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NEWS & PRESS RELEASE ARCHIVES
Tuesday, October 17, 2006 :: Dear Fellow Shareholder Tuesday, September 26, 2006 :: Imaging Diagnostic Systems Adds Malaysia, Mexico, Sweden, Denmark and Norway Distributors Tuesday, August 8, 2006 :: Imaging Diagnostic Systems to Install First Tuesday, August 1, 2006 :: Imaging Diagnostic Systems Ships Second Wednesday, June 28, 2006 :: IDSI Clinical Researcher to Present New Breast Imaging Technology at Argentinean Symposium
Dear Fellow Shareholder,
It is my pleasure to issue this shareholder letter in advance of our November 8th annual shareholder’s meeting. We want you to be well informed about progress on our key initiatives and to share our enthusiasm for the future.
Priority one, the CT Laser Mammography PMA, is moving forward with installations in a number of prestigious U.S. sites, although the process of securing sites in general has not progressed as quickly as we had anticipated. As I noted in an earlier letter, the FDA determined that CTLM® trials under our intended use would constitute a Non-Significant Risk device study; we assumed such a reclassification would have enabled us to more quickly engage U.S. clinical “partners.” We found, however, that the processes through Investigational Review Boards and legal departments had become much more complex and lengthy in recent years. We also experienced delays because many of our preferred sites were simply too busy to participate in our study due to serious understaffing and workload issues, a recurring theme in the larger departments we contacted. Consequently, we needed to approach many more prospective sites than originally intended. As we work towards finalizing the remaining sites, we are continuing to contact others as back-ups. Our practice is to limit public identification of the sites so that the study members may participate without publicity or distraction.
We previously stated our plans to update all CTLMs shipped to PMA sites with the latest hardware and software developments to best reflect the system’s capabilities as an adjunctive breast imaging tool. Sites are using the latest CTLM configurations. Because the CTLM imaging technique is completely new to doctors and technologists and training could affect results, we improved our certified training programs and added computerized calibration and QA software to the systems. These improvements take full advantage of the experience we have gained through our 7,500 international breast exams and our service histories.
There remain uncertainties about the time it may take to accrue the total number of cases needed for final PMA submission because each site has a unique workload and patient volunteer recruitment process. Internally, we have an excellent team of staff radiologists, applications specialists, data managers, and service engineers on the PMA project. That excellence extends to the prestigious institutions and mammographers we have chosen; the outside PMA services of King & Spalding, a leading regulatory law firm; the
independent biometric firm performing our statistical analyses; the study auditing and monitoring firm, M Squared Associates; and other associates. I believe the PMA process is well in hand and fully resourced.
Our Global Commercialization initiatives have been given additional resources to speed up the pace of target market penetration. We have dedicated additional marketing resources to Mexico, Central and South America, and we installed demonstration sites in Argentina and in a private clinic in Colombia. Recently, we added an exclusive distributor in Mexico and received regulatory approval to sell CTLM systems in Brazil, where we are in the final stage of distributor selection.
In the Asia-Pacific Region, we contracted with BAC, Inc. to manage our existing distributors and develop new areas. BAC is now managing our China distributor activities and has led IDSI in establishing a representative office in Beijing. We have a full-time manager (BAC contract), a marketing specialist, and we plan to add a lead service supervisor: three dedicated Chinese nationals in Beijing. Clinical studies at our Beijing hospital site are going well, and, although we have the Chinese clinical studies needed, the process to gain CTLM procedure reimbursement status has been particularly long. We expect reimbursement to be announced very soon, which will greatly enhance the attractiveness of CTLM to the market.
Elsewhere in the Asia-Pacific region, BAC is pursuing business connections in Australia, Singapore, Malaysia, New Zealand, Hong Kong, Macao, Taiwan, and the Philippines to enhance our existing representation in South Korea and China. We have signed an exclusive distributor in Malaysia, where interest in breast cancer detection and treatment is surging due to publicity surrounding their First Lady, who succumbed to the disease. We are pleased with BAC’s efforts, and we are gaining momentum through their experience and connections.
Activities in Europe and the Middle East are top priorities for our International Sales VP, who highlighted progress by holding the first IDSI Users Meeting last April in Berlin. Our international users have been doing excellent clinical work and have contributed to our Image Interpretation Manual and User Training Program. Earlier this year, we received an order for six CTLM systems from our Polish distributor. The first of those systems shipped in June, giving us three systems in Poland, all serving major oncology centers. The remaining CTLM units on the order have not yet been scheduled for shipment. Among our global users, we have three systems operating in Poland, four in Italy, two each in the Czech Republic and the United Arab Emirates, as well as systems in Germany and Austria; all are adding to CTLM’s growing clinical presence in the regions. In September, we added an exclusive distributor responsible for Norway, Sweden and Denmark.
