*IMDS* 0002 * 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.
107 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
108 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.