Imaging Diagnostic Systems, Inc. - Breast Imaging - CTLM
News & Press - Archives

« BACK

NEWS & PRESS RELEASE ARCHIVES

Tuesday, April 28, 2009 :: Imaging Diagnostic Systems Selects Distributor for Eastern Europe
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc. (OTCBB:IMDS) announced today that it has signed a non-exclusive agreement with Neomedica d.o.o. Beograd to market the CT Laser Mammography (CTLM®) system to the private and public sectors of Slovenia, Croatia, Serbia, Montenegro, and Macedonia.

Neomedica d.o.o. Beograd was founded in 1984 in Belgrade, Serbia and shortly thereafter expanded by adding four sister companies located in Croatia, Slovenia and Macedonia as a result of the increasing demand for innovative medical technologies throughout these rejoins. Their focus for the past twenty years has been introducing innovative medical technologies and minimally invasive procedures to the medical community. The company holds ISO 9001:2000 and SA 8000 certificates, the first company in Serbia with SA Certification.

“For the past twenty years we have established strong relationships with key Opinion Leaders in the medical field. We are currently investing in organizing awareness and training to the prestigious University Clinics giving the doctors the opportunity to learn new procedures. There is an increasing demand for new technologies and products such as the CTLM system," explained Nikola Markovic, Neomedica Deputy Director. “With our experience and know-how in the introduction of new products and technologies, particularly in oncology, radiology, and surgery markets, we would like to expand our portfolio and be the first to introduce CTLM in our territories."

Neomedica expects sales projections for 2009 to exceed 5 million (EURO) in revenues. Their sister companies expect to have around 4.5 million in sales revenue for 2009.

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 patented new breast imaging system that utilizes continuous wave laser technology and patented 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.

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 (CTLM®) 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 corporate 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.

Thursday, April 16, 2009 :: Imaging Diagnostic Systems Renews Its Distribution Agreement with EDO-MED Poland
Imaging Diagnostic Systems, Inc., IMDS announced today that it has renewed its distribution agreement with EDO-MED Sp. Z.o.o. as the exclusive distributor in Poland. EDO MED will continue to market and provide technical service support for the CT Laser Mammography (CTLM®) system throughout Poland, as well as to assist with and promote the ongoing research efforts utilizing CTLM technology at the Comprehensive Cancer Centre in Gliwice, Poland, and other institutes and research centers.

IDSI will continue to collaborate with EDO MED to develop the CTLM clinical research program in Poland, providing support for hospitals using the system as part of their routine practice and research to further investigate additional usage of the system. The Company will also provide assistance for EDO MED’s sales and marketing initiatives.

“Poland continues to seek methods that can improve breast cancer detection,” commented Jaroslaw Borkulak, EDO MED President. “EDO MED is a well established company in the functional imaging and oncology market, and CTLM technology complements our product base of innovative, well-established products. EDO MED is pleased to continue our business relationship with IDSI, as we see great potential for the CTLM system for women, both in Poland and internationally.”

In Poland, the CTLM system is currently used at the Comprehensive Cancer Center, Maria Sklodowska-Curie Memorial Institute, and the Military Institute of Health Services in Gliwice and Warsaw.

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 patented new breast imaging system that utilizes continuous wave laser technology and patented 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.

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 (CTLM®) 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 corporate 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

Tuesday, March 24, 2009 :: Imaging Diagnostic Systems Achieves Technical Breakthrough with New Reconstruction Algorithm
March 24, 2009 13:40 UTC

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)-- Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast cancer imaging systems, announced today that it has enhanced its CT Laser Mammography (CTLM®) system with a reconstruction algorithm that improves visualization of angiogenesis (cancer) in its images.

During a CTLM examination the breast is illuminated by a laser and the transmitted light is collected by a series of photo detectors and transformed into digital data. The reconstruction algorithm uses this data to create the various images of the breasts. The improved algorithm enhances the images by reducing the number of artifacts occasionally produced during an examination thereby making diagnosis easier.

