Message #18 From:
NewsBot Date: September 20, 2005 11:30:00 PM
DBMI News DOBI Medical International Progresses with ComfortScan(R) PMA Clinical Trial
MAHWAH, N.J.--(BUSINESS WIRE)--Sept. 21, 2005--DOBI Medical International, Inc. (DBMI.OB) today announced that it has added its twentieth trial site to its pre-market approval (PMA) clinical trial studying its Dynamic Optical Breast Imaging (DOBI(R)) system. The results of the clinical trial will serve as the basis for the PMA application to the U.S. Food and Drug Administration. The company has contracted with three more sites and is in discussion with several others.
Michael Silver Ph.D., Vice President of Clinical Research at DOBI Medical International said, "We continue to make progress toward our goal of completing our clinical trial, the subject of the fifth module and final submission towards satisfying the requirements for full review of our PMA application by the FDA. A number of clinical centers around the country have expressed interest and enthusiasm in participating in our clinical trial, which targets women 50 and under in the U.S. They share our commitment for developing new technology that will have an impact on improved breast cancer diagnosis, particularly for this generally underserved age group."
The trial is designed to gather clinical data relative to the use of the company's ComfortScan(R) system as an adjunct to mammography to help physicians diagnosis possible breast cancer. The ComfortScan system is a noninvasive, nonionizing (non X-ray) device that uses light-emitting diodes (LEDs), proprietary software and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. Angiogenesis has been linked with malignant tumors and other breast diseases.
The trial began last fall with three U.S. sites. The Company selects a site based on its represented ability to enroll a satisfactory number of patients under the age of 50, perform mammography, and provide pathology results from biopsies. Diagnostic analysis will take place upon completion of the data gathering phase of the study.
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 neovascularization ("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 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. DOBI Medical is a certified ISO 9001:2000 and ISO 13485:2003 company. The Company currently sells its ComfortScan systems to international distributors for installation at international clinical trial sites. The ComfortScan system is not being sold in the U.S. as it is limited by U.S. law to investigational use 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 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 report. 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, and the "Risk Factors" in our Registration Statement, 2005 on Form SB-2 declared effective on May 11, 2005, our 2005 Second Quarter Report on Form 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.
