Healthcare Industry News:  Vacuum Assisted Closure 

Devices Wound Care FDA

 News Release - October 14, 2008

KCI Receives FDA Clearance for its LifeCell Tissue Matrix for the Management of Wounds Utilizing Proprietary Strattice(R) Technology

SAN ANTONIO--(HSMN NewsFeed)--Kinetic Concepts, Inc. (NYSE: KCI ) today announced that it has received FDA 510(k) clearance for its LifeCell Tissue Matrix for the management of chronic, trauma, surgical and other acute wounds. The product utilizes the company’s proprietary Strattice® technology, which is a sterile reconstructive tissue matrix that supports tissue regeneration.

The Strattice technology is a porcine-based, acellular dermal matrix that acts as a scaffold that is revascularized and repopulated with cells by the host, ultimately converting it into functional, living tissue. The new product provides an environment that supports wound healing and can be used in the management of a wide range of wound types, including pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, surgical wounds, trauma wounds and other acute wounds.

“This announcement represents an important milestone in our plans to build on LifeCell’s market leadership position in the field of regenerative medicine while leveraging our strength in the wound care market,” said Catherine M. Burzik, President and CEO of KCI. “The use of the LifeCell Tissue Matrix in wound management is further evidence of our commitment to our strategy of utilizing the Strattice® technology to further expand our advanced wound care business along the spectrum of care with a product that will promote wound healing and closure in conjunction with V.A.C.® Therapy.”

Today’s announcement marks the fourth FDA clearance received for Strattice, which is recommended for soft tissue reinforcement, including hernia repair and breast reconstruction.

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 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.


Source: Kinetic Concepts

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