DOBI Medical International Exhibits ComfortScan(R) System at CHINA-PHARM Conference.
DOBI Medical recently signed a ComfortScan system consulting agreement with the China Center for Pharmaceutical International Exchange (CCPIE) in Beijing, China, serving as another key step in the continued expansion of its international presence. Under the agreement terms, CCPIE is working with the SFDA, China's governmental agency having oversight over approval of medical devices, to conduct a clinical investigation of the ComfortScan system to aid in obtaining national approval. Last month, the ComfortScan system passed technical inspection, one of several requirements precedent to SFDA approval for medical devices in China.
The Chinese Anti-cancer Association estimates that more than 300 million women are at risk for breast cancer in China, making it one of the most common cancers among women in that nation. Breast cancer incidence has increased annually by at least 27% over the past decade, replacing lung cancer as the most rapidly growing cancer in China. In addition, the death rate from breast cancer has increased by 3% annually in recent years, making breast cancer the leading killer of Chinese women. In fact, the incidence in China's major cities has reached the level of western countries. According to reports, Chinese women between the ages of 40 and 49 fall into the highest risk age groups.
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 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. For more information on DOBI Medical International or the ComfortScan system, visit www.dobimedical.com.
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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|Date:||Oct 25, 2005|
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