DOBI Medical International, Inc., together with its wholly owned subsidiary, DOBI Medical Systems, Inc., is an advanced medical technology imaging company. It is engaged in the business of developing and commercializing a non-invasive means for the diagnosis of breast cancer and other diseases through the detection of vascular changes (known as angiogenesis) associated with malignant tumors. The Company is a development-stage company and is in the process of seeking pre-market approval (PMA) from the United States Food and Drug Administration (FDA) for its ComfortScan system as an adjunct to mammography. ComfortScan system is a non-invasive and non-ionizing (no x-ray radiation) optical imaging system designed to assist physicians when used with mammography in the identification and management of breast disease. During the year ended December 31, 2004, DOBI Medical International released ComfortScan version 1.0, established a manufacturing facility, received its FDA export certificate, finalized agreements with several international distributors in select countries in Latin America, Europe and the Asia-Pacific regions, verified and validated its first release of the ComfortScan system, and sold and shipped 12 production-level ComfortScan investigative units to international markets for the purpose of conducting local clinical regulatory and marketing studies. In addition, the Company's PMA clinical trial protocol was accepted by the FDA, it delivered and installed ComfortScan system in its first three PMA sites, and the Company commenced the collection of patient scan data pursuant to its PMA clinical trial protocol. During the year ended December 31, 2005, the Company expanded the number of clinical sites participating in its PMA clinical trial to 23 sites, with an enrollment capacity of more than 200 patients per month. It has enrolled more than 1,200 patients. During 2005, DOBI Medical International has also signed agreements with an additional five international distributors and delivered four investigational ComfortScan systems to distributors in order to commence clinical studies. The Company has commenced a number of clinical studies in international locations. In January 2006, DOBI Medical International released ComfortScan version 2.0. The Windows-based ComfortScan 2.0 software suite consists of three individual elements, including ComfortScan acquisition software for patient data acquisition, ComfortNet for image database management, and ComfortView for image-processing and display, allowing for reading and diagnostic interpretation by physicians.

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