Clinivation Announces Record Results, Growth, and Profitability for 2005

Clinivation, Inc. today announced record year-end revenue, growth, and profitability results for 2005.
    “We are pleased to have achieved yet another year of record results, growth and profitability,” said Joseph Kozikowski, M.D., clinivation’s Founder, Chairman, and Chief Executive Officer.
    “We have now deployed software across North America, Europe, Asia Pacific, and the Middle East, and are delivering services on several continents. We have expanded our infrastructure across North America and our software development operations in China. By every measure, 2005 was the most successful year in our company’s history, and our growth is continuing to accelerate,” he continued.
    Multinationals Adopt clinivation® Global® Software for Productivity and Compliance
    “With thousands of products in over 50 countries, I was seeking a system that would allow my department to better manage product information and registrations. Clinivation Global software has been just the thing!” said Barb Law, Regulatory Affairs Manager at Medex, Inc., a subsidiary of Smiths Medical and Smiths Group plc, a global leader in medical devices used during critical and intensive care, surgery, and post-operative care that has over 15,000 employees in 40 countries. “Information we previously managed through multiple spreadsheets and files is now right at our fingertips in one well- organized system.”
    “I would like to communicate how pleased we are with clinivation Global software,” said Tamara Nelson, International Regulatory Affairs Supervisor at Implant Innovation Services, Inc., a subsidiary of Biomet, Inc., a global leader in surgical and nonsurgical products that has operations at over 50 locations and distributes its products in over 100 countries. “Clinivation Global software is very easy to use, and we like the flexibility to customize reports for regulatory and other departments. Furthermore, the support that clinivation has provided has been exceptional.”
    Clinivation Global software easily integrates with the ERP systems of multinational enterprises. Clinivation Global 2.0 is fully validated on InterSystems® Ensemble® Integration Technology, a comprehensive integration platform that uniquely incorporates the functionality of an integration server, application server, high performance object database, and a unified development and management environment in a single, seamless product.
    “Customer organizations of all sizes are delighted with clinivation Global’s ease of ERP integration and deployment,” said Roger Mazzella, M.S., Director, Global Sales at clinivation. “Accordingly, we expect triple-digit revenue growth to continue.”
    Clinivation Global software automates and controls the management of highly-regulated business processes for worldwide medical device submissions and approvals. Without clinivation Global software, companies are exposed to regulatory and compliance risks that include inaccurate reporting of active and expired regulatory approvals, inadequate quarantine of unapproved product exports, and other violations of U.S. and international medical device export and import regulations.
    “Smart companies understand that compliance with Section 406 of the Sarbanes-Oxley Act requires internal controls for compliance with applicable governmental laws, rules, and regulations. Clinivation Global software mitigates compliance risk by providing executive officers subject to a code of ethics with timely, accurate, available, and controlled regulatory data,” said Richard Morroney, R.A.C., C.Q.A., Vice President, Quality and Regulatory Solutions at clinivation.
    According to a recent study funded by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), in a one year period, 452,000 visits to emergency departments were for injuries associated with medical devices. During these visits, 58,000 patients died or were hospitalized for injuries associated with medical devices. And among patients hospitalized for other reasons, it is estimated that more than one million injuries associated with medical devices occur every year.
    To address this growing problem, the FDA has launched the Medical Device Postmarket Transformation Initiative that includes the CDRH Medical Device Postmarket Safety Program. In addition, the Global Harmonization Task Force (GHTF) is extending these postmarket safety initiatives to medical device companies worldwide.
    Clinivation Registry Suite enables medical device companies to achieve better postmarket safety by reporting postmarket, real-world data to regulatory authorities and company executives faster and more accurately than ever before. It is the first complete solution to deliver on medical device industry and regulatory requirements for registry design, platform and architecture flexibility, and productivity features for more efficient data capture, tracking, validation, and reporting.
    “We designed clinivation Registry Suite to transform the medical device industry and reverse the trend of ever-increasing patient injuries that now number in the millions,” said Joseph Kozikowski, M.D., clinivation’s Chief Executive Officer. “We expect widespread adoption, because achieving better postmarket safety is now a mandated goal of every medical device company in the world.”