Healthcare Industry News: anastomosis system
News Release - September 20, 2007
Cook Medical and Cardica Sign Agreement to Expand Cook Vascular Closure Device Product FamilyBLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical, the world's largest privately held medical device manufacturer, and Cardica, Inc. (Nasdaq: CRDC ) today announced that they have expanded their original agreement regarding the development of vascular closure devices. Cook Medical will pay Cardica up to $750,000 for the development of an additional product for the closure device product line.
"We are excited to apply Cardica's innovative product design and development to the next device in our vascular closure product line, as we believe that this technology has the potential to effectively address large and growing market needs" said Brian Bates, senior vice president of business development for Cook Medical. "We plan to launch the first product of the Cook Vascular Closure Device line in Europe in the next six months."
Similar to the original agreement under which Cardica developed the Cook Vascular Closure Device (CVCD), under this amendment Cardica is responsible for product design and pre-clinical development and is entitled to receive royalties on any future worldwide sales by Cook. Cook is responsible for clinical development and regulatory approval, and has exclusive commercialization rights.
"We look forward to expanding upon our excellent working relationship with Cook by broadening our closure device product line using our proprietary microclip technology," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica.
The CVCD Advantage for Interventional Procedures
An estimated 8.5 million diagnostic and interventional catheterization procedures were performed worldwide in 2006, all of which required access site closure either by manual compression or alternative vascular closure devices and techniques. In approximately 45 percent of these cases, a closure device was used, and that number is steadily increasing. The worldwide market for femoral artery closure devices alone is estimated to be over $750 million by 2008.
The potential advantages of the closure devices developed by Cardica and Cook include a simple user interface, the ability to place it through the same introducer sheath used for the interventional procedure for greater convenience and speed, scalability, and lower cost of goods.
About Cook Medical
Cook Medical was the first company to introduce interventional devices in the United States. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.
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 the ability to perform 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 www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements relating to the potential efficacy of the Cook Vascular Closure Device and a second closure device, Cardica's potential receipt of payment from Cook and the future market for vascular closure devices. Any statements contained in this press release that are not historical facts, may be deemed to be forward-looking statements. The words "believe," "plan," "expect," "estimate," "intend," "may" 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 timing and success of pre-clinical studies and clinical trials and market acceptance of the closure devices and Cardica's dependence upon Cook Incorporated for continued development of the device, as well as other risks detailed from time to time in Cardica's SEC reports, including its Annual Report on Form 10-K for the year ended June 30, 2007. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
Source: Cook Medical
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