Healthcare Industry News: Patent Foramen Ovale
News Release - June 19, 2007
Cardica and Cook Medical Enter New Collaboration Agreement to Develop and Commercialize Closure Device for Heart DefectsREDWOOD CITY, Calif., June 19 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) and Cook Medical today announced that they have entered into an agreement to develop and commercialize a specialized device designed to close the Patent Foramen Ovale (PFO), 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.
"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."
About Patent Foramen Ovale
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.
About Cook Medical
The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOKŪ Medical (http://www.cookmedical.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 drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.
About Cardica, Inc.
Cardica designs and manufactures automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica provides cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure.
Cardica's C-PortŪ Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-PortŪ Proximal Anastomosis System is marketed in Europe and Japan and is being evaluated in a pivotal trial in the United States and Europe. Cardica also is developing additional devices to facilitate vascular and other surgical procedures. Go to http://www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements regarding Cardica, including statements relating to potential features and benefits of the PFO closure device to be designed and developed by Cardica and Cook Medical and the potential receipt by Cardica of milestone payments and royalties by Cardica on product sales from Cook Medical. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "believe," "eligible," "potential" and "will" or similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Cardica's results to differ materially from those indicated by these forward- looking statements, including risks associated with the development of the PFO closure device and degree of its market acceptance as well as other risks detailed from time to time in Cardica's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read the Company's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
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