I'm long on this one..
Breakthrough Technology Will Enable Physicians Worldwide to Perform Simple and
Highly Accurate Osteoporosis Tests in Their Own Offices
MANHATTAN BEACH, Calif., May 25 /PRNewswire/ -- CompuMed, Inc. (Nasdaq: CMPD) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its Automated OsteoGram(R) 2000, the world's first device that enables physicians to perform convenient and accurate bone density tests in their own offices utilizing their existing standard x-ray equipment. Over 100,000 facilities in the U.S. and over 1 million facilities worldwide already have the standard x-ray equipment required to perform the procedure. The potential worldwide market for devices such as the Automated OsteoGram 2000 system is estimated to exceed $2 billion.
"This is a breakthrough product with significant implications for patients and physicians everywhere," said Michael A. Davis, M.D., D.Sc., Professor of Radiology and Director of Radiologic Research at the University of Massachusetts Medical Center. "The market for a low-cost yet highly accurate bone densitometry test in physicians' offices is enormous. Currently, only a few thousand bone densitometers are scattered throughout the U.S. and the rest of the world, mainly in specialized osteoporosis centers. Now, physicians everywhere will have access to a practical and reliable way of evaluating and treating the millions of patients at risk for osteoporosis," added Dr. Davis.
The Automated OsteoGram 2000 system consists of a desktop scanner, standard PC and OsteoGram bone density analysis software. A simple hand x-ray is taken, then scanned into the computer for automated analysis. The procedure takes less than one minute to perform, and is approved for reimbursement by Medicare and the vast majority of third-party payors in the U.S. The list price for the entire system will be substantially lower than the cost of bone densitometers on the market today, while offering unsurpassed clinical performance.
In a landmark 3-year study sponsored by Merck & Co., Inc.(NYSE: MRK), the U.S. Public Health Service and the Hawaii Osteoporosis Foundation, published in November, 1998, the OsteoGram achieved the highest osteoporosis prediction score of any bone density test ever. The Automated OsteoGram 2000 can also precisely monitor changes in bone mass over time.
"Since one in two women and one in five men alive in the U.S. today are likely to suffer hip, spine or wrist fractures caused by osteoporosis, and effective therapies exist that can dramatically reduce that risk, it is necessary for doctors to have the tools to manage osteoporosis in their own offices," stated James Linesch, President of CompuMed. "We are very proud to have created the diagnostic technology that will finally make that possible."
CompuMed, based in Manhattan Beach, California, develops solutions to important medical problems through the use of computer technology. In addition to the Automated OsteoGram 2000, CompuMed is developing the Digital OsteoView(R) 2000, which will combine the Automated OsteoGram software with the world's first automated test for arthritis. The developmental OsteoView technology utilizes a filmless digital x-ray detector developed by Varian Medical Systems (NYSE: VAR) and Xerox Corporation (NYSE: XRX), under a grant from the U.S. Defense Advanced Research Projects Agency (DARPA). CompuMed is also working with The Johns Hopkins University Medical School and Applied Physics Laboratory to create the first device that can measure bone structure in three dimensions (3-D), to even more accurately assess the risk of future fractures and monitor bone changes over time. CompuMed has also developed computer-aided diagnostic telemedicine services for cardiology and currently provides on-line computer interpretation of electrocardiograms (EKGs) to physicians, government and corporate healthcare providers.
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance and underlying assumptions and other statements that are other than statements of historical facts. 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 defined in this document. All such forward-looking statements whether written or oral, and whether made by or on behalf of the Company are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof. SOURCE CompuMed, Inc.
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05/25/99 /NOTE TO EDITORS: This release is available on the Internet at www.compumed.net or www.noonanrusso.com. Dr. Davis serves as a medical advisor to CompuMed and can be reached for comment at michael.davis@banyan.ummed.edu. Complimentary reprints of the complete peer reviewed journal article described above are available from CompuMed./
/CONTACT: James Linesch, President and Chief Executive Officer of CompuMed, Inc., 310-643-5106, ext. 115, jiml@compumed.net; or media - Heather Regan of Noonan/Russo Communications, Inc., 212-696-4455, ext. 241, news@noonanrusso.com, for CompuMed, Inc./
/Web site: htt://www.noonanrusso.com/ /Web site: compumed.net
(CMPD MRK) CO: CompuMed, Inc. ST: California IN: MTC SU: PDT |