« BACK
NEWS & PRESS RELEASE ARCHIVES
Tuesday, September 28, 2004 :: IDSI INKS $26 MM CHINA CONTRACT
IDSI INKS $26 MM CHINA CONTRACT
Fort Lauderdale, Florida, September 28, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced that it has signed a multi-year agreement with China Far East International Trading Corporation (CFETC) for the exclusive sale of the CT Laser Mammography System (CTLM®) in the People’s Republic of China. Superseding a previous distribution contact, this new agreement also includes clinical research and collaboration programs.
“We are extremely pleased to have received this major contract especially with the recent approval from China’s State Food and Drug Administration to begin commercialization within the PRC,” stated Tim Hansen, CEO of Imaging Diagnostic Systems, Inc.
IDSI’s exclusive distributor, CFETC has already received 4 CTLM systems under the previous agreement and expects additional units before year-end as part of this $26 million dollar multi-year agreement. CFETC is one of China’s top 500 Enterprises in import and export volume. CFETC operates under the control of State-owned Assets Supervision and Administration Commission of the State Council. CFETC is located in Beijing with branches in Guangdong, Zhejiang, Jiangsu, Hainan, Fujian, Shenzhen, and Zhuhai.
Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast imaging system. The CTLMâ system is the first patented breast-imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography. The CTLMâ system is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission.
Investor Relations: Public Relations:
Rick Lutz Margie Adelman
404-261-1196 561-347-6768
lcgroup@mindspring.com madelman@adelmancommunications.com
Monday, September 27, 2004 :: CHINA’S FDA APPROVES IDSI LASER BREAST
CHINA’S FDA APPROVES IDSI LASER BREAST
IMAGING DEVICE
Fort Lauderdale, Florida, September 27, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced today that its CT Laser Mammography system (CTLMâ) has received Chinese State Food and Drug Administration (SFDA) marketing approval. Following extensive inspection the Peoples Republic of China SFDA issued the registration "Certificate for Medical Device” representing the first approved laser based breast cancer detection system in China. The medical device registration number is 20043241646.
“The SFDA approval of our device is a major step in our global commercialization program. China is an enormous market for cancer detection devices since cancer became the leading cause of death in 1966. There has been a steep increase in the number of lung, breast, and colon cancers according to the Globoscan 2000 database. CTLM patient acceptance should be high because it uses no harmful radiation, just laser light, and the procedure is painless for the woman since there is no compressing or even touching of the breast,” stated Tim Hansen, CEO of Imaging Diagnostic Systems.
IDSI’s exclusive distributor, China Far East International Trading Corporation, (CFETC) has already received 4 CTLMâ systems. CFETC is one of China’s top 500 Enterprises in import and export volume. CFETC operates under the control of State-owned Assets Supervision and Administration Commission of the State Council. CFETC is located in Beijing with branches in Guangdong, Zhejiang, Jiangsu, Hainan, Fujian, Shenzhen, and Zhuhai.
Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast imaging system. The CTLMâ system is the first patented breast-imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography. The CTLMâ system is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission.
Investor Relations: Public Relations:
Rick Lutz Margie Adelman
404-261-1196 561-347-6768
lcgroup@mindspring.com madelman@adelmancommunications.com
Thursday, September 23, 2004 :: IMAGING DIAGNOSTICS’ THIRD CT LASER MAMMOGRAPHY SYSTEM INSTALLED FOR SCHERING AG TO SUPPORT HUMAN FLUORESCENT IMAGING RESEARCH
IMAGING DIAGNOSTICS’ THIRD CT LASER MAMMOGRAPHY SYSTEM INSTALLED FOR SCHERING AG TO SUPPORT HUMAN FLUORESCENT IMAGING RESEARCH
For Immediate Release
Fort Lauderdale, Florida, September 23, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced today that Schering AG, Germany, has installed the third CT Laser Mammography (CTLMâ) system as part of their Phase 1 clinical study of the fluorescent imaging compound SF64. This system was installed in the prestigious Charite Hospital in Berlin. The study will be conducted under the guidance of Dr. Alexander Poellinger, principal investigator for IDSI’s PMA clinical studies since 2001. Schering AG included Charite as an additional site to expand Schering’s optical mammography study program.
“Schering AG and Imaging Diagnostic Systems, Inc. have previously collaborated to install two CTLMâ systems at Robert-Rössle Clinic and the University of Muenster, where research has been underway for 12 months,” commented Tim Hansen, IDSI’s CEO. “The CTLMâ system can already highlight angiogenesis without fluorescent enhancement, but just as compounds have improved results in CT, X-ray, Nuclear Medicine and MRI, optical imaging should also benefit from Schering AG’s leadership work. Our system has been tuned to their compound and we are pleased to be part of the program,” continued Tim Hansen/CEO.
The clinical studies will assist in determining the potential benefits of using both absorption and fluorescent techniques adjunctively to further enhance the CTLM® system abilities in detecting breast cancer. Women with dense breasts or who have an inconclusive X-ray mammogram, and those with an increased genetic risk of breast cancer could potentially benefit from this new development. These women are at a higher risk of developing breast cancer at a young age.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology & Andrology, Oncology and, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life.
