IRVINE — Trimedyne Inc., a manufacturer of surgical laser devices, said it has received U.S. Food and Drug Administration approval to market a new laser device designed to treat stomach and intestinal maladies.
Word of Wednesday's federal approval of the lateralase catheter for use in gastroenterology sent Trimedyne's stock up 75 cents a share by the end of the day to close at $10.63 in brisk over-the-counter trading. The stock closed Thursday at $10.13 a share, still 25 cents higher than Tuesday's pre-approval closing price of $9.88 a share.
FDA approval "is a magic word," said Trimedyne spokeswoman Kathy Price. "People are always looking for positive news."
For instance, when Trimedyne announced FDA approval in January for a laser to treat spinal disks that cause back pain, the firm's stock soared 35% immediately afterward.
In fact, the company has enjoyed a resurgence of stock market interest, after reaching a low of $3 a share last year.
The lateralase catheter, measuring one-tenth of an inch in diameter, is similar to catheters designed for other surgical techniques, such as prostate surgery.
In its new application, however, the catheter will be used to guide laser beams that will cauterize bleeding ulcers and vaporize cancerous polyps in the digestive tract, said Hany Hussein, Trimedyne's executive vice president.
The advantage of the lateralase catheter lies in a technique that bends the laser beam by as much as 90 degrees, allowing it to reach difficult areas without surgical incisions, he said.
"The length of hospitalization will be substantially less than for conventional surgery," Hussein said.
He said the market for the device is substantial because about 130,000 people are hospitalized in the United States each year for treatment of stomach ulcers and intestinal cancer.
The disposable catheter, which eventually will be distributed worldwide by C.R. Bard Inc., will undergo clinical trials for the next three to 12 months.