Novadaq Technologies, Inc. Receives FDA Clearance For SPY Labeling Changes
TORONTO, May 9 /PRNewswire-FirstCall/ - Novadaq(R) Technologies Inc. , a developer of medical imaging systems for the operating room, announced today that it has received a 510(k) pre-market clearance from the United States Food and Drug Administration for a labeling revision for its SPY(R) Intra-operative Imaging System. This labeling will give cardiac surgeons greater flexibility for the administration of the imaging agent while enhancing image quality during coronary artery bypass graft (CABG) procedures.
SPY is the first and only fluorescence guided system that enables cardiac surgeons to visually assess coronary vasculature and bypass grafts during the course of a CABG procedure. It also allows surgeons to view, record, replay, print and archive high-quality image sequences of the coronary arteries and by-pass grafts. SPY provides surgeons the ability to identify the unpredictable need to perform graft revisions during the original surgical procedure - an opportunity that until now, had never been routinely possible. The revised labeling for the product allows direct injection of the imaging agent to the vessels in the region of interest. This gives the surgeon greater flexibility without posing any additional risk to the patient.
The Company also announced the start of two additional clinical trials in different therapeutic applications for SPY: cerebral angiography during neurosurgery and the evaluation of access points for renal failure patients who are undergoing hemodialysis. Both studies are being conducted in Canada.
"The ability to apply our imaging platform to different therapeutic areas, with no significant investment in technology, demonstrates the potential to expand the market opportunity for Novadaq over time," said Dr. Arun Menawat, CEO and President, Novadaq Technologies Inc. "This is how LUNA(TM) was conceived and how we intend to continue to pursue opportunities to become a leading imaging company in the operating room."
About Novadaq Technologies
Novadaq Technologies Inc. develops and commercializes medical devices based on its proprietary imaging platform for the diagnosis and treatment of human vascular, ophthalmic, and neurologic diseases and conditions. Novadaq's SPY Intra-operative Imaging System, commercially available worldwide, enables cardiac surgeons to visually assess coronary vasculature and bypass graft functionality during the course of open-heart bypass surgery. Novadaq's ophthalmic product, the OPTTX(R) System, is aimed at the diagnosis, evaluation, treatment and on-going management of wet Age- related Macular Degeneration (AMD) by using the same core imaging technology that is used in the SPY System. The OPTTX System is currently being evaluated in clinical trials. Novadaq's product for nerve visualization in prostate surgery, LUNA is designed to enable surgeons to visualize nerve bundles and the lymphatic system during the course of urological procedures, including radical prostatectomy in order to reduce negative outcomes including, but not limited to, impotency. For more information, please visit the company's website at www.novadaq.com.
Certain matters discussed in this release could constitute forward- looking statements that are subject to risks and uncertainties relating to Novadaq's future financial or business performance. Actual results could differ materially from those anticipated in these forward-looking statements. Forward-looking information may relate to management's future outlook and anticipated events or results, and may include statements or information regarding the future financial position, business strategy and strategic goals, research and development activities, projected costs and capital expenditures, financial results, research and clinical testing outcomes, taxes and plans and objectives of or involving Novadaq. Particularly, information regarding future sales and marketing activities, future revenues and research and development activities, as well as the Company's plans for each of the SPY System, OPTTX System and LUNA System, is forward-looking information.
Forward-looking information is based on certain factors and assumptions regarding, among other things, market acceptance and the rate of market penetration of Novadaq's SPY System, the clinical results of the use of the SPY System, the results from clinical tests of the OPTTX System, and potential opportunities in the AMD treatment market and in image guided conventional and minimally invasive urological applications including nerve-sparing radical prostatectomy. While the Company considers these assumptions to be reasonable based on information currently available to it, they may prove to be incorrect.
Forward looking-information is subject to certain factors, including risks and uncertainties that could cause actual results to differ materially from what we currently expect. These factors include risks relating to the transition from research and development activities to commercial activities, market acceptance and adoption of the SPY System, dependence on key suppliers for components of the SPY System and the OPTTX System, regulatory and clinical risks, risks relating to the protection of intellectual property, risks inherent in the conduct of research and development activities, including the risk of unfavorable or inconclusive clinical trial outcomes, potential product liability, competition and the risks posed by potential technological advances, and risks relating to fluctuations in the exchange rate between the US dollar and the Canadian dollar.
You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While Novadaq may elect to, Novadaq is under no obligation and does not undertake to update this information at any particular time.Novadaq Technologies Inc.
CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,PhD, MBA, President & CEO, Novadaq Technologies Inc., (905) 629-3822 x 202,email@example.com; Michael Moore, Investor Relations, The Equicom Group,(416) 815-0700 x 241, firstname.lastname@example.org