Novadaq Corp. Receives FDA Clearance for SPY Endoscopic Imaging System
Novadaq Technologies Inc., a developer of real-time imaging systems for use in the operating room, today announced the SPY endoscopic imaging system has received 510(k) clearance from the U.S. Food and Drug Administration for use during minimally invasive surgery (MIS).
Novadaq's SPY "scope" combines the traditional features of a state of the art, high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures. SPY scope will allow surgeons performing minimally invasive surgeries to simultaneously perform visible light endoscopy and fluorescence visual assessment of blood flow and related tissue perfusion through a single endoscope.
"The expansion of our core SPY imaging technology into minimally invasive surgery is a natural progression, and furthers our vision to be the leading imaging company in the operating room," said Dr. Arun Menawat, President and CEO of Novadaq. "The MIS market fits perfectly within our growth strategy, as many surgeons using SPY imaging during open access surgeries are also performing MIS procedures. Surgeon opinion leaders propose that SPY scope will positively impact overall minimally invasive surgical success by enabling simultaneous visible and fluorescence imaging assessment in procedures where by design the traditional field of view is limited. We fully expect data will show that SPY scope offers clinical and economic benefits in MIS that are similar to those reported on the use of SPY in open procedures."
About Novadaq Technologies Inc.
Novadaq develops and commercializes real-time imaging systems for use in the operating room. Novadaq's SPY? Imaging System uniquely enables surgeons to visualize blood vessels, tumors, tumor margins, blood flow and the lymphatic system in real-time during surgery. This core technology is now being applied across multiple surgical markets such as cardiac, plastic and reconstructive, urological, general, micro and transplant. The PINPOINT(TM) System for endoscopic autofluorescence imaging is Novadaq's first minimally invasive product. PINPOINT allows surgeons to differentiate between healthy and cancerous tissue in the lung and other hollow organs. To expand its portfolio of minimally invasive products, Novadaq is developing SPY scope which combines the typical features of a standard endoscope with the capabilities of SPY Imaging. The ability to visualize tissue perfusion and flow through vessels, ducts and the lymphatic system adds another dimension to the images available to surgeons during endoscopic surgical procedures. Novadaq also leverages its core technology to offer the OPTTX? System, which is designed for the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD). Novadaq is the exclusive United States distributor of PLC Medical's CO2 HEART LASER(TM) System, which is used in the same cardiac procedures as the SPY Imaging System. For more information, please visit the company's website at http://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, results of future clinical tests of PINPOINT, SPY scope and the SPY Imaging System, 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. Contact:
Contacts: Novadaq Technologies Inc. Suzie Robinson Investor Relations 905-629-3822, x333 srobinson@novadaq.com www.novadaq.com