Toronto, Ontario – March 29, 2007 – Novadaq® Technologies
Inc. (TSX: NDQ), a developer of real-time medical imaging systems and image
guided therapies for the operating room, today provided a market update on
the status of the supply of Indocyanine Green
(ICG). On January 19, 2007, the United States Food and Drug Administration
(FDA) advised of a shortage of ICG. In its advisory, the FDA advised that
Akorn, Inc. (Akorn), currently the sole supplier of ICG in the United States,
had filed a manufacturing site change supplement for ICG with the FDA and
is working with the FDA Drug Shortage team and the CDER Reviewing Division
to bring this product to market in an expedited manner.
While Akorn had previously advised that its current inventory of ICG had an
expiration date through the end of January 2007, Novadaq’s policy of
maintaining a six month supply of ICG has permitted it to have ICG inventory-on-hand
with an expiration date to the end of March 2007.
Novadaq understands from Akorn that it has a current inventory of ICG that
could be shipped immediately following FDA approval and that it is working
closely with the FDA in order to facilitate that approval by the end of March
or early April, 2007. Novadaq also understands that Pulsion Medical Systems
expects FDA approval for its ICG during the second half of 2007. In
the interim, Novadaq has provided to the FDA data which may be used by the
FDA to support an extension of the expiration date of its current inventory-on-hand.
“Given the FDA’s policy to help prevent or alleviate shortages
primarily of medically necessary drug products, and our understanding of
the current efforts of Akorn, the FDA and others, we remain cautiously optimistic
that the current ICG shortage will be resolved in the near term,” said
Dr. Arun Menawat, President and Chief Executive Officer of Novadaq Technologies
Inc. “Based on our discussions and other correspondence with
the FDA and Akorn, we are encouraged by the level of co-operation and attention
being given to this matter. However, like many companies in the United
States whose products require ICG and who are dependent upon the FDA and
Akorn to resolve this drug shortage, any significant delay in obtaining ICG
could have a material adverse effect on our ability to sell our systems and
products and to continue clinical trials. This issue has no impact on Novadaq’s
newly acquired agreement for the distribution of Transmyocardial Therapy
(TMR) products of PLC Medical System Inc.”
About Novadaq Technologies
Novadaq Technologies Inc. (TSX: NDQ) 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™ 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™ 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.
Certain statements included in this press release may be considered forward-looking.
Such statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements to
be materially different from those implied by such statements, and therefore
these statements should not be read as guarantees of future performance
or results. All forward-looking statements are based on Novadaq's current
beliefs as well as assumptions made by and information currently available
to Novadaq and relate to, among other things, anticipated financial performance,
business prospects, strategies, regulatory developments, market acceptance
and future commitments. Without limiting the generality of the
foregoing, there can be no assurance that the FDA will approve Akorn’s
ICG inventory or Pulsion’s ICG for distribution in the United States
as currently anticipated or at all or that the FDA will approve Novadaq’s
application for an extension of the expiration date of its ICG inventory-on-hand;
any material continued inability of Novadaq to obtain FDA-approved ICG
could adversely affect Novadaq’s ability to sell its systems and
products and continue clinical trials, which (individually or in the
aggregate) could have a material adverse effect on Novadaq’s business,
operations and prospects. Readers are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the
risks and uncertainties identified by Novadaq in its public securities
filings; actual events may differ materially from current expectations.
Novadaq disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
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
