TRIMEDYNE ANNOUNCES IMPORTANT FDA CLEARANCE
18, 2005 – Irvine, CA: TRIMEDYNE, INC. (OTCBB “TMED”) today
announced it received clearance from the Food and Drug Administration (FDA) to
market its new, patented VaporMAX™ Side
Firing Laser Fiber which, based upon animal tissue bench
testing and published data, vaporizes tissue faster and lasts longer than other
currently marketed side firing
laser fibers. Marketing of the VaporMAX™ Fiber will commence in June.
VaporMAX™ Laser Fiber has been cleared
for sale by the FDA for use with Trimedyne's
80 watt Holmium
Lasers and Lumenis
(Coherent) 60-100 watt Holmium Lasers, which are cleared for
the treatment of benign prostatic hyperplasia or BPH, commonly referred to as an
enlarged prostate. > BPH affects
approximately 50% of men over age 55, and about 200,000 procedures are performed
to treat BPH each year in the United States.
hospitals in the
United States and overseas already own, lease or rent a high
power Trimedyne or
Lumenis (Coherent) Holmium
Laser. These hospitals can buy
VaporMAX™ Fiber to treat BPH, without having to buy a new laser.
Laser vaporization of the prostate procedures to treat BPH are now
being reimbursed by Medicare under the New Technology Ambulatory Payment
Classification (APC) Code 2525 (CMS Transmittal 132, Publication 100-04) at
$3,750 per treatment, about twice the old reimbursement rate.
vaporization of the prostate is rapidly replacing surgical resection of the
it typically eliminates
the 1-3 day hospital stay reduces
the bleeding, general anesthesia risk, impotence and incontinence of the
surgical procedure. Rapid
vaporization of the prostate minimizes
costly operating room time,
and the higher reimbursement rate makes these procedures attractive to
physicians, hospitals and outpatient surgery centers.
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,
"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.