Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imag...( Secures 10th U....),Health

Secures 10th U.S. Clinical Site

FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast imaging, announced today that the Company has secured its 10th U.S. clinical site to participate in its CTLM(R) clinical trials. Under an approved protocol, the sites are collecting patient studies for the eventual submission of a Premarket Approval (PMA) application to the Food and Drug Administration.

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"We are very pleased to have achieved our goal of 10 clinical sites. The CT Laser Mammography (CTLM(R)) system promises to add significant adjunctive value to current mammography practices," stated Deborah O'Brien, IDSI Senior Vice President. "While we have performed over 13,000 CTLM breast exams internationally, we have elected to utilize only those cases collected in the U.S. under our approved PMA clinical trials protocol. We may also include two additional U.S. clinical sites to further shorten the time needed to collect the prescribed number of confirmed cancer and non-cancer cases to be used for the statistical analysis as a major component of our PMA application."

O'Brien continued, "Upon completion of the data collection phase, we will conduct an image interpretation or 'reading' phase where CTLM scans and conventional mammography exams will be read adjunctively by specially trained radiologists. That data, along with confirmed biopsy results, will then be analyzed according to our primary and secondary intended uses by an outside biostatistical firm. Their results will be submitted to King and Spalding, who will assist in our preparation of the final PMA application. Unlike IDSI's prior PMA application, the new PMA application will not be submitted in the modular form, although IDSI
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