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DBMI News DOBI Medical International Retains Beardsworth Consulting Group for ComfortScan(R) PMA Clinical Trial; Updates PMA Study Progress

Headquartered in Flemington, New Jersey, Beardsworth is a well recognized and experienced full-service contract research organization specializing in complex clinical trials. Beardsworth has conducted over 50 oncology-related clinical trials and also provides full clinical trial services in other therapeutic areas around the world.

"This new partnership marks our continued dedication to the collection of the highest quality data for our U.S. Pre-Marketing Approval (PMA) Application submission," said Michael Silver, PhD, Vice President of Clinical Research for DOBI Medical International. "Beardsworth's expertise in study management and patient recruitment will provide DOBI Medical with the support needed to expedite the successful completion of our PMA clinical trial."

Donna E. Beardsworth, President & CEO, Beardsworth Consulting Group, Inc. commented, "Accurate and timely diagnosis is the first step on the path to effective treatment of breast cancer. It is fitting that at the conclusion of National Breast Cancer Awareness Month that Beardsworth, a full-service contract research organization (CRO) and a Certified Woman-Owned Business, embarks on this partnership with DOBI Medical. We look forward to applying our 20 years of clinical trial experience and expertise to this important research."

PMA Study Progress

The PMA clinical trial protocol, as accepted by the US Food and Drug Administration (FDA), requires the enrollment of approximately 1,200 patients between the ages of 18 and 50 in order to obtain at least 120 malignant scans. This will be followed by blinded physician reads of 120 benign cases and 120 malignant cases. These cases will be used to compare the diagnostic results achieved by a combination of ComfortScan and mammography against the diagnostic results of mammography alone, while comparing both to biopsy results and attendant pathology reports.

The Company has expanded the number of clinical sites participating in the PMA clinical trial from 10 sites in June 2005 to 23 sites. To date, more than 700 patients have been enrolled, of which 400 have been enrolled in the last 90 days. The enrollment capacity of the PMA clinical sites is more than 200 cases per month and has historically generated a malignancy prevalence rate of approximately 12%. Following completion of the blinded reading and statistical analysis portions of the clinical trial, the Company plans to submit the fifth and final module of the submission package to the FDA.

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 identification of abnormal vascularization ("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 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. 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 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 PMA 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 including without limitation our ability to timely and successfully release version 2.0 of the 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 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 and 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.