Healthcare Industry News: V.A.C. Therapy
News Release - September 8, 2009
KCI Announces Expected Regulatory Approval to Enter Japan MarketSAN ANTONIO--(HSMN NewsFeed)--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.(R) 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.(R) Therapy in Japan.
Kinetic Concepts, Inc. (NYSE: KCI ) 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.
Forward Looking Statements
This press release contains forward-looking statements regarding expected timing of reimbursement approval and commercial launch of V.A.C. Therapy in Japan. Forward-looking statements may contain words such as believes, expects, anticipates, estimates, projects, intends, should, seeks, future, continue, or the negative of such terms, or other comparable terminology. Forward-looking statements are subject to risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from those expressed in or indicated by them. Additional risks and factors are identified in KCI's filings with the U.S. Securities Exchange Commission (the SEC), including its Annual Report on Form 10-K for the fiscal year ending December 31, 2008, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, which are available on the SEC's Web site at http://www.sec.gov. KCI undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Kinetic Concepts
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