MAHWAH, N.J.--(BUSINESS WIRE)--Feb. 14, 2006--DOBI Medical International, Inc. (OTCBB:DBMI - News) released company highlights and its financial results for the year ended December 31, 2005. Company Summary of Year-End Highlights
The Company released the ComfortScan® Version 2.0 Software Suite. The suite currently consists of three individual elements, including: ComfortScan acquisition software for patient data acquisition; ComfortNet(TM) for image database management; and ComfortView(TM) software for image processing and display, allowing reading and diagnostic interpretation by physicians. Highly sophisticated imaging processing and display capabilities make the image data available to physicians for reading in near real time. The Company expanded the number of clinical sites participating in the FDA Premarket Approval (PMA) clinical trial to 23 sites. To date, we have enrolled more than 1,200 patients. A number of clinical studies are being conducted in international locations for the purpose of submitting these for local regulatory approval of the ComfortScan system. Furthest along in these efforts is our clinical study in Beijing, China, where the patient recruitment and data collection process was recently completed. Following this, we provided detailed image interpretation training for three Chinese physicians who participated in a blinded read of all the cases. The initial documentation of this study has been submitted for review by the Chinese State Food and Drug Administration (SFDA), China's medical device approving authority. DOBI Medical has successfully completed four of the five required steps in the PMA process, and anticipates submitting updates to the first four modules in conjunction with the submission of the pivotal PMA clinical trial research study to the FDA. "This has been a year of advancement, in which we have made steady progress toward the completion of our PMA clinical trial, expanded our clinical presence outside the United States, and released ComfortScan version 2.0 to a growing international clinical community," commented Robert B. Machinist, Chairman of the Board of Directors of DOBI Medical. "These achievements are each critical to the company's growth. We are excited about our prospects on these fronts in 2006."
The DOBI Medical ComfortScan system is a noninvasive, nonionizing device that uses light-emitting diodes and gentle external pressure to identify tumor angiogenesis, the growth of new blood vessels in the breast. Tumor angiogenesis has been scientifically linked with malignant tumors as a key element in their growth and development. Because most common imaging technologies do not detect angiogenesis, the ComfortScan system, in conjunction with screening mammography, can potentially improve a physician's ability to accurately diagnose breast cancer.
Company Year-End Financials
Revenues for the full year were approximately $303,000 in 2005 as compared to $321,000 in 2004. The net loss applicable to common stock for 2005 was approximately $10,921,000, or $.18 per share, compared with a net loss of approximately $8,022,000, or $.21 per share, in the prior year.
Total operating expenses in 2005 were $10.28 million compared to $6.95 million in 2004. The increase relates to costs incurred in development of the ComfortScan system, initiation of clinical testing associated with the Company's FDA PMA application, expansion of the Company's international distributor network, and other operational expenses.
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