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DOBI Medical Commences U.S. Clinical Trials for Final Module of PMA

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Mahwah, NJ, November 30,  2004 - DOBI Medical International, Inc. (DBMI.OB) today announced that it has initiated the clinical trial which will be the subject of the fifth and final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its flagship product, the ComfortScan™ system. Patient enrollment has begun at several leading U.S. medical sites, including: Hackensack University Medical Center, Hackensack, NJ; Sally Jobe Breast Centers, Greenwood Village, CO; and Comprehensive Breast Center of Coral Springs, Coral Springs, FL. The ComfortScan system is a non-invasive, non-ionizing, and gentle dynamic optical imaging system designed to assist physicians in the diagnosis and management of breast cancer. Additional sites are expected to begin enrolling patients in early 2005.

The ComfortScan system uses high-intensity light-emitting diodes (LEDs) to detect vascular abnormalities or tumor angiogenesis (the growth of new blood vessels) in the breast. This blood vessel growth is often associated with aggressive or malignant breast tumors. Since standard technologies, such as mammography and ultrasound do not show this growth, the ComfortScan system has the potential to improve the physician's accuracy in diagnosing breast cancer.

Phillip C. Thomas, chief executive officer, DOBI Medical International, commented, "We have successfully completed four of the five required steps in the FDA pre-market approval process. Completing the first twenty scans for Module 5 puts the company on track to submit the module to the FDA in the summer of 2005."

DOBI Medical will hold a press conference at RSNA on Tuesday, November 30th, 1:00 pm, highlighting these latest corporate milestones. The Company will also have a technical exhibit at the show (booth #2758).

About DOBI Medical International, Inc.

DOBI Medical is a development 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, non-invasive, and non-ionizing, optical imaging system designed 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 are not readily available today. The ComfortScan system is an investigational device and is not commercially available in the United States.


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 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; our ability to secure the additional financing adequate to execute our business plan; the success of 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, 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; our ability to meet the performance milestones and obtain the funding to close on the second tranche of the private placement completed in December, 2003; 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 2003 Annual Report on Form 10-KSB/A, our 2004 Third Quarter Report on Form 10-QSB and our Registration Statement on Form SB-2 declared effective September 27, 2004, all of which may be accessed from our website at igaot.pt. 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.

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For further information:
Please contact: Michael Jorgensen, Chief Financial Officer
201-760-6464
mike@igaot.pt

DOBI Medical International
1200 MacArthur Blvd.
Mahwah, New Jersey 07430
Voice: (201) 760 6464
Fax: (201) 760 8860
e-mail: information@igaot.pt

 
 


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