Novadaq Technologies Inc.

Novadaq Technologies Inc.

November 06, 2006 10:52 ET

Novadaq Announces CE Mark for OPTTX System

TORONTO, ONTARIO--(Marketwire - Nov. 6, 2006) -

Attention Business Editors:

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™ (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™ 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, 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

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.

For further information: visit our website at

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