STAAR Surgical's Visian® ICL Surpasses 200,000 Implants

MONROVIA, Calif., Jan. 4, 2011 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the worldwide total number of Visian® ICL implants in patients has exceeded 200,000.  Since 1994, STAAR's Implantable Collamer® Lenses (ICLs) have been used in refractive eye surgery as an alternative to LASIK.  Manufactured with STAAR's proprietary Collamer material, Visian ICLs provide a safe and effective alternative in the permanent correction of myopia, hyperopia, and in the case of the Toric ICL, astigmatism.

"This milestone demonstrates that STAAR's ICL technology continues to transform the refractive market with increased share in the global surgical market," said Barry G. Caldwell, president and CEO of STAAR Surgical. "During the last half of 2010 we began shipping the new expanded version of the Vision ICL in countries that accept CE Mark Certification.  During 2010 Visian ICL sales increased by 15%, while the LASIK segment continues to be challenged.  We are most proud of the high level of patient satisfaction delivered by STAAR's technology for placing correction in the posterior segment, which avoids problems experienced with anterior segment phakic lenses.  Of the over 200,000 ICLs implanted over the past 17 years, over 14,000 of those have been in eyes for over 10 years.  The overall safety and patient satisfaction data is very encouraging and differentiates the Visian product line from other refractive surgical options," Mr. Caldwell concluded.

The Company is focused on driving awareness of the benefits of its Visian ICL over LASIK surgery.  In the fall of 2010, STAAR initiated a direct-to-consumer marketing campaign that includes a series of seven videos that describe the features of its ICL in a funny, easily accessible manner.  STAAR, in conjunction with ophthalmologists, is rolling out these videos around the world.  In South Korea, where the ICL has captured over 10% of the refractive surgery market, STAAR's distributor has invested in a direct-to-consumer educational video which will be shown with pre-movie trailers during the first quarter.

"During 2011, it is important that we continue to make progress toward regulatory approval for the Visian Toric ICL in the United States and Japan," continued Mr. Caldwell.  "The market in Japan offers a very large opportunity for the ICL technology, particularly given the high percentage of the population who experience myopia and astigmatism.  With the Japan market for the ICL available the entire year, we expect our growth rates in 2011 to exceed our level in 2010."

About STAAR Surgical

STAAR, 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.  A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL."  A lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL."  Over 200,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com.  STAAR has approximately 300 full time employees and markets lenses in approximately 50 countries.  Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA.  For more information, please visit the Company's website at www.staar.com or call 626-303-7902.  

The Visian ICL for hyperopia and Toric ICL for astigmatism have not been approved for sale in the United States.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about efforts to obtain regulatory approval in any country and expectations for growth in sales of Visian ICL products, any statements of belief; and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: the broad discretion of regulators in approving medical devices in our major markets, which can require costly and time consuming research and result in the indefinite delay or denial of approval; poor global economic conditions that can depress sales of products, especially products like the ICL used in non-reimbursed elective procedures; the risk of unfavorable changes in currency exchange rates; the willingness of surgeons and patients to adopt a new product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market; a general decline in the demand for refractive surgery, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and general economic conditions; our limited capital resources and limited access to financing; and the challenge of managing our foreign subsidiaries.  

SOURCE STAAR Surgical Company

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