The DOBI ComfortScanTM System

The DOBI ComfortScanTM System is an advanced digital-imaging system that uses high-intensity light-emitting diodes and gentle external pressure to highlight areas of vascular development common to malignant tumors in the breast. The DOBI technology is based on detecting tumor angiogenesis, or vascular change, the process whereby a cancerous growth surrounds itself with a dense network of tiny blood-filled capillaries. These vascular "feeding tubes" provide oxygen and nutrients to active tumors and are unique physiological "markers" that reveal the presence of cancer.

Angiogenesis is a natural occurrence in the body. In cases where cancer is involved, the growth of new blood vessels occurs around, and in support of, a malignant tumor. This process is vital, since without it, these tumors remain small and harmless. When a woman discovers a lump within her breast, it has likely been developing for a number of years, as cancerous tumors often take many years to become palpable.

The DOBI System's high-intensity light-emitting diodes transmit near-infrared light through the breast, recording one image per second via a CCD camera for approximately 45 seconds. If the light encounters an angiogenic (and thus potentially cancerous) region of the breast, it is absorbed by the higher-than-normal concentrations of hemoglobin in that area of the breast. It thus appears on the DOBI image in marked contrast to normal portions of the breast. As a result, the DOBI System focuses on dynamic functional imaging (i.e., what is occurring within the tissue in near real-time) rather than a singular morphological image (i.e., a static anatomical snapshot showing physical details at a single point in time) such as those created by mammography. These unprecedented images provide the physician with new, physiological information which may be associated with cancer development.

The initial application of ComfortScanTM is as an adjunct to mammography and physical exam. The DOBI System has been designed and tested to show that it provides substantially higher levels of specificity in detecting benign lesions within the breast, thus 1) reducing the number of false positives generated by current techniques; and 2) potentially avoiding a high number of breast biopsies or other downstream testing. The DOBI System may have the potential to increase screening sensitivity when used in conjunction with mammography.

The DOBI System has the potential to provide many improvements over currently available imaging technologies in the areas of accuracy, speed, comfort, safety, convenience, ease of use, and system and scan costs. The Company has consciously selected this initial use for the technology because 1) breast cancer is the most prevalent type of cancer with the highest amount of evidence for angiogenesis-dependency; 2) there is a significant market need; and 3) a shorter, less expensive time frame to FDA approval is anticipated for an adjunctive device.



Advantages of the DOBI System

ComfortScanTM (currently an investigational device) is being designed to provide:

Feature
Benefit
Advantage
Targets angiogenesis
  • Helps reduce ambiguity associated with methods that look at morphological images
  • High sensitivity, specificity and negative predictive value
  • Detects cancer at its earliest stages
  • Can reduce the $5 billion in annual surgical biopsy costs
  • Earlier detection aids in increased survival rates
  • May offer opportunities for monitoring of efficacy of anti-angiogenesis treatment
Digital format
  • Records can be easily stored, transmitted and retrieved electronically
  • Minimal storage costs
  • Facilitates easy transmission for second opinion and/or remote analysis
Soft breast holder
  • More comfortable than mammography and other downstream testing methods
  • Enhances attractiveness of DOBI as a downstream test
  • Improved patient compliance
Ease of use
  • Procedure can be completed in less than 10 minutes n Scan results available immediately
  • Does not require advanced skills
  • High throughput per machine; relatively quick payback
  • Larger number of technicians and physicians may be able to use system; reduced incidence of inaccurate reading
High intensity light-emitting diodes
  • Overcomes density limitations associated with mammography
  • Reduces the need for additional mammographic and other tests
  • Can be used for premenopausal women and women on hormone replacement therapy

 



Dynamic Functional Imaging

The DOBI ComfortScanTM System is based upon a platform technology called Dynamic Functional Imaging. ComfortScanTM is sensitive to dynamic volumetric changes in blood and changes in deoxyhemoglobin. Both of these changes are commonly found in malignant tumors. The System is able to measure these changes by applying a uniform pressure to the breast. The change in pressure is believed to trap blood in the tortuous angiogenic structures that form around the tumor. This trapped blood gets deoxygenated up to four times faster than normal tissue. The System displays the effects of the changes in volume and/or changes in deoxyhemoglobin over time. These changes show up in the images as low light levels because of greater light absorption. Normal or benign tissue, which has normal vascular structures and a slower metabolic rate, does not absorb as much light and thus has a higher light level than malignant tissue.



Patient Imaging Process

During examination, the patient stands in front of the machine while her breast is positioned onto a panel of red light emitting diodes (LEDs) and enveloped by a thin silicone membrane that acts as a breast holder. The breast holder then gently inflates to a pressure of less than 10mm Hg (~1/4 psi). The computer controls the light that is transmitted through the breast and recorded by the highly sensitive digital CCD camera located above the breast. ComfortScanTM accumulates the sequence of images in digital memory and the computer processes the minimal differences in the variations of intensity between normal or benign and malignant tissue. The entire procedure takes less than 10 minutes and results are immediately available to the technologist or physician.



Physician Interpretation of DOBI Images

The Company has prepared a set of clinical guidelines for the proper interpretation of DOBI images. These are adaptable to the technologists' and radiologists' body of knowledge, procedures and clinical practice.



Future Uses for the DOBI System

The Company fully expects that, over time, clinical trial data and market usage will engender confidence in its technology to the extent that the marketplace will adopt its widespread use as a diagnostic screening tool for women with an identified high risk for breast cancer. This use can likely develop significantly faster in certain foreign countries where current mammographic techniques are more flexible due to a number of factors including financial constraints, concern over radiation, and other considerations.

The DOBI ComfortScanTM System can be an exciting resource for underserved or developing countries since it is transportable, has no special environmental or power requirements, and uses no expensive or bulky film cassettes or chemicals. Images can be stored locally and sent electronically to other locations for collaborative readings or analysis. Thus, ComfortScanTM can be transported to non-urban areas and the images gathered there could be sent electronically and read at remote central locations if local radiological expertise is limited.

"Seeing" the presence of angiogenesis in the body opens the door to many potential opportunities for the Company's technology. The latest research indicates that angiogenesis is found in many significant disease states, including rheumatoid arthritis, adult blindness, and others. Thus, future uses of DOBI technology may be for many other diseases as well as cancer. Furthermore, therapeutic monitoring is considered a near-term application of the DOBI Medical technology. The Company has begun a series of discussions with select pharmaceutical firms to investigate these opportunities.

 
Investigational Device: Limited by Federal Law to Investigational Use Only. Copyright ©2000-2001 DOBI Medical Systems All Rights Reserved.
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