Healthcare Industry News: AMD
News Release - November 6, 2006
Novadaq announces CE Mark for OPTTX SystemTORONTO, Nov. 6 (HSMN NewsFeed) - Novadaq® Technologies Inc. (TSX: NDQ ), a developer of medical imaging systems for the operating room, today announced that it has received the necessary CE Mark Certificates from their Notified Body to market the OPTTX® System in Europe. The OPTTX System is the only commercially available medical device that allows for diagnosis, treatment and on-going management of wet Age-related Macular Degeneration (AMD) patients, all in a single device.
The OPTTX System produces ultra high-speed indocyanine green (ICG) angiograms and facilitates the identification of choroidal feeder vessels (FVs). In addition, the OPTTX System allows for viewing a real-time angiogram in which the treatment laser is able to track and fire precisely while the FV is visible. The System then enables the retinal specialist to immediately confirm the effectiveness of the treatment. This treatment modality with the OPTTX System is called Choroidal Vessel Closure(TM) (CVC), which is the evolution of the previously reported conventional feeder vessel therapy (FVT), that uses two medical devices, one for imaging, and the second for treatment.
Europe was selected as the first market entry because ophthalmologists in Europe routinely use ICG angiography for its differential diagnosis capabilities, and are experienced and comfortable performing their own photography in managing their patients with retinal diseases, such as AMD. This choice allows Novadaq to conduct a limited launch of the OPTTX System with experienced practitioners of high-speed ICG angiography and FVT to better understand the market positioning, company resource requirements and device attributes, required for full commercialization, currently planned for the second quarter of 2007. As part of the market development activities, Novadaq has already identified three key opinion leaders in Italy, England and Switzerland to initiate this launch.
Novadaq will penetrate the market during the subsequent broader commercial launch with the aid of data that will be generated as part of this current initiative. Three post market Registry trials will be conducted, with the selected opinion leaders, to evaluate both mono therapy with the OPTTX System and combination therapy with the OPTTX System and intra-vitreal injections of anti-vascular endothelial growth factor (anti-VEGF) products. It is expected that all three Registry centers will be active by the end of 2006. The data from these Registries is expected to provide meaningful, real life information about wet AMD patient treatment, management and compliance.
"The Registry trials have been developed with some of the top surgeons in the field that are using high-speed ICG angiography, are familiar with conventional FVT, and are treating AMD patients with intra-vitreal anti-VEGF injections in their clinics today," said Dr. Arun Menawat, President and Chief Executive Officer, Novadaq Technologies Inc. "We expect to show that the combination of the OPTTX System with intra-vitreal injections has the potential to reduce the number of anti-VEGF injections the patients require while maintaining their visual acuity; making clinic management much more efficient, while still preserving the patient's quality of life."
"The CE Mark for the OPTTX System was a difficult task given the complexity and sophistication of the System itself," said Allison Manners, Vice President, Regulatory and Clinical Affairs, Novadaq Technologies Inc. "This approval was due in part to positive clinical data that have been generated during the development of the product and previously reported."
About Choroidal Vessel Closure
Retinal specialists have practiced laser photocoagulation for the treatment of wet AMD, the precursor of FVT and CVC, since the 1970's. Conventional FVT is currently performed using two separate devices: an imaging device to locate the abnormal choroidal FVs and a treatment device, such as a slit lamp laser, to photocoagulate or cauterize the FVs. The conventional treatment device is not capable of imaging the abnormal FVs, which are located behind the retina. As a result, FVT, as currently generally practiced, first involves the use of an imaging procedure to generate a hand tracing or photograph that identifies the vascular landscape including the abnormal FVs and the target treatment area. The treatment is then administered by a separate laser device, which involves firing a cauterizing laser in small bursts in and around the area where, based on the prior map, the retinal specialist believes the FV to be located. The need to use two devices renders FVT, as currently practiced, a time consuming and technically difficult procedure. Despite these limitations, FVT, as it is currently practiced, is a safe and relatively effective treatment for wet AMD. CVC is the evolution of FVT. It uses the OPTTX System to target and treat the abnormal choroidal FV in the presence of ICG for a more precise and durable treatment.
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 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 received CE Mark approval for the OPTTX System in November 2006 and expects a limited launch in Europe by year end. Novadaq's product for urology, LUNA(TM) 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 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 the initial commercialization launch of the OPTTX System in Europe, the currently planned broader commercialization of the OPTTX System, the planned Registry trials and Novadaq's expectations regarding the results of these Registry trials, 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 the OPTTX System, the clinical results of the use 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, sales and distribution risks, 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.
Source: Novadaq Technologies
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