Trimedyne Laser OKd for Urology Surgeries

Trimedyne Inc. said Thursday that it has received federal approval to market a laser product for urological surgeries.

“We believe this will provide a significant and material effect on the future growth of our company,” said Richard A. Dremmer, Trimedyne’s corporate secretary.

Irvine-based Trimedyne markets lasers and laser catheters for opening clogged blood vessels and for use in surgery. Last year, the firm won Food and Drug Administration approval to use a laser for removing gallbladders.

The company’s laser catheter vaporizes or coagulates tissues with the heat it generates. Conventional devices could not reach the tissues, the company says.

The FDA had previously cleared the company’s Lateralase catheter for certain gynecology applications.

Trimedyne stock closed Thursday at $4 per share, up 12.5 cents in over-the-counter trading.

Although Trimedyne expects the federal approval to result in increased laser sales, securities analyst Jeffrey Kilpatrick cautioned that it may be too soon to tell what the impact will be on sales. “These are often new markets that have not been developed yet,” said Kilpatrick, president of Newport Securities in Costa Mesa.

Trimedyne also said it has signed an agreement with C.R. Bard Inc., under which the Atlanta-based division of that company will have exclusive rights to market Trimedyne’s Lateralase catheter for use in urology, gynecology and gastroenterology.

The agreement calls for Trimedyne to receive a royalty on Bard’s worldwide sales of the laser product.

Bard will also reimburse Trimedyne for certain past and future research and development expenses, as well as for certain future clinical trial and patent expenses. And the Atlanta company will make minimum annual purchases of the laser product.