anticipates that in October the MHLW will review that all necessary regulatory steps have been addressed before the application is taken to the Minister’s Office for signature.

Following regulatory approval this fall, KCI anticipates reimbursement approval in the first half of 2010. Once reimbursement approval is obtained, KCI will begin commercializing V.A.C.® Therapy in Japan.

http://www.kci1.com/

Posted in: Device / Technology News

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