Confirma Introduces Next Generation CADstream System; Advanced Features Expand Leading Breast MRI CAD System.

KIRKLAND, Wash. -- Confirma Showcases Complete Offering for Breast MRI -- CADstream(TM) and the Access(TM) Breast Coil -- at the 2004 RSNA Meeting in Chicago

Confirma, Inc., the market leader in computer-aided-detection (CAD) for MRI, today announced the next generation of its successful CADstream product, the standard in CAD for breast MRI. The latest developments in CADstream contain advanced features that include a streamlined portfolio for more comprehensive patient treatment planning -- incorporating the ACR BI-RADS(R) Atlas for lesion classification -- and a multimodality ready configuration, offering users the ability to access, view and reference patients' mammography and ultrasound studies while interpreting breast MRI with CADstream. Confirma has filed CADstream's new features with the FDA.

CADstream's advanced features and the Access Breast Coil are currently being showcased at the Radiological Society of North America (RSNA) 2004 meeting in booth 7140 (Hall B) in Chicago, IL. Confirma will be hosting a press briefing today from 3:00 to 3:30 pm CT at McCormick Place in the RSNA News Conference Room to discuss the evolution of its CADstream product.

"CADstream has led to a profound improvement of our breast MRI program at First Hill Diagnostic Imaging," said Justin P. Smith, MD, First Hill Diagnostic Imaging, Seattle, WA. "We have seen improvement in a variety of elements that affect our program, including workflow, standardization, communication and study volumes. The new features in CADstream, I believe, will further improve our women's imaging program. We now have even better, more informative tools to interpret and communicate the extent of disease."

"Fortunately, with recent advances in breast MRI, breast surgeons are now better able to understand and plan for a patient's breast surgery," said Peter D. Beitsch, MD, FACS, Dallas Surgical Group, Dallas, TX. "Since breast MRI is such a new and complex imaging method, radiology reports sometimes lack the standardization and detail a surgeon needs. The CADstream Portfolio now includes the ACR BI-RADS Atlas for lesion classification, the lesion location, quadrant and size information and relevant images. These are important elements for planning and better surgical outcomes."

CADstream -- Expanding Women's Imaging

CADstream enhances the efficiency and workflow of breast MRI studies by automating data analysis, improving image management and correcting for patient movement, which assists radiologists in the interpretation, standardization and reporting of these data-intensive studies. CADstream's core automated features include adaptive, high-order image registration (2D/3D), multiplanar reformatting, subtractions, angiogenesis maps, interactive real-time contrast curves, maximum intensity projections (MIPs) and volume summaries. CADstream is the market leader in breast MRI CAD and currently has an installed base of over 150 systems throughout the U.S. and Europe.

CADstream new, advanced features will include:

Streamlined CADstream Portfolio for treatment planning

--Automatically provides summaries with size, classification and location for tumor volume of interest

--Incorporates ACR BI-RADS(R) Atlas for lesion classification

Multimodality ready

--Offers the ability to access and view patients' mammography and ultrasound studies while interpreting breast MRI studies in CADstream -- all on the same PC or workstation

Interactive maximum intensity projections (MIPs)

--Includes AngioMap overlays and are correlated for 3D navigation and mammography views

DICOM 

--Provides query-retrieve and printing capabilities

Current CADstream advanced features include:

DICOM

--Provides connectivity and archiving

Interventional guidance tool, SureLoc(TM)

--Guidance tool for calculating needle position and insertion coordinates for interventional procedures. Supports angled needle access and medial, lateral, and cranial-caudal access approaches.

"The new, advanced features in CADstream have the ability to create even greater efficiencies in breast MRI and breast cancer detection," said Dan Bickford, vice president of sales and marketing for Confirma. "Confirma's product development is based on customer feedback and MRI technology innovations; our 150-plus customers have contributed immensely to the advances in CADstream. Our customers asked for better, more detailed reporting tools, the ability to reference patients' mammography and ultrasound studies and to produce color MIPs. We are pleased that with the latest developments in CADstream, we will further deliver on our customers' feedback and needs."

Breast MRI Gains Acceptance as Important Diagnostic Tool

Clinical indications for breast MRI exams continue to expand as physicians increasingly recognize the value of this highly useful study. Since 1999, there has been a 40 percent per year increase in the number of breast MRI examinations in the United States.(1) Breast MRI is primarily used for determining extent of disease (staging), monitoring response to therapy in breast cancer patients and screening high risk patients. Clinical research has reported that MRI demonstrates high sensitivity for detecting invasive breast cancer.(2)

Scientific literature also shows the effectiveness of MRI in screening women at high risk for breast cancer. In May 2003, the American Cancer Society released updated guidelines for breast cancer screening indicating that breast MRI, when used with mammography, may enhance the effectiveness of screening and diagnosis.(3) Additionally, in July 2004, the New England Journal of Medicine published strong evidence to suggest that breast MRI studies can be effective in finding tumors in women at high risk for breast cancer.(4) Approximately 8.5 million women are at high risk for breast cancer in the United States.

Access Breast Coil

As breast MRI gains acceptance as a highly effective diagnostic tool, imaging centers are requiring new tools for performing and interpreting these important studies. In addition to CADstream, Confirma plans to offer the Access Breast Coil (now available for investigational use only) as an advanced, more versatile alternative to the currently available breast coils. The Access Breast Coil has a dual purpose design, offering both high quality diagnostic imaging and flexibility in interventional access.

About Confirma, Inc.

Confirma, Inc. develops and markets computer-aided-detection (CAD) systems and accessories for medical imaging. The company's core product, CADstream(TM), is the standard in CAD for magnetic resonance imaging (MRI). CADstream automates the processing of MRI studies, providing higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. In its initial application, CADstream is being used to assist in the analysis and interpretation of breast MRI. Confirma plans to include medical imaging accessories, such as the Access(TM) Breast Coil. Access is designed to be a multi-channel coil for parallel imaging and improved interventional access. Confirma has partnered with over 150 imaging centers since 2003, helping develop more standardized, high performance breast MRI programs that deliver premium patient care. For more information, visit www.confirma.com or call 877-811-2356.

(1) MRI Census Market Summary Report, June 2002. IMV Medical Information Division, Des Plaines, IL.

(2) Tillman, Gayle F. Effect of Breast Magnetic Resonance Imaging on the Clinical Management of Women with Early-Stage Breast Carcinoma. J Clin Onc. 2002; 16:3413-3423.

(3) Smith RA, Saslow D, Sawyer KA, et al. American Cancer Society Guidelines for Breast Cancer Screening: Update 2003. Cancer J Clin. 2003; 53:141-169.

(4) Liberman, L, et al. Breast Cancer Screening with MRI -- What are the data for patients at high risk? The New England Journal of Medicine. 2004;351:497-500.