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News Release

Contact: Kimberly Eggen
American Medical Systems
Public Relations


Alcohol Injection Procedure, Designed to Simplify Treatment for Millions of Men, Begins Nationwide Trials

Los Angeles, California, March 20, 2001 -- A Los Angeles physician today announced the initiation of a clinical trial, evaluating a new therapeutic option for men suffering the urinary discomfort of an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH).

Dr. Leonard Marks, M.D., reported the first treatments with the AMS ProstaJect™ Ethanol Injection System, a minimally-invasive, transurethral therapy. The new treatment involves use of a slim, precision injection technique to deliver medical-grade ethanol to ablate (destroy) cells of an enlarged prostate gland. The procedure is designed to shrink the bulk of the gland, which surrounds the urethra, thus facilitating the flow of urine and allowing the bladder to empty more quickly and completely. This alcohol injection method should be of most interest to men with BPH, who are not satisfied with drug therapy, and who wish to avoid surgery, according to Dr. Marks.

The study is sponsored by American Medical Systems, Inc. (AMS) Minneapolis, and is being conducted under an investigational new drug application (IND) which was issued by the U.S. Food and Drug Administration in January. An AMS spokesperson said ProstaJect investigators would be enrolling patients at 13 U.S. medical centers across the U.S. in this first phase of the clinical evaluations. The results of this study will add to existing experience using this therapy in Europe and other countries.

Most men may not even know they have an enlarged prostate, the gland that surrounds the urethra. However, they are very much aware of the daily annoyances caused by the gland's enlarged size, such as: urgency, frequency, dribbling and repeated nighttime bathroom visits. If left untreated, complications can be severe and lead to infection and other diseases. The standard treatments to date have been costly drugs, or invasive surgery that removes some or all of the enlarged prostate gland but may leave men impotent and/or incontinent.

Dr. Marks, Clinical Associate Professor of Urology at UCLA, commented that the first procedures were uneventful, requiring only a few minutes of cystoscopy time, and that the patients were able to go home after a few hours. Dr. Marks practices urology in West Los Angeles and is Medical Director of Urological Sciences Research Foundation, a California non-profit organization based in Culver City.

Douglas W. Kohrs, president and chief executive officer of AMS noted, "The new therapy holds promise for millions of men, as a first-line option for proactive treatment of BPH. The ProstaJect System will potentially offer a patient-friendly alternative that is less invasive and less costly than current BPH treatments."

Kohrs adds, "While this is the first U.S. clinical study for the application of ethanol in the prostate gland, the procedure has already produced excellent results in Europe. The ProstaJect System is an example of AMS' commitment to lead the urology market in meeting men's health needs through minimally invasive product innovation."

While ethanol has been injected to ablate cells in the human liver, esophagus, and colon, this is the first U.S. study involving the prostate gland.

BPH, which is the most common type of benign prostate disease, affects more than 13 million men in the United States alone. More than half of men in their 60s, and up to 90 percent of those older, suffer from the condition. AMS estimates that two million men in the United States are currently undergoing drug therapy for BPH.

American Medical Systems (Nasdaq: AMMD) is a leading medical technology company dedicated to surgeon-choice urological solutions for obstructions related to prostate disease, male and female incontinence, and erectile dysfunction. For additional information about AMS or its products, visit

Information about Urological Sciences Research Foundation and the Prostaject study are available online at

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