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TRIMEDYNE ANNOUNCES U.S. PATENT OFFICE ALLOWANCE OF IMPORTANT PATENT ON NEW LASER ANGIOPLASTY DEVICE
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October
25, 2004 – Irvine, CA: TRIMEDYNE, INC. (OTCBB “TMED”)
today announced the U.S. Patent Office has allowed its Patent
Application on a new laser angioplasty device.
The Patent will issue in a few months.
The
Patent covers unique optical fiber devices designed to make
smooth channels through plaque deposits in arteries, without
radiating heat sideways, which could harm the vessel walls.
The device is designed for use with small, portable,
relatively inexpensive, solid-state diode or Holmium lasers.
While lasers used in angioplasty typically sell for
$200,000 or more and usually necessitate costly maintenance,
Trimedyne’s small Holmium or diode lasers would sell for about
$50,000, are simple to operate and require minimal maintenance.
Glenn
D. Yeik, President of Trimedyne, said, “The new device can be
made as small as 0.7 millimeters (1/30 inch) in diameter,
allowing it to be used in arteries too small to admit current balloon angioplasty or stent delivery catheters.
In addition, the device is designed to create a channel
through fully blocked vessels, allowing balloon angioplasty or
stent delivery catheters to be used.
Mr.
Yeik added, “More than one million balloon angioplasty
procedures, many accompanied with stent implantations, are
performed each year in the United States.
Angiograms (heart x-rays) enable many persons with
blockages in very small vessels to be diagnosed, but current
balloon angioplasty catheters cannot be employed to treat them.
Also, if a major coronary artery is fully blocked,
balloon angioplasty cannot be performed, and the patient must
undergo bypass surgery. We
hope these new devices will be an alternative for these
patients.
Clinical
trials of the new device in each of the above-described
applications will be required before an application to market
the new devices and lasers can be submitted to the U.S. Food and
Drug Administration (FDA).
Such trials are costly, can take several years and their
outcome cannot be predicted.
Trimedyne hopes to secure a marketing arrangement with an
established company in the cardiology field to conduct the
clinical studies and, if FDA approval is received, market the
new devices. There
is no assurance any marketing agreement with an established
company can be obtained.
Trimedyne
manufactures lasers and proprietary fiber optic devices for a
variety of minimally invasive surgical procedures, many of which
are performed on an outpatient basis at substantially less cost
than conventional surgery. For product, financial and other information, visit
Trimedyne's website, http://www.trimedyne.com.
"Safe Harbor" Statement
Under the Private Securities Litigation Reform Act:
Statements in this news release may contain
forward-looking statements within the meaning of Section 27A of
the U.S. Securities Act of 1993 and Section 21E of the
Securities and Exchange Act of 1934.
Such statements may involve various risks and
uncertainties, some of which may be discussed in the Company's
most recent report on Form 10-KSB and subsequently filed SEC
reports. There is
no assurance any new products can be cleared for sale by the FDA
or successfully commercialized or any forward-looking statements
will prove accurate, as actual results and future events could
differ materially from those presently anticipated.
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