Novadaq Technologies Inc.

Novadaq Technologies Inc.

September 11, 2006 09:00 ET

Novadaq Updates on OPTTX Clinical Results as Presented at this Year's Joint American Society of Retina Specialists and European Vitreo Retinal Society Meeting

TORONTO, ONTARIO--(Marketwire - Sept. 11, 2006) - Novadaq Technologies Inc. (TSX:NDQ) -

Professor Giovanni Staurenghi, Associate Professor of Ophthalmology, Chairman Eye Clinic, Director II School of Ophthalmology, Department of Clinical Science Luigi Sacco, Sacco Hospital, University of Milan, Italy, today presented at the joint American Society of Retinal Specialists (ASRS), European Vitreo Retinal Society (EVRS) meeting in Cannes, France, the results of a 12 month follow up trial in wet AMD patients treated by either conventional feeder vessel therapy (FVT) or FVT in the presence of indocyanine green (ICG), with both groups being treated with Novadaq's proprietary OPTTX® System. Professor Staurenghi is the Principal Investigator of this randomized clinical trial.

The clinical trial enrolled 40 patients in total, with 20 patients in a conventional FVT arm and 20 patients in a FVT + ICG arm in which ICG was administered during the course of treatment, allowing the doctor to visualize the site of treatment throughout the procedure. The imaging agent preferentially absorbs the heat energy emitted by the OPTTX System's treatment laser relative to the surrounding tissue allowing the feeder vessel (FV) to close more effectively with relatively less collateral damage to the surrounding retinal tissue. The identification of FVs and their treatment was performed using the OPTTX System in both treatment arms.

Building on the historical data published in peer reviewed literature that demonstrates that FVT is not only a viable treatment modality for wet AMD, but an effective one, this trial demonstrated:

1. That the amount of energy needed to close abnormal vessels, which are a manifestation of wet AMD, was ~ 7 times less per treatment in the arm that used ICG (5.7 J / Tx session) during the course of treatment than the conventional FVT arm (38.9 J / Tx session). This was the primary objective of the trial and the endpoint was met.

2. That the treatment was more effective and more durable in the FVT + ICG arm, as 90 % of the patients in the FVT + ICG arm were able to have their FV closed or partially closed with 70 % of those vessels remaining closed at the last treatment assessment, compared to 77 % and 44 % in the conventional FVT arm, respectively.

3. Importantly, the trial showed that using the OPTTX System, FVT is a practical treatment modality for wet AMD from both a patient and clinic logistics stand point, in that:

a. Diagnosis, identification of FV, treatment and confirmation of treatment effectiveness was similar between the 2 groups ranging from 21 - 23 minutes; and

b. On average the FVT + ICG arm required 5 treatment sessions over the course of 1 year (range 1 - 9).

4. Visual Acuity (VA) at the end of the treatment phase of this trial, as measured by the Early Treatment Diabetic Retinopathy Scale (ETDRS), shows that, for the whole treated population, on average the VA was stable, and 29% of all patients seen at this visit had an improvement in vision. This percentage rises to 50% for those patients that followed the trial visit schedule.

"I am satisfied with the results generated in this trial. They are consistent with previously published results for FVT and I look forward to using the OPTTX System for my patients as soon as it is commercially available in Europe", stated Professor, Giovanni Staurenghi.

This data builds on the previously reported results of conventional FVT from the literature, as well as results derived from shorter duration studies conducted in the past with earlier versions of the OPTTX System. One earlier study in 11 wet AMD patients, showed that with successful closure of FV, approximately 60% of the patients experienced decreased exudation and improved VA. A second study in 12 patients demonstrated that vision remained stable in 10 of the 12 treated patients (83%), with 5 of those having either no change or an improvement in VA.

"We are very excited about the outcome of this trial and these findings will be used to further support our regulatory strategies for OPTTX" says Allison Manners, Novadaq's VP Regulatory and Clinical Affairs. "We also know from experience with our SPY® System that additional clinical evidence is required to drive adoption of the technology and facilitate full commercialization of the product." Novadaq is currently awaiting the outcome of their CE Mark Technical file review, expected before the end of the year, and plans to initiate 2 separate Patient Registry trials in the last quarter of 2006 to further evaluate the practicality of FVT, as well as to assess the potential for FVT + ICG treatment with the OPTTX System in combination with intravitreal anti-VEGF injections in reducing the number of intravitreal injections and hence patient visits.

"Our imaging and laser capabilities all built in a single device, is the key to precise diagnosis, targeted treatment, and on-going management of the patients who have wet AMD. We believe that FVT using the OPTTX System has the potential to become the laser treatment of choice either as mono therapy or in combination with other drug therapies for this disease." said Dr. Arun Menawat, President and CEO, Novadaq Technologies Inc.

About Feeder Vessel Therapy

Retinal specialists have practiced laser photocoagulation for the treatment of wet AMD, the precursor of FVT, since the 1970's. FVT is currently generally performed using 2 separate devices: an imaging device to locate the abnormal 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 2 devices renders FVT, as currently generally 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.

About The OPTTX System

The OPTTX System, using the same core technology as the commercially available SPY System, is a single device that performs multiple functions. OPTTX is designed to enable retinal specialists to diagnose, treat and provide on-going management of patients suffering from wet AMD. As the only imaging device with the ability to visualize the disease state of wet AMD during treatment, OPTTX allows retinal specialists to accurately diagnose and treat, by targeting and closing the abnormal FVs in real-time, within a single patient visit. OPTTX also allows the retinal specialist to immediately confirm the effectiveness of the 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, 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® 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 a CE Mark for the OPTTX System at the end of Q2 2006 and expects a limited launch in Europe by year end. Novadaq's product for nerve visualization in prostate surgery, LUNA™ is designed to enable surgeons to visualize nerve bundles during the course of 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, 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, 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 and expectations 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, 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, dependence on key suppliers for components of the SPY System, the OPTTX System and the LUNA 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.

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