Healthcare Industry News: LifeCell
News Release - June 30, 2008
V.A.C.(R) Therapy Clinical Study in Japan Shows Significant Efficacy in the Treatment of Acute WoundsSAN ANTONIO--(HSMN NewsFeed)--Kinetic Concepts, Inc. (NYSE: KCI ) announced today that it is another step closer to introducing its V.A.C.® Therapy wound care system in Japan with the completion of a two-phase clinical study designed to determine the clinical efficacy, safety and utility of V.A.C. Therapy for wound healing in that country. Results of the study, which compared the use of V.A.C. Therapy to standard moist wound therapy for the treatment of acute wounds, were recently presented at the 3rd Congress of the World Union of Wound Healing Societies (WUWHS) in Toronto, Canada.
The study was the first to evaluate negative pressure wound therapy for use in Japan and compared results from a multi-center prospective clinical trial to historical control data derived from a retrospective study of standard care treatment for acute wounds, including open traumatic and post-operative wounds. Results showed a significant (p<0.001) treatment difference in median time to wound closure of 15 days for V.A.C. Therapy versus 41 days for the historical control. In addition, 50% granulation tissue formation, which is an indication of healing, was achieved in half of the patients on V.A.C. Therapy approximately one week after treatment initiation. The clinical study also confirmed that the use of V.A.C. Therapy in Japan was found to be safe and effective for acute wounds.
“Japan is the second largest medical device market in the world,” said Linwood Staub, President – Global V.A.C. Therapy for KCI. “We estimate that in Japan approximately 250,000 wounds annually are appropriate for V.A.C. Therapy which provides a substantial market opportunity for KCI. This study helps us complete another important step in the regulatory process in Japan. It also adds to KCI’s significant body of clinical data that clearly shows that our V.A.C. Therapy system, including its unique foam dressing, provides clinical advantage for treatment of traumatic and post operative wounds. We look forward to the opportunity to help improve patient outcomes while reducing the overall cost of care in Japan.”
The data from this study, along with its submission for regulatory approval, has been submitted to the Pharmaceutical and Medical Devices Agency (PMDA) in Japan for review.
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.
KCI’s three primary businesses include:
Advanced Wound Care – Includes KCI’s proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, which has been clinically demonstrated to promote wound healing through unique mechanisms of action while reducing the overall cost of treating patients with complex wounds.
Tissue Regeneration – Represented by KCI’s LifeCell business and includes tissue-based products for use in reconstructive, orthopedic and urogynecologic surgical procedures to repair soft tissue defects.
Therapeutic Support Systems - Includes specialty hospital beds, mattress replacement systems and overlays designed to address pulmonary complications associated with immobility, to reduce skin breakdown and assist caregivers in the safe and dignified handling of patients of size.
The company employs 7,000 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.
This press release may contain forward-looking statements regarding the expected performance of the company. 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, 2007 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, 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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