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DOBI Medical International Releases ComfortScan(R) Version 2.0 Software Suite; Updates FDA PMA Study Progress

Posted on: Wednesday, 18 January 2006, 06:00 CST

DOBI Medical International, Inc. (OTC BB: DBMI) has released the latest version of its Dynamic Optical Breast Imaging (DOBI(R)) technology software for its ComfortScan(R) breast imaging system. The ComfortScan system is a near infrared based, noninvasive, and nonionizing imaging system designed to improve the diagnosis of breast cancer by identifying tumor angiogenesis - the growth of new blood vessels often associated with cancer. Recent blinded software verification and validation tests, conducted at an independent imaging core lab and under the supervision of an outside medical consultant, determined that, when used in conjunction with mammography for women undergoing a biopsy, physicians utilizing the ComfortScan system improved their identification of breast cancers, or sensitivity, over mammography alone.

The Company's Windows(R)-based, ComfortScan 2.0 software suite currently consists of three individual elements, including ComfortScan acquisition software for patient data acquisition, ComfortNet(TM) for image database management, and ComfortView(TM) for image processing and display, allowing reading and diagnostic interpretation by physicians. Highly sophisticated imaging processing and display capabilities make the image data available to physicians for reading in near real time.

"Completion of this version of the ComfortScan system software suite reflects the Company's long-term efforts to make ComfortScan an important tool for improving breast cancer diagnosis," said Phillip C. Thomas, CEO and Co-founder of DOBI Medical. "The latest clinical test results indicate that physicians using the ComfortScan system on women referred to biopsy can identify cancers that mammography alone may not have visualized. The release of version 2.0 marks the completion of a significant milestone in our preparation for a larger, blinded multi-physician read, a key part of the final submission module of our FDA Pre-Market Approval ("PMA") application.

Mr. Thomas added that in order to submit the Company's PMA clinical study for FDA approval of the ComfortScan 2.0 system, which is currently planned for the second quarter of this year, important additional work remains to be done to improve diagnostic specificity through continued refinement of ComfortScan reading rules and more physician training on those reading rules.

A. Robert Sohval, PhD, Vice President of Research and Development at DOBI Medical, indicated the new version of the ComfortScan software should aid physicians in a number of additional areas. "The new software advances in ComfortScan image acquisition and processing, with a number of improved image reconstruction techniques, are designed to help improve visualization of potential sites of angiogenesis within the breast," according to Dr. Sohval. "Furthermore, faster set-up time and higher scan acceptance rates will also reduce the time it takes to scan and the need to rescan patients. Physicians will benefit from the ability to more easily retrieve ComfortScan files from the image archive and across a network."

The new software also enables a quick review of color-mapped images to aid physicians in identifying regions of increased vascularity in the breast. To enhance information flow, images can be easily printed or digitally archived for future use and interpretation, allowing clinicians to manage their databases of these medical images. ComfortScan 2.0 is also now compliant with DICOM 3.0 (Digital Imaging and Communications in Medicine) - a standard for viewing and distributing information in the medical diagnostic imaging industry, and supports Storage Class, Query/Retrieve and Worklist Management.

FDA PMA Update

The Company has now enrolled over 1,000 patients, at multiple locations across the U.S., to take part in its multi-center clinical trial designed to help determine the efficacy of the ComfortScan system in its prospective role as an adjunct to screening mammography. The Company currently anticipates that it will complete patient enrollment during the first calendar quarter of 2006. Most common imaging technologies do not identify angiogenesis, which has been linked in many independent scientific studies to the growth and development of malignant tumors. Therefore, the ComfortScan system will be evaluated, in conjunction with screening mammography, in this PMA clinical study for its potential to improve a physician's ability to accurately identify benign lesions in those cases that are being sent to biopsy based on mammography (specificity). As noted above, improving overall diagnostic accuracy by increasing true negative rates, while maintaining true positive (sensitivity) levels will be necessary for submission of our PMA clinical study to the FDA.

The Company has begun making plans for an investor call open to the public in the near future to provide a general update to interested shareholders about this and other topics. Further information will be forthcoming.

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 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. 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 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, including China; 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 subsequent versions of our ComfortScan system, including our ability to improve specificity and maintain sensitivity sufficient for submission of Module 5 of our PMA application to the FDA; 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 our 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 "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 on Form SB-2 declared effective on May 11, 2005, our Quarterly Reports on 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.

Source: Business Wire

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