Manny Villafaña, Chairman and Chief Executive Officer of Kips Bay Medical, Inc. (NASDAQ:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery (CABG), provided the following business update to Kips Bay shareholders and the financial community.
Dear shareholders and friends:
I felt it would be good to provide a business update to all of our shareholders via a press release so that everyone can understand the activities underway at Kips Bay Medical.
First of all, we continue to have successful implants throughout the world. We now estimate that we have 500+ commercial implants in Europe and the Middle East since the commercialization of our product began in June of 2010. Over this time, there have been no reportable adverse events related to our device.
Additionally, with the U.S. Food and Drug Administration (FDA) approval to begin feasibility trials here in the United States, we have begun working with some of the leading cardiac research centers in the United States. We have had, or are in the process of, patient enrollment at the following centers: Northeast Georgia Heart Center of Gainesville, GA; the Mayo Clinic of Rochester, MN; Emory University Hospital Heart and Vascular Center in Atlanta, GA; and the Texas Heart Institute in Houston, TX. Furthermore, we have additional U.S. sites that are working to be ready to join our feasibility trial in the event that we receive approval from the FDA to add more clinical trial sites in the United States. The Lenox Hill Hospital in New York has received its required internal approval and has signed a clinical trial agreement with us, and we are presently working with the Cleveland Clinic, in Cleveland, Ohio, to complete their internal review and approval process. And, of course, this is in addition to our work overseas where we have five centers enrolling patients and three more getting ready to begin. We now have 30 patients enrolled in the feasibility trial.