Nov 27 2007
Imaging Diagnostic Systems, Inc., 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.
"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 will use the previous work in preparing the new single PMA filing. Once the new PMA application is submitted, a 180-day clock will begin for the FDA to review the application. The FDA may also require a panel of experts to review the findings in order to make a final recommendation."
According to FDA regulations, new technologies such as the Company's CT Laser Mammography system are subject to the PMA process. IDSI believes that it is prepared for the rigorous PMA process with well-documented, established and previously approved quality and manufacturing practices in place. The FDA has declared the current U.S. trial a non-significant risk (NSR) device study.
The Company is also governed by other international regulatory agencies. The CTLM system has completed registrations including the CE Mark, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.