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SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 18, 1996
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Trimedyne, Inc.
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(Exact name of registrant as specified in its charter)
Nevada 0-10581 36-3094439
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(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)
2801 Barranca Road
P.O. Box 57001
Irvine, California 92619-700
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (714) 559-5300
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(Former name or former address, if changed since last report)
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TRIMEDYNE, INC.
FORM 8-K
MARCH 20, 1996
Item 5. Other Events
On March 19, 1996, Trimedyne, Inc. announced that the U.S.
Food and Drug Administration ("FDA") has cleared its proprietary side-firing
laser fibers and Nd:YAG lasers for sale for the treatment of benign prostatic
hyperplasia or BPH, a condition affecting more than 50% of men over age 55.
More than 250,000 electrosurgical resections of the prostate
are performed annually in the United States to treat this condition at a cost
estimated to exceed approximately $2.5 billion per year.
Based on published studies, the traditional surgical procedure
to treat BPH entails significant pain and bleeding, 3-4 days of hospitalization
and up to two weeks of recuperation at home, blood transfusions for up to 10%
of the patients, and a substantial risk of impotence and incontinence.
Based on a randomized, controlled clinical study, Trimedyne's
side-firing laser fibers enabled the treatment of BPH to be performed safely
and effectively in less than 30 minutes with significantly less pain, very
little bleeding and no incontinence.
A clinical study with long term follow-up showed that
Trimedyne's side-firing laser fibers produced results comparable to the
traditional surgical procedure over a period of three years, with substantially
fewer complications. Published studies have also shown that Trimedyne's laser
procedure can be safely performed on an outpatient basis for at least $2,000
per case less than the cost of the traditional surgical procedure.
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TRIMEDYNE, INC.
FORM 8-K
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
TRIMEDYNE, INC.
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(Registrant)
Dated: March 21, 1996 By: /s/ JAMES L. KELLY
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James L. Kelly
Vice President - Finance and
Chief Financial and Accounting
Officer
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