Trimedyne Announces U.S. Patent Office Allowance of Important Patent on New Laser Angioplasty Device

Business Wire, Oct 25, 2004

IRVINE, Calif. -- 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."

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 Web site, 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.