"Our first-generation reconstruction algorithms were developed and evaluated using data acquired during our initial clinical trials. Since those trails, we have deployed over 26 systems worldwide, providing us with CTLM data from thousands of patients. IDSI’s Research & Development team used this data to optimize the reconstruction algorithms in order to provide better clarity and reduced artifact in CTLM images. We also incorporated streamlined numerical methods into the software so that the new algorithm does not require additional computing resources, allowing us to provide the improved functionality to existing customers as a software upgrade," stated Steven Ponder, Ph.D., Director of Advanced Development/Imaging Diagnostic Systems.

"The new algorithm has improved the visualization and distinction of several known patterns of angiogenesis from normal patterns of breast perfusion, making it easier for the radiologist to detect cancer. Of even greater importance; breasts which are too dense to be penetrated by X-ray mammography are quite translucent to the laser beam. The CTLM system therefore has much greater sensitivity than mammography in the dense breast and can reveal between two and three times the number," stated Dr. Eric Milne Director of Clinical Research/Imaging Diagnostic Systems Inc.

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 patented new breast imaging system that utilizes continuous wave laser technology and patented 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.

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 (CTLM®) 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 corporate 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.

Thursday, March 19, 2009 :: Imaging Diagnostic Systems Continues to Expand Its International Marketing Efforts with New Distributors
IDSI Appoints New Distributor for Australia, New Zealand and China Experienced in Launching Innovative Medical Technologies

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast cancer imaging systems, announced today that Jainsons Pty Ltd Company has been appointed as the new distributor for its CT Laser Mammography system for Australia, New Zealand and China.

Dr. Mukesh Jain, Chairman of Jainsons Pty Ltd, commented, “This is a very innovative and exciting technological breakthrough for breast cancer detection. This can revolutionize the breast cancer industry and has great potential in the Asian market. I believe that with time, this technology will be an alternative method to mammography.”
Jainsons Pty Ltd is a medical equipment distribution company with over 15 years experience in launching new technologies to the medical markets with a focus in laser medical technologies. The company has offices in Australia, India and the Philippines and agents throughout Asia.
Breast cancer is the most commonly diagnosed cancer in Australian women, with 1 in 11 who will develop breast cancer before the age of 75. In New Zealand, 1 in 9 women are diagnosed with breast cancer.
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 patented new breast imaging system that utilizes continuous wave laser technology and patented 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.
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 (CTLM®) 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 corporate website: http://cts.businesswire.com/ct/CT?id=smartlink&div=dejigfgdj&url=http%3A%2F%2Fwww.imds.com&esheet=5921431&lan=en_US&anchor=www.imds.com&index=1.
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.

Wednesday, March 18, 2009 :: Imaging Diagnostic Systems Selects CT Laser Mammography Distributor for Oman
Imaging Diagnostic Systems, Inc., IMDS announced today that Shihab Muscat United (SMU) L.L.C. has been appointed as the exclusive distributor for the country of Oman. The company will market and service the CT Laser Mammography (CTLM®) system to the private and public sector of Oman.

IDSI exhibited at the Arab Health 2009 medical conference during which they met with many officials interested in marketing the CTLM system throughout different countries. In particular, IDSI discussed the marketing potential for the CTLM system for the country of Oman with a prominent company by the name of Shihab Muscat United L.L.C., which markets and services medical and dental products throughout Oman.

“One of the highlights of the CTLM system at the Arab Health conference was the discrete manner in which a woman is examined which is desirable in the Middle East due to the cultural customs. We hope to produce a long lasting relationship with SMU and introduce the CTLM system to the women of Oman,” stated Deborah O’Brien, Senior Vice President of Imaging Diagnostic Systems, Inc.

The quality of healthcare in Oman is generally high and equal to that in Western Europe. In addition, Oman recently announced plans to develop a healthcare city near Muscat with an investment of 300-400 million Rilas (Iranian currency). Managing Director Arvind Gaikwad of Shihab Muscat United L.L.C. will present the CT Laser Mammography system to the Ministry of Health officials of Oman and to the private imaging centers.

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 patented new breast imaging system that utilizes continuous wave laser technology and patented 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.

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 (CTLM®) 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 corporate 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.

 

Subscribe - IMDS Mailing List