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DOBI Medical International Progresses With ComfortScan(TM) Clinical Trial

Posted on: Monday, 11 July 2005, 18:01 CDT

DOBI Medical International, Inc. (DBMI.OB) announced today that it has entered into contracts with 17 U.S. sites in connection with the Company's clinical trial studying its ComfortScan system. The ComfortScan system has been installed in 16 of those sites, thus far, and other locations will receive systems in the near future. The Company also continues to discuss participation in this clinical study with a number of additional domestic locations. The clinical trial is the final element of the Company's Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA).

The ComfortScan system is designed as an adjunct to screening mammography to aid in breast cancer diagnosis. It is a noninvasive, nonionizing (non X-ray) device that uses light-emitting diodes, sophisticated imaging processing and display software, and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. Angiogenesis has been widely linked within the scientific and medical communities with the growth and development of malignant tumors.

For more information on DOBI Medical International or the ComfortScan system, visit www.dobimedical.com.

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 that is not readily available today. The ComfortScan system has CE Mark and UL certifications for international sales, and DOBI Medical is a certified ISO 9001:2000 and ISO 13485 company. The ComfortScan system is not yet commercially available in the U.S. as it is limited by U.S. law to investigational use until approved by the FDA as an adjunct to mammography, which cannot be guaranteed.

CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS

Statements in this press release contain information that includes or is based upon certain "forward-looking statements" relating to our business. These forward-looking statements represent management's current judgments and assumptions as of the date of this report Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts, and are frequently accompanied by the use of such words as "may", "will", "anticipates,""plans,""believes,""expects,""projects,""intends,""seeks", "anticipates", and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors, including without limitation, successful verification and validation for release of our ComfortScan 2.0 system; 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 submission and final approval of our ComfortScan system in various international markets, which approval cannot be assured; the success and continued improvements in 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 to maintain our ISO, UL and FDA Export certifications; our ability to timely and successfully ship and deliver our products into international markets; the acceptance and use of our ComfortScan system by physicians, hospitals, imaging clinics, and patients; and our ability to obtain adequate third party coverage, coding and reimbursement from U.S. and foreign government and private payers.

We caution readers not to place undue reliance on forward-looking statements, which speak only as of the date of this release. Any one of these or other risks, uncertainties, other factors or any inaccurate judgments and assumptions could cause actual results to be materially different from those described herein or elsewhere by us. Certain of these risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the Securities and Exchange Commission, which we strongly urge you to read and consider, including the "Investment Considerations" and the "Cautionary Factors That May Affect Future Results" as set forth in our 2004 Annual Report on Form 10-KSB, as amended, our First Quarter, 2005 10-QSB/A, and the "Risk Factors" in our Registration Statement on Form SB-2 declared effective on May 11, 2005, all of which may be accessed from our website at www.dobimedical.com. 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 Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.

Source: Business Wire

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