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DOBI MEDICAL INTERNATIONAL, INC. REACHES AGREEMENT WITH FDA REGARDING MULTI-SITE CLINICAL TRIAL OF ITS COMFORTSCAN™ SYSTEM

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Mahwah, NJ, June 8, 2004. DOBI Medical International, Inc. (OTCBB:DBMI) announced today that it has reached agreement with the Food and Drug Administration (FDA) regarding the clinical study the Company will conduct as its final step in its Pre-Market Approval (“PMA”) application. The ComfortScan™ system, an advanced development stage imaging device, was created to provide a new means for the improved diagnosis of cancer though the detection of abnormal vascularization (“angiogenesis”) associated with tumors.

Dr. Angelo Secci, Vice President of Clinical Research for the Company, stated, “We are confident that the development of our ComfortScan system is ready for the commencement of this final phase of the FDA review process. I believe that this medical device has the potential to provide functional, physiological data currently not readily available to physicians regarding abnormal vascularization in an area of interest in the breast. The ComfortScan system could become an important tool used by the physician, in conjunction with information acquired with other diagnostic methods, to assess the suspected malignancy of identified lesions in the breast.”

The clinical study design was developed in collaboration with the FDA and a number of medical experts in the field of angiogenesis, breast cancer management, and clinical trial design/management.

The study, expected to commence in Q3 of this year, will take place at approximately a dozen research sites in the United States and will involve the enrollment of up to 600 patients previously referred to biopsy following a suspicious or indeterminate initial finding. At the end of the clinical study, an independent group of physicians, blinded to the results of the biopsied patients, will interpret the scans acquired by the ComfortScan system.
The results of this study will be used in the submission of DOBI Medical’s fifth and final PMA module to the FDA. Successful completion of the study and its associated requirements should support the company’s planned commercialization in the United States.

Phillip C. Thomas, Chief Executive Officer, commented, “We have completed a significant corporate milestone in finalizing our PMA protocol with the FDA, and continue with plans to commence the final PMA clinical trial in September, 2004. We are on plan and meeting all our business objectives to achieve the commercialization of the ComfortScan system.”

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’s first application of the technology is the ComfortScan system, a non-invasive, non-ionizing, and pain-free dynamic 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.

CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements contained in this press release may contain information that includes or is based upon certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act 1995 relating to the business of DOBI Medical. 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 “anticipate”, “plans”, “believes”, “expects”, “project”, “intends”, or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties, including uncertainties relating to our ability to secure additional financing; success of product development efforts; our ability to timely meet federal, local and foreign government and industry regulations and standards; timely and successful completion of our patient clinical trials and submission of our pre-market approval application to the FDA; final approval of our ComfortScan system by the FDA; delays in the manufacturing process caused by our inabilities or the inabilities of our subcontractors to timely meet our specifications; our ability to establish international and domestic distribution networks, our ability to timely export our products to international markets; acceptance and use of our ComfortScan system by physicians, imaging clinics, and patients; our ability to obtain third party payer reimbursement; and our ability to compete on price and quality. Any one of these or other risks and uncertainties may cause actual results to be materially different from those described herein or elsewhere by us. Certain of these risks and uncertainties are or will be described in greater detail in our filings from time to time with the Securities and Exchange Commission, which we strongly urge you to read, including our 2003 Annual Report on Form 10-KSB/A and our Quarterly Report for the period ending March 31, 2004. 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 and risk factors 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: Phillip C. Thomas, Chief Executive Officer
201-760-6464
pct@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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