DOBI Medical releases ComfortScan upgrade; gives update on FDA PMA study

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DOBI Medical International Inc. has released a new version of its Dynamic Optical Breast Imaging (DOBI) technology software for its ComfortScan Version 2.0 breast imaging system.

The ComfortScan system is a near infrared based, noninvasive, and nonionizing imaging system designed to improve the diagnosis of breast cancer by identifying tumor angiogenesis - the growth of new blood vessels often associated with cancer. Recent testing has determined that, when used in conjunction with mammography for women undergoing a biopsy, the ComfortScan system can improve a physician's identification of breast cancers, or sensitivity, over mammography alone, the company said.

The ComfortScan 2.0 suite is a Windows-based software consisting of three individual elements, including ComfortScan acquisition software for patient data acquisition, ComfortNet for image database management, and ComfortView for image processing and display.

"Completion of this version of the ComfortScan system software suite reflects the company's long-term efforts to make ComfortScan an important tool for improving breast cancer diagnosis," said Phillip C. Thomas, CEO and co-founder of DOBI Medical. "The latest clinical test results indicate that physicians using the ComfortScan system on women referred to biopsy can identify cancers that mammography alone may not have visualized. The release of version 2.0 marks the completion of a significant milestone in our preparation for a larger, blinded multi-physician read, a key part of the final submission module of our FDA pre-market approval (PMA) application," Thomas added.

DOBI Medical has now enrolled 1,000+ patients in its multi-center clinical trial designed to help determine the efficacy of the ComfortScan system in its prospective role as an adjunct to screening mammography. It is expected that it will complete patient enrollment first quarter 2006.