Pharmaceutical and Medical Devices Agency (PMDA) in Japan has informed Kinetic Concepts, Inc. (KCI) that the Ministry of Health, Labor and Welfare (MHLW) will grant the company regulatory approval in October 2009 to initiate market development activities in Japan for its V.A.C. Therapy product.
“This is exciting news for the medical community and patients in Japan,” said Catherine Burzik, KCI president and chief executive officer. “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.
KCI is a company developing advanced wound care, negative pressure wound therapy (NPWT) and therapeutic support systems.