Our expanded approach involving the three regions described above has increased our Global Commercialization investment, which we believe will increase short-term sales and accelerate market acceptance.
We remain tightly focused on women’s health opportunities as we continue to explore optical molecular imaging and image fusion research projects involving fluorescent markers and methods to highlight and quantify the angiogenesis process. As a pioneer in laser breast imaging, it is gratifying to see others now recognize the technological and clinical potential. Late in 2005, we noted that Philips Medical Systems had entered the laser optical scanning arena with a joint Schering AG program. Notably, Philips stated in a recent publication that they will use continuous wave near-infrared (NIR) methodologies; this supports our technological approach over the ART alternatives. GE Medical is also stepping up activity and has installed several ART optical imaging systems in North America to collect PMA data. We also believe Siemens Medical has optical breast imaging devices under development. In the past 18 months, there has been a substantial increase in the number of MRI breast examinations and publications which validate the relationship of angiogenesis to breast cancer and the fundamental capability of imaging the angiogenesis process. We see these developments as very positive, as they validate our position that imaging angiogenesis in the breast is both clinically useful and commercially attractive. IDSI’s leadership is well demonstrated in the large number of clinical exams we have completed, in our patent position, and in the fact that only CTLM uses true CT continuous wave laser breast imaging techniques.
In August, we concluded a major licensing transaction concerning our Laser Imaging for Lab Animals (LILA) technology. As I noted in my first shareholders letter, LILA has great optical molecular imaging potential, but is not, strictly speaking, a women’s health technology. We, therefore, chose to license our animal imaging technologies to Bioscan, Inc., a company operating in that market and who possesses the capability to commercialize LILA technologies. IDSI will receive a front-end license fee and substantial royalties on future Bioscan sales. As a result, we will receive the economic benefits of this project much sooner with Bioscan than if we had pursued it on our own. Furthermore, licensing LILA permits IDSI to focus on our core business in women’s health markets and on the development of a family of laser breast imaging systems. We believe the license agreement enhances IDSI shareholder value economically and strategically.
Fellow shareholders, we have a great team behind these initiatives. Every IDSI associate is motivated to fulfill our mission and to improve breast cancer detection and case management methods. Our technology is unique and revolutionary, and has the potential to become a family of related systems. It serves us well to remember that other new imaging technologies such as CT and MRI started small, but over time, grew to become mainstream tools. We see that opportunity in laser breast imaging.
On behalf of all IDSI employees and our customers, we thank you for your support and patience. We look forward to seeing you at our annual meeting on November 8th in Florida.
Sincerely,
Tim Hansen
Imaging Diagnostic Systems Adds Malaysia, Mexico, Sweden, Denmark and Norway Distributors
Fort Lauderdale, Florida, September 26, 2006—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), a pioneer in laser optical breast imaging, has signed three exclusive distributors and added five countries to its global distribution network. These additions will increase market awareness of the new CT Laser Mammography (CTLM®) technology for women in the regions.
Able Global, an experienced multimodality imaging distributor, will address the growing need in Malaysia for improved breast cancer detection as IDSI’s exclusive distributor. According to the Malaysian National Cancer Registry, breast cancer is the most common cancer in Malaysian women and the number of breast cancer cases is on the rise. Since the October 2005 passing of Malaysia’s First Lady from breast cancer, there has been an increased emphasis on breast cancer detection and treatment throughout Malaysia.
IDSI’s Latin and South American distributor network will expand into Mexico as Mayerick, S.A. de C.V., one of the first radiological distributors in Mexico, begins exclusive CTLM distribution in Mexico. According to the Mexican Histopathological Registry of Neoplasias, breast cancer is the second most common type of cancer in women and the rates of new cases and deaths are increasing.
HAWA Imaging AB, an experienced medical imaging equipment distributor in Sweden, will become part of IDSI’s European Region and have exclusive coverage in Sweden, Denmark, and Norway. According to the European Network of Cancer Registries, Northern European countries, particularly Denmark and Sweden, have some of the highest incidence rates of breast cancer in Europe.
