REDWOOD CITY, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Cardica, Inc. today announced that it achieved its third product development milestone for the X-Port(TM) Vascular Access Closure Device. As a result, Cardica received a $500,000 payment from Cook Incorporated, Cardica’s partner for the development and commercialization of the X-Port device, an innovative automated system designed to close access openings in femoral arteries after interventional vascular procedures.
“We are pleased with the development progress of the X-Port system and believe that Cardica’s proprietary product offers an innovative, single- product solution to effectively address the growing need for a next-generation vascular access closure device,” said Brian Bates, senior vice president, business development of Cook Incorporated. “Pending the successful completion of animal model studies, we look forward to initiating human clinical trials in 2007.”
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, will have exclusive commercialization rights to market the X-Port device. Cardica has achieved a total of $1.5 million in product development milestone payments under the collaboration to date, including the payment in connection with the most recent milestone achievement, and could receive an additional $500,000 upon successful completion of the final product development milestone. Cardica is also entitled to receive royalties on any future worldwide sales by Cook.
“Our novel design and rapid development of the X-Port device further validate the precision and diverse applicability of our innovative technology,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. “We believe that we are positioned to build a leading business focused on closure devices for blood vessels that we expect to produce substantial revenue growth in the years ahead.”
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, with this percentage 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 compared to existing products 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 than existing closure devices with a minimal amount of foreign material placed in the vessel wall. Cardica demonstrated safety and preliminary efficacy of the X-Port device in preclinical studies.
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. The company won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine.
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-Port(R) Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-Port(R) 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, the outcome of animal model studies and potential initiation of clinical trials of the X-Port Vascular Closure Device, the potential receipt of additional milestones and royalties under the Cook Incorporated collaboration agreement, 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 September 30, 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.
Cardica, Inc.
CONTACT: Bob Newell, Vice President, Finance and Operations, ChiefFinancial Officer of Cardica, Inc., +1-650-331-7133, 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
