Novadaq Announces Initiation Of LUNA System Human Clinical Trials
This first trial enrolled and imaged its first patients over the past week at the Strong Memorial Hospital, University of Rochester, Rochester, N.Y., USA. This first application uses the LUNA System to assist the surgeon to evaluate and identify tumor margins in kidney tumors. It is anticipated that successful tumor identification will aid the surgeon in removing as much of the tumor as possible, while preserving normal tissue. The initial images demonstrate the differential perfusion of the tumor to normal tissue allowing the doctor to clearly identify the extent of the tumor, while surgically removing it.
The trial is designed to evaluate the clinical utility of the images, as well as correlate the findings to standard histopathology determinations of tumor margins. In addition, LUNA can be used to evaluate perfusion of the kidney after partial nephrectomy, something that is not routinely or practically done in the operating room without the LUNA System. Novadaq intends to initiate further clinical work in radical prostatectomy surgery later this year.
"The images from the initial patients are very promising," remarked Dr. Edward Messing, Winfield W. Scott Professor and Chairman Department of Urology, Principal Investigator of this trial. "This technology holds a lot of potential for many urological applications, and we are looking forward to continuing the clinical development of this product for those different procedures."
"I would like to congratulate the Rochester team for making tremendous progress on taking the urological applications for LUNA from concept to clinic in such a short period of time," said Dr. Arun Menawat, President and CEO, Novadaq Technologies Inc. "We entered into this research arrangement in February 2006 and are already conducting our first human trial with encouraging early images and findings."
About Novadaq Technologies
Novadaq Technologies Inc. (TSX: NDQ) develops and commercializes medical devices based on its proprietary imaging platform for the diagnosis and treatment of human vascular and ophthalmic 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 surgery. Novadaq's ophthalmic product, the OPTTX(R) System, is aimed at the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD) by using the same core imaging technology that is used in the SPY System. Novadaq filed for CE Mark approval for the OPTTX System at the end of Q2 2006 and expects a limited launch in Europe by year end. Novadaq's product for urology, LUNA is designed to enable surgeons to visualize nerve bundles during the course of urological procedures such as radical prostatectomy in order to reduce negative outcomes including impotency. For more information, please visit the company's website at http://www.novadaq.com.
This press release contains certain information that may constitute forward-looking information within the meaning of securities laws. In some cases, forward-looking information can be identified by the use of terms such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "intend", "estimate", "predict", "potential", "continue" or other similar expressions concerning matters that are not historical facts.
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, and plans and objectives of or involving Novadaq. Particularly, information regarding future sales and marketing activities, the future roll-out of the SPY System in Europe and Emerging Markets, future revenues and research and development activities, expectations for regulatory approval and commercial launch of the OPTTX System, as well as the Company's plans for each of the SPY, OPTTX and Luna Systems, is forward-looking information.
Forward-looking information is based on certain factors and assumptions regarding, among other things, current sales and distribution plans, 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, the likelihood of regulatory approval in Europe for the OPTTX System, potential opportunities in the AMD treatment market, and potential opportunities 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, sales and distribution risks, 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.
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Novadaq Technologies Inc
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Novadaq anunþã iniþierea LUNA Sistemul Omului studiile clinice - Novadaq Announces Initiation Of LUNA System Human Clinical Trials - articole medicale engleza - startsanatate