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NEWS & PRESS RELEASE ARCHIVES
Tuesday, February 1, 2005 :: CT LASER MAMMOGRAPHY SYSTEM SOLD IN ABU DHABI Thursday, January 27, 2005 :: CT LASER MAMMOGRAPHY SYSTEM SOLD IN ITALY Thursday, January 27, 2005 :: Dear Shareholder, Thursday, January 20, 2005 :: IDSI BEGINS 2005 WITH SIX CT LASER MAMMOGRAPHY ORDERS Tuesday, January 4, 2005 :: CT LASER MAMMOGRAPHY DISTRIBUTOR SELECTED FOR TURKEY
CT LASER MAMMOGRAPHY SYSTEM SOLD IN ABU DHABI
Third CTLMâ system sold in region
Fort Lauderdale, Florida, February 1, 2005—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced today that it has sold a CT Laser Mammography system to be installed at Al Salama Hospital in Abu Dhabi, United Arab Emirates. The installation will mark the third CT Laser Optical Mammography system sold in the region.
Al Salama Hospital, established in 1979, is a member of the International Hospital Association and an accredited certified teaching hospital. They received the Shiekh Khalifa Excellence award in 2004 for providing medical services in accordance with the highest caliber of international standards.
“Al Salama is a highly regarded hospital that could open many doors and potential sales in my country. We are planning to exhibit at the 2005 Arab Health conference and Al Salama may be a great place for serious customers to see the revolutionary CTLM system in action,” stated IDSI distributor, Mr. Vassileios Avdos, Managing Director of Abu Dhabi International Medical Services.
“Tim Hansen, IDSI CEO commented, “We are pleased with the general acceptance of our new technology in the region. We are also proud to be associated with Al Salama Hospital in the important work of helping to manage breast cancer care.”
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 Exchange Commission.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
CT LASER MAMMOGRAPHY SYSTEM SOLD IN ITALY
First Commercial Laser Breast Imaging System In Italy
Fort Lauderdale, Florida, January 27th, 2005—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced today that it has sold a CT Laser Mammography system to its distributor Biomedical International Snc., Rome, Italy for installation at the Hospital Civile di Teramo, Teramo, Italy.
“The CTLMâ system will be used in the Oncology Department. The Hospital is known for offering the latest technologies to their patients and we believe that laser optical mammography will be well received,” commented Mr. G. Luciano Perrazi, President, Biomedical International.
Tim Hansen, Imaging Diagnostic Systems CEO stated, “ This is the third operating CTLM system in Italy but the first sale in the country. We have another order pending. It is gratifying to see the acceptance of CT Laser Mammography begin to take hold in Italy and we look forward to working with our new users in providing this procedure to women in their areas.”
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 Exchange Commission.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
January 27, 2005
Dear Shareholder,
In our October letter to you we highlighted three top priorities: U.S. FDA Pre-Market Approval, global commercialization, and a roadmap to enhance our long-term growth. Here is a brief status update on each.
As you have seen from our recent press releases, global commercialization has been progressing nicely. We have six backlog orders including three under our China contract, two new systems in Italy, and a third Middle East order in UAE to Abu Dhabi. Our efforts to align with major luminary and research centers in Europe have garnered an impressive group. In addition to existing systems including Charite Hospital, Berlin, and the University of Vienna, we have added two new relationships with the Comprehensive Cancer Center, Gliwice, Poland, and Catholic University Hospital, Rome. We now have seven installed CTLM® systems under clinical agreements in Europe and we are targeting more.
We recently announced the appointment of several new distributors. These companies have been selected using criteria including their customer satisfaction focus, market coverage and a high degree of involvement in molecular imaging in their respective markets. These firms will be participating in a combined service-training program so that CTLM support will be directly available in the European region.
Our roadmap for the future is now tightly focused on women’s health and the opportunities with CT Laser Optical Breast Imaging as an emerging new modality. The FDA informed us that the CTLM has been reclassified as a Non-Significant Risk (NSR) device. This reclass may enable us to more quickly engage U.S. Clinical partners in the future.
On the PMA activities, we are altering course. The clinical study we have analyzed and which we intended to submit to the FDA did not, in our opinion, adequately reflect the capabilities of CTLM as an adjunctive mammography tool. Our clinical cases were collected on CTLM systems dating back to 2001. Since that time IDSI has developed significant improvements in the scanning subsystems, image reconstruction and image display software. We have also improved quality assurance routines to ensure better
operator and physician training, and improved image quality control. These enhancements are routinely implemented as they become validated on our international CTLM shipments, but the same changes were not made to the 2001 units in order to maintain our PMA modules in their original forms. We now intend to collect data using our latest systems because we believe the results will yield a stronger study to support our PMA application.
Consequently, we will install updated CTLM systems in the US and upgrade several international units to collect data under a new protocol. Our plan will extend the time to actual PMA submission from what we were anticipating in October, but we believe this approach will better support the application.
Once again we thank you for your patience and for your confidence in our technologies.
Tim Hansen
Chief Executive Officer
Imaging Diagnostic Systems, Inc.
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.
IDSI BEGINS 2005 WITH SIX CT LASER MAMMOGRAPHY ORDERS
China and Europe to receive CTLM systems
Fort Lauderdale, Florida, January 20, 2005—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced receipt of six International orders for CTLM® systems.
The orders reflect the Company’s new emphasis on Global Commercialization and recent efforts to strengthen IDSI’s international distribution network supported by clinical luminary partnerships.
“We are pleased to begin 2005 with an order backlog. The distribution changes we have implemented, especially in Europe, are very encouraging”, stated Tim Hansen, CEO.
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 Exchange Commission.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
CT LASER MAMMOGRAPHY DISTRIBUTOR SELECTED FOR TURKEY
Fort Lauderdale, Florida, January 4, 2005—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced today that Kurt & Kurt, Inc. has been appointed the exclusive Distributor in Turkey. The company will market and service the CT Laser Mammography (CTLM®) system as an adjunct to mammography procedures to provide more information prior to recommending patients for biopsies.
Mr. Janusz Ostrowski, IDSI International Sales Vice President, commented, “ Kurt & Kurt Inc., founded in 1973, is the most experienced medical imaging company in Turkey. They have an excellent reputation and an existing customer base of over 180 CT Scanners, 40 MRI systems, 500 X-Ray units, 2,000 Ultrasound instruments and 50 Mammography units. This appointment is another of several expected in the European region as we commercialize the CTLM system.”
Mr. Sinan Malkoç, Kurt & Kurt Executive Board Member offered, “I am excited about the unique CTLM technology and the possibilities it presents to improve the diagnosis of breast cancer. I am very much impressed with the 3D optical imaging technique which can display a neoplasm even in the most dense breast and about the potential of laser imaging techniques to distinguish non-invasively, in vivo, between benign and malignant lesions. I look forward to working with the IDSI group in our territory and introduce this new technology to our market.”
The CTLM 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, China SFDA and FDA export certification for its CT Laser Breast Imaging system. The Company is seeking Pre-Market Approval (PMA) from the Food and Drug Administration (FDA) for its CTLM 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: Company Contact:
Rick Lutz Deborah O’Brien
404-261-1196 954-581-9800
lcgroup@mindspring.com obrien@imds.com
