Medipattern Receives FDA 510 k Clearance for B-CAD, the first Computer Aided Detection 'CAD' solution designed to assist radiologists to analyze breast ultrasound images

Business Wire, June 2, 2005

TORONTO -- The Medipattern Corporation (TSX VENTURE:MKI) today announced that their B-CAD(TM) Software has received 510(k) clearance from the US Food & Drug Administration (FDA), and will soon be commercially available in the United States. As the only CAD designed to assist radiologists to analyze breast ultrasound images, B-CAD will support ultrasound images used today and into the future.

B-CAD has been designed to help radiologists in the identification of sonographic characteristics associated with breast lesions and assist the radiologist in assessing the need to biopsy a selected nodule. The software's innovative design allows the processing; review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The initial application for the Medipattern software platform is B-CAD, a computer-aided detection (CAD) software application designed to analyze ultrasound images. B-CAD automatically analyzes, segments, and classifies shape and orientation characteristics of user-selected regions of interest (ROI).

"B-CAD should facilitate acceptance and utilization of the ACR BI-RADS(R) Ultrasound Lexicon by radiologists as a standard upon which the foundation of CAD enabled ultrasound can be built," said Dr. A. Thomas Stavros, MD of The Sally Jobe Breast Center in Denver, Colorado. Dr. Stavros is a member of Medipattern's Scientific Advisory Board and is a pioneer in feature identification and classification of breast lesions in ultrasound. "It has been a pleasure working with the team at Medipattern to develop a tool that may improve a radiologist's interpretive confidence. B-CAD has the potential to be an important technology for radiologists. Ultrasound CAD has many possible indications including assisting radiologists in analysis of solid breast nodules which is a significant first milestone" continued Dr. Stavros.

The Medipattern software platform is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors. The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select inputs for the report from various pull-down menus and toggle buttons and the user may direct the B-CAD software to pre-populate various fields contained in the report.

All fields may be modified by the user at any time during the analysis and prior to archiving. B-CAD includes the option to add annotations based on the ACR BI-RADS(R) Breast Imaging Atlas (American College of Radiology Breast Imaging and Reporting Data System). In addition, the report form has been designed to support compliance with the ACR BI-RADS(R) Ultrasound Lexicon Classification Form. Due to the increasing utilization of breast ultrasound, the ACR recently developed the BI-RADS Ultrasound Lexicon for breast sonography to standardize the characterization of sonographic lesions. The original BI-RADS lexicon, which was developed for mammography, was quickly adopted by the Mammography Quality Standards Act (MQSA) and it is anticipated that the MQSA will adopt the new Ultrasound Lexicon as a standardized reporting format.

Luminary tests will be underway next month to evaluate B-CAD's ability to help analyze the sonographic features used in the ACR BI-RADS(R) Ultrasound Lexicon Classification Form. "Breast ultrasound information can be invaluable, but too often has been compromised by its operator dependence. The images obtained depend upon equipment and scan technique, and assessment of images varies with terminology and rules of characterization. The ACR BI-RADS Lexicon cannot improve equipment variations, but together with accreditation, can help improve scan technique, and will definitely help minimize variations in terminology and characterization rules," continued Dr. Stavros.

"B-CAD is a personal victory for me," said Jeff Collins, Chief Executive Officer of Medipattern. "I was motivated by the death of my aunt, who died from breast cancer, to develop solutions for early detection of cancer. We have every intention of extending our pattern recognition platform to other indications and modalities to help in the earliest possible detection and intervention for cancer and other diseases. Automated reporting and imaging functions were designed into B-CAD to help radiologists' workflow. Medipattern is dedicated to combining sound business solutions with leading edge imaging technology," stated Mr. Collins.

B-CAD will be available through Cedara Software Corp., a division of MERGE TECHNOLOGIES INCORPORATED (NASDAQ: MRGE; TSX: MRG) on its Cedara I-ReadMammo(TM) Workstation or as a standalone product that can be integrated into existing Picture Archiving and Communications Systems (PACS). "Being first to market with a product like B-CAD reinforces the role Cedara can play in helping launch clinical application companies like Medipattern" said Chris Barlow, Director of Business Development at Cedara. "We are extremely excited about the CAD marketplace and have already received much interest in B-CAD from both end user and OEM customers."