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DOBI Medical International Receives ISO 13485:2003 Certification and Renews Canadian Quality System Certifications

Posted on: Tuesday, 19 July 2005, 18:01 CDT

DOBI Medical International, Inc. (DBMI.OB) announced today that it has received its EN: ISO 13485:2003 certification and the renewal of its CAN/CSA: ISO 13485:1998/ISO 13485:1996, based upon TUV-USA's inspection of the DOBI Medical's Quality Management System earlier in the year. The above ISO certifications, awarded by TUV-NORD, a European Union certifying registrar, are in recognition of the Company's continued adherence to the highest, most recent and up-to-date comprehensive quality standards in the design and manufacturing of its ComfortScan(TM) system at its Mahwah, New Jersey facility.

This International Standard, ISO13485:2003, "Medical devices -- Quality management systems -- Requirements for regulatory purposes" is the current standard for medical device companies which specifies the requirements for a quality management system used by an enterprise for the design and development, production, installation and servicing of medical devices, and related services. The primary objective of the ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems among participating countries.

The above certifications demonstrate DOBI Medical's continuing commitment to international quality management system standards. The ISO 13485:2003 certification is a mandatory requirement for ISO participating countries in 2006.

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

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 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 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 for international sales, and DOBI Medical is a certified ISO 9001:2000 and ISO 13485:2003 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.

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 release. 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, our First Quarter, 2005 10-QSB/A, and the "Risk Factors" in our Registration Statement on Form SB-2 declared effective on May 11, 2005, 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.

Source: Business Wire

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