Frequently Asked Question Concerning IDSI
The Company has been in the development and research of the Computed Tomography Laser Breast Imaging (CTLM®) system since early 1994.
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.
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.
IDSI has been issued 21 patents.
In order to sell the CTLM® commercially in the United States, we must obtain marketing clearance from the Food and Drug Administration which is 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.
FDA approval is expected after completion of our Clinical Trials. The Company plans on submitting to the FDA soon. However, it is impossible to predict the actions of a government regulatory agency.
The CTLM® system is being used internationally in countries such as Hungary, China and Malaysia.
The Company has sold systems to Hungary, India, Indonesia, Italy, Malaysia, and the U.A.E.. It is currently engaging the services of International Distributors to market the CTLM® system throughout the various Countries.
The CTLM® system will be used as an adjunct to mammography for patients with dense breasts to provide additional information to the radiologist. The system can be used in Hospitals, Imaging Centers, Clinics, and private practices.
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.
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.
The Company issues press releases on material events. Press Releases may be received electronically by Subscribing to the IDSI mailing list.
CTLM® – Laser Breast
Imaging Without Compression
Facts About CTLM® And Optical Imaging:
- CTLM® – Computed Tomography Laser Mammography is part of the emerging field of optical imaging.
- Scientific data has demonstrated that CTLM® images angiogenesis. Angiogenesis is a requirement for any process in the breast that has increased metabolic demands such as invasive and in situ cancers.
- CTLM® does not use ionizing radiation (no x-rays).
- CTLM® was designed as an adjunct to mammography for imaging dense breasts.
- There is NO breast compression with CTLM® and the breast hangs in the machine opening in it’s natural position.
- In a study of over 100 women, including 30 with breast cancer, optical imaging increased sensitivity and specificity of breast cancer detection by more than 90% (Britton Chance, Molecular Imaging, Vol. 2 #2)
- CTLM® – Computed Tomography Laser Mammography provides additional functional information that may be useful in assisting with the early detection of breast cancer.