Closure Device For Heart Defects To Be Developed

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Heart Defects

Cardica have entered into an agreement to develop and commercialize a specialized device designed to close the patent foramen ovale, a relatively common heart defect present in approximately 15 to 20 percent of the general population.

Under the terms of the agreement, Cardica will receive $900,000 in upfront fees and is eligible to receive approximately $2.7 million in additional milestone payments during the development effort over the next 12 to 18 months as well as royalties on future worldwide sales of the device.

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"We are pleased to once again partner with Cardica, combining Cardica's leading-edge automated closure technology with our clinical and marketing expertise, as we believe it will allow us to provide an effective PFO closure device for the patients at risk for stroke or systemic embolism, as well as potentially those suffering from debilitating migraine headaches," said Brian Bates, senior vice president, business development of Cook Medical. "This is an underserved patient population that would greatly benefit from a less invasive, straight-forward procedure to permanently and effectively close a hole in their heart."

Under the agreement, Cardica is responsible for the design, production and manufacturing of the PFO closure device, which will be directed by a development committee with representatives from both companies. Cook is responsible for preclinical and clinical development, as well as regulatory approval of the product, and will have exclusive worldwide commercialization rights to market the PFO closure device.

"We look forward to building on our exceptional relationship with Cook as we leverage our proprietary closure technology to facilitate minimally-invasive surgery in the growing field of PFO closures," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "This agreement expands our reach into new areas of cardiovascular health while maintaining our focus on our innovative automated closure technology and has the potential to offer a new treatment alternative for patients who have experienced transient ischemic attack, stroke, paradoxical embolism or debilitating migraines."

A patent foramen ovale (PFO) is a congenital heart defect. During fetal development, the heart's two upper chambers are connected by a hole which allows blood to be diverted away from the lungs because they are not yet developed. This hole, called the foramen ovale, is necessary for healthy fetal development and closes naturally in approximately 80 percent of the general population by the age of two. When it remains open after this period, it is said to be patent, or open.

People with PFO often are asymptomatic, but are at greater risk for stroke and systemic embolism because of the potential formation of blood clots. With larger PFOs, patients may experience labored breathing, recurrent respiratory infections and even heart failure or death. Today, PFOs are treated by the use of a blood thinning medication (aspirin or warfarin) to prevent blood clots, or the PFO is closed through open heart surgery or transcatheter closure procedure.

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