$4.4 Million Available to Advance Premarket Approval Study and Current
FORT LAUDERDALE, Fla., Sept. 19 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast cancer imaging systems, announced completion of a financing arrangement intended to reduce its dependency on equity financing.
The Company has sold its headquarters building for $4.4 million in cash pursuant to a sale/leaseback agreement.
Tim Hansen, IMDS Chief Executive Officer, commented, "We are very pleased to have completed this arrangement. IMDS is at a critical point in its history; the market has never been more ready for a product like our CT Laser Mammography system (CTLM(R)). We have grown to eight sites participating in our U.S. clinical trials, and we may add more to accelerate data collection. We have tapped a cash source at the right time to support the PMA process without diluting our investors with continued drawing on our equity funding agreement. All of this is good news for our shareholders, who have patiently supported the Company through the lengthy product development stages. We believe this sale/leaseback move will help keep us financially and strategically poised to advance the PMA process and bring an exciting and revolutionary CTLM breast cancer imaging system to women worldwide."
Details of the sale/leaseback agreement are available in an 8K filing with the SEC.
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. 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.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography 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.
|SOURCE Imaging Diagnostic Systems, Inc.|
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