COMPUMED EARNS CE MARK APPROVAL AND ISO 13485 CERTIFICATION FOR OSTEOGRAMŽ
COMPANY PREPARES FOR EUROPEAN UNION SALES
LOS ANGELES, Sept. 6 2005 -- CompuMed, Inc. (CMPD.OB) -- a developer of Computer Aided Diagnostic (CAD) solutions for the healthcare industry -- today announced it has received approval to use CE marking to market its OsteoGram system throughout the European Union (EU). TUV Rhineland North America conducted the audit.
The CE Mark ("Conformite Europeene") is a prerequisite for an array of products, including medical devices, marketed in the 25 EU nations. It specifies that a product complies with essential EU health, safety and environmental protection requirements.
"With the CE Mark announced today, CompuMed takes a significant step forward in providing European customers with an exciting new solution for routine osteoporosis testing," said CompuMed CEO Jerry McLaughlin. "We can now confidently enter EU markets where demand for low-cost osteoporosis testing methods is growing dramatically, as countries with national health plans are being forced to evaluate inevitable limits on the acquisition of high-cost DXA equipment."
In addition to CE Mark approval, CompuMed also earned certification to ISO 13485, the internationally recognized standard developed to ensure that companies provide medical devices that consistently meet customer and regulatory requirements. ISO certification verifies that CompuMed meets strict requirements for quality management systems applicable to medical devices and related services. The formal certification reflects CompuMed's commitment to continuous improvement and to delivering the highest level of customer service. It also increases CompuMed's potential for licensing partnerships with other ISO certified manufacturers of digital radiographic platforms.
CompuMed's OsteoGram is a software-based system for screening, diagnosing and monitoring osteoporosis. It provides an accurate, low-cost alternative to DXA bone mineral density (BMD) screening. As the global population ages, the costs associated with osteoporosis-related disease are predicted to rise dramatically.
"We believe the OsteoGram is an ideal solution in countries under financial pressure to lower health care costs," McLaughlin added.
The OsteoGram can be utilized in conjunction with rapidly proliferating digital (i.e., filmless) x-ray equipment, as well as existing film-based machines. Its vast benefits in terms of cost and efficiency facilitate wider osteoporosis screening and treatment of at-risk patients. It is far less costly and cumbersome to use than conventional BMD testing systems, which require dedicated and expensive equipment, computers, office space and staff. The UK recently launched a program to utilize peripheral devices, such as the OsteoGram system, for widespread osteoporosis screening.
Osteoporosis is a silent disease that affects more than 200 million people worldwide. The International Osteoporosis Foundation estimates that in Europe alone, 611,000 women and 179,000 men will suffer a hip fracture each year. The annual direct cost of all osteoporotic fractures in Europe is Euro 25 billion. Costs are expected to increase to Euro 76.7 billion by 2050, based on expected changes in demographics and increasing life expectancies.
About CompuMed:
Founded in 1973, CompuMed, Inc. (BB:CMPD) is a leading provider of computer-aided telemedicine and diagnostics technology. The Company's core products are the OsteoGram and CardioGram systems. The OsteoGram, which is cleared by the FDA for commercial use, is an accurate and precise technology for low-cost osteoporosis testing. The CardioGram system remotely interprets electrocardiograms and is used by private practice, government and corporate healthcare providers nationwide. CompuMed is headquartered in Los Angeles. Visit CompuMed at www.compumed.net or call (310) 258-5000.
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning CompuMed's plans, objectives, goals, strategies, future events or performance and underlying assumptions and other statements that are not statements of historical fact. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, ability to raise capital, the availability of appropriate acquisition candidates and/or business partnerships, economic conditions, the impact of competition and pricing, capacity and supply constraints or difficulties, government regulation and other risks identified in the Company's filings with the Securities and Exchange Commission. All such forward-looking statements are expressly qualified by these cautionary statements. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
CONTACT: Erik Deutsch - Tellem Worldwide, +1 (310) 479-6111 x.15, edeutsch@tellem.com