REDWOOD CITY, Calif., May 8 /PRNewswire-FirstCall/ -- Cardica, Inc. today announced the successful completion of the second development milestone for the X-Port(TM) Vascular Access Closure Device, an innovative automated device intended to be used to close access openings in the femoral arteries after interventional vascular procedures, which it is developing with Cook Incorporated. Achievement of this milestone triggers a $500,000 payment from Cook.
“Cardica is progressing in the development of this unique vascular access closure device,” said Brian Bates, senior vice president, business development of Cook Incorporated. “The number of interventional vascular procedures is growing, and there is a significant need for next-generation access closure devices. We believe Cardica’s microclip technology, precision engineering and creative approach are contributing to an innovative design that could potentially have broad application.”
In December 2005, Cardica and Cook entered into an agreement to develop the X-Port device under which Cardica is responsible for design and pre- clinical development, which is being directed by a committee that includes representatives from both parties. Cook is responsible for clinical development and regulatory approval, and, if the product receives regulatory approval, will have exclusive commercialization rights to market the X-Port device. Cardica has accomplished a total of $1 million in product development milestones under the collaboration to date, and could receive an additional $1 million upon successful completion of other product development milestones. Also, Cardica is entitled to receive royalties on any future worldwide sales by Cook.
“In less than six months after initiating our collaboration with Cook, we have achieved two development milestones, demonstrating our ability to efficiently leverage our proprietary automated technology into additional minimally invasive surgical interventions,” said Bernard Hausen, M.D., Ph.D., president and CEO of Cardica.
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 percent 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. Cardica is now conducting preclinical studies to assess safety and preliminary efficacy of the X-Port device.
About Cook Incorporated
The world’s largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., Cook(R) Group Inc. (www.cookgroup.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 stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.
About Cardica, Inc.
Cardica designs and manufactures automated anastomotic 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, the most critical aspect of the CABG procedure.
The C-Port(R) Distal Anastomosis System is marketed in Europe and the United States. The PAS-Port(R) Proximal Anastomosis System is marketed in Europe and Japan. 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, the progress of preclinical and clinical development of the X-Port Vascular Closure Device, the size of the market for such a device, and the likelihood of the receipt of additional milestones under the Cook Incorporated collaboration agreement. 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 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, 2005. 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 www.sec.gov.
Cardica, Inc.; Cook Inc.
CONTACT: Bob Newell, Vice President, Finance and Operations, ChiefFinancial Officer of Cardica, Inc., +1-650-331-7166, orinvestors@cardica.com; or Daryl Messinger of WeissComm Partners, Inc.,+1-415-999-2361, or daryl@weisscommpartners.com, for Cardica, Inc.; orDavid J. McCarty, Director of Public Relations of Cook Inc.,+1-812-339-2235, ext. 2387, or dmccarty@cook-inc.com
