Gish Biomedical Inc., a Santa Ana supplier of medical care equipment, announced Wednesday that the costs of developing and securing regulatory approval for its new opthalmic laser will reduce the company's earnings in its just-concluded quarter.
Jack Brown, chairman and president, said he is not yet sure whether the company lost money in the period ended Sept. 30 or merely earned less than the $17,000 posted in the same period last year. "Whatever the numbers are, it's going to be close (to break even)," Brown said, adding that the quarter's results will be announced shortly.
Gish is trying to secure approval from the U.S. Food and Drug Administration for a new opthalmic laser for out-patient surgery and has spent thousands of dollars completing the required patient testing and paperwork. Brown said virtually all of the costs were charged in the first quarter and should not affect future quarters.
The laser, the company's first entry into the surgical laser market, has received a recommendation for approval from a U.S. Food and Drug Administration advisory panel responsible for reviewing new laser devices. Full FDA approval, however, is still pending and Brown said the company could not predict when the agency would act.