DOBI MEDICAL RECEIVES FDA MODULE TWO ACCEPTANCE FOR BREAST CANCER DETECTION SYSTEM
Mahwah, New Jersey, October 9, 2001. DOBI Medical Systems, LLC, announced today that the U.S. Food and Drug Administration (FDA) has accepted the second module of its Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan. This module was submitted in June and is the second of five modules to be submitted, according to the Company's modular submission plan previously approved by the FDA. DOBI Medical Systems is seeking FDA approval for its non-invasive imaging system to be used as an adjunct to mammography to differentiate malignant from benign tumors by detecting angiogenesis development in the breast.
Module 2 contains information demonstrating compliance with a number of applicable design standards, including testing of electrical safety, electromagnetic compatibility as well as packaging and shipping. The module also provides detailed bench test data for the key components used in ComfortScanú.
In announcing the acceptance of Module 2 by the FDA, Phillip C. Thomas, President and Chief Executive Officer of DOBI Medical Systems stated, "We are extremely pleased that the FDA accepted Module 2 so promptly. This conforms to our overall PMA timeline and represents a significant milestone in the approval process."
"Module 2 acceptance demonstrates the successful completion of many hours of design and testing activity by our engineering team, added John D. Gardner, Vice President, Technology. DOBI Medical Systems is utilizing the FDA's modular submission approach, which divides the traditional PMA application into a series of data modules. This technique facilitates progressive review and acceptance of each module of the total data required, thus expediting the overall approval process
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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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