Corazon's demineralization technology is uniquely positioned to improve native valve function. The company is now expanding its application to be used as an enabling treatment for valve replacement by demineralization of the implantation site prior to valve replacement. The Corazon technology is anticipated to facilitate aortic valve replacement and improve outcomes, including implant durability. In addition, both applications are being incorporated into a beating heart platform. It is believed this beating heart platform will allow clinicians to perform valve repairs or enable valve replacements either percutaneously or surgically. The beating heart system is planned for clinical evaluation during the first half of 2005.
"We are pleased with the early results from our International study," said Geoffrey Dillon, President and CEO of Corazon Technologies, Inc. "We have made tremendous progress in advancing the technology associated with valve repair. We are now beginning to move from our very promising early stage results to positioning the company for beating heart valve repair and enabling technologies for percutaneous valve replacement."
Corazon has been granted an IDE by the FDA for its stopped-heart device in the United States. U.S. clinical trials are expected to begin before year's end, and will occur in three sites, including The Cleveland Clinic in Cleveland; Brigham & Women's Hospital in Boston; and the University of Michigan in Ann Arbor.
"Percutaneous heart valve replacement is in the future, and Corazon's technology has the potential to enable these procedures," says the Cleveland Clinic heart-valve surgeon and CEO, Dr. Delos M. "Toby" Cosgrove. "Currently surgeons debride and prepare the site for valve implantation during open chest procedures. Demineralization of the valve prior to percutaneous aortic valve replacement may help eliminate some of the shortcomings of this procedure."
Corazon Technologies, Inc. is an emerging medical device company focused on the treatment of calcific cardiovascular tissue and is developing proprietary devices that improve native valve performance by demineralizing calcific tissue. Corazon's unique demineralization technology is the only treatment positioned to restore native valve function by repairing diseased tissue. Corazon technology may create a new treatment option for heart valve patients with mild-to-moderate stenotic disease.