STAAR Surgical Co. (STAA) Lines out Q4 2011 Expectations, Announces Regulatory Approval for Product Marketing in Japan

QualityStocks would like to highlight STAAR Surgical (NASDAQ: STAA). The company, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures, and markets implantable lenses for the eye. All of these lenses are foldable, which permits the surgeon to insert them through a small incision.

In the company’s news yesterday,

STAAR Surgical announced that it expects revenue for the fourth quarter ended December 31, 2010, to exceed $14.2 million. The company said it expects to announce its fourth quarter and full year 2010 results March 1, 2011.

The company posted revenues for the full year at approximately $55 million, a 7-percent increase over 2009 revenues, driven by a 10-percent increase in revenues from its core ICL and IOL product lines.

“Our estimated fourth-quarter revenues were driven by strong growth in the Visian ICL product lines, which achieved a record in both revenues and units,” Barry G. Caldwell, president and CEO of STAAR stated in the press release.

Expected ICL revenues grew roughly 13 percent from the fourth quarter of 2009, and 8 percent from the previous third quarter 2010 record.

Caldwell said that during the fourth quarter, approximately 10 percent of the company’s ICL sales in its recently introduced expanded range Visian ICL models were in segments where STAAR had not previously participated.

“This demonstrates the demand and opportunity for the expanded treatment range, which received CE Mark approval during late third quarter. The strong growth for the Visian ICL continued in China, India and the Middle East during the quarter, and revenues in Japan began to reflect our extremely positive efforts in that market,” Caldwell stated.

STAAR also announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its three-piece KS-X2 Preloaded Single Piece Hydrophobic Acrylic Injector System in Japan.

STAAR has offered the system in Japan for two years, as well as in selective CE Mark countries for the past year. In light of the approval, the company said it expects pre-market launch of the new product in Japan during the first quarter of 2011 with full release during the second quarter.

“The approval of our single piece injector system is an important achievement and expands the products that we can offer to ophthalmologists in Japan,” Caldwell stated. “Approval of the KS-X2 allows us to compete in the single piece hydrophobic acrylic space, the largest segment of the IOL market, according to Market Scope, and certainly the most lucrative segment globally. We anticipate CE Mark approval of the product during the third quarter of this year, with launch shortly thereafter. This product once again illustrates STAAR’s core competency in preloaded delivery systems.”

Caldwell lined out the company’s expectations for 2011 and said it will continue to seek regulatory approval for its products in Japan and the U.S.

“We have made significant progress during 2010 from both a product delivery and financial standpoint. During 2011, we remain focused on continuing our efforts to gain regulatory approvals for the Visian Toric ICL in both Japan and the United States, expanding our direct-to-consumer marketing campaign and driving revenue growth and profitability. We look forward to sharing additional details when we announce our financial results for 2010,” Caldwell concluded.

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