Technology

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. 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 and metastasize to other parts of the body.

In addition, white light cannot easily differentiate flat or tiny malignant and premalignant 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.[1]

[1] http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-treating-by-stage

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 fluorescence imaging agents, or chemical dyes, such as Cysview[2]. 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. As well as affecting the flow and efficiency of the O.R., the time delay limits the widespread use of this method in the less-expensive physicians’ office setting.

In addition, this system projects two different images onto separate monitors 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 for a practical (reduced prep time), ultra-sensitive imaging instrument to correctly and safely diagnose and treat bladder cancer is acute.

[2] Cysview® is a trademark of Photocure ASA, and is a trade name for hexaminolevulinate hydrochloride (HAL-BLC)

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

Imagin Medical is developing the i/Blue™ Imaging System that will establish a “new standard of care” for urologists and will address the limitations of the current technology in the early detection of bladder cancer through endoscopes. The Company has completed development of the Prototype Alpha B, an advanced combination of optical/light sensor technology, white light and near-infrared fluorescence that is estimated to be 100 times more sensitive than current systems with the ability to expose the specifics of the image in less than 15 minutes versus the full hour required by conventional fluorescence systems. Premalignant lesions and tumor tissue along the margins will be highlighted and identified for removal, thus reducing the chances of recurrence. Producing superior imaging quality in less than one quarter of the time of current systems is expected to increase the efficiency of the operating room and reduce healthcare costs by potentially enabling follow-up exams to be performed in the less-expensive physician’s office.

In addition, the surgeon will no longer need to switch back and forth between two images. The i/Blue’s specialized cameras will employ Simultaneous Acquisition of Differing Images, a patented technology which blends the white and blue light images into one, putting the cancer into context and enabling the surgeon to better visualize and resect the cancer.

The i/Blue’s patented technology can be seamlessly adapted to most endoscopes on the market today.

Benefits of the i/Blue Imaging System

  • “Sees” the cancer is less than 15 minutes vs. one hour
    • Optics 100 times more sensitive
  • No switching back and forth
    • Simultaneous acquisition of two different images blends the white light and fluorescence images into one
    • Puts the cancer into context within the bladder
    • Enables surgeon to better visualize and resect the cancer, helping to reduce recurrence
  • Adapts to blue light method with added unique fluorescence wavelengths

Future Development

i/Vision Imaging System**

The i/Blue Imagin System will be expanded to incorporate multiple illumination sources so that detection of different contrast agents can be realized by the same system. Such a system can be custom made or designed to accommodate the most commonly used fluorescing contrast agents, such as those currently available based on the emission of Protoporphyrin IX (PpIX) and Indocyanine green (ICG). This instrument will enable expansion into multiple endoscopic procedures such as laparoscopic (general and gynecology), colorectal, thoracic and a variety of gastroenterology procedures related to both cancer or noncancerous conditions.

i/Red Imaging System**

The i/Red Imaging System, Imagin’s next advancement, uses a unique method to illuminate the cancer with red light and requires no imaging agents at all. This breakthrough technology uses only fluorescence produced by the body and the tumor itself. This product requires specialized light sources, sensitive cameras and a unique optical design. The i/Red Imaging System will dramatically broaden the market to all cancer specialists using any type of scopes.

Benefits of the i/Red Imaging System

  • Uses only  the fluorescence produced by the body and the tumor itself
  • Potentially reaches and detects cancer in other parts of the body where imaging agents cannot be practically administered
  • Contrast between normal/cancer tissue is potentially related to difference in porphyrin content within the cells, which in turn relates to the difference in metabolism of the cancer cells
  • Like i/Blue, i/Red employs dual imaging technology, adapts to most endoscopes, orders of magnitude more sensitive

Imagin Medical, Inc. is a development stage company and does not currently have any Medical Device Regulatory Approvals or Clearances to market products in any jurisdiction.

*Cysview® is a trademark of Photocure ASA, and is a trade name for hexaminolevulinate hydrochloride (HAL-BLC)

**Initial prototypes of this system were successfully used at the UC Davis Comprehensive Cancer Center. The company’s current strategy is to focus on the i/Blue Imaging System and in 2017 begin the development of the i/Red Imaging System.

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