DOBI MEDICAL SYSTEMS SUBMITS SECOND MODULE TO FDA FOR PRE-MARKET APPROVAL APPLICATION
Mahwah, New Jersey, June 21, 2001. DOBI Medical Systems, LLC, announced today that it has submitted the second module of its Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan, to the U.S. Food and Drug Administration (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 in the breast by identifying angiogenesis.
Module 2 contains information pertaining to testing to demonstrate compliance with applicable standards, including electrical safety, electromagnetic compatibility as well as packaging and shipping testing. Additional detailed bench test data is provided for the key components used in DOBI Medical Systems' ComfortScan.
In announcing the submission of Module 2 to the FDA, Phillip C. Thomas, President and Chief Executive Officer of DOBI Medical Systems said, We are very pleased to be moving ahead with the submission of Module 2 to the FDA. Compliance with electrical safety standards represents a significant achievement in assuring a quality product.
DOBI Medical Systems is utilizing the FDA's modular submission approach, which divides the traditional PMA application into five modules. This system allows progressive review and acceptance of each modular portion of the total data required, thus facilitating the overall approval process. The FDA has previously accepted the first of the five modules required for the Companys PMA. We anticipate submission of Module 3 within 60 days, which will further our goal to obtain full FDA approval in 2002, concludes John D. Gardner, Vice President, Technology.
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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