Kinetic Concepts, Inc. (KCI) announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted final regulatory approval for KCI to market and sell its V.A.C. Therapy System in the country.
“Japan has a deep heritage of providing outstanding medical care, and the people of KCI are pleased and humbled to have the opportunity to serve this market,” said Catherine Burzik, KCI president and CEO. “What makes us especially proud is that our clinically proven V.A.C.® Therapy System will fill a real unmet medical need in Japan for hard-to-heal wounds.”
Reimbursement applications have been submitted following regulatory approval. Operational preparations, including employee hiring, are underway for commercial launch at the time of reimbursement approval. KCI anticipates reimbursement approval in the first half of 2010.