TORONTO, Feb. 14 /PRNewswire-FirstCall/ - Novadaq(R) Technologies Inc. , a developer of medical imaging systems for the operating room, today announced that post market patient registry studies are being initiated with its CE Mark approved OPTTX(R) System in Europe. Two OPTTX Systems have been placed, one in Italy and the other in England, with a third site planned for Switzerland in the first quarter of 2007.
“The OPTTX System is a minimally invasive treatment for wet Age-related Macular Degeneration and has the potential to be a treatment of choice either as monotherapy or in combination with anti-VEGF. This milestone is a significant achievement for Novadaq and represents another step towards the successful commercialization of our technology platform,” said Dr. Arun Menawat, President and Chief Executive Officer of Novadaq Technologies Inc. “The OPTTX System is both a diagnostic and a therapeutic tool making it potentially a convenient device of choice for retinal surgeons.”
The OPTTX System is the first and only commercially available device able to diagnose and treat wet Age-related Macular Degeneration (AMD) all in one system and manage the disease on an on-going basis. The OPTTX System uses the same core imaging technology that is used in the Company’s SPY(R) System, with proprietary optics designed for precise identification of the disease state, followed immediately by targeted treatment. The unique imaging capabilities also allows the surgeon to immediately confirm the physical effect of the treatment and allows for a greater understanding of the hemodynamics of the vasculature underlying the retina, the root of the disease. The OPTTX System is designed for stand alone treatment known as choroidal vessel closure(TM) (CVC) or in combination by using CVC with other treatment modalities allowing for the physical closure of leaking choroidal and retinal vessels, as well as, the ability to modulate the physiological aspects of the disease.
“I am pleased that the device is now available in Europe,” said Robert Devenyi, Ophthalmologist-in-Chief, and Director of Retinal Services, The University Health Network, The University of Toronto. “I believe that the registry trials have the potential to show that the combination of CVC and anti-VEGF treatment may reduce the frequency and the number of intra-vitreal injections needed during the course of care for patients suffering from wet AMD.”
Novadaq is undertaking two post market registry studies to further evaluate the benefits of CVC when used as a monotherapy or in combination with anti-VEGF treatments. These studies will be conducted in the three centers previously identified. One center will focus on CVC alone, while the other two will evaluate CVC effects on the need to re-treat with intra-vitreal injections of anti-VEGF drugs, evaluating both the interval between intra-vitreal injections and the total number of injections required over the duration of the study. It is anticipated that approximately 100 - 120 patients will be treated and followed in these registry studies.
About Novadaq Technologies
Novadaq Technologies Inc. develops and commercializes medical imaging devices for use in the operating room. Novadaq’s proprietary imaging platform can be used to visualize blood vessels, nerves and the lymphatic system during surgical procedures. 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 which received CE Mark approval in November 2006, 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. The HELIOS(TM) System, which received FDA clearance in January 2007, is the first fluorescent imaging system available for use during plastic reconstructive surgery allowing surgeons to evaluate pre- and intra-operative blood flow, as well as post-surgery perfusion. Novadaq’s LUNA(TM) system is designed to enable surgeons to visualize nerve bundles during the course of urological and neurological procedures. LUNA has been granted a license for use by Health Canada. For more information, please visit the company’s website at 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, taxes and plans and objectives of or involving Novadaq. Without limitation information regarding future sales and marketing activities, placement expectations for the OPTTX System, the European registry studies involving the OPTXX System, and the planned European commercial launch of the OPTTX System, as well as the Company’s plans for each of the SPY System, the OPTTX System, the HELIOS System and LUNA, is forward-looking information.
Forward-looking information is based on certain factors and assumptions regarding, among other things, the results from clinical tests of the OPTTX System and potential opportunities in the AMD treatment market. 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 OPTTX System, risks related to third party contractual performance, dependence on key suppliers for components of 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, except as required by law.
This press release was prepared by management from information available to February 13, 2007.
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,amenawat@novadaq.com; Michael Moore, Investor Relations, The Equicom Group,(416) 815-0700 x 241, mmoore@equicomgroup.com