Devices Radiology Oncology

 News Release - November 29, 2006

Study Presented at 92nd Annual RSNA Meeting Demonstrates That CADstream(TM) May Increase Confidence in Breast MRI Interpretation

Compliance with ACR BI-RADS(R), Flexible Workflow-Based Architecture, Validation by Published Research and Thousands of Physician Users Continue to Define the Standard in CAD for Breast MRI

CHICAGO--(HSMN NewsFeed)--Confirma(TM), the leader in computer-aided-detection (CAD) for breast MRI, announced today that the results of a recent study at the University of California, San Francisco, led by Nola Hylton, Ph.D., indicated that automatic volume measurements from the company's CADstream(TM) system are predictive of length of recurrence-free survival and support the robustness of volumetric measurements of tumor response as a surrogate endpoint for survival outcomes. Dr. Hylton's study will be presented at the 92nd Annual Radiological Society of North America (RSNA) meeting, currently underway in Chicago, IL. The poster will be presented at the Lakeside Learning Center in the McCormick Place Convention Center today at 12:15 pm. "CAD is essential for a premier breast MR program," said Bruce A. Porter, M.D., F.A.C.R., Medical Director, First Hill Diagnostic Imaging, Seattle, WA. "CADstream continues to define the standard in CAD for breast MRI. By providing validated CAD technology and flexible workflow-based architecture, CADstream is increasing confidence in breast MRI."

CADstream was developed in accordance with the American College of Radiology's BI-RADS® standards and is supported by published research and clinical validation through its use by more than 2000 physician users in over 650 breast MRI programs. CADstream, along with CADalog(TM) for instant prior study recall, are currently being showcased at the RSNA 2006 meeting in booth 6741 (Hall B).

CADstream's workflow-based, thin-client architecture provides access to studies anywhere on a network, which allows physicians to read from virtually any location. CADstream is a centralized system located on the customer's network; physicians securely access CADstream from existing computers through a web-based user interface. In addition to increased convenience, CADstream's unique architecture creates a central database that allows multiple readers to access and work from the same study list, regardless of their location.

"CADstream has markedly reduced breast MRI study analysis and interpretation time and has improved our diagnostic confidence," explained Andrew Osiason, M.D., Hackensack Radiology Group, NJ. "The thin-client architecture has further increased efficiency, allowing us to read study images from anywhere in our network."

CADstream's tools for higher quality imaging studies, efficient and standardized interpretation, and accurate analysis continue to be validated by a growing body of published research:

Increased confidence in breast MRI interpretation with automatic volume analysis:

In a recent study, a team at the University of California, San Francisco, led by Nola Hylton, Ph.D., studied serial breast MR tumor volume measurements using CADstream as predictive of length of recurrence-free survival (LRFS) in patients receiving neoadjuvant chemotherapy for locally advanced breast cancer. The results indicated that CADstream's volume measurements are predictive of LRFS and support the robustness of volumetric measurements of tumor response as a surrogate endpoint for survival outcomes. Dr. Hylton's study will be presented this week at the RSNA meeting.

Increased specificity without decrease in sensitivity for breast MRI:

A study recently published in the American Journal of Roentgeneology by Seattle Cancer Care Alliance discusses the use of CADstream computer-aided-detection evaluation for breast MRI in assessing the need for biopsies of MR-detected lesions in women at high risk for breast cancer. If results from this study are validated in larger studies with varied imaging protocols, the number of unnecessary MRI-guided biopsies may be reduced.

Increased efficiency and accuracy in breast MRI evaluation:

A study by J.C. Vilanova, M.D., and J. Barcelo of Clinica Girona in Barcelona, Spain (RSNA, 2005), evaluated the effectiveness of CADstream in detecting breast cancer based on MR mammography features and pathology results. The study indicated that breast MRI CAD may be helpful to assess breast cancer and to assist radiologists by saving substantial time during the analysis and interpretation of studies and by improving accuracy of breast MR evaluation.

Increased accuracy in breast MRI interpretation with registration:

A quality control study led by Michael Middleton, M.D., University of California, San Diego (ARRS, 2003), evaluated motion correction (registration) of breast MR images using CADstream. Registration significantly reduced the small number of artifacts observed, in comparison to unsubtracted images. When corrected subtraction images were blindly compared directly to uncorrected subtraction images, artifact was seen to be reduced by registration in 37/40 patients.

About CADstream

CADstream is advancing breast MRI by enhancing efficiency, standardization, access and compatibility of studies. The system automates analysis, reporting and interventional planning of studies and promotes standardization with the incorporation of the ACR BI-RADS® Atlas. CADstream is designed for any workflow scenario, integrating with existing equipment and providing access to studies anywhere on the network. Automated features include image registration, multiplanar reformatting, subtractions, angiogenesis maps, curves, maximum intensity projections (MIPs), volume summaries, morphology characterization, Portfolio for reporting, SureLoc(TM) for interventional guidance and multimodality capability.

About Confirma, Inc.

Confirma, Inc. develops and markets CAD systems and accessories for medical imaging. CADstream(TM) is the standard in CAD for Magnetic Resonance Imaging (MRI). CADstream automates the analysis and interventional guidance 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, interventional guidance and reporting of breast MRI studies. CADstream is DICOM 3.0 compliant, allowing integration with any MRI scanner and PACS. The company plans to adapt its proven CAD technology to advance other medical imaging applications.

Confirma has established partnerships with companies including GE Healthcare, Philips Medical Systems, Hologic, iCAD and Vital Images. Confirma has partnered with hundreds of imaging centers and corporate partners worldwide since 2003, helping develop more standardized, high-performance breast MRI programs that deliver premium patient care. Confirma Europe GmbH opened operations recently in Berlin to further develop the European market. Frost & Sullivan recently recognized Confirma with the 2006 Industry Innovation and Advancement Award for the U.S. CAD market. For more information, visit www.confirma.com or call 877-811-2356.

Source: Confirma, Inc.

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