Tomophase Corporation Product

Investigational Airway & Pulmonary
Tissue Imaging Systems

The Tomophase imaging system is
investigational and not available for sale in the U.S.

Tomophase has developed an investigational real-time endoscopic tissue imaging system based on its proprietary technology in Optical Coherence Tomography (OCT). The Tomophase system is designed to enable the high-resolution visualization of bronchial and pulmonary tissue cross-sections without biopsy. Its design features include:

◙ Subsurface Microanatomy Visualization (within 2-3 mm)

◙ Real-Time Operation

◙ Micron Scale Resolution

◙ Superior Image Clarity to other OCT Technologies

◙ No Radiation, UV light or Contrast Agents

◙ Sample Site Morphology Information Retained

◙ Both Forward and Side Scan Imaging (in development)

◙ Tissue Metabolic/Biochemical Information (in development)

The investigational Tomophase imaging system is designed to operate in conjunction with video or fiber-optic endoscopes. For pulmonology, it is compatible with various flexible bronchoscopes and their extended working channels. To acquire images of lung tissues, the disposable imaging catheter is inserted into the working channel of the bronchoscope. The near infrared (NIR) light beam emitted from the distal tip of the catheter can then be steered to target the tissue of interest. Back scattered light is collected by the catheter and processed optically and electronically to produce high resolution, real-time and cross-sectional images of the tissues that the light beam penetrates.

With the investigational Tomophase system, airway and tissue cross-sections can be visualized in greater detail than with other currently existing imaging tools. Its optical resolution is on the order of microns, which would be 10-100 times better than other imaging technologies such as ultrasound and computed tomography (CT) [resolution on the order of 0.2-2 millimeters, respectively]. Using our real time imaging system, it is now possible to visualize micro-anatomic features such as airway epithelia, mucosa, and the smooth muscle layer both in-vivo and in-situ.

In the near future, Tomophase will be adding spectral absorbance mapping in the imaged cross-sections. Spectral absorbance (SA) is the basis for one of the most successful medical devices, i.e. the pulse oximeter. Various other SA features can be related to biochemical and metabolic activities of living tissues. Tomophase imaging will be configured to utilize a differential SA tomography (SAT) to spatially map important spectral features on a microscopic scale. The resultant spatially resolved SAT maps could potentially reveal the level of biochemical and metabolic activity of the pulmonary tissue under examination, providing valuable information to physicians. This information may be important in the case of early stage lung cancer as it may help identify tumors with high metabolic rates.

Future Potential Applications in Pulmonology

Tomophase imaging system may have potential pulmonary applications where real time, in-situ tomographic microanatomy visualization may be beneficial.

Early Stage Lung Cancer	The Tomophase system has the potential to distinguish between normal and abnormal tissue during bronchoscopy. Subject to future clinical validation, the system may be a useful adjunct to biopsy.
Asthma/COPD Research	In vivo imaging of bronchial structures such as smooth muscle has the capability to expand the understanding of the etiology of these diseases.
Aerosol Drug Development	Tomophase system is designed to allow for real time visualization of both the airway and sub-epithelial tissue. This new capability may enhance the researcher’s ability to observe the biological response to aerosol drug therapies in vivo at the microanatomy level which may in turn aid in improving drug design, dosage, etc.
Pulmonary Fibrosis	Visualization of the evolution of fibrotic pulmonary lesions may provide researchers clues to the origins of PF.
Pulmonary Stent Development	The Tomophase system can provide high resolution sub-epithelial images of the airway. As such, it may be useful in the evaluation of various stent configurations and approaches.
Surgical Guidance	Visualization without the dose burden and contrast agent limitations of fluoroscopy may allow for improved surgical procedures.

◙ Tomophase is interested in discussing research collaborations
in these and other areas. ◙

Future Potential Applications in Other Areas

The unique potential capabilities of the investigational Tomophase OCT technology and systems have the potential to address many unmet and challenging endoscopic tissue imaging needs. Early investigation by Tomophase has identified several medical applications well suited to our proprietary technology. The following three areas are representative of the future potential utility of our technology or that we will be investigating.

◙ Early Cancer Detection

Tomophase OCT technology and systems have the capability to image tissue on a multi-modal basis utilizing a minimally-invasive endoscopic procedure. For many cancers, the ability to follow-up broad-based population screening procedures with a safe, non-biopsy based test could have significant utility.

In addition, many imaging technologies currently used or under development for cancer diagnostics do not have the adequate resolution. Tomophase OCT technology has the potential for significantly improved performance without the use of radiation, UV light or contrast agents which can have negative side-effects.

◙ Cardiovascular Imaging

Tomophase OCT may provide high resolution, sub-epithelial endoscopic arterial imaging. Such capability could allow for the evaluation of the clinical utility of various stent configurations and therapeutic approaches.

In addition, vulnerable, non-obstructive plaque is generally asymptomatic, has a minimal affect on blood flow, but can result in sudden death. Currently, there is no established in-vivo detection method to diagnose this condition. In-vivo imaging may help detect plaque deposits which have thin caps [so-called TCVAs] and are thought to present the greatest risk.

◙ Surgical Guidance

Various surgeries where extremely precise guidance is required and visualization is difficult are potential applications for Tomophase OCT catheter-based systems. This could include spinal cord surgery, guided placement of electrodes in the brain for the treatment of Parkinson’s tremors, and improved guide wire control in the treatment of Chronic Total Occlusion of the coronary arteries.

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