Cardica, Inc. Receives Milestone Payment From Cook Incorporated For X-Port Vascular Access Closure Device Collaboration
REDWOOD CITY, Calif., March 8 /PRNewswire-FirstCall/ -- Cardica, Inc. today announced that it has received a $500,000 payment from Cook Incorporated after the successful completion of the first milestone in the development the X-Port(TM) Vascular Access Closure Device, an innovative automated device intended to be used to close holes in the femoral arteries after interventional vascular procedures.
"We believe that Cardica's design and micro-clip miniaturization expertise will lead to a significantly enhanced approach to vascular access closure," said Brian Bates, senior vice president, business development of Cook Incorporated. "We are pleased with the progress we are making on this next-generation closure device."
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 will have exclusive commercialization rights to market the X-Port device for medical procedures anywhere in the body. Cardica is eligible to receive additional product development milestone payments of up to $1.5 million upon successful completion, as well as, royalties on future worldwide sales.
"We are excited to be working with Cook and believe that this collaboration brings together Cook's innovative leadership and expertise in interventional cardiology with our commitment to provide reliable automated systems to enhance the care of patients with a wide range of cardiovascular and other conditions," said Bernard Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "Cook's support of this program helps us leverage the versatility of our proprietary technology and has the potential to expand beyond this initial development effort."
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. 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) system, a distal anastomosis system, is marketed in Europe and received 510(K) clearance from the U.S. Food and Drug Administration in November 2005. The PAS-Port(R) system, a 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.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