DOBI Medical Systems

DOBI Medical Systems, headquartered in Mahwah, NJ, is a technology-based medical device company that has developed a unique, accurate, and potentially lifesaving means for the improved diagnosis of cancer through the detection of vascular changes associated specifically with malignant tumors.

Our first application of this technology has been to develop an adjunctive tool to mammography - a key diagnostic imaging modality widely used to aid in the diagnosis of breast cancer. While mammography has long been considered an important tool for breast cancer detection, it has been shown to have numerous limitations. The process is often painful, it irradiates the patient, is limited in its ability to identify breast cancer in its earliest stages, and most importantly, is often unable to differentiate malignant from benign tumors.

While still the most common tool for detecting breast cancer, the mammogram also has limited applicability to millions of women under the age of 40 and women on hormone-replacement therapy, due to the lack of contrast in x-ray images of dense breast tissue. The American Cancer Society estimates that 5 to 10 percent of mammography tests are abnormal or inconclusive, necessitating further testing that can be painful, invasive, and expensive.

Our Dynamic Optical Breast Imaging (DOBI) System (the ComfortScanTM System) is a noninvasive, non-ionizing medical-equipment product designed to assist physicians in the detection of breast cancer at the earliest stages of development - earlier than is possible using mammography alone. We are able achieve this on a cost-effective basis by providing new, image-based, physiological information never before available.

 

Our Vision

Our vision for the future is to introduce a new standard in vascular imaging worldwide. And our immediate goal is to reduce the incidence of invasive intervention in the breast cancer diagnostic process. To these ends we are building a fully integrated medical device company whose focus is the development and commercialization of a new generation of angiogenesis-based imaging systems. Such imaging systems are intended to offer more accurate screening, diagnosis, and monitoring of most major diseases.

The DOBI System is designed to alert physicians to the first indication of breast cancer by detecting angiogenesis, which in turn facilitates the differentiation between benign and malignant breast tumors. Once we have completed the final process to gain FDA approval (4 modules of 5 have already been reviewed and accepted), DOBI Medical Systems can move ahead to provide a new diagnostic resource for physicians, service providers and scientists; cost savings to third-party payers; a positive impact on breast health; and, finally, improved quality-of-life for women around the world. Ultimately, we expect clinical trial data and market usage to engender confidence in our technology to the extent that it will be adopted worldwide as a breast cancer screening tool.


Frequently Asked Questions (FAQs)

What is a DOBI System and how much does it cost?
The DOBI System is an advanced digital-imaging system that uses high-intensity light-emitting diodes (LED's), gentle external pressure, a low-noise charged-coupled device (CCD) camera, and proprietary image-processing algorithms to highlight areas of vascular development common to malignant tumors in the breast. The technology is based on detecting tumor angiogenesis, the growth of a dense network of tiny blood-filled capillaries that surround a cancerous tumor. Initially, the Company will introduce the DOBI System as an adjunct to x-ray mammography. Pricing is expected to be competitive with analog mammography systems and ultrasound devices, but it should market at about a third of the price of the new digital mammography systems.

How does it work?
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. As the red light encounters the angiogenic (and thus potentially malignant) region of the breast, it is absorbed by the higher-than-normal concentrations of hemoglobin in that area of the breast, in contrast to the 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.

What is angiogenesis and why is it important?
Angiogenesis is the growth of new blood vessels in the body, a type of vascular change. It is an important, natural process that occurs both in health and disease. Angiogenesis occurs in the healthy body for healing wounds and for restoring blood flow. The healthy body controls angiogenesis through a series of "on" and "off" switches, maintaining a perfect balance between these angiogenesis modulators. However, in a diseased state, the body loses control over the angiogenesis process. Angiogenesis-dependent diseases result when new blood vessels either grow excessively or insufficiently. Excessive angiogenesis occurs in the development of cancers. New blood vessels feed the cancer, allowing a tumor to grow up to 16,000 times in size (sometimes in a matter of weeks). At the same time, cancer cells escape into the circulation via the blood vessels and lodge into other organs (via metastasis).

According to the most recent scientific research from the Angiogenesis Foundation, angiogenesis is associated with virtually every type of cancer known. Furthermore, angiogenesis is an underlying indicator in more than 70 conditions, including cardiac disease, arthritis, AIDS, ophthalmic and skin diseases, as well as other solid tumors. Angiogenesis can also impact surgical incisions, trauma-related injuries, and ulcers that rely on the angiogenic process for healing. The Angiogenesis Foundation estimates that more than 500 million cases of angiogenesis-based disease are currently afflicting patients in the western world.

DOBI Medical's technology is built on its ability to accurately identify angiogenesis non-invasively - thus providing a new tool to assist physicians in the detection of virtually all cancers, including breast cancer.


