| Novadaq Technologies Receives FDA Clearance for SPY Intra-operative Imaging System for Cardiac Surgery |
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Toronto, Ontario and Tampa, Florida – January 24, 2005 Novadaq™ Technologies announced today that the SPY™ Intra-operative Imaging System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use during Coronary Artery Bypass Surgery (CABG). This announcement came during the 2005 Society of Thoracic Surgeons Meeting being held in Tampa , Florida . The company will begin marketing the system in the United States immediately. The SPY Intra-operative Imaging System is the first fluorescent imaging system available for use during CABG. SPY enables cardiac surgeons to simply and efficiently confirm proper placement of their bypass grafts and assess the functionality of those grafts while the patient is still on the operating room table. Use of Novadaq's SPY Imaging System may potentially reduce the number of patients that must return to the operating room for the revision of improperly functioning or potentially misplaced grafts. The SPY Imaging System has been used in more than 1000 CABG cases in Europe, Canada and Japan. Speaking from the STS meeting in Tampa , Professor David Taggart, MD, PhD, of the Oxford Heart Centre at the John Radcliffe Hosptial in Oxford , UK who has one of the largest experiences using the SPY system said, “ Coronary artery bypass graft surgery is one of the few interventions where there is little or no intra-operative quality control. This is a major issue, particularly as surgical cases become technically more challenging. Until recently, there has been no user friendly system available to check graft quality in the OR that produces high quality mages that are also easy to interpret. The SPY Imaging System meets these criteria. For a cardiologist to deploy a stent without checking the result would be unacceptable and the same situation could be argued for coronary artery bypass surgery.” Peter J. Fitzgerald, MD, PhD, Associate Professor of Cardiovascular Medicine and Engineering at Stanford University , agrees with Professor Taggart, “As a cardiologist, I would never place a stent or perform an intervention without obtaining a post-procedure image to ensure that my results are optimal. Surgeons can for the first time, do the same thing. I have seen the SPY images and they are outstanding. My surgical colleagues and I look forward to using the SPY System.” In 2005 over 400,000 bypass surgeries are likely to be performed in the United States alone. The SPY Imaging System is practical for use in both traditional on-pump coronary artery bypass procedures, where the patient's heart is stopped and blood is pumped through the body via a heart-lung machine, and off- pump coronary artery bypass procedures, where the heart is not stopped. Unlike conventional X-ray imaging which is not practical for routine use during cardiac surgery, use of the SPY system does not involve any ionizing radiation. “CABG is one of the most invasive, technically challenging surgeries and complications can lead to incomplete recovery or even death. ” said Arun Menawat, CEO and President of Novadaq Technologies. “We have seen the benefits SPY provides to surgeons and patients in our large experience outside of the United States . Clinical data have shown that with the use of the SPY System, as many as 5% of all bypass grafts were found to not be functioning properly following placement. The ability to revise or fix these poorly functioning grafts while the patient is still in the OR may ultimately prevent complications that might have occurred later in the patient's recovery.” About Novadaq TechnologiesNovadaq Technologies is a privately held Canadian company, focused on developing and marketing diagnostic and therapeutic medical devices for cardiovascular and ophthalmic procedures. Novadaq's SPY system fulfils the unmet need of validating graft patency during CABG surgery. Novadaq's ophthalmic product is aimed at the diagnosis and treatment of Age-Related Macular Degeneration (AMD) by using the same core imaging technology that is used in the SPY Intra-operative Imaging System. Novadaq's ophthalmic system is currently being used in clinical trials. In April of 2000, Novadaq acquired exclusive worldwide rights to technology used to visually validate the success of cardiovascular surgery from the National Research Council of Canada (NRC). Additionally, in 2001 the company also exclusively licensed Intellectual Property from Johns Hopkins University (JHU) for visually locating and treating abnormal blood vessels in the eye found in patients with Age-Related Macular Degeneration (AMD). For more informationabout Novadaq Technologies, Inc. and Novadaq products please visit the company's website at www.novadaq.com or contact:
Mary Kay Baggs
Arun Menawat |