Message #27 From:
NewsBot Date: October 25, 2005 05:35:00 AM
DBMI News DOBI Medical International Outlines China Business Development Strategy; Agreement Signed with China SFDA Advisor; SFDA Technical Inspection of ComfortScan(R) System Completed; Clinical Study Commences; China Area Business Manager Appointed
MAHWAH, N.J.--(BUSINESS WIRE)--Oct. 25, 2005--
Local Legal Counsel Retained
DOBI Medical International, Inc. (DBMI.OB) today announced a multi-faceted business development strategy for China designed to increase the Company's presence in the Far East. Key elements of the business development strategy are outlined below.
First, the Company recently signed an agreement with the China Center for Pharmaceutical International Exchange (CCPIE). Under the agreement, CCPIE will work closely with the Company and the Chinese State Food and Drug Administration (SFDA), China's FDA organization, to oversee all the elements of the product approval cycle required by SFDA. The first step in the cycle was to conduct a technical review of the DOBI Medical ComfortScan(R) system. This was successfully completed recently and a clinical investigation certificate was awarded on September 27. The next step in the process is a multi-site clinical study in which CCPIE will assist in the management and support of the clinical sites involved with this clinical trial. After the recent arrival of two ComfortScan systems into China, this clinical study commenced at two sites in Beijing. When the study data have been gathered, CCPIE will centralize and compile the research results and submit the final documentation to the SFDA for their review.
"This new agreement marks our continued expansion into the very significant Asian marketplace. Statistics in China, alone, prove there is a great need for the benefits that we believe are inherent in a health exam utilizing our ComfortScan technology," said Robert Ellis, Vice President of Marketing, Sales and Service for DOBI Medical International. "Moreover, we expect that the extensive local market expertise of CCPIE will further enhance our ability to commercialize in China with more ease and speed."
To enhance DOBI Medical's international expansion in the Far East, G. John Zhang, PhD, has been hired as Area Business Manager, Asia/Pacific to oversee activity in that region. Dr. Zhang, a native of China and a graduate of the Massachusetts Institute of Technology, is highly experienced in the area of Chinese business development and recently left Boston Instruments to join DOBI Medical. Commenting on his new role, Dr. Zhang indicated, "China has both the population and the intense need for the ComfortScan system. We expect the Asia/Pacific region to be a significant market for sales following the successful completion of our SFDA scientific and clinical review."
To further aid its efforts in the region, the Company has also retained legal counsel in China. Fong & Ng, one of the areas largest law firms, in association with King & Wood, has been retained as the Company's China and Hong Kong legal counsel. The firm is expected to provide legal support to the Company's efforts in the region as activities expand in the coming months.
Breast Cancer in China
According to the Chinese Anti-Cancer Association (CACA), more than 300 million women are at risk for breast cancer in China, making it one of the most common cancers among women in the country. The death rate from breast cancer has increased by 3% annually in recent years, making breast cancer the biggest killer of Chinese women. In the past 10 years, diagnosis of breast cancer has increased by at least 27% and death rates in China's major cities have risen approximately 38%, replacing lung cancer as the most immediate cancer threat in China and reaching the levels of western countries. Forty percent of Chinese women diagnosed with breast cancer die within five years because the cancer is already very advanced when diagnosed. The highest risk age group for Chinese women is between the ages of 40 and 49.
ComfortScan Around the Globe
The DOBI Medical global distribution network now has 12 international distributors representing 16 countries - or almost one-half of the world's population, including India, Russia, Canada, Panama, Costa Rica, Colombia, Nicaragua, Brazil, the Czech Republic, Greece, Italy, Portugal, Switzerland, Liechtenstein and the Netherlands. The Company expects to sign additional distribution agreements as it continues to expand its international network of partners.
For more information on DOBI Medical International or the ComfortScan system, visit www.dobimedical.com.
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 high risk and malignant breast disease 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 identification and management of breast disease. 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 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 in the U.S. as it is limited by U.S. law to investigational use as an adjunct to mammography 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 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 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 Securities and Exchange Commission, which we strongly urge you to read and consider, including our 2004 Annual Report on Form 10-KSB, 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.
