KCI Announces FDA Clearance of V.A.C.® Therapy for Venous Insufficiency Ulcers
Extends KCI's Reach Across All Three Major Chronic Wound Types
SAN ANTONIO—May 28, 2010—Kinetic Concepts, Inc. (NYSE: KCI) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the treatment of venous insufficiency ulcers, also known as venous leg ulcers (VLUs).
"KCI's business is about helping people heal and restoring them to active, healthy lives," according to Mike Genau, president of KCI's Active Healing Solutions™ business unit. "We are now able to use our V.A.C.® Therapy System to treat all three major categories of chronic wounds: diabetic foot ulcers, pressure ulcers and venous leg ulcers. This extends KCI's reach across the entire chronic wound care market."
VLUs are often hard-to-heal, recalcitrant wounds that pose significant clinical challenges. They can be painful and debilitating, seriously impacting a patient's physical and emotional quality of life.
"In our practice, the V.A.C.® Therapy System has proven very effective in treating complex venous leg ulcers," said Dr. John Lantis, chief of Vascular and Endovascular Surgery at St. Luke's – Roosevelt Hospital Center and Associate Clinical Professor of Surgery, Columbia University, New York. "The benefits V.A.C.® Therapy delivers, especially in the treatment of massive ulcers and those with difficult-to-manage drainage, are significant. In addition, a clinical study has shown that the time to wound bed preparation is noticeably reduced when compared to traditional therapies."
VLUs affect an estimated 500,000 Americans at an annual cost of more than $1 billion. KCI estimates its total market opportunity in the U.S. for the treatment of these wounds at more than $300 million.
For more information about KCI please visit www.KCI1.com.
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 is rooted in a legacy of innovation and a passion for significantly improving the healing and the lives of patients around the world.
The Company employs 6,800 people and markets its products in 20 countries. For more information about KCI, and how its products are changing the practice of medicine, visit www.KCI1.com.
This press release contains forward-looking statements regarding management's estimated market size for procedures eligible for use in accordance with the new indication. 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. In particular, our ability to recognize increased sales and profitability from our VLU clearance is subject to all the risks associated with the commercialization of new products based on innovative technologies, including unanticipated technical problems, manufacturing difficulties, gaining customer acceptance and other factors beyond our control. 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, 2009, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, 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.
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Source: Kinetic Concepts, Inc.