FDA ACCEPTS FOURTH MODULE FOR DOBI MEDICAL SYSTEMS' ANGIOGENESIS BASED BREAST IMAGING SYSTEM
Mahwah, New Jersey, October 23, 2002. DOBI Medical Systems, LLC, announced today that the U.S. Food and Drug Administration (FDA) has accepted the fourth module of its Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan. The fourth module, submitted earlier this year, is part of the Company's five-module submission plan previously accepted by the FDA. DOBI Medical Systems is seeking FDA approval for its non-invasive breast imaging system to be used as a new tool to aid mammography and other diagnostic techniques in improving the accuracy of breast cancer diagnosis. The ComfortScan System identifies angiogenesis, or vascular changes, in the breast as a new means to help physicians more effectively differentiate malignant from benign tumors.
DOBI Medical Systems is utilizing the FDA's modular-submission approach, which divides the traditional PMA application into modules. This allows progressive review and acceptance of each modular portion of the total data required, thus facilitating the overall approval process. The FDA previously accepted the first, second and third modules of the five modules required for the Company's PMA.
Module 4 contains detailed information on manufacturing processes at DOBI Medical. Key elements contain emphasis on compliance to the FDA's Quality System and Good Manufacturing Practices (GMP's). These systems ensure that each ComfortScan device meets stringent quality and reliability standards and facilitates control of manufacturing processes where the product is being produced. In announcing the FDA's acceptance of Module 4, Phillip C. Thomas, President and Chief Executive Officer of DOBI Medical Systems, said, "We are pleased that the FDA approval process continues to move along expeditiously, and we remain enthusiastic regarding our progress toward final approval of our angiogenesis-based breast imaging system."
Eric W. Mueller, Manufacturing Director for DOBI Medical Systems, said, "A controlled manufacturing process is essential to achieving and maintaining consistent quality. Establishing definitive quality processes and applying them consistently to each system is the best way to control factors such as overall product performance, cost, inventory and lead-time. Approval of Module 4 indicates that we are on the proper track to ensure consistent production of a high quality product. We are very excited about bringing the DOBI ComfortScan one step closer to market approval."
About DOBI Medical Systems
Except for historical information contained herein, the matters discussed in this news release may contain forward-looking statements that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are not guarantees of future performance due to factors that could cause actual results to differ materially, including but not limited to, results of future clinical trials, technical risks associated with new technology development, government regulatory approval, market acceptance of our product, competition and technological change.
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