Q: What is the stock symbol and which exchange is it on? How long has it been trading? Can I buy stock directly from the Company?
A: The stock symbol is IMDS and it trades on the OTC Bulletin Board. The stock has publicly traded since 1994. Stock purchases cannot be made directly through the Company. Stock purchases can be made through Investment Brokerage firms and through the various Internet Financial websites.
Q: How long has the Company been in operation?
A: The Company has been in the development and research of the Computed Tomography Laser Breast Imaging (CTLM®) system since early 1994.
Q: How is the CTLM® system different from the regular mammogram?
A: The CTLM® system uses state-of-the-art laser technology, special array of detectors and proprietary computed algorithms. The CTLM® system does not expose the patient to ionizing radiation or require breast compression. Conventional mammography uses x-rays for its energy source and requires breast compression during the examination.
Q: How does the CTLM® system work?
A: A patient lies comfortably in the prone position with one breast suspended in the scanning chamber. The laser beam sweeps 360 degrees around the breast starting from the chest wall moving forward until the entire breast is scanned. The data is acquired by our patented array of specialized detectors, where it is reconstructed by our proprietary computed algorithms to create three-dimensional cross sectional images of the breast. The examination takes approximately 15 minutes to perform and requires no breast compression.
Q: Does the Company hold any patents?
A: IDSI holds seventeen (17) patents for the various components and technology with an additional thirty-five (35) international patents pending.
Q: What requirements are necessary to market the CTLM system in the United States.
A: In order to sell the CTLM® commercially in the United States, we must obtain marketing clearance from the Food and Drug Administration. A Pre-Market Approval application must be supported by extensive data, including pre-clinical and clinical trial data, as well as extensive literature to prove the safety and effectiveness of the device. The Company is currently compiling the information necessary to resubmit the PMA application.
Q: What is the expected target date for FDA approval?
A: The Company is in the process of resubmitting the Pre-Market Approval Application. Once the PMA is submitted the FDA has 180 days to render a decision. We are hopeful that the FDA will review our PMA in a timely manner. However, it is impossible to predict the actions of a government regulatory agency.
Q: Where is this product being used currently?
A: The CTLM® system is being used internationally. Austria, Germany, Italy, China and Poland.
Q: What about foreign sales?
A: The Company has sold systems to the Middle East and China. It is currently engaging the services of International Distributors to market the CTLM system throughout the various Countries
Q: How will the CTLM® system be used?
A: The CTLM® system will be used as an adjunct to mammography to provide additional information to the radiologist. The system can be used in Hospitals, Imaging Centers, Clinics, and private practices. However, it is the goal of the company to continue clinical studies to evolve the system as a screening device for women of all ages.
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.
Q: Will the CTLM® system replace the conventional mammography systems?
A: Promising new technologies are always evolving, in hopes to provide the medical industry with additional support in the fight against breast cancer. Our CTLM® system is designed to provide the industry with a powerful adjunctive tool to aid the detection of breast cancer. With additional development and clinical studies the CTLM® may in the future be presented as an alternative method to mammography.
Q: Are there other applications utilizing this technology beyond breast imaging?
A: The Company is researching potential supplements to the existing technology and other medical applications utilizing optical tomography techniques. The Company has engaged in the development of a Laser Imager for Lab Animals (LILA) targeting pharmaceutical developers researching new cancer treatment drugs.
Q: How does the Company stay operational if it doesn't generate revenues or earnings?
A: The Company has raised capital through debt and/or equity financing. (See our SEC filings for terms and conditions)
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.
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?
Q: Has the Company collaborated with other groups?
Q: How do I locate the SEC financial filings?
A: By logging onto edgar-online.com
Q: How do I keep informed on the latest developments?
A: The Company issues press releases on material events. Press Releases may be received electronically by Subscribing to the IDSI mailing list.
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Although there are no guarantees about the stock market or IDSI stock, before you invest in any security, you can help protect yourself by being an educated investor. If you are interested in IDSI's stock, we recommend that, at a minimum, you read our latest annual report and 10-K, 10-Q and S-1 report to the SEC. Our recent proxy statement from our shareholders meeting also contains important information. It is also advisable to learn more about IDSI and our industry through a variety of public materials.