Today’s Market – The Patient Treatment Challenge
Conventional Endoscopes with White Light
It is well-documented that the endoscopic instruments currently on the market have limited ability to distinguish cancer from normal tissue. Conventional endoscopes rely on white light, or visible light, which can be seen with the naked eye. This technology has been used for decades to illuminate tissues and provide the physician with an image to help detect, assess and remove suspicious lesions. Using white light, the physician can easily see cancerous growths that protrude above an organ surface, such as the bladder (see image below, left side).
However, white light is limited in its ability to visualize the borders of the tumor to determine where it begins and ends (the margins). If the surgeon cannot see the full range of the cancer and some cells remain, the tumor can grow back, or recur, and metastasize to other parts of the body.
In addition, white light cannot easily differentiate flat or tiny malignant and pre-malignant tumors from normal tissue. As a result, physicians may not be able to identify some aggressive cancers. In order to be safe, physicians often collect multiple biopsies as the only possible way to ensure that cancer is not missed in high-risk patients.
Initial treatment of bladder cancer is based on a tumor’s clinical stage, determined by how deep the tumor is thought to have grown into the bladder wall, and whether or not it has spread beyond the bladder. Other factors, such as the size and grade of the tumor, may also affect treatment options. Treatment decisions are ultimately based on the results of exams, cystoscopies, and imaging tests, however inaccurate they may be.
 Cysview® is a trademark of Photocure ASA, and is a trade name for hexaminolevulinate hydrochloride (HAL-BLC)
Endoscopes with Blue Light and Fluorescence Imaging Agents
Because of the limitations of white light in visualizing bladder cancer, various companies have begun to explore the use of blue light in conjunction with fluorescing imaging agents, or chemical dyes, such as Cysview. These photosensitizing agents, administered through a catheter one hour prior to the procedure, become absorbed by the cancerous cells in the bladder and, when exposed to blue light, highlight the suspicious tissue in a bright pink fluorescence (see images below by Photocure, using Cysview). This advancement has improved the surgeon’s ability to detect even flat cancers and to visualize their margins for more thorough removal, thus reducing the risk of recurrence and slowing the progression of the disease. In cystoscopies, blue light (white light with a blue filter) is now commercially available and FDA approved.
As effective as chemical agents are in visualizing cancerous cells, the full hour required for prep time poses logistical challenges for the operating room. Establishing a protocol to effectively coordinate the schedules of the O.R., the staff and the surgeon, often makes this method impractical and costly. The time delay also limits the widespread use of this method in the less-expensive physicians’ office setting.
In addition, this system projects a white light image or a blue light image – one at a time – onto a monitor for viewing by the surgeon: 1) a white light image shows the full landscape of the bladder, but doesn’t highlight the cancer and 2) a blue-filtered image shows a highlighted image of the cancer, but without any indication of its precise location in the bladder. Viewing these images requires the surgeon to manually switch back and forth between the two in order to accurately assess the details of the tumor and its exact location, posing an additional challenge for the surgical team. There is no question that the need is acute for a practical, ultra-sensitive imaging instrument to correctly and safely diagnose and treat bladder cancer.
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
Endoscopes with i/Blue™ Imaging System
The i/Blue Imaging System is expected to dramatically improve physicians’ ability to visualize cancerous cells. Working in conjunction with fluorescing imaging agents, this advanced, ultrasensitive imaging technology combines sophisticated opto-electronic functions and near-infrared fluorescence to deliver images far superior to conventional white light systems. High-definition images that highlight not only cancerous cells above the bladder wall, but also pre-malignant lesions, flat tumors and tumor tissue along the margins will produce more successful surgical outcomes.
The i/Blue Imaging System is a device external to the body that attaches to an endoscope and uses both white and blue light in combination with imaging agents to cause the cancerous cells to fluoresce within an hour or less. The system enables the surgeon to view the white and blue light images in real-time and provides the options of displaying them one at a time, side-by-side or blended together, producing a composite image that places the cancer into context within the bladder. This advancement eliminates the surgeon’s need to switch back and forth between the white and blue light images. These options make the i/Blue Imaging System more effective and practical, improving the surgeon’s ability to resect the cancer.
Imagin believes producing superior image quality in less time than current systems will increase the efficiency of the operating room and potentially reduce healthcare costs by enabling procedures to be performed in the less-expensive physician’s office.
The i/Blue’s patented technology can be seamlessly adapted to most endoscopes on the market today.
Benefits of the i/Blue Imaging System
- No switching back and forth – Patented Simultaneous Acquisition of Differing Images provides multiple display options in real time
- White and light images side-by-side simultaneously
- Composite images placing the cancer into context within the bladder
- Produces superior images in less time
- Adapts to most endoscopes on the market
- Potentially expands application to other minimally invasive procedures
i/Vision ™ Imaging System
The i/Vision Imaging System, the Company’s next advancement, will incorporate the current features of the i/Blue Imaging System which uses the HLA contrast agent, and will include other fluorescing contrast agents such as Indocyanine green (ICG). This instrument will enable expansion into multiple endoscopic procedures, cancerous or noncancerous conditions, such as laparoscopic (general and gynecology), colorectal and thoracic.