Trimedyne’s Shares Drop by Nearly 50% : Stocks: The Irvine medical laser maker blames unmet expectations and uncertainty over FDA approval for product.

Shares of medical laser maker Trimedyne Inc. lost almost half their value in the final hour of trading Wednesday amid concerns about the company’s latest quarterly results and a delay in federal approval for marketing of one of its products.

Trimedyne, based in Irvine, said Wednesday it lost $594,000, or 7 cents a share, for its third fiscal quarter, which ended June 30. That compared to a loss of $561,000, or 6 cents a share, for the same period a year earlier. Revenue rose 3% to $3.4 million from $3.3 million.

While the quarter’s performance was not substantially different from that a year earlier, Trimedyne Chairman Marvin P. Loeb said Wednesday that several analysts had issued reports predicting better numbers for the latest period.

The stock price plunge resulted from “a combination of the usual problems companies encounter when analysts’ predictions aren’t met, as well as continuing uncertainty over FDA approval” for a laser catheter Trimedyne wants to market in the United States, Loeb said.

Analyst Fred Toney of Pacific Growth Equities in San Francisco had projected a profit of 2 cents a share on revenue of $4 million for the quarter. He still recommends purchase of Trimedyne stock, noting that it is selling near its book value.

Trimedyne stock dropped $3.25 a share on the Nasdaq market Wednesday to close at $3.625. Nearly 2.6 million shares--28.6% of the 9.1 million outstanding--changed hands.

The company’s stock price has been dropping steadily this year and closed Wednesday down nearly 80% from its March high of more than $16 a share.

For the first nine months of its fiscal year, Trimedyne reported a loss of $1.5 million, or 17 cents a share. That compared to a loss of $616,000, or 7 cents a share, for the same period a year earlier. Nine-month revenue was down 8% to $10.3 million from $11.2 million.

The U.S. Food and Drug Administration has delayed approval of Trimedyne’s Urelase device for treatment of benign prostatic hyperplasia, an ailment afflicting many men over 55 years of age. In March, the company said the FDA requested more information and analysis of the clinical study data submitted in an application for the product. It has been approved for general urological use, Loeb said.

“The uncertainty is can we get the FDA to give us pre-market approval,” he said.

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Bloomberg Business News contributed to this report.

Stock Plunges

Trimedyne, an Irvine-based manufacturer of medical lasers, has suffered a drop of nearly 80% in the value of its stock since March.

Monthly peak stock prices:

March 1994: $16.38

Wed. close: $3.63

Sources: Bloomberg Business News; Researched by JANICE L. JONES / Los Angeles Times