DOBI Medical International to Exhibit ComfortScan(R) System at 2006 CHINA MED.
One of the leading exhibitions in Asia, last year's CHINA MED drew a record 37,000 trade visitors. This year more than 400 exhibitors are expected to participate in what is the 18th annual exhibition of worldwide innovative technologies. As in recent years, over 60% of the exhibitors will be from outside of China, including the U.S. and Europe.
According to the Global Cancer Statistics 2002 report from The American Cancer Society (ACS), breast cancer, is by far the most frequent cancer among women. There were an estimated 1.15 million new cases in 2002, while Chinese cancer registries report steady annual increases in incidence of 3 to 4%.
The ComfortScan system is an investigational digital-imaging system utilizing high-intensity, light-emitting diodes and gentle external pressure to highlight areas with vascular abnormalities in the breast. ComfortScan technology is based on identifying tumor angiogenesis, the process whereby a cancerous growth surrounds itself with a dense network of tiny blood-filled capillaries which serve to aid in its growth and development. The ComfortScan system is designed to be used as an adjunct to mammography, and clinical trials are evaluating its ability to provide additional information which may aid the physician in diagnosing breast cancer more effectively.
About DOBI Medical International, Inc.
DOBI Medical is a developmental stage, medical imaging company working to create a new means for the improved diagnosis of malignant breast disease through the identification of abnormal vascularization ("angiogenesis") associated with tumors. The Company's first application of the technology is the ComfortScan(R) system, a gentle, noninvasive, and nonionizing, optical imaging system designed to assist physicians in the identification and management of breast cancer as an adjunct to screening mammography. 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 designations, and DOBI Medical is a certified ISO 9001:2000, ISO 13485:2003 and CAN/CSA: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, which cannot be guaranteed. Sales of the ComfortScan system to international distributors are limited to sales for investigational use for installation at clinical trial sites. For more information on DOBI Medical International or the ComfortScan system, visit www.dobimedical.com.
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 U.S. Food and Drug Administration ("FDA") patient Pre-Market Approval ("PMA") clinical trials, as well as our other clinical trials being conducted around the world; our ability to timely and successfully complete and submit to the FDA our PMA application of the PMA clinical trial results; the timely and final approval by local foreign governments of our ComfortScan system as an adjunct to mammography in various international markets; the success and continued improvements of our product development and research efforts, including without limitation, our ability to timely and successfully release version 2.0 and subsequent versions of our ComfortScan system; 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 ISO, UL and FDA export certifications; our ability to timely deliver our products into international markets; the acceptance, adoption, 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 governments and private payers.
Any one of these or other risks, uncertainties, other factors, and 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 Securities and Exchange Commission, which we strongly urge you to read and consider, including the "Risk Factors" as set forth in our 2005 Annual Report on Form 10-KSB, 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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|Date:||Apr 6, 2006|
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