Healthcare Industry News: Proximal Anastomosis
News Release - March 13, 2007
Cardica Receives $1.25 Million From Cook Medical for Development and Tooling for Vascular Access Closure DeviceREDWOOD CITY, Calif., March 13 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that it received $1.25 million in payments from Cook Medical for development and high volume production tooling for the Cook Vascular Access Closure Device, an innovative automated system designed to close access openings in femoral arteries after interventional vascular procedures. The device, also known as the X-Port(TM) device, is being developed by Cardica in partnership with Cook.
"We are pleased with Cardica's development of the Cook Vascular Access Closure Device, and believe that with its unique features and streamlined design, this product has the potential to address the large and growing market need for next-generation vascular closure devices," said Brian Bates, senior vice president of business development for Cook Medical. "We have initiated human feasibility studies with the goal of securing CE Mark (Conformite Europeenne)."
In December 2005, Cardica and Cook entered into an agreement to develop the X-Port device. Under the agreement, Cardica is responsible for design and pre-clinical development. Cook is responsible for clinical development and regulatory approval, and, if the product receives regulatory approval, Cook will have exclusive commercialization rights to market the X-Port device. To date, Cardica has received a total of approximately $2.75 million in development milestones and payments for high volume production tooling under the collaboration. Cardica could receive an additional $500,000 upon successful completion of the final product development milestone under the agreement, and is entitled to receive royalties on any future worldwide sales by Cook.
"Our partnership with Cook highlights the broad applicability and diverse market opportunities for our proprietary microclip technology and we look forward to exploring additional uses for this innovative device," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc.
The X-Port Advantage for Interventional Procedures
An estimated 8.5 million diagnostic and interventional catheterization procedures were performed worldwide in 2005, all of which required access site closure either by manual compression or alternative vascular closure devices and techniques. In approximately 45% of these cases, a closure device was used, and that number is steadily increasing. The worldwide market for femoral artery closure devices alone was estimated to be approximately $500 million in 2005, and is expected to increase to over $750 million by 2008.
The potential advantages of the X-Port device 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. In addition, X-Port is designed to be less invasive with a minimal amount of foreign material placed in the vessel wall.
About Cook Medical
Cook Medical, the world's largest privately held manufacturer of medical devices, has pioneered numerous innovative clinical technologies for diagnostic and therapeutic procedures since its founding in 1963. Known worldwide as a leading developer, manufacturer and global distributor of medical therapies in the fields of radiology, cardiology, urology, endovascular therapy, women's health, critical care medicine, surgery and soft tissue repair, gastroenterology, bone access, oncology and cellular and genetic treatments, the company 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 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 X-Port Vascular Closure Device, human feasibility studies of the X-Port Vascular Closure Device, the potential receipt of additional milestones and royalties under the Cook Medical collaboration agreement, Cook's ability to secure CE Mark, Cardica's potential for revenue growth in future years 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" 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 X-Port Vascular Closure Device and Cardica's dependence on 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 Quarterly Report on Form 10-Q for the quarter ended December 31, 2006. 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.
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