Toronto, Ontario – May 9, 2006 Novadaq® Technologies Inc. (TSX:
NDQ), a developer of medical imaging systems for the operating room,
announced today that it has received a 510(k) pre-market clearance from
the United States Food and Drug Administration for a labeling revision
for its SPY® Intra-operative Imaging System. This labeling will give
cardiac surgeons greater flexibility for the administration of the
imaging agent while enhancing image quality during coronary artery
bypass graft (CABG) procedures.
SPY is the first and only fluorescence guided system that enables
cardiac surgeons to visually assess coronary vasculature and bypass
grafts during the course of a CABG procedure. It also allows surgeons
to view, record, replay, print and archive high-quality image sequences
of the coronary arteries and by-pass grafts. SPY provides surgeons the
ability to identify the unpredictable need to perform graft revisions
during the original surgical procedure – an opportunity that until now,
had never been routinely possible. The revised labeling for the product
allows direct injection of the imaging agent to the vessels in the
region of interest. This gives the surgeon greater flexibility without
posing any additional risk to the patient.
The Company also announced the start of two additional clinical trials
in different therapeutic applications for SPY: cerebral angiography
during neurosurgery and the evaluation of access points for renal
failure patients who are undergoing hemodialysis. Both studies are
being conducted in Canada.
“The ability to apply our imaging platform to different therapeutic
areas, with no significant investment in technology, demonstrates the
potential to expand the market opportunity for Novadaq over time,” said
Dr. Arun Menawat, CEO and President, Novadaq Technologies Inc. “This is
how LUNATM was conceived and how we intend to continue to pursue
opportunities to become a leading imaging company in the operating
room.”
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, treatment and
on-going management of wet Age-related Macular Degeneration (AMD) by
using the same core imaging technology that is used in the SPY System.
The OPTTX System is currently being evaluated in clinical trials.
Novadaq’s product for nerve visualization in prostate surgery, LUNA™ is
designed to enable surgeons to visualize nerve bundles and the
lymphatic system during the course of urological procedures, including
radical prostatectomy in order to reduce negative outcomes including,
but not limited to, impotency.
For more information, please visit the company's website at www.novadaq.com.
Certain matters discussed in this release could constitute
forward-looking statements that are subject to risks and uncertainties
relating to Novadaq's future financial or business performance. Actual
results could differ materially from those anticipated in these
forward-looking statements. 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. Particularly, information
regarding future sales and marketing activities, future revenues and
research and development activities, as well as the Company’s plans for
each of the SPY System, OPTTX System and LUNA System, 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,
and potential opportunities in the AMD treatment market and 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
and 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.
For further information visit our website at www.novadaq.com, or contact:
Arun Menawat, PhD, MBA
President & CEO
Novadaq Technologies Inc.
Phone: 905-629-3822 x 202
amenawat@novadaq.com
Investor Relations:
Michael Moore
The Equicom Group
Phone: 416-815-0700 x 241
mmoore@equicomgroup.com