The CTLMâ system is the first patented breast imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast Imaging system. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities and Exchange Commission.
Investor Relations: Public Relations:
Rick Lutz Margie Adelman
404-261-1196 561-347-6768
lcgroup@mindspring.com madelman@adelmancommunications.com
Thursday, September 9, 2004 :: IDSI ADDS VP TO COMMERCIALIZE LASER MAMMOGRAPHY IN GLOBAL MARKETS
IDSI ADDS VP TO COMMERCIALIZE LASER MAMMOGRAPHY IN GLOBAL MARKETS
FOR IMMEDIATE RELEASE
Fort Lauderdale, Florida, September 9, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced that Mr. Janusz Ostrowski has joined Imaging Diagnostic Systems, Inc (IDSI), as Vice President, International Sales. Mr. Ostrowski will be responsible for implementing and managing the distribution network outside the US.
“Mr. Ostrowski is a very experienced imaging equipment industry executive who has spent his career introducing new products and services to global markets,” commented Tim Hansen, CEO of IDSI. “I have known Janusz for 19 years and have seen first-hand how he increased sales of CT, MRI, NM and X-ray for Picker International and how he grew significant business for Acuson with a revolutionary new Ultrasound device. We are extremely fortunate to have someone of his caliber taking our new CTLMâ modality to the molecular imaging market,” continued Mr. Hansen.
Mr. Ostrowski was most recently President of Klinicki St. Paul, Warsaw, Poland, a provider of independent imaging centers, which he founded in 1999. He previously was President of European Distribution Organization, a seller of imaging equipment and service contracts. From 1982 to 1988, Mr. Ostrowski managed strategic planning and marketing activities for Picker International, a manufacture of medical imaging equipment including CT, MRI and Nuclear Medicine. Mr. Ostrowski served as Distribution Director of the international market for Acuson, an Ultrasound technology company from 1988 to 1992. Mr. Ostrowski returned to Picker International from 1992 to 1998 as Distribution Director for the international market.
Mr. Ostrowski has a Masters Degree in Foreign Trade, BS in Economics from the University of Lodz, Lodz, Poland. In addition, he holds an Executive Master of Business Administration from Case Western Reserve University, Cleveland, Ohio.
The CTLMâ system is the first patented breast imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast Imaging system. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission.
Investor Relations: Public Relations:
Rick Lutz Margie Adelman
404-261-1196 madelman@adelmancommunications.com
Lcgroup@mindspring.com 561.347.6768
Tuesday, July 13, 2004 :: IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES APPOINTMENT OF NEW CEO AND DIRECTOR
IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES APPOINTMENT OF NEW CEO AND DIRECTOR
For Immediate Release
Fort Lauderdale, Florida, July 13, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), an industry leader in the field of Medical Optical Imaging, which has developed a patented breast-imaging system that utilizes state-of-the-art laser technology and proprietary algorithms to create three-dimensional cross-sectional images of the breast for the detection of cancer, announced today that Tim Hansen was appointed by the Board of Directors to serve as the new Chief Executive Officer and Board member. IDSI conducted a three-month search after Linda B. Grable, founder and CEO retired on April 15, 2004.
Mr. Hansen has served in top-level executive positions in the medical imaging industry over a 30-year period and was notably President of Picker Medical Systems, a leading company in the diagnostic imaging market. As President of Picker, he led the $1.2 billion group to improve market share and profitability in the global equipment and service business. In particular, he increased the CT scanner business via technology developments to fuel Picker’s overall profit growth.
Most recently, Mr. Hansen was with Cardinal Health, Inc. as the general manager of the Radiation Management Services, a leading provider of medical imaging quality assurance instruments and solutions. He brings executive-level experience, managing business operations, global marketing and sales, technology development, and developing luminary relationships in the diagnostic imaging field.
“Tim’s outstanding track record and well-rounded background in the medical technology industry will add immediate strength and strategic leadership to IDSI”, states Jay Bendis, Co-Chairman of the Board. Mr. Bendis also added, “We are fortunate to have attracted an executive of Mr. Hansen’s caliber and vision to lead the company at this stage of its global commercialization growth. Mr. Hansen comes to the IDSI team with enthusiasm, strong leadership skills, and diverse experience that will both position IDSI as an industry leader and increase shareholder value.
“I am excited about the unique IDSI technology and the possibilities it presents to improve the diagnosis of breast cancer. I look forward to working with the IDSI scientists, the clinical team and our development partners to guide the Company to full realization of this important adjunct to mammography,” stated Tim Hansen.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast imaging system. The CTLMâ system is the first patented breast-imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography. The CTLMâ system is a non-invasive, painless examination that does not expose the patient to radiation nor require breast compression.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities and Exchange Commission.
Investor Relations: Public Relations:
Rick Lutz Margie Adelman
404-261-1196 561-347-6768
lcgroup@mindspring.com madelman@adelmancommunicatins.com