September 15, 2008
Cardica Receives $1 Million Milestone Payment From Cook Medical for Development of Heart Defect Closure Device
REDWOOD CITY, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Cardica, Inc. today announced that it received a $1 million milestone payment from Cook Medical (Cook) for the successful development of a specialized automated device used to close holes in the heart known as patent foramen ovales (PFO), a relatively common heart defect present in 15 to 20 percent of the general population.
"Patients with PFO may be at increased risk for several serious medical conditions, including stroke and systemic embolism, because blood clots can pass directly through the hole and into the main circulation," said Brian Bates, senior vice president of business development for Cook. "We believe the innovative closure device developed by Cardica provides patients with a direct minimally invasive alternative to current treatments to permanently close the hole in the heart. This may potentially reduce the risk of stroke, transient ischemic attack and debilitating migraines."
In June 2007, Cardica and Cook entered into an agreement to develop a PFO closure device, whereby Cardica is responsible for the design, production and manufacturing, which is directed by a development committee with representatives from both companies. Cook is responsible for preclinical and clinical development, as well as regulatory approval of the product, and, subject to regulatory approval will have exclusive worldwide commercialization rights to market the PFO closure device. Cardica has received a total of $3.1 million to date under the agreement. Cardica also is eligible to receive additional payments, of up to $500,000 over the next year if specified milestones are met, as well as royalties on future worldwide sales, if any.
"We believe the PFO closure market provides a natural extension for our automated closure technology beyond cardiac bypass surgery and that our device addresses an underserved patient population," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "We look forward to initiating final preclinical testing of our device later this fiscal year."
About Patent Foramen Ovale
A PFO is a very common structural genetic heart defect. During fetal development, the heart's two upper chambers are connected by a hole that allows blood to be diverted away from the lungs because they are not yet developed. This hole, called the foramen ovale, is necessary for healthy fetal development and closes naturally by age two in approximately 80 percent of the general population. When it remains open after this period, it is said to be patent.
People with PFO often are asymptomatic, but they are at greater risk for stroke, systemic embolism and debilitating migraine headaches because routine blood clots are passed from the right atrium to the left atrium, bypassing the lungs where they are typically filtered out. The National Stroke Association estimates that approximately 100,000 people in the United States suffer PFO-related strokes each year. In addition, several studies suggest that up to 50 percent of the 3 to 6 million patients suffering from migraine headaches preceded by aura may have a PFO.
With larger PFOs, patients may experience labored breathing, recurrent respiratory infections and heart failure or death. Today, PFOs are treated by the use of a blood thinning medication (aspirin or warfarin) to prevent blood clots, or surgically through an open chest or transcatheter closure procedure.
About Cook Medical
The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK(R) Medical (http://www.cookmedical.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 drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.
Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide 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 Cardica has received 510(k) clearance to market the PAS-Port system in the United States. Cardica also is developing additional devices with Cook Medical to facilitate vascular closure and other surgical procedures.
This press release contains "forward-looking" statements, including statements relating to the potential benefits of the PFO closure device. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "believe,""may,""potentially" 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 lack of data regarding the safety and efficacy of the PFO device, the need for Cardica's products to gain market acceptance, 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 fiscal year ended June 30, 2008. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read the Cardica's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov/.
CONTACT: Bob Newell, Vice President, Finance and Chief Financial Officerof Cardica, Inc., +1-650-331-7133, [email protected]; or Daryl Messingerof WeissComm Partners, Inc., +1-415-999-2361, [email protected], forCardica, Inc.
Web site: http://www.cookmedical.com/