Imaging Diagnostic Systems (fka IMDS)

[Penny Machine]

From 10Q, Shows that IMDS is selling their Product to Allot of different Country's $$$$$$$$$

We were pleased to learn in June 2012 that a clinical paper produced by Dr. J. Qi, an independent CTLM® researcher based in Tianjin Medical University Cancer Institute and Hospital Tianjin, China, is pending publication in "Clinical Imaging," a highly respected radiology journal based in New York, NY. Each article accepted for publication undergoes a through review for content and accuracy by an editorial board of Radiologists.

The paper by Dr. Qi titled, "CTLM as an adjunct to Mammography in the diagnosis of Patients with Dense Breasts", reported that when a CTLM® study was combined with a (digital) x-ray based mammogram -breast cancer detection rate otherwise medically referred to as test "sensitivity" was significantly improved from a low of 34.40% to a new high of 81.57% when dealing with Extremely Dense Breasts (ACR classification). In addition, the researchers "could distinguish malignant from benign lesions".

We are very pleased that the clinical benefits of a CTLM® breast exam have been validated by a group of independent researchers. We believe that Dr. Qi's results will be further validated upon completion of our PMA application to the FDA.

The abstract of the article can be found at www.clinicalimaging.org and searched under the title "CTLM as an adjunct to mammography in the diagnosis of patients with dense breasts".

We have temporarily discontinued discussions with other hospitals and clinics wishing to participate in our clinical collaboration program and plan to resume discussions if we secure the necessary funding to continue the program. We have been commercializing the CTLM® in many global markets and we previously announced our plans to set up this network to foster research and to promote the technology in local markets. We will continue to support similar programs outside of the United States if and when we are able to allocate funds for these programs. These investments have the potential to accelerate CTLM® market acceptance while providing valuable clinical experiences.

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10-Q Table of Contents
International Distributors - Global Commercialization

The following table details the regulatory requirement and status of each country in which we have sold or marketed the CTLM®.

Country
Sold
Marketed
Regulatory Requirement
Regulatory Status
United States
No
No
Food & Drug Administration
Preparing for PMA Submission
Argentina
Yes
Yes
ANVISA
Expired(1)
Australia
No
Yes
TGA Approval
Canceled, Distributor Will Re-Submit(8)
Austria
No
Yes
CE Mark
Approved
Brazil
No
Yes
ANVISA
Expired(2)
Canada
No
Yes
Health Canada Approval
Approved
China
Yes
Yes
SFDA Approval
Approved
Croatia
No
Yes
CIHI(4)
Not Submitted Yet
Colombia
No
Yes
Register with MOH(3)
Not Submitted Yet
Curacao
No
Yes
MOH
Submitted by distributor-No Status(14)
Czech Republic
Yes
Yes
CE Mark
Approved
Egypt
No
Yes
CE Mark & Egypt MOH
Not Submitted Yet
Germany
No
Yes
CE Mark
Approved
Hong Kong
No
Yes
CE/SFDA
Not Submitted Yet
Hungary
Yes
Yes
CE Mark
Approved
India
Yes
Yes
CE Mark & BIS Certification
Not Required(9)
Indonesia
Yes
Yes
DirJen POM
Pending(12)
Israel
No
Yes
Import License
Approved
Italy
Yes
Yes
CE Mark
Approved
Jordan
No
Yes
JFDA(6)
Not Submitted Yet
Kazakhstan
No
Yes
Registration Cert. & GOSTR Cert.
Not Submitted Yet
Kuwait
No
Yes
MOH
Approved
Macedonia
No
Yes
CE Mark
Not Submitted Yet
Malaysia
Yes
Yes
BPFK
Not Required(10)
Mexico
Yes
Yes
MOH - COFERPRIS
Pending(11)
Montenegro
No
Yes
MOH
Not Submitted Yet
New Zealand
No
Yes
CE Mark
Not Submitted Yet
Oman
No
Yes
MOH
Not Submitted Yet
Philippines
No
Yes
BHDT(7)
Not Submitted Yet
Poland
Yes
Yes
CE Mark
Approved
Romania
Yes
Yes
CE Mark
Approved
Russia
No
Yes
ROSZDRAVNADZOR
Pending(13)
Saudi Arabia
No
Yes
CE Mark & MOH
Not Submitted Yet
Serbia
No
Yes
CE Mark
Approved
Slovenia
No
Yes
CE Mark
Approved
South Africa
No
Yes
CE Mark & DOH(4)
Not Submitted Yet
Turkey
Yes
Yes
CE Mark
Approved
Ukraine
No
Yes
CE Mark
Not Submitted Yet
United Arab Emirates
Yes
Yes
UAE/MOH
Approved
Vietnam
No
Yes
MOH
Not Submitted Yet

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10-Q Table of Contents
(1) Will be renewed upon appointment of new distributor.
(2) Distributor will renew ANVISA.
(3) MOH - Ministry of Health
(4) DOH - Department of Health
(5) CICI - The Croatian Institute for Health Insurance
(6) JFDA – Jordan Food and Drug Administration
(7) BHDT - Bureau of Health Devices and Technology
(8) TGA had requested additional documentation of our initial approval from our former distributor, which they did not provide timely. The initial approval was canceled and our new distributor will resubmit the application.
(9) CDSCO – Medical Device Division, Not required as this time but will be required for some classes of medical devices in 2011 or 2012.
(10) BPFK – Malaysia National Pharmaceutical Control Bureau, Registration is voluntary
(11) COFEPRIS – Mexico Ministry of Health
(12) DirJenPOM – We received a deposit from our distributor Jainsons Pty Ltd. and the system was installed in Jakarta, Indonesia. Our distributor is responsible for registering the CTLM® with the Indonesia Director General of Food and Drugs ("DirJen POM") who controls the registration of medical devices. Product registrations for medical devices issued from certain designated countries such as Canada can be used to support the registration in Indonesia with the DirJen POM. The CTLM® system has received international certifications and licenses from the European Union, CE mark; Canada, CMDCAS Canadian Health screening; China, SFDA; and ISO 13485 issued by UL.
(13) Our distributor, National Diagnostic Service and Management LLC (National) of Novi, Michigan, through its affiliate Phoenix Med of Moscow, Russia, has submitted an application to the Ministry of Health which is currently pending. The distributor has defaulted on its obligations stipulated in their distributor agreement and agreed to transfer the distributor agreement to their Moscow based affiliate. We are in the process of signing a new distributor agreement using the same or similar terms and conditions of the agreement with National. The new distributor would take over and continue the registration process with the Ministry of Health.
(14) Our distributor, Medical Care Systems, CA, filed an application with the Curacao Ministry of Health for a Women's Imaging Center in Curacao. The distributor defaulted on its obligations stipulated in their distributor agreement and we allowed the distributor agreement to expire.


We market our CTLM® system in the countries listed in the table above, where permitted. Product registration is not necessarily required to market our CTLM® in a particular country. Prior to processing a Purchase Order, we would contact either a regulatory service or the distributor in that particular country to determine what, if any, product registration is required.

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