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European Journal of Radiology Article Discusses DOBI Medical’s ComfortScan™ System’s Potential as an Adjunctive Breast Cancer Diagnostic Tool

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Mahwah, NJ, April 15, 2005 – DOBI Medical International (DBMI.OB) announced today that an article authored by Daniel Vanel, M.D., of the radiology department at the Institute Gustave-Roussy in Villejuif, France, entitled “Dynamic Optical Breast Imaging (DOBI): A New Technique to Visualise Breast Vessels: Comparison with Breast MRI and Preliminary Results,” was published this month in a special breast cancer edition of the European Journal of Radiology. Dr. Vanel used the DOBI Medical ComfortScan system as a key element of his study. The ComfortScan system is a nonionizing, advanced optical imaging system that uses light-emitting diodes (LEDs) and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. This blood vessel growth is often associated with malignant breast tumors. The article in EJR reports that the ComfortScan system could potentially be a complementary, adjunctive imaging modality in women with inconclusive mammograms and/or physical examinations.

“The promise of the ComfortScan system, as demonstrated in this initial study warrants additional investigation, but the preliminary results are encouraging,” stated Dr. Daniel Vanel. “The sensitivity of the ComfortScan system technology was extremely strong and the specificity rates also were positive.”

About the Trial

In the 25-patient study, patients underwent both breast MRI and optical scans in addition to standard mammography and ultrasonography. Patients’ ages ranged between 28 and 78 years of age and all patients scanned did not have recent trauma, breast surgery or biopsy.

Results

ComfortScan system images were positive in four of the five cases where MRI was positive. In the only case where the ComfortScan system disagreed with the MRI finding, a three-month follow-up with MRI showed up as negative when scanned a second time, aligning the MRI with the ComfortScan system findings. Investigators noted that they found the potential advantages of ComfortScan system imaging included the ease of patient positioning, quick exam time, and the absence of ionizing (X-ray) radiation. Investigators also concluded that ComfortScan system imaging may also be valuable in cases of claustrophobic patients or in other cases where MRI may be contraindicated.

The Institute Gustave-Roussy is a non-profit private institution, exclusively devoted to oncology and is one of the premiere cancer treatment centers in Europe. Breast cancer patients account for the largest number of new cancer patients at the institute (more than 20% of its patient base). Additional studies with the ComfortScan system are slated for later this later year.

For more information on DOBI Medical or the ComfortScan system, visit igaot.pt.
 

About DOBI Medical International, Inc.

DOBI Medical is a microcap, developmental stage, medical imaging company working to create a new means for the improved diagnosis of cancer through the detection of abnormal vascularization ("angiogenesis") associated with tumors. DOBI Medical International’s first application of the technology is the ComfortScan system, a gentle, noninvasive, and non-ionizing, optical imaging system designed to assist physicians in the detection and management of breast cancer. The ComfortScan system is intended to achieve this by providing new, physiology-based imagery of abnormal vascularization in the breast not readily available today. The ComfortScan system has its CE Mark and UL for international sales, and DOBI Medical is a certified ISO 9001:2000 and ISO 13485 company. The ComfortScan system is not yet commercially available as an adjunct to mammography in the U.S. as it is limited by U.S. law to investigational use until approved by the FDA, which cannot be guaranteed.

CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS

Statements contained in this press release may contain information that includes or is based upon certain "forward-looking statements" relating to our business. These forward-looking statements represent management's current judgment and assumptions, and can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements are frequently accompanied by the use of such words as "anticipates," "plans," "believes," "expects," "projects," "intends," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, including without limitation, those relating to our ability to timely and successfully complete our patient clinical trials; our ability to timely and successfully complete and submit our premarket approval application to the FDA; the timely and final approval by the FDA of our ComfortScan system as a adjunct to mammography, which approval in the U.S. cannot be assured; the success of our product development and research efforts; our ability to timely meet U. S. and foreign government laws and industry standards; our ability to meet U.S. and foreign medical device quality regulation standards required to maintain our CE Mark and our ISO, UL and FDA export certifications; our ability to timely deliver our products into international markets; the acceptance and use of our ComfortScan system by physicians, imaging clinics, and patients; and our ability to obtain third party reimbursement from U.S. and foreign government and private payers.
Any one of these or other risks, uncertainties, other factors, or any inaccurate assumptions may cause actual results to be materially different from those described herein or elsewhere by us. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the U.S. Securities and Exchange Commission, which we strongly urge you to read and consider, including our 2004 Annual Report on Form 10-KSB, which may be accessed from our website at igaot.pt. Subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth above and elsewhere in our reports filed with the U.S. Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.

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For further information:
Please contact: Michael Jorgensen, Chief Financial Officer
201-760-6464
mike@igaot.pt

DOBI Medical International
1200 MacArthur Blvd.
Mahwah, New Jersey 07430
Voice: (201) 760 6464
Fax: (201) 760 8860
e-mail: information@igaot.pt

 
 


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