Novadaq feels the crunch, keeps glowing

TORONTO, ON, CANADA--In mid-April, Novadaq Technologies, developer of real-time medical imaging and image-guidance systems for use in the operating room, received a $1 million payment from Intuitive Surgical (Sunnyvale, CA), maker of the most widely used surgical robotic system with more than 1000 installations.

TORONTO, ON, CANADA--In mid-April, Novadaq Technologies, developer of real-time medical imaging and image-guidance systems for use in the operating room, received a $1 million payment from Intuitive Surgical (Sunnyvale, CA), maker of the most widely used surgical robotic system with more than 1000 installations (see bioopticsworld.com/articles/359717). Intuitive made the payment to Novadaq for achieving the first pre-defined milestone specified in a multi-year agreement the partners signed in January.

The agreement describes a relationship whereby the two companies are working to integrate Novadaq’s SPY imaging technology into the 3-D high-definition (HD) imaging capabilities of Intuitive’s endoscopic da Vinci robotic surgery instrument.

SPY enables surgeons to visualize blood vessels, tumors, tumor margins, blood flow, and the lymphatic system in real-time during surgery. Its near-infrared (NIR) imaging technology works in conjunction with a fluorescent dye (IC-Green), which is injected into the patient’s bloodstream. “The system illuminates the area of interest with an NIR laser system centered at 808 nm,” Novadaq’s chief engineer Rich Croft told Optoelectronics Report. The laser is a 2.6 W, 808 nm, F-6 diode from Coherent (Santa Clara, CA). “Any dye exposed to the NIR light will fluoresce in response.” The system’s Hitachi (Woodbury, NY) KP-M2RN CCD camera, with a half-inch imager, detects the peak emission wavelength. An optical filter blocks the excitation light from the camera and lets the fluorescent signal through. “The resulting images are displayed for the surgeon real time and are also recorded and stored on the system’s computer for future reference,” says Croft. The system also includes optical fiber cables by Prairie Fiber Optics (Hutchinson, MN).

Genesis and applications

Novadaq and Intuitive began exploring the use of SPY imaging for minimally invasive surgical surgical robotic procedures in late 2007. That collaboration resulted in the January agreement covering licensing and development, for which Novadaq received an upfront license payment--and now the first of three milestone payments. Thanks to a second multi-year agreement, Novadaq will also receive royalty payments for each da Vinci Surgical System sold with, or upgraded to include SPY, following commercialization of the integrated system. The supply agreement names Novadaq as Intuitive’s exclusive supplier of a key component of the electronic sub-system that enables the fluorescence imaging capability, and the consumable fluorescence agent used in each imaging procedure.

This core technology is now being applied to and across multiple surgical markets such as cardiac, plastic and reconstructive, urological, general, and organ transplant operations. SPY received 510(k) pre-market notification clearance from the U.S. FDA in January 2008 for use during organ transplant surgery. At the time, Novadaq said SPY was “the first fluorescent imaging system available for use during very complex, technically demanding surgeries such as heart, liver, pancreas and kidney transplants.” Edmund Q. Sanchez, assistant director of Transplantation Services at Baylor University Medical Center in Dallas, TX gave the system a hearty endorsement, saying, “Intra-operative fluorescence imaging using the SPY System has opened a new portal in transplant surgery.”

At the same time, Novadaq announced it had also received a broader indication for the use of SPY in cardiovascular surgery, beyond the originally cleared indication in coronary artery bypass.

Keeping on

A year later, this past January, Novadaq cited the “current economic climate” in announcing strategic restructuring, including senior management changes and a staff reduction of 25 employees, initiated during Q3–2008. The reductions left the company with approximately 60 employees.

The company reported expenses associated with the move on March 16, as part of its financial results for the fiscal year and fourth quarter ended December 31, 2008. The statement noted that SPY kits sales were up 76% and SPY capital sales were up 61% over 2007--with 50 new SPY units placed in 2008. For the quarter, though, revenue decreased 4% from $2,959,000 in Q4 2007, driven by a year-over-year 56% reduction in capital sales overall, thanks to the poor credit market.

Novadaq’s first minimally invasive product, the Pinpoint system, provides endoscopic autofluorescence so surgeons can differentiate between healthy and cancerous tissue in the lung and other hollow organs. And the company’s SPY scope combines the typical features of a standard endoscope with the capabilities of SPY imaging. 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). And, Novadaq is the exclusive U.S. distributor of PLC Medical’s CO2 Heart Laser System, which is used in the same cardiac procedures as SPY.

--Barbara Goode

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