TORONTO, March 29 /PRNewswire-FirstCall/ - Novadaq(R) Technologies Inc. , 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. 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(R) 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(R) 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 HELIOSTM 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 LUNATM 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.
Novadaq Technologies Inc.
CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,PhD, MBA, President & CEO, Novadaq Technologies Inc., (905) 629-3822 x 202,amenawat@novadaq.com; Michael Moore, Investor Relations, The Equicom Group,(416) 815-0700 x 241, mmoore@equicomgroup.com