• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

DOBI Medical Provides Clinical Trial Update; China Clinical Study Also Updated

Posted on: Thursday, 2 February 2006, 06:00 CST

Clinical data recently collected in connection with DOBI Medical International's (OTCBB:DBMI) ComfortScan(R) system indicates that, if the Company's current PMA clinical study is modified, there may be an opportunity to demonstrate more accurate results in pre-menopausal women. Consequently, the Company plans to discuss possible changes to its current clinical study protocol with the FDA. In the event the FDA concurs with this approach, it may be necessary to enroll additional patients in its clinical study, thus extending the enrollment phase of the study into the third quarter of 2006.

Phillip C. Thomas, President and CEO of DOBI Medical International indicated, "In order to enhance the quality and clinical strength of our PMA submission and maximize the likelihood of bringing this important technology to market in the U.S., we anticipate the possibility of amending our study protocol to reflect preliminary results from data obtained at overseas clinical sites. Naturally, we want to confer with the FDA before this is implemented and thus we are in the process of preparing for a review and discussion of this new information with the FDA." In 2005, DOBI Medical expanded the number of clinical sites participating in the Company's PMA clinical trial to 23 domestic sites. To date, more than 1,100 patients have been enrolled.

China Clinical Study Update

In addition to its regulatory work in the United States, the Company is also involved with clinical testing of the ComfortScan system in several international locations. Furthest along in this effort is China, where the patient recruitment and data collection process for the Company's clinical study in Beijing was recently completed. Following this phase, detailed image interpretation training for three Chinese physicians who participated in a blinded read of the patient cases was completed. Initial documentation of this study has now been submitted for review by the Chinese State Food and Drug Administration (SFDA), China's medical device approving authority. The Company expects to meet with the SFDA in the near future to discuss questions they may have regarding the ComfortScan system and the results of the study. After a complete review by the SFDA of all relevant data, the SFDA will determine whether to grant approval for the sale of ComfortScan systems in China. However, this approval cannot be assured.

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 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 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; 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 "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

More News in this Category