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Message #22
From: NewsBot
Date: October 12, 2005 09:38:00 AM

DBMI News DOBI Medical Enters Research Agreement with Dartmouth

MAHWAH, N.J.--(BUSINESS WIRE)--Oct. 12, 2005--DOBI Medical International, Inc. (DBMI.OB) today announced a research agreement with the Dartmouth's Thayer School of Engineering to aid in furthering the development of the Company's ComfortScan(R) breast imaging system. Researchers at the school will conduct a year-long study to test various simulations of the company's ComfortScan system to assist in determining the optimal configuration to identify tumor angiogenesis in the breast. This effort is expected to commence in the near future. DOBI Medical is currently developing the ComfortScan system, a gentle, noninvasive, nonionizing (non X-ray) device that uses light-emitting diodes (LEDs) and gentle external pressure to identify tumor angiogenesis in the breast. Angiogenesis has been widely linked within the scientific and medical communities with the growth and development of malignant tumors. DOBI Medical is currently conducting the pre-market approval (PMA) clinical study of the ComfortScan system, and the system is currently investigational in the U.S.

"We are delighted to be working with this prestigious group of researchers at Dartmouth who are widely recognized as leaders in medical optical imaging," said A. Robert Sohval, Vice-President, Research and Development of DOBI Medical International. "The data analysis provided by this group should not only help us in developing our ComfortScan system as a diagnostic tool for breast cancer, but may also provide a foundation for the development of platforms for other uses."

"The ComfortScan system is a very exciting new technology which has the potential to aid physicians in diagnosing breast cancer and may have diagnostic applications in other diseases," said Hamid Dehghani, Ph.D., Assistant Professor of Engineering at Dartmouth's Thayer School of Engineering and lead investigator of the study. "We look forward to conducting this research with the ComfortScan system to enhance its potential as a breast cancer diagnostic device and understand these potential new applications."

Dr. Brian Pogue, Ph.D., Associate Professor of Engineering, will lead the Dartmouth group to conduct simulations to measure the internal distribution of pressure caused by the ComfortScan Soft Holder, a patented part of the system that applies slight pressure on the breast to improve imaging. The group will also conduct quantitative tests to determine how sensitive the ComfortScan system is in detecting objects of varying sizes and optical contrast within tissue. The project will also compute the expected effects of pressure changes on tumors within breasts of varying size and density.

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

About Dartmouth's Thayer School of Engineering

Founded in 1867, Dartmouth's Thayer School of Engineering comprises both the Undergraduate Department of Engineering Sciences and a professional school with degrees through the doctorate. Thayer School offers unique multidisciplinary opportunities within a non-departmental structure, conducting its instructional program within a single integrated building. Thayer School is uniquely small in comparison to its peers at major research universities -- this relatively small size is intentional and maintains a sense of community and close student-faculty interaction, as well as facilitating quick response to new technological developments.

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 neovascularization ("angiogenesis") associated with tumors. DOBI Medical International's first application of the technology is the ComfortScan system, a gentle, noninvasive, and nonionizing, optical imaging system designed as an adjunct to mammography 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. DOBI Medical is a certified ISO 9001:2000 and ISO 13485:2003 company. The Company currently sells its ComfortScan systems to international distributors for installation at international clinical trial sites. The ComfortScan system is not being sold 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 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," 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 report. 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, and the "Risk Factors" in our Registration Statement, 2005 on Form SB-2 declared effective on May 11, 2005, our 2005 Second Quarter Report on Form 10-QSB, and our Current Reports on Form 8-K, 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.

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