Edwards Lifesciences, COOK Biotech Announce Agreement Related to Engineered Tissue Technologies

Exclusive Biomaterials Licensing and Supply Agreements Enable Edwards to Explore Development of “Living” Heart Valve

IRVINE, Calif. – Edwards Lifesciences Corporation (NYSE: EW), a global leader in products and technologies to treat advanced cardiovascular disease, and Cook Biotech Incorporated, a leading developer of tissue-engineered biomaterials, announced today that the companies have entered into exclusive technology licensing and supply agreements to pursue the development of tissue-engineered heart valves and related cardiovascular implants using proprietary biomaterials developed by Cook Biotech.

Under terms of the agreements, Edwards obtains an exclusive worldwide license to submucosa tissue technology developed by Cook Biotech, as well as access to all related intellectual property rights for development of specific cardiovascular implants. Financial details of the agreements were not disclosed.

“Edwards is the world’s leading heart valve company, and we are very intrigued by the potential for engineered tissue and its possible future application in heart valve therapy,” said Stuart L. Foster, Edwards’ corporate vice president of Technology & Discovery. “This agreement represents just the latest step in our continuing commitment to provide innovative heart valve therapies to clinicians and their patients.”

“Cook Biotech is actively working to provide bioscaffolds for development of tissue-engineered medical products. We believe Edwards is an excellent partner to fully utilize our biotechnology as a basis for new products to help patients suffering from cardiovascular diseases,” said Mark W. Bleyer, president and CEO of Cook Biotech.

Cook Biotech manufactures tissue-engineered medical products from the submucosal layer of porcine tissues. This special tissue is harvested and developed into a strong, pliable biomaterial that provides a rich environment for cell attachment and growth. This technology is currently incorporated into biocompatible scaffolds to make medical products for surgical repair of hernias, wounds, burns and other soft-tissue injuries.

Heart Valve Disease and the Potential for a “Living” Therapy

Each year, more than 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves.

“Younger patients currently have limited options to address their heart valve disease. This technology shows promise for creating a tissue-engineered therapy that could become a “living” replacement option for these individuals,” Foster said.

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company’s global brands, which are sold in over 80 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com.

Cook Biotech Incorporated, a COOK Group company, located in West Lafayette, Indiana, researches, develops and manufactures products based on tissue scaffolds derived from extracellular matrix (ECM) technology. Cook Biotech is actively developing ECM biomaterials for numerous medical purposes. Medical products utilizing Cook’s patented ECM technology are currently marketed worldwide for use in wound management and surgical repair of soft tissue. Together with a network of medical practitioners, Cook Biotech is identifying the medical needs most compatible with ECM technology and developing products to meet these needs.

With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.com/) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.

This news release includes forward-looking statements that involve risks and uncertainties including those related to results of the successful development of tissue heart valves and other cardiovascular implants using Cook’s biomaterials, the ability to provide innovative and clinically meaningful heart valve therapies, and more generally, timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and other regulatory agencies, technological advances in the medical field, product pricing, local and foreign government reimbursement rates or policies, product demand and market acceptance, the effect of changing economic conditions, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.

News Media Contacts:

Edwards Investor Contact:
David K. Erickson, 949-250-6826

Edwards Media Contact:
Laura Brooks, 949-250-5070

Cook Biotech Media Contact:
Madia Milks, 888-299-4224

 back |  top