DOBI Medical International Updates Progress in China And Announces Exhibit of ComfortScan(R) System at the 2006 CHINA MED.MAHWAH, N.J. -- Representatives of DOBI DOBI Division of Banking and Insurance Medical International, Inc. (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). : DBMI DBMI Department of BioMedical Informatics
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SFDA Saudi Food & Drug Authority "). The meeting was part of the process required by the SFDA for companies seeking government approval for the sale of medical devices in China.
As indicated in the Company's 2005 Annual Report, it will only be after full review by the SFDA of all relevant data that a determination by the SFDA as to approval will be made and reported to the Company. This determination will be made by the SFDA in a time frame consistent with its normal processing for such applications. In the interim, the Company otherwise confirms its disclosures regarding China contained in its 2005 Annual Report on Form 10-KSB. There can be no assurance that the Company will receive SFDA approval prior to the end of the first half of 2006. We will update the status of our China SFDA submission once a final written determination is received from the SFDA.
The Company will exhibit its ComfortScan system at the 2006 CHINA MED International Medical Instruments and Equipment Exhibition Conference, April 11-14, at the China International Exhibition Centre, Beijing, China (Booth 8A052-53).
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 vascularization /vas·cu·lar·iza·tion/ (vas?ku-ler-i-za´shun)
1. the process of becoming vascular.
3. the surgically induced development of vessels in a tissue. ("angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.
n. ") 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 mammography, diagnostic procedure that uses low-dose X rays to detect abnormalities in the breasts. The early diagnosis of breast cancer made possible by the routine use of mammography for screening women increases a woman's treatment alternatives and improves her . 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 (1) See ISO speed.
(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. , 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 forward-looking statement
A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
Statements contained in this press release may contain information that includes or is based upon certain "forward-looking statements" relating to relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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 PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy ") 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.