Medical Device Daily Associate

Cook Biotech (West Lafayette, Indiana) and CorMatrix Cardiovascular (Marietta, Georgia) reported that they have established a cross-license agreement to encourage the development of certain cardiovascular medical devices using proprietary extracellular biomaterials held by each company.

CorMatrix, a tissue-engineering and medical device manufacturer, will develop products for repair of the heart using the licenses it has obtained from Cook. It said potential products from the merger include cardiac patch applications for adult and pediatric heart defect repair and myocardial grafts to treat congestive heart failure, as well as applications to stimulate myocardial angiogenesis.

"CorMatrix is focused on the research and development of a proprietary group of extracellular matrix materials for the treatment of cardiac tissue diseases," said Beecher Lewis, president and chief operating officer of CorMatrix. "We are excited about the addition of Cook's widely used biomaterials to our existing technology platform and believe that Cook Biotech's experience in the manufacture of these materials should greatly enhance our development efforts."

The extracellular matrix (ECM) biomaterials providing the basis of this cross-license agreement are biological substrates that guide cell growth and act as tissue scaffolds to support tissue specific remodeling – that is, restoring both form and function to injured tissues. Remodeling then occurs over time as the implant is replaced by host tissue.

"Cook Biotech is actively working to provide a selection of well-characterized ECM biomaterials for use in tissue-engineered medical products. We believe CorMatrix is an excellent partner to fully utilize our ECM tissue scaffolds as a basis for new products for cardiovascular applications," said Dennis Abbott, director of business development at Cook Biotech.

Lewis said that his company held the patents to several important ECM materials and that Cook Biotech held the rights to another key ECM patent.

Lewis told Medical Device Daily, "We gave them access to our ECMs for heart valve repair, and they gave us the rights to their ECM for repair of heart tissue in general, which is basically repair of diseased myocardial tissue."

Lewis added that the technology swap essentially gives CorMatrix exclusivity in the areas of myocardial repair, "with all of the currently known, naturally derived extracellular matrices." These rights "give CorMatrix a huge competitive advantage from the standpoint of congestive heart failure or angiogenesis applications," he said.

While the company gave up its rights to the heart valve patents, Lewis noted that the company picked up what he termed a "much larger" potential opportunity. "The congestive heart failure, myocardial repair angiogenesis market is projected to be somewhere in the neighborhood of $8 billion between now and 2013," he said.

One of the ECM scaffolds, derived from the porcine small intestinal submucosa (SIS), presently is being used for numerous medical and surgical procedures. Thousands of patients have been treated with the SIS scaffolds for wounds, hernias and various other soft-tissue injuries.

Michael Hiles, PhD, vice president of research for Cook Biotech, said that the agreement was unique for Cook because of its complexity. He told MDD that Purdue University (West Lafayette, Indiana) had developed several different biomaterials from several different tissue sources and then licensed one biomaterial to Cook for one thing and the other biomaterials to CorMatrix for another.

"The agreement is that we're kind of pooling all the biomaterials and then dividing up the fields of use," Hiles said, adding, "CorMatrix is really going to on cardiovascular applications of all the biomaterials, and Cook is going to focus on the other applications of the biomaterials."

Cook Biotech is a business of Cook (Bloomington, Indiana). It was established in 1995 to develop products based on ECM technology and is developing ECM and scaffold-based 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.