Kinetic Concepts, Inc. announced 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.
Kinetic Concepts, Inc. is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care, tissue regeneration and therapeutic support system markets. Headquartered in San Antonio, Texas, KCI's success spans more than three decades and can be traced to a history deeply rooted in innovation and a passion for significantly improving the healing and the lives of patients around the world.
The Company employs approximately 6,700 people and markets its products in more than 20 countries. For more information about KCI, and how its products are changing the practice of medicine, visit www.KCI1.com .
Source: Kinetic Concepts, Inc.
Kinetic Concepts, Inc., San Antonio