| IMDS.COM |
| IMDS FAQs For Investors Site Created 2/28/2001 To visit the Official Website of Imaging Diagnostic Systems, Inc. simply click on their logo. |
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| IMDS.COM |
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| Imaging Diagnostic Systems, Inc. - Frequently Asked Questions for Investors - Updated 11/27/2007 This FAQ includes basic info, definitions, patents, pricing, sales, DD sources, FDA info, and competition together with various links. It is intended as an overview and should not be used as a substitute for your own due diligence efforts. |
| THE BASICS Imaging Diagnostic Systems, Inc. is often referred to as IDSI. The stock symbol is (IMDS). Common Shares Authorized = 450,000,000 For the Latest Basics Visit Common Shares Outstanding = 318,210,000 The Yahoo Market Guide Trading Shares (Float) = apx. 295,960,000 52 Week Low = $0.04 on 08/21/2007 52 Week High = $0.16 on 01/04/2007 Average Daily Volume (3 Mo.) = 461,989 Average Daily Volume (10 Day) = 400,800 50-Day Moving Average: $0.06 Article by Dr. Milne 200-Day Moving Average: $0.05 Latest stats are available at: http://finance.yahoo.com/q/ks?s=IMDS.OB Total Investors = 53,000+ per IR (as of Jan 2001) Investor Relations: Rick Lutz 404-261-1196 [email protected] |
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| LATEST PRESS RELEASES |
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| GENERAL Q: Does IDSI have a website? A: Yes. http://www.imds.com/ Q: Is IMDS a "pink sheet" stock? A: No. IDSI is a fully reporting company trading on the OTCBB Q: What is CTLM�? A: CTLM� is an acronym for Computed Tomography Laser Mammography...the company's patented medical device for...and process of...scanning and imaging breast tissue: Computed - refers to it being a DIGITAL process. Tomography * - refers to body imaging...in this case 3 DIMENSIONAL BODY IMAGING Laser - refers to the method of obtaining the image Mammography - refers to the particular portion of the anatomy being imaged In my opinion, the CTLM� technology is so revolutionary that the definitions below of the words "tomography" and "mammography" will have to be changed...the word "laser" will have to be added to them if and when the CTLM� receives FDA approval and becomes accepted by the medical community. to�mog�ra�phy [to m�ggrfee ] noun production of body image: the technique of using ultrasound, gamma rays, or X-rays to produce a focused image of the structures across a certain depth within the body, while blurring details at other depths. A series of such images can be combined, for example, by computer, to give a high-definition three-dimensional image. mam�mog�ra�phy [ma m�ggre fee ] noun breast-screening procedure: X-ray examination of the breast, used for the early detection of developing tumors, especially cancerous ones. |
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| Photonics Online Article |
Q: How good are the CTLM� images...how do they compare to x-ray images? A: Click Here ---> PATENT INFORMATION Q: Does IDSI have any patents on their process? (Click on RESEARCH, type in the A: Yes. IDSI holds 20 U.S. Patents granted with an additional Click Here ---> patent number and click "GO") 7 patents pending plus ... 15 International Patents and 7 more pending (The following international patent site shows more patent information.) Click Here ----------> Partial list of IDSI patents: US7155274: 12/26/2006 Optical Computed Tomography Scanner for Small Laboratory Animals US6738658: 05/18/2004 Medical optical imaging scanner using multiple wavelength simultaneous data acquisition for breast imaging US6693287: 02/17/2004 LASER IMAGING APPARATUS USING BIOMEDICAL MARKERS THAT BIND TO CANCER CELLS US6681130: 01/20/2004 Method for improving the accuracy of data obtained in a laser imaging apparatus US6662042: 12/09/2003 Diagnostic tomographic laser imaging apparatus US6571116: 05/27/2003 Medical optical imaging scanner using multiple wavelength simultaneous data acquistion for breast imaging US6339216: 01/15/2002 Time-resolved breast imaging device US6331700: 12/18/2001 Detector array variable gain amplifiers for use in a laser imaging apparatus US6211512: 04/03/2001 Detector array for use in a laser imaging apparatus US6195580: 02/27/2001 Diagnostic tomographic laser imaging apparatus US6150649: 11/21/2000 Detector array with variable gain amplifiers for use in a laser imaging apparatus US6130958: 10/20/2000 Method for reconstructing the image of an object scanned with a laser imaging apparatus US6100520: 08/08/2000 Detector array for use in a laser imaging apparatus US6044288: 03/28/2000 Apparatus and method for determining the perimeter of the surface of an object being scanned US6029077: 02/22/2000 Device for determining the perimeter of the surface of an object being scanned