Today’s Market – The Patient Treatment Challenge
Conventional Methods of Visualizing Bladder Cancer
The conventional method of visualizing bladder cancer is via an endoscopic procedure called a cystoscopy, which uses white light to illuminate the bladder. White light has been the gold standard for decades and is currently used by more than 90% of the market. In typical white light cystoscopy, a small camera is mounted at the end of the cystoscope and enters the body through the urethra and into the bladder, projecting the images onto a surgical monitor. Tumors that protrude above the bladder are easily visualized and evaluated for possible removal. The finer edges of the tumor and the cancerous cells that lie flat against the bladder, however, are difficult to visualize using this method. This increases the risk that some cancerous cells are left behind during resection, contributing to bladder cancer’s more than 50% recurrence rate.
Cystoscopies with Blue Light and Fluorescing Contrast Agents
Blue light cystoscopy, which uses blue-filtered white light, was introduced to address the limitations of white light cystoscopy. This method involves the administration of a contrast agent through a catheter one hour prior to the procedure, which is absorbed by the cancerous cells in the bladder. When exposed to blue light, these cells fluoresce, improving the surgeons’ ability to detect flat tumors and visualize the cancer’s margins for removal, thus reducing the risk of recurrence.
While blue light cystoscopy highlights the cancer, surgeons still need to view the white light image to orient their location within the bladder. Since currently available blue light cystoscopes can only project one image on the surgical monitor at a time, surgeons have to switch back and forth between blue and white light images and rely on memory when performing the procedure under white light.
Another constraint associated with this method is that it requires proprietary endoscopes that can’t be used for any other purpose.
Bladder cancer tumor, visualized through an endoscope using white light (two left images) and blue light using Photocure’s chemical agent called Cysview®* (right image)
Imagin’s Clinical Solution
Cystoscopies with i/Blue™ Imaging System
The i/Blue Imaging System addresses the limitations of white and blue light cystoscopy by combining the advantages of both methods with innovative optic and light sensor technology. The i/Blue System combines white and blue light with a U.S. Food and Drug Administration (FDA)-approved imaging agent and simultaneously displays both images on the surgical monitor, side-by-side and in real-time, eliminating the need to switch back and forth between the two images. This feature has the potential to make bladder cancer detection and removal more accurate and efficient, which could dramatically reduce bladder cancer recurrence rates and as well as healthcare costs.
The i/Blue Imaging System offers additional benefits. Unlike currently-used methods, the i/Blue System is external to the body and attaches to almost any cystoscope model on the market. In addition to significantly reducing the System’s cost, this means that hospitals can use the standard cystoscope they already own. And, while the current blue light method requires a system tower that houses the light source, camera control and video data recorder units, the i/Blue Imaging System consolidates this instrumentation, combining these three modules into one compact device.
Benefits of the i/Blue Imaging System
- Simultaneous side-by-side white and blue light images
- No switching back and forth between images
- Shows cancer in context within the bladder
- Enables surgeons to better visualize cancerous for more accurate resection
- Adapts to most endoscopes on the market
- Potentially expands application to other minimally invasive procedures
Imagin intends to build on the i/Blue technology, which currently works with hexaminolevulinate hydrochloride (HAL), and adapt it to other FDA-approved contrast agents, such as Indocyanine green (ICG). These additional products will expand Imagin’s market potential, facilitating entry into multiple endoscopic procedures, such as laparoscopic (general and gynecology), colorectal and thoracic.