Novadaq Technologies Inc.

Novadaq Technologies Inc.

December 12, 2006 08:00 ET

Novadaq Announces Health Canada Approval of LUNA for Urological Procedures

TORONTO, ONTARIO--(Marketwire - Dec. 12, 2006) -

Attention: Business Editors

Novadaq® Technologies Inc. (TSX:NDQ), a developer of medical imaging systems for the operating room, today announced Health Canada's issuance of a medical device license for LUNA™. LUNA has been approved for use for the assessment of organs, tissues and vessels in urological procedures, such as open radical prostatectomy, tumor resections, evaluating perfusion in suspected testicular torsion cases, and aiding in the assessment of vessel reconstruction procedures. LUNA can be used pre-, intra- and post-operatively as an aid in the diagnosis, intervention and evaluation of urological procedures.

"Health Canada's recent approval of LUNA for urological procedures is a significant first step towards our goal of broadening our product offering and becoming a new standard for imaging in the operating room," said Dr. Arun Menawat, President and Chief Executive Officer Novadaq Technologies Inc. "We plan to follow the same model that was used to commercialize the SPY System worldwide. The Canadian marketplace was chosen as the first point of entry for LUNA because the standard of care for early stage prostate cancer is open radical prostatectomy. We plan to commercialize LUNA in open radical prostatectomy in world markets while we further develop next generation devices to enable the use of this innovation in minimally invasive procedures. If LUNA can assist surgeons in sparing nerves in only a small portion of the radical prostatectomy surgeries conducted every year, thousands of men can be spared the severe side effects of this life saving surgery. We believe the quality of the technology and imaging, as well as the need expressed by both surgeons and patients, will enable us to drive market adoption efficiently."

About Urological Disorders Treated by Surgical Intervention

According to the Canadian Cancer Society, in Canada alone, each year 20,700 men will be diagnosed with prostate cancer, 4,200 will die and 9,000 will undergo radical prostatectomy surgery in an effort to eliminate or control the disease. Radical prostatectomy is the most common treatment for localized prostate cancer. Radical prostatectomy is major surgery performed under general or regional anesthesia that removes the entire prostate gland plus some surrounding tissue. During the procedure the pelvic lymph nodes may also be biopsied for further assessment. The goal is to remove the cancer entirely and prevent its spread to other parts of the body. Literature indicates that approximately 30 - 50 percent of all men undergoing nerve sparing radical prostatectomy surgery will have post surgical complications related to nerve damage during surgery, including impotence and urinary incontinence. In Canada, it is estimated that the new cases of prostate cancer will exceed lung, colorectal and bladder cancer, however, death due to prostate cancer will be third after lung and colorectal cancers. Other urological conditions and surgical procedures that have the potential to be assisted with LUNA are testicular torsion or acute scrotal pain which is estimated to occur in 1 in 4,000 males younger than 25 years, bladder and kidney cancer which are the 4th and 6th most commonly occurring cancers in men in Canada, respectively.

About Novadaq Technologies

Novadaq Technologies Inc. (TSX:NDQ) develops and commercializes medical imaging devices for the operating room based on its proprietary imaging platform. 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 OPTTX® System, commercially available in Europe, 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'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

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, commercialization plans and strategies, 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. Without limitation information regarding future sales and marketing activities, SPY System placement targets and utilization rates, the implementation of a reimbursement code for the SPY System, future revenues and research and development activities and future commercialization strategies, as well as the Company's plans for each of the SPY System, the OPTTX System and LUNA, 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 effect of a recommended reimbursement code for the SPY System, the clinical results of the use of the SPY System, the results from clinical tests of the OPTTX System and LUNA, 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, the OPTTX System and LUNA, the risk that a recommended reimbursement code will not be fully implemented or that it will not affect acceptance of the SPY System, risks related to third party contractual performance, dependence on key suppliers for components of the SPY System, the OPTTX System and LUNA, 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.

This press release was prepared by management from information available to December 12, 2006.

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