and for limiting reflection from the object surface US5952664: 09/14/1999 Laser imaging apparatus using biomedical markers that bind to cancer cells US5692511: 12/02/1997 Diagnostic tomographic laser imaging apparatus (all rights licensed to IDSI) [NOTE: Patent #US05692511 is the main patent for the CTLM�. Through the "Patent License Agreement", IDSI owns all the rights to the patent "for the life of the patent and any renewal thereof." (See SEC 10KSB filed 9/27/01 and previous filings under Patent License Agreement.)] DUE DILIGENCE Q: Where else can I find good DD on IDSI? A: At the company's official website: http://www.imds.com/ which has a company FAQ http://www.imds.com/investor/faqs1.php and see the links to SEC filings and News Releases above or at the company's website. Also there is the IMDS Longs Club at Yahoo Groups with great Bookmarks to DD sites and much more. You must be a member to read or post messages. groups.yahoo.com/group/imdslongsclub/ PLACEMENTS Q: Where is this product being used currently? A: The CTLM� system is being used internationally. Austria, Germany, Italy, China and Poland. PROCEDURE Q: How long does a breast scan take using the CTLM� A: A breast exam utilizing the CTLM(R) is non-invasive and can be performed by a medical technician in less than 15 minutes.(Form:10KSB-Filing Date: 9/27/2001 SALES INFORMATION Q: What is the price of the CTLM�? A: The suggested price of the CTLM� is $320,000. The cost of an exam will be $125 to $150 and take a total of about 15 minutes. (Source: SEC filings) Q: Has Imaging Diagnostic Systems, Inc. had any sales to date? A: Yes...the company has recently sold five machines overseas. As of 9/17/04, revenues have been reported at an average introductory price of approximately $183,500 per unit with a gross profit of approximately 60% of total Sales and 150% of cost of sales. (Total Sales of $917,296 with Cost of Sales of $363,871 and Gross Profit of $553,425) Q: Does IDSI have any distribution agreements? A: The Company has entered into agreements with various distributors located throughout Europe, Asia, Canada, Mexico and South America to market the CTLM� device. The terms of these agreements range from eighteen months to three years. The Company has the right to renew the agreements, with renewal periods ranging from one to five years. Q: What is the potential market size of the CTLM system? A: We have at least three major markets. The first market for the current CTLM system used adjunctively with mammography so wherever the mammography system is used the CTLM system. The second market is for a more sophisticated version of the CTLM, which may use injected agents such as fluorescence to help characterize breast tissue. This device could replace other functional imaging techniques such as MRI and Pet especially where the access ability to those devices is limited e.g., many foreign markets. The third is for the ultimate application of the simpler CTLM devices to screen the younger patient population. FUNDING Q: Where does the Company get funds for its operations? A: Like many or most start-up and development stage companies, they are funded through equity financing. For IDSI's funding, the discount is 7% which means at vaious points in time, the Company sells stock to the funder at 7% less than the market value at the time. The Company currently has a $15 million line of credit with Charlton, LLC which was put in place as of 1/9/2004 and is known as the "Fourth Private Equity Credit Agreement". FDA Q: Where does IDSI stand with the FDA? A: Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM�) system to be used as an adjunct to mammography. The FDA has determined that the Company's clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM� system is the first patented breast imaging system that utilizes state-of-the-art laser technology and patented algorithms to create 3-D images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system. ECR 2003 Meeting: Differential diagnosis of breast lesions using computed tomographic laser mammography (CTLM) E.N.C. Milne; Plantation, FL/US Presentation#/Poster#: C-0257 Purpose: Computed tomographic laser mammography has been developed to eliminate some of the problems associated with conventional mammography: neccessity for compression, use of ionising radiation, low specificity (causing a high percentage of negative biopsies) and low sensitivity in dense breasts. Materials and Methods: We have performed over 800 mammogram/CTLM pairs at 6 different centers in the U.S.A. and Europe. All cases were subsequently biopsied. The CTLMs were initially analysed "blind" by themselves and latterly in conjunction with the mammograms (previously read "blindly" by themselves). Results: Our analysis showed an improvement in specificity from approximately 30% using mammography