Toronto, Ontario, Jan. 17, 2008 – Novadaq’s SPY System Receives Clearance for use in Organ Transplant Surgery
Novadaq® Technologies Inc. (TSX: NDQ), a developer of medical imaging systems for the operating room, announced today that it has received 510(k) pre–market notification clearance from the United States Food and Drug Administration (FDA) for its imaging system for use during organ transplant surgery. Novadaq’s SPY® System is the first fluorescent imaging system available for use during very complex, technically demanding surgeries such as heart, liver, pancreas and kidney transplants. SPY enables surgeons performing life saving transplants to visualize blood flow in co–joined vessels which are responsible for providing adequate blood supply and the quality of blood perfusion to the new organ.
“Intra–operative fluorescence imaging using the SPY System has
opened a new portal in transplant surgery. Potentially, the days of
qualitative assessment of organ appearance, pulse quality, and simple
quantitative vascular flow measurements using electromagnetic devices
as the sole measurement of an organ transplant are limited,” said Dr.
Edmund Q. Sanchez, Assistant Director of Transplantation Services,
Baylor University Medical Center in Dallas, TX. “Our familiarity study
of SPY in liver, kidney, and pancreas transplant has demonstrated many
potentially beneficial aspects of intra–operatively assessing organ
perfusion through imaging. The success of organ transplantation is
highly dependent on vascular patency and allograft perfusion. The SPY
System has allowed intra–operative visualization of both immediately
after reperfusion. The utility of SPY imaging organ transplantation is
clearly evident.”
The creation and maintenance of adequate blood supply to the
newly transplanted organ or “allograft” is critical to the ultimate
success of the transplant surgery. Inadequate blood flow can lead to
serious complications such as organ thrombosis and allograft failure.
The United Network for Organ Sharing reports that while outcomes
following transplantation have improved over the years, allograft loss
is a problem ultimately confronted by many recipients. For such
patients, repeat transplantation often provides the best chance for
survival and good health. Retransplantation offers hope, but according
to previous studies have demonstrated that outcomes following repeat
transplantation are in general, inferior to those observed with first
transplants. Since every organ used for repeat transplantation
represents an opportunity that cannot be directed to another candidate,
the potentially expanding role of retransplantation has been of growing
concern. Use of the SPY System may allow surgeons to quickly identify
areas of inadequate blood perfusion and potentially make immediate
technical revisions which ultimately may save the organ, improve
outcomes and reduce the overall costs of recovery.
“Organ transplant is a life saving operation and often offers
the only hope for patients suffering from organ failure,” said Dr. Arun
Menawat, President and Chief Executive Officer Novadaq Technologies
Inc. “The lack of available donors makes the use of each organ and the
success of each transplant critical not only to the patient undergoing
the transplant, but for those on the waiting list as well. The use of
SPY has been shown to improve the opportunity for technically perfect
surgeries which may save the new organ and in turn improve clinical
outcomes for patients, prevent life threatening complications, reduce
the need for retransplant and overall reduce costs. This new indication
for SPY along with previously cleared indications in cardiovascular and
plastic and reconstructive surgery gives hospitals a complete solution
for performing imaging in the operating room during complex
procedures.”
According to the United States Organ Procurement and
Transplantation Network (OPTN), Transplant surgery has saved more than
300,000 lives. In 2006 there were 28,931 transplants performed in the
United States and today, more than 94,000 patients suffering from organ
failure are on the waiting list. Kidney transplant procedure costs can
range widely but most average from $25,000 to $150,000, depending on
the extent of kidney disease and whether the patient has a deceased or
living donor transplant. Liver transplant procedure costs can also
range, but most average between $100,000 to $400,000, depending on time
in the hospital ICU and extent of liver disease before transplantation.
Costs can also vary greatly depending on a number of factors including
the patient’s health at baseline, rate of recovery, any pre–existing
conditions and/or potential complications after surgery.
In addition to the clearance for organ transplant, Novadaq has
also received a broader indication for the use of SPY in cardiovascular
surgery, beyond the originally cleared indication in coronary artery
bypass.
About Novadaq Technologies
Novadaq Technologies Inc. (TSX: NDQ) develops and
commercializes medical imaging systems and real–time image guided
therapies for use in the operating room. Novadaq’s proprietary ICG
imaging systems can be used to visualize blood vessels, nerves and the
lymphatic system during a variety of surgical procedures. Novadaq’s SPY
Imaging System, commercially available worldwide, enables cardiac
surgeons to visually assess coronary vasculature and bypass graft
functionality during the course of heart bypass surgery. The SPY System
is expandable to include upgrade kits for use during other surgeries
such as plastic, reconstructive and organ transplant surgery allowing
surgeons to evaluate blood flow and tissue and organ perfusion. In
addition, SPY is ideal for use during urological procedures enabling
surgeons to visualize vessels, tumors, the lymphatic system and
potentially nerve bundles. Novadaq’s
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 Imaging System. Novadaq also offers the FDA approved
PINPOINT™ endoscopic system for visualizing
native tissue fluorescence which allows surgeons to differentiate
between healthy and cancerous tissue in the lung during thoracic
surgery. Novadaq is also the exclusive United States distributor of PLC
Medical’s CO2 HEART LASER™ System for TMR
(Trans–Myocardial Revascularization). For more information, please
visit the company’s website at www.novadaq.com
Forward looking Statements
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. 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:
Investor Relations:
Michael Moore
The Equicom Group
416-815-0700 x 241