FORT LAUDERDALE, Fla., June 26 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., a pioneer in laser optical breast imaging systems, announced the release and publication of select results highlighting the advantages of using CT laser breast imaging as an adjunct to conventional mammography to improve detection of occult cancers in dense breasts.
“These CTLM results are being released as a response to the growing number of requests for performance statistics received from distributors and prospective customers worldwide. The results were obtained from our initial PMA-designed clinical study,” commented Tim Hansen, IMDS Chief Executive Officer.
“The findings are quite positive,” stated Eric Milne, MD, IMDS Director of Clinical Research. “The study, from four sites in North America, involving 705 breasts of 515 patients, biopsied in 451 cases, was scientifically rigorous. It demonstrated that, in a dense breast population, the adjunctive use of CTLM, classifying DCIS as malignant, increased sensitivity from 50.0 to 58.3% over mammography alone and improved specificity from 75.5 to 86.8%. When DCIS is classified as pre-malignant, the figures changed slightly, increasing sensitivity from 43.8% to 56.2% over mammography alone and improving specificity from 73.6% to 84.4%. The difference between the two sets of results reflects, we believe, that the pathologically ‘benign’ form of DCIS shows angiogenesis in only 30% of cases, whereas comedocarcinoma shows angiogenesis in 75%, an observation that that might prove useful for stratifying DCIS for treatment purposes. One of the more remarkable results of using CTLM as an adjunct was that specificity also improved along with sensitivity, reducing the negative biopsy rate.”
Hansen added, “The combination of these results, plus the publication of CTLM research results in the peer-reviewed journal Investigative Radiology and routine clinical use results in the Egyptian Journal of Radiology, should provide confidence in the clinical merits of our technology. We have also completed over 9,000 CTLM breast studies in various global sites. We believe that releasing these results will reinforce the clinical value of our CTLM studies until the outcome of our current US PMA study is disclosed.”
The results, presented in the tables below, were published in Vol. 16, Issue 3/07, Mammo-Update 10, of European Hospital.
DCIS classified as malignant: Sensitivity Specificity NPV PPV Mammography alone 50.0% 75.5% 90.9% 23.5% Mammography + CTLM 58.3% 86.8% 93.2% 40.0% P-value 0.56 0.01 DCIS classified as ‘pre-malignant': Sensitivity Specificity NPV PPV Mammography alone 43.8% 73.6% 93.2% 13.7% Mammography + CTLM 56.2% 84.4% 95.3% 25.7% P-value 0.41 0.02
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM(R) system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM(R)) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) application for the Computed Tomography Laser Mammography (CTLM(R)) system to be used as an adjunct to mammography. The FDA has determined that the Company’s clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
For more information, visit our website: http://www.imds.com
As contemplated by the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995, this news release may contain forward-looking statements pertaining to future, anticipated, or projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates or predictions of future results or events and there can be no assurance that actual results or events will not materially differ from expectations. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filings with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
Investor Relations: Rick Lutz (404) 261-1196 lcgroup@mindspring.com Media Contact: Elizabeth Williams (954) 581-9800 williams@imds.com
Imaging Diagnostic Systems, Inc.
CONTACT: Investor Relations: Rick Lutz, +1-404-261-1196,lcgroup@mindspring.com, or Media Contact: Elizabeth Williams,+1-954-581-9800, williams@imds.com, both for Imaging Diagnostic Systems,Inc.
Web site: http://www.imds.com/