alone to 70% using CTLM as an adjunct. In addition however the unique ability of CTLM to show distribution of perfusion also allowed us to differentiate between non-neoplastic tissues, e.g. to determine whether the density of a breast was due to fibrous, fibro-glandular or glandular tissue, to visualise cystic structures which were either equivocal or invisible on ultrasound and to show (without compression distortion) the true size, shape and position of prostheses (with frequently surprising results). Conclusion: CTLM not only improves our ability to determine benign from malignant masses but also assists us in the differential diagnosis of all non-neoplastic breast lesions. COMPETITION (loosely using the term) http://www.imds.com/investor/faqs1.php Q: What about competition? A: Management continues to monitor the progress of various competing technologies evolving in the industry of breast imaging. Based upon our research and scientific conferences we found that the CTLM� Laser Breast System differs from any other optical imaging device in several ways: CTLM� employs advanced continuous wave laser signals versus transillumination or time domain approaches which we tested earlier and subsequently abandoned. CTLM� does not compress or even touch the breast�it is painless. CTLM� is truly 3D and presents the breast study as a volume on a viewing workstation vs. planar or 2D approaches that superimpose many layers of information upon themselves. CT and MRI are examples of 3D imagers like CTLM�. Two companies, to our knowledge, are targeting the breast optical imaging markets. Advanced Research Technologies, Inc. (ART) (TSX:ARA) is developing a non-3D imager which does not utilize our patented continuous wave technology and in which the breast must be immersed in a gel. ART has signed distribution agreements with GE Medical should a product become available. IDSI views GE Medical�s interest in optical imaging an endorsement of the IDSI business model. DOBI Medical International, Inc. (DBMI:OB) is developing an optical imager based upon compression and transillumination of the breast, which produces a 2D �map� of relative oxygenation. IDSI views this adaptation of older technology as unlikely to become a threat to our CT laser 3D approach. Neither ART nor DOBI have FDA approval. To IDSI�s knowledge, no other company has a functioning optical imaging device designed for use as an adjunct to mammography. Competition In Summation: (the following is this author's opinion) I feel all the above technologies are, each in their own way, somewhat better than that to which women are currently being subjected, and therefore, will help save lives. It's a big world and cancer is a very big disease with lots of room for many newer and better technologies. I do not believe that for one technology to "win", all others have to "lose". The reason I believe the word competition is "used loosely" is due to the fact that the CTLM� is the first and only technology that employs Computerized Laser Tomography (read Digital Laser 3D), has a patented fluorescent marker system to enhance the images, and has a therapeutic potential through the use of PDT's (photo dynamic therapeutic drugs). This means that IDSI's CTLM� could not only be best at locating cancerous cells in their infancy, but also will be able to kill them. To my knowledge, no other technology currently under development exhibits all of those aspects. Good luck and Best Regards to all IMDS "longs". LuckyIMDS (Ron) DISCLOUSURE: Other than basic information, press releases, SEC information, and patent information, the foregoing is solely the author's opinion. I am not currently employed by IDSI nor have I ever been in the past. This information is intended only as an overview and should not be used as a substitute for your own due diligence. I am not qualified to give investment advice nor am I attempting to do so by posting statements or responding to anyone's questions on this or any other message board. I've come to these conclusions through extensive due diligence as an investor over the past 12 years. |
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| Press Release Source: Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System Tuesday November 27, 9:30 am ET Secures 10th U.S. Clinical Site FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS - News) 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� 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�) 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. 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� 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�) 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. 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. For more information, visit our website: 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. |