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PERCEPTIVE INFORMATICS ENHANCES MUSCULOSKELETAL MEDICAL IMAGING CAPABILITIES THROUGH ALLIANCE WITH OPTASIABoston, MA, September 16, 2009. Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it has enhanced its capabilities to provide medical imaging measurements for osteoarthritis clinical trials through an alliance with Optasia Medical, Inc. Perceptive Informatics is using Optasia’s KneeAnalyzerTM software to supplement its existing medical imaging technology to improve the reproducibility of and reduce the time involved with image analysis of the knee in osteoarthritis patients. “Medical imaging plays an important role in the early evaluation of new compounds in musculoskeletal related clinical research, including in the growing areas of rheumatoid arthritis, osteoporosis, and osteoarthritis,” said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics. “Our alliance with Optasia provides customers with better surrogate measurements in trials focused on knee-related osteoarthritis, a progressive disease. This relationship represents our commitment to help customers accelerate trials and speed new treatments to patients in the musculoskeletal therapeutic area.”Optasia develops software, which is used in clinical trials to identify and monitor patients who will benefit from treatment, to facilitate the more rapid, accurate evaluation of medical images with greater reproducibility. Optasia’s software applications are based on the Optasia Platform, which employs model-based vision technology to detect, measure, classify and compare two-dimensional medical images. Perceptive Informatics has a broad range of musculoskeletal imaging clinical research experience and capabilities. The Medical Imaging Group of Perceptive Informatics offers a range of capabilities in the application of imaging techniques from early clinical development through peri-approval studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, neurology, rheumatology, cardiology, and endocrinology. About Perceptive Informatics - Perceptive Informatics, a leading eClinical solutions provider and subsidiary of PAREXEL, is focused on helping customers to accelerate the product development process through innovation. The Perceptive Informatics industry-leading eClinical product portfolio is built on advanced technology that benefits from extensive medical and clinical expertise as well as a deep understanding of the regulatory environment. The portfolio includes Randomization and Trial Supply Management (RTSM) technologies, Medical Imaging, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Electronic Patient-Reported Outcomes (ePRO). For more information about the integrated solutions in Perceptive’s eClinical Suite visit: www.perceptive.com. About PAREXEL International - PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 52 countries around the world, and has over 9,275 employees. For more information about PAREXEL International visit: www.PAREXEL.com.
OPTASIA AND CARDEA TECHNOLOGY ANNOUNCE PLANS TO COLLABORATE27th August 2009 - Manchester, UK. Cardea Technology, Inc. and Optasia Medical, Ltd., announce plans to collaborate and configure their software tools for Vertebral Fracture Assessment, a method for evaluating vertebral fractures from images on bone densitometers, to exchange information and create reports for the management of osteoporosis. Optasia Medical, Ltd. has developed SpineAnalyzerTM, a product that aids in the identification of vertebral spine deformities by efficiently and comprehensively annotating spine anatomy. This unique software workflow solution enables rapid and reproducible assessment of 6-point morphometry, while simultaneously providing full contours outlining vertebral shape. The software employs a proprietary statistical model-based image analysis technique, which uses a simple manual single-point initialization to automatically segment the lateral vertebrae from T4 to L4. SpineAnalyzerTM is designed to fit seamlessly into the existing workflow of scoring a lateral spine image. Cardea Technology develops BoneStation, a web-based software program that automates the review of VFA and X-Ray scans and the creation of bone density reports. BoneStation facilitates the secure transmission of DXA scans and data from a bone densitometer to a central database where scans are instantly viewed from any computer with internet access. During the scan review in BoneStation, a physician can incorporate a patient’s bone fracture risk factors into the patient’s overall assessment and report. With new data sharing functions, BoneStation and SpineAnalyzerTM provide physicians with enhanced capability to measure and report on vertebral spine deformities. After an operator creates a 6-point morphometry assessment with SpineAnalyzerTM, it is displayed in the BoneStation interface and integrated into BoneStation’s comprehensive osteoporosis assessment reports. For more information and a tour of BoneStation’s capabilities, please visit www.bonestation.com. For more information on Optasia Medical and Spine AnalyzerTM, please visit www.optasiamedical.com. SpineAnalyzerTM is pending FDA approval and is not currently available for sale in the US.
OPTASIA ACHIEVES ISO 9001 AND ISO 13485 CERTIFICATION9th April 2009 - Manchester, UK. We are pleased to announce that we have received certification for the successful registration of our quality management system to both ISO 9001:2008 and ISO 13485:2003. The certification was performed by a representative of Intertek in January 2009. The Intertek auditor examined the Company's quality policy, objectives, processes, record keeping, and interviewed on-site staff. Our successful pursuit of certification to these voluntary standards demonstrates our commitment to producing reliable and innovative medical devices that meet or exceed our customers' expectations, and shows our dedication to achieving the highest standards of quality control.
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