FORT LAUDERDALE, Fla.-( Business Wire )-
Imaging Diagnostic Systems, Inc., (“IDSI”) (OTCBB:IMDS) a pioneer in laser based Diffuse Optical Tomography (DOT) for breast cancer detection, announced that it remains fully committed to securing FDA approval. The company is in the process of submitting a PMA application to the FDA.
Linda Grable, Chairman and CEO of IDSI commented that: “After years of developing a truly unique and non-invasive breast imaging technology, we are pleased to be recognized as ‘Diffuse Optical Tomography.’ In addition, as possibly the first DOT breast imaging modality to seek FDA approval, we are completely dedicated to meeting all of the FDA requirements as quickly as possible.”
Mrs. Grable goes on to state that: “IDSI’s management team remains focused on providing shareholder value. Management is presently investigating several long term financing strategies that will both maintain and increase shareholder value and achieve our FDA objectives. IDSI understands that there have been some unidentified and uncontrollable forces putting pressure on our stock price. IDSI is a late stage research and development company that currently has various international registrations and approvals. CTLM® (Computed Tomography Laser Mammography) is being used daily by doctors in those markets as a non invasive breast imaging modality. Our ultimate goal is to provide this technology and its benefits to women in the United States.”
Dr. S. Ponder Director, Advanced Development for IDSI states that: “We continue to be encouraged by our clinical study results. Especially, when dealing with heterogeneous and extremely dense breasts. We have been able to demonstrate that CTLM® increases detection sensitivity especially in Extremely Dense Breast (BIRADS classification), when compared to x-ray based mammography. The CTLM® examination is performed without breast compression, x-ray radiation, or contrast injections. In addition, the non-invasive and non-radiation patient benefits of CTLM could become a very important future clinical benefit especially now that many breast screening programs are under significant scrutiny.”
About Imaging Diagnostic Systems, Inc.
The CTLM system is a near infrared laser based breast imaging system intended to provide the physician with physiological and clinical information non-invasively and without the use of ionizing radiation. The patient is positioned in the prone position comfortably on the scanning bed. The laser beam sweeps 360 degrees starting at the chest wall moving forward until the entire breast is scanned. The CTLM features 3-dimensional and Multi-planar views that display the distribution of blood supply within the vasculature structures of the breast. This information when interpreted by a trained physician can be useful in diagnostic determination. The CTLM system has received the following certification and licenses enabling international sales; European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO13485:2003 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.
Imaging Diagnostic Systems, Inc.Michael Addley, 954-581-9800