Kinetic Concepts, Inc. LifeCell Granted CE Mark for its Strattice(R) Reconstructive Tissue Matrix
Strattice, manufactured using LifeCell’s pioneering and proprietary processing technology, is a porcine-based, acellular dermal matrix that acts as a scaffold that is revascularized and repopulated by the host, ultimately converting the matrix into functional, living tissue. The product is recommended for use in a range of applications involving tissue repair to reinforce soft tissue where weakness exists, such as challenging hernia repair and breast reconstruction. Strattice has demonstrated rapid revascularization and cell repopulation within two weeks of implantation and a mature vascular structure six months post implant in an animal model.
“With the granting of the CE Mark for Strattice Reconstructive Tissue Matrix, KCI has reached another milestone as we pave the way for the broader roll-out of LifeCell products internationally,” said Catherine M. Burzik, President and CEO of KCI. “Strattice’s availability within the EU will allow further expansion of our Regenerative Medicine business and demonstrates KCI’s commitment to developing innovative therapies that address unmet medical needs of clinicians and their patients around the world.”
Strattice is available immediately for surgeons in select EU markets with the full commercial launch of LifeCell’s new reconstructive tissue matrix anticipated in the first half of 2009. In the EU5 markets (France, Germany, Italy, Spain and the UK) KCI estimates approximately 100,000 challenging hernia repair procedures and nearly 25,000 breast reconstruction procedures, appropriate for treatment with biologics, are performed annually.
About KCI
Kinetic Concepts, Inc. (NYSE: KCI - News) 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.
Forward-Looking Statements
This press release contains forward-looking statements regarding the expected launch of the new products. 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 September 30, 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.
Contact:
Kinetic Concepts, Inc., San Antonio Investor Relations: Rich Cockrell, +1-210-255-6331 rich.cockrell@kci1.com or Media Relations: Roger Bennett, +31-204-260-014 rbennett@kci-medical.com or David Holmes, +1-210-255-6892 david.holmes@kci1.com
Source: Kinetic Concepts, Inc.