Cardiac Science (Irvine, California), a manufacturer of automated public-access defibrillators, reported that it has expanded its multi-year strategic distribution agreements with GE Healthcare (Waukesha, Wisconsin), a division of General Electric, giving it an inroad for the first time into the in-hospital external automated defibrillator (AED) market in North America. Under the agreements, GE Healthcare will market Cardiac Science's line of Powerheart-brand AEDs on an exclusive basis to hospitals in the U.S. and Canada. GE Healthcare first began selling an OEM version of the Cardiac Science-manufactured AEDs internationally in late 2003. In October 2004, Cardiac Science made its first shipments to GE Healthcare of its G3 PRO AED, designed for medical professionals, under the Responder label. GE also confirmed the assignment of the distribution agreements to the new corporate entity being created through the pending merger deal between Cardiac Science and Quinton Cardiology Systems (Bothell, Washington). The agreements provide GE Healthcare exclusivity in North American hospitals, based on certain annual performance criteria, for Cardiac Science's line of defibrillators, including Powerheart G3 AEDs, Powerheart CRM and Cardiac Science's new traditional "crash cart" in-hospital AED, which is pending FDA 510(k) clearance and anticipated to be released for worldwide sales this summer.

Cardiovascular Clinical Studies (Boston), a cardiovascular research organization, and Virtify (Cambridge, Massachusetts), a provider of information technology and scientific solutions to the pharmaceutical and biotech industries, have entered into a strategic partnership to develop clinical trial software systems for CCS' clinical trial administration and cardiovascular core laboratories businesses. Doug Gregory, PhD, the CEO of Cardiovascular Clinical Studies, cited the close fit between the two organizations.

Celladon (La Jolla, California) said it has entered into an agreement with V-Kardia, a company of the Baker Research Institute (both Melbourne, Australia), under which V-Kardia will develop its V-Focus device for percutaneous delivery of Celladon's gene therapy for congestive heart failure and supply devices to Celladon. V-Kardia will develop the device for Celladon's gene therapy product and provide devices for Celladon's clinical trials in heart failure patients scheduled to begin in 2006. V-Kardia receives contract development payments, payments for devices, and license fees including milestones and royalties on product sales. Celladon receives options to use the V-Kardia system with five additional therapeutic targets for cardiovascular and other indications. V-Kardia developed the V-Focus device based on the pioneering work of the Baker Research Institute. The system delivers therapeutics to the heart in a closed loop system that includes special catheters, an oxygenator and perfusion pump. The catheter technique is similar to methods currently used for coronary angioplasty, and is easily adapted by interventional cardiologists, the company said.

CryoLife (Kennesaw, Georgia) reported that it and the Magdi Yacoub Institute at Imperial College (London) have entered into a three-year research collaboration to develop methods to improve the utilization of unfixed xenografts (animal tissues) for human transplantation. A primary focus of the collaboration will be on the technology that is used to decellularize porcine heart valves. The research effort will leverage the Magdi Yacoub Institute's knowledge of heart valve structure and biochemistry, and is designed to optimize decellularization technology in the preparation of animal tissues for human implantation. Steven Anderson, president and CEO of CryoLife, said, "The studies in this collaboration will provide information on how a decellularized animal tissue may function similar to human tissues. This is significant because there is a large supply of porcine heart valves that may be used in reconstructive heart surgery to replace pulmonary and aortic valves that are damaged or have congenital defects."

Edwards Lifesciences (Irvine, California), a manufacturer of heart valve technologies, and 3F Therapeutics (Lake Forest, California) have restructured the development and supply agreements bet-ween Percutaneous Valve Technologies (PVT; Fort Lee, New Jersey) and 3F Therapeutics, established prior to Edwards' acquisition of PVT in early 2004. PVT was an early stage company engaged in the development of a catheter-based (or percutaneous) heart valve. Under terms of the new agreements, Edwards will pay 3F Therapeutics $25 million and will obtain the right to self-manufacture all components of its percutaneous heart valves and to apply, it said, "the entire array of Edwards' capabilities and materials," including its Perimount heart valve technology, to those products. Edwards also may apply any technologies developed for its percutaneous program in all other applications and is free to market any of those products. 3F Therapeutics will have co-exclusive, royalty-bearing licenses to select Edwards patents related to minimally invasive, beating heart, surgical valve replacement and venous valve systems aimed at tricuspid valve regurgitation associated with congestive heart failure.

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