“We are pleased to announce additions to three of our global regions. Asia-Pacific, Latin and South America, and greater Europe each hold tremendous opportunities for commercialization of CTLM. Our latest distributors are experienced in the diagnostic imaging capital equipment business and have excellent customer relationships,” stated Tim Hansen, IDSI Chief Executive Officer. “Malaysia and Mexico add substantially to our global geographic coverage. Historically, there have been many scientific and clinical breast imaging developments from Scandinavia, so we anticipate an excellent reception to our new laser breast imaging technology there.”
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The FDA has determined that the Company’s clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). 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 images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system.
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.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
Imaging Diagnostic Systems to Install First
CT Laser Mammography System in Colombia
Fort Lauderdale, Florida, August 8, 2006—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced that a CT Laser Mammography (CTLM®) system has been shipped to Colombia for installation in a prestigious private mammography center in Bogota. The center specializes in breast screening as well as diagnostic exams using conventional mammography and ultrasound techniques.
CTLM imaging will be conducted under the direction of Dr. Bernardo Sanchez and his staff.
“I am looking forward to working with the CTLM system,” stated Dr. Sanchez. “It will fit in very well with the modalities and the types of cases that we treat, particularly women with dense breasts and breast implants. We would also like to use CTLM technology to evaluate patients who are undergoing treatment for breast cancer.”
The CTLM system is being installed to generate local physician and patient interest in the new noninvasive laser imaging technology. IDSI has been developing the South American market through a reference system installed in Argentina and through participation in imaging congresses and symposia.
“We are pleased to have placed the first CTLM system in Colombia and expanded our South American position,” stated Deborah O’Brien, IDSI Senior Vice President. “Through the efforts of Dr. Sanchez in Colombia and progress in Argentina, we will increase the commercial and clinical exposure of CT Laser Mammography.”
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The FDA has determined that the Company’s clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). 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 images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
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.
Investor Relations:
Rick Lutz
Imaging Diagnostic Systems Ships Second
CT Laser Mammography System to Czech Republic
Fort Lauderdale, Florida, August 1, 2006—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced that a second CT Laser Mammography (CTLM®) system has been shipped to the Czech Republic. The CTLM system will be placed at the 3rd Faculty Hospital in Prague.
“Following the clinical protocols at the Polak Family Breast Diagnostic Center in Prague, we are pleased to announce the placement of another system in the Czech Republic,” stated Michal Srb, President of EDOMED A.S. “The 3rd Faculty Hospital features a large oncology ward, which will use the CTLM system in breast examinations. We expect a high volume of studies, which will complement the work done at the Polak Center with CTLM as a screening adjunct.”
CTLM exams will be conducted under the direction of Dr. Bohuslav Svoboda, CSc, Dean of 3rd Faculty Hospital.
“We look forward to having Dr. Svoboda and the 3rd Faculty Hospital as part of our growing community of CTLM users,” stated Deborah O’Brien, IDSI Senior Vice President. “We are pleased to have a CTLM system placed at such a well-regarded institution and will be anticipating the clinical results.”
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The FDA has determined that the Company’s clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). 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 images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
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.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
IDSI Clinical Researcher to Present New Breast Imaging Technology at Argentinean Symposium
Fort Lauderdale, Florida, June 28, 2006—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced today that José Cisneros, MD, PhD, IDSI Assistant Director of Clinical Research, will be a presenter at the 1st Symposium on Breast Imaging on June 28 in Buenos Aires, Argentina.
The symposium will be held at Maimonides University and is sponsored by the Institute of Multiple Automatic Analyses (IAMA). The Institute features a Women’s Health department, which recently began patient studies with the CT Laser Mammography system (CTLM®). It is the first CTLM system operating in the country.
Entitled “The Current State of Breast Imaging Modalities,” the symposium is designed to inform physicians in the region on updates and developments in breast imaging. Dr. Cisneros will give two presentations: “Physical and Technological Fundamentals of Breast Imaging Modalities,” and “Conclusions on the Current Workflow of Breast Imaging Diagnosis.”
“With the symposium’s emphasis on multiple modalities, the new CTLM technology will be introduced as a tool to be used in conjunction with mammography to diagnose breast cancer,” stated Dr. Cisneros. “My presentations will explain how and when CTLM studies may be needed to provide additional information on difficult cases such as dense breast studies.”
The Company’s CTLM system recently entered US clinical trials to gather data for submission of a PMA application.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The FDA has determined that the Company’s clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). 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 images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
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.
Investor Relations:
Rick Lutz
404-261-1196
lcgroup@mindspring.com
