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Say you’re one of the roughly 300,000 Americans who will need sinus surgery this year. The good news is the surgeon probably won’t have to make any incisions on your face; instead, he or she can thread a video-camera-equipped tube called an endoscope through your nose into the ailing sinus, then pass the surgical tools through the tube. The bad news is that even with the help of the camera, the surgeon can’t see your optic nerve lying just behind the sinus wall-and damage to the nerve could mean blindness in one eye. It’s a rare complication, but just the sort of disaster that Palo Alto, CA-based Cbyon would like to help avoid. The company’s 3-D visualization software shows a surgeon not only where each instrument is, but also what important structures-nerves, blood vessels, tumors-lie hidden nearby.

The software is the brainchild of Stanford University bioengineer Ramin Shahidi, who has taken leave from the institution to serve as chief technology officer of Cbyon, which he helped found in February 1999. Using data from x-rays, MRI images, ultrasound and other scans, Shahidi’s software builds a digital model of the patient’s anatomy. During surgery, a computer tracks the position of the surgical tools in relation to the digital model and displays that information on a screen. Up to this point, the Cbyon system is similar to other products for image-guided surgery that have been on the market for years. But where those systems usually display a set of two-dimensional slices that a surgeon must mentally translate into a three-dimensional object, Cbyon’s software offers what’s called “3-D perspective volumetric rendering”-a visualization technique that gives the surgeon a realistic 3-D anatomical model. That image can match the camera’s perspective in real time and reveal critical structures that the camera can’t see-the optic nerve, for example-by marking them with bright colors and making the overlying tissues transparent. Shahidi can’t resist calling it “Superman 3-D x-ray vision.”

Now 50 people strong and banking more than $20 million in venture capital and other financing, Cbyon has already gained U.S. Food and Drug Administration approval to market its technology for a number of applications, including neurosurgery and ear, nose and throat procedures. For $120,000 to $150,000, a hospital can buy a complete package that includes the 3-D software along with a computer, a monitor and equipment that tracks surgical tools during an operation. The startup hopes its 3-D advantage will help it capture a healthy share of the fast growing $270 million market for such image-guided surgery systems.
But even with a visualization component that is without question the best available, says Saint Louis University School of Medicine surgeon Richard Bucholz, Cbyon could face tough challenges in the marketplace. Bucholz, who developed one of the first and most widely used image-guided surgery systems-now sold by Medtronic of Minneapolis, MN-points to at least two other companies that make diagnostic tools that incorporate 3-D rendering software similar to Cbyon’s. That software could readily be adapted to a surgical guidance system.

Furthermore, says Bucholz, doctors will not adopt Cbyon’s core software technology if they don’t like the hardware that comes with it, or if it’s not compatible with favorite image-guided surgery components that they have already. “Surgeons have very strong preferences for particular units-a surgeon likes this type of scalpel, she likes that type of ultrasound device, this type of clamp-and the same desires are going to be made vis–vis the components of the operating room of the future,” he says.

The son of an eye surgeon, Shahidi is well aware of how important ergonomic details and preferences are to a surgeon. When his father saw a demo of the Cbyon system, says Shahidi, “The first thing he told me was Your cart is too big,’ so immediately we went and reduced the size.” Continuing to seek and heed such feedback will likely be critical to the company’s future, and to determining whether Cbyon can help make thousands of surgeries a year a little bit safer.

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Tagged: Biomedicine

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