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STAAR Surgical reports net loss for quarter

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MONROVIA, Calif. — STAAR Surgical recorded just over $12 million in sales for the second quarter of 2004, down from $12.95 million in the same quarter 1 year ago, the company announced in a financial press release.

Net loss for the quarter was $3.4 million, an increase from $1.2 million in the second quarter of 2003.

“While international sales of our Visian ICL continue to grow and were up 22% during the quarter, the IOL market, particularly in the U.S., remains a challenge,” said David Bailey, president and chief executive officer of STAAR, in the press release. Mr. Bailey predicted that STAAR’s U.S. IOL sales will have a “positive momentum” later this year.

During the quarter, the Food and Drug Administration completed its preapproval inspection of the company’s Switzerland manufacturing facility and began a reinspection of STAAR’s Monrovia facility this quarter. In April, the company received a second warning letter from the FDA surrounding events that occurred between 1997 and 2001. The company has received notice from the FDA that the agency is satisfied with how STAAR plans to address those concerns.

Mr. Bailey said the company believes it remains on schedule to launch the ICL in the United States during the fourth quarter of 2004.