How is this helpful in diagnosing breast cancer?
Research by the U.S. and international scientific communities has documented the process of angiogenesis as it occurs in the development of breast cancer. In fact, breast cancer mortality has been highly correlated to, and has the highest amount of evidence for, angiogenesis dependency. All solid breast tumors become clinically relevant once they recruit their own blood supply. Angiogenesis occurs when cancerous breast tumors are only one to two millimeters in size. By contrast, breast cancers that are detected when they are 10 millimeters in diameter already contain more than one billion cancer cells.

Recent developments in optical imaging technology and image processing make it possible to identify minute vascular changes within a growing cancer in the breast when it is still in its earliest stages. Once detected, the changes constitute a unique vascular profile that can indicate the presence of breast cancer before a cancerous lesion is discernible by most conventional means. A generally accepted principle in medicine is that earlier detection leads to earlier treatment, which in turn presents a better prognosis for cure. For a more detailed discussion, go to the "angiogenesis" section on this website.

What is going on at DOBI Medical now?
Currently, we are in the process of obtaining FDA approval for the ComfortScanTM to be used as an adjunctive testing device supplemental to mammography. We have 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 timeframe to FDA approval is anticipated for an adjunctive device.

However, we intend to use the confidence and market acceptance gained from this initial application to broaden the DOBI System's applicability. Although there is no assurance of final FDA approval, we are developing a next-generation application for the device as a broad-based screening tool for breast cancer.

In addition, we believe that our technology has high potential in the area of therapy monitoring, allowing physicians and pharmaceutical companies to monitor the effectiveness of anti-angiogenic drugs. We also plan to expand testing into other areas where angiogenesis is an underlying indicator of disease, such as cardiac disease, arthritis, AIDS, ophthalmic and skin diseases, as well as other solid tumors.

Where do you stand with the FDA now?
In August 2000, we received FDA review and acceptance of our five-step Pre-Marketing Application (PMA) submission plan. The first data module of the plan was submitted and accepted shortly thereafter, followed by acceptance in 2001 of Modules Two and Three. Module Four was submitted and accepted in 2002. A clinical test of approximately 1,200 patients will complete the fifth and final module of the Company's PMA. 

What is the goal of the clinical trial?
The successful completion of the trial will enable the Company to meet its goal of obtaining FDA approval and entering the market as quickly as possible. The Company continues to work closely with the FDA and has already begun submitting data regarding the DOBI System.

Where is the DOBI System being tested?
We have an excellent group of highly regarded medical institutions that either have been or are testing the DOBI System including The Hospital San Carlos (Madrid, Spain), The European Institute of Oncology (Milan, Italy), Gustave Roussy Institute (Paris, France), the Cancer Institute of New Jersey, Columbia Presbyterian Hospital in New York City, and Massachusetts General Hospital in Boston. For more information, see our "clinical" section on this website.


Can I get a DOBI Scan?
Currently, the testing program is restricted to those women who are part of our research program at pre-selected sites. However, at such time as FDA approval is granted, your doctor would be able to direct you to an appropriate breast-imaging center with a DOBI System and tell you whether a DOBI Scan is right for you.

What sets the DOBI System apart from other techniques?
As in many natural processes, such as vision, multiple sensors are often combined to produce improved results. By combining the imaging capabilities of the DOBI System (which produces images of vascular change or physiological elements of the breast) with structural or morphological images of the breast, physicians will have breast cancer diagnostic information that has never before been so readily available.

A next-generation version of the DOBI System (which would combine the diagnostic capabilities of ultrasound, x-rays, or other imaging modalities, with the DOBI System's capabilities) would offer an advanced process that would considerably improve the current potential of breast cancer screening and diagnosis. We expect to see the application of this new diagnostic capability to other cancers, as well as to many additional diseases of the human body affected by angiogenesis. Such application would not only be instrumental in the monitoring of the effectiveness of treatments for many diseases but also may help to identify disease at the earliest possible stages by targeting its angiogenic properties.

If the DOBI System is good at differentiating benign from malignant tumors in the breast, can it be used for other, similar applications?
Currently, the Company is in the process of obtaining FDA approval for its first application as an adjunctive testing device supplemental to mammography. However, DOBI Medical intends to use the confidence and market acceptance gained from this initial application to broaden the DOBI System's applicability. Although there is no assurance of FDA approval, the Company intends to develop a next-generation application for the device as a broad-based screening tool for breast and other types of cancer.

In addition, the Company believes its technology has high utility in the area of therapy monitoring, allowing physicians and pharmaceutical companies to monitor the effectiveness of anti-angiogenic drugs. Furthermore, the Company plans to expand testing into other areas where angiogenesis is an underlying indicator of disease, such as cardiac disease, arthritis, AIDS, ophthalmic and skin diseases as well as other solid tumors. The Company also believes its technology may have a potential role in assessing surgical incisions, as well as trauma-related injuries and ulcers, which rely on the angiogenic process for healing.

Does the Company have a CE Mark or ISO certification?
The Company received its CE Mark Apr 12, 2000, for the DOBI System and ISO 9001 certification for the Company in December 2000.

How can I follow the progress of the Company?
Continue to visit us here at igaot.pt. We will regularly update the site with DOBI Medical Systems news and activities.


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