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KCI Issues Statement Regarding AHRQ Draft Report

Released : 13 Nisan 2009

SAN ANTONIO, Texas, Apr 13, 2009 (BUSINESS WIRE) -- In response to a draft report issued April 10, 2009 by the Agency for Healthcare Research and Quality (AHRQ), Kinetic Concepts, Inc. (NYSE:KCI) is issuing the following statement regarding the results of AHRQ's technical assessment. This assessment was conducted on negative pressure wound therapy (NPWT) devices reimbursed by the Centers for Medicare and Medicaid Services (CMS).

While affirming in its report that KCI is the only NPWT provider with significant clinical evidence, the AHRQ concluded that it was unable to identify therapeutic distinctions between different NPWT systems because of a lack of significant studies comparing one NPWT system to another. Following its own defined research protocol, the AHRQ found after reviewing 38 NPWT clinical studies that all of the clinical trials involved the evaluation of KCI's V.A.C.® Therapy System against control groups treated with advanced wound care therapies, but none of the control groups utilized any other NPWT system or product. Notably, the AHRQ also did not conclude in its recent report that the NPWT systems they evaluated were similar in function or efficacy.

"We understand and support the need to reduce the cost of care for patients across America," said Catherine Burzik, President and Chief Executive Officer of KCI. "KCI strongly endorses and promotes evidence-based medicine and outcomes-based reimbursement. The AHRQ draft report confirms that only KCI has conducted significant clinical trials of NPWT - a fact that is already well-known by institutions and care providers utilizing this technology. The fact that the AHRQ was unable to find comparative NPWT studies does not imply an absence of significant differences between the KCI V.A.C. Therapy System and other NPWT products. Indeed, despite significant competition in the NPWT space, KCI's V.A.C. Therapy remains the NPWT system of choice, each and every day, for tens of thousands of physicians and caregivers across the globe."

The Company believes that since 2005, CMS has inappropriately grouped together KCI's clinically-proven V.A.C. Therapy with multiple, lower-technology NPWT products that lack meaningful clinical evidence, and thereby has disregarded the importance of clinical efficacy, the primary driver of cost-savings in the system. It is the efficacy of the NPWT system in these clinical settings, and not the price of the therapy, that drives down healthcare costs. Further, KCI believes that any follow-on CMS coding or reimbursement decisions that do not appropriately recognize the unique mechanisms of action and proven clinical efficacy of V.A.C. Therapy could unfortunately lead to a potential reduction in the access to and quality of wound care received by Medicare patients, which could ultimately drive higher healthcare costs.

The Company also points out that in the acute care environment, where there is no separate CMS reimbursement for NPWT, KCI has seen the average length of treatment decrease by approximately 20% over time as a result of the efficacy of the V.A.C. Therapy System. Numerous studies have been conducted to determine the average cost of a single day of care in the hospital environment, which ranges between $1,500-$2,000 per day. A one to two day decrease in the length of treatment, therefore, would save an average hospital $1,500-$4,000 per patient, far less than the cost of V.A.C. Therapy for that patient. In addition, in one randomized controlled clinical trial, V.A.C. Therapy was shown to reduce the rate of diabetic amputations by 60% versus the control patients. Studies have estimated that an amputation takes place in America once every 30 seconds.

Over the last ten years, KCI has accumulated a library of more than 15 randomized controlled clinical trials and approximately 500 peer-reviewed journal articles supporting the unparalleled clinical efficacy and cost-effectiveness of the KCI V.A.C. Therapy System.

About KCI

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.

Regenerative Medicine - 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 approximately 6,800 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.

SOURCE: Kinetic Concepts, Inc.

FOR MORE INFORMATION, CONTACT:

Kinetic Concepts, Inc.
Media Relations:
Media@kci1.com for journalists only.
or
Investors Relations:
IR@kci1.com for Investor Relations inquiries.


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