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OsteoGram Regulatory Clearance |
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CompuMed Receives Regulatory Clearance by China’s State
Food and Drug Administration for OsteoGram Product
Other Topics:
Web-based Heart Attack Alert
System, Predictive
Medical Informatics
CompuMed, Inc.
July 28, 2008
LOS ANGELES, CA -- CompuMed, Inc. (OTCBB:CMPD) -- a medical
informatics company serving the healthcare community with
diagnostic software solutions -- today announced it has received
approval from the State Food and Drug Administration (SFDA) of
the People’s Republic of China to market the OsteoGram system
for screening, diagnosing and monitoring osteoporosis.
The approval (Reg. # SFDA(I) 20083701577) enables CompuMed to
sell the OsteoGram product as an approved clinical device in
China and will allow CompuMed to work with its Chinese OEMs to
target a market with substantial strategic importance. |
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“With
this approval, we have passed all of the regulatory hurdles
necessary to support our effort in the Chinese market where the
demographics are very favorable and the incidence of bone
disease is very high,” said CompuMed CEO Maurizio Vecchione.
Osteoporosis affects more than 200 million people worldwide and
is especially prevalent in China, where the traditional diet
lacks calcium. According to China’s most recent national census,
about 100 million Chinese citizens suffer from the disease in
various stages.
The OsteoGram is a software-based bone density measurement
system that can be used with digital (i.e., filmless) x-ray
equipment, as well as with older film-based machines. It
provides an accurate, low-cost alternative to DXA bone mineral
density (BMD) screening systems, which require dedicated and
costly equipment, office space and staff. The OsteoGram’s
benefits in terms of cost and efficiency can help facilitate
more widespread osteoporosis screening and treatment of at-risk
patients.
For more information, contact CompuMed at (310) 258-5000, or
visit www.compumed.net.
About CompuMed
CompuMed, Inc. (OTCBB:CMPD) develops and
markets products and services that combine advanced imaging with
medical informatics. Its focus is on analysis and remote
monitoring for patients with cardiovascular and musculoskeletal
diseases. The Company has specialized expertise and intellectual
property in telemonitoring imaging and analysis designed to
improve healthcare provider workflow and patient care while
reducing costs. CompuMed's core products, the OsteoGram(R) and
CardioGram(TM), are cleared by the FDA and reimbursable by
Medicare. The OsteoGram is a non-invasive diagnostic system that
has been proven by many clinical studies to provide effective
and accurate bone density measurement for screening osteoporosis
and assessing hip fracture risk. The OsteoGram has significant
cost advantages over other technologies in the marketplace. The
CardioGram system is one of the first telecommunication networks
designed to remotely interpret electrocardiograms and is used by
private practice, as well as government and corporate healthcare
providers nationwide. The CardioGram delivers online
electrocardiogram interpretations within minutes of receipt and
has the additional capability of automatically providing an
over-read (i.e., follow-up review) by a cardiologist. CompuMed
is headquartered in Los Angeles and distributes its products
worldwide both directly and through OEM partners. Visit CompuMed
on-line at www.compumed.net.
Statements contained in this press release that are not
historical facts, such as statements about prospective earnings,
savings, revenue, operations, revenue and earnings growth,
results of contracts and other financial results, are
forward-looking statements pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. All such forward-looking statements including statements
concerning the Company's plans, objectives, expectations and
intentions are based largely on management's expectations and
are subject to and qualified by risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. These statements are
subject to uncertainties and risks including, without
limitation, competitive factors, outsourcing trends in the
pharmaceutical industry, 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 including its Annual Report on Form 10-KSB and
Quarterly Reports on Form 10-QSB. All such forward-looking
statements are expressly qualified by these cautionary
statements. The Company expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements to reflect events, conditions or
circumstances on which any such statement is based after the
date hereof, except as required by law. |
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