Trimedyne Wins FDA OK on Tumor Device

Trimedyne Inc. received approval from the Food and Drug Administration to begin marketing a laser catheter system that “vaporizes” tumors in the stomach, intestinal and urinary tracts of the body.

According to Trimedyne President Michael Henson, the Santa Ana manufacturer of laser catheters spent between $9 million to $10 million conducting studies necessary to gain approval of basic laser technology for the catheters. While the FDA allows the company to market the catheters to any hospital--for certain limited uses only--Henson said the company will conduct a form of test marketing, beginning in mid-October. The company will sell the catheters to 10 to 20 of the country’s leading cancer treatment hospitals during the rest of the calendar year and then expand sales in 1987.

Henson said Trimedyne is “right in the middle” of the “transition from an R&D; (research and development) company to a manufacturer and marketing company,” and that he expects the company to become profitable within the next 12 to 24 months.

The company’s revenues have been increasing over the past year and its losses decreasing, Henson said. For the third quarter ended in June, the company posted a net loss of $144,000--the smallest loss since the company became operational in 1983, Henson said. For the first nine months of 1986, Trimedyne had losses of $549,000, compared to a $724,000 loss during the first nine months of 1985.