Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - June 1, 2011

STAAR Surgical Receives Two Key Regulatory Approvals

CE Mark Approval for KS-SP Preloaded Single Piece Hydrophobic Acrylic IOL

Visian ICL Approved in Brazil

Four New Product Launches Now Scheduled during the Second Half of 2011

MONROVIA, Calif., June 1, 2011 -- (Healthcare Sales & Marketing Network) -- STAAR Surgical Company (NASDAQ:STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic lenses which go inside the eye, today announced two strategically important regulatory approvals. The Company received CE Mark approval for the KS-SP Preloaded Single Piece Hydrophobic Acrylic intraocular lens (IOL). In addition, its Visian® Implantable Collamer® Lens (ICL™) V4 design was approved for marketing in Brazil. The Company plans to launch both new products during the second half of 2011.

"These recent approvals provide STAAR with the opportunity to significantly expand its product offerings to ophthalmologists in Europe and Latin America," said Hans Blickensdoerfer, STAAR's President of Europe and Latin America. "With CE Mark approval of the KS-SP, STAAR has a much more competitive product line as the single piece hydrophobic acrylic segment represents the largest segment of the IOL market today. Initially, we plan to focus on the markets in Germany, France and Italy. With the recent approval of the nanoFLEX IOL in Europe and the anticipated nanoFLEX Toric IOL later this year, we are evaluating expansion into additional key markets in Europe with this new expansive and competitive IOL product offering."

The KS-SP single piece preloaded IOL is made from hydrophobic acrylic material. The lens is delivered into the eye through a 2.8 millimeter incision, similar to the most commonly used small incision cataract extraction procedures. While most IOLs sold throughout the world are made with hydrophobic acrylic materials, issues with glistening have become increasingly apparent. STAAR's proprietary injector system employs an independently sourced lens that has been shown to be 'glistening free,' an important customer advantage. A limited marketing launch of the product is planned beginning in July with full market launch starting the fourth quarter.

"Approval of the Visian ICL in Brazil is also an important development for STAAR. Brazil could be considered one of our top ten market targets for the Visian ICL, roughly the size of Germany and France in terms of refractive procedures," Mr. Blickensdoerfer continued. "This approval represents a cornerstone in the overall market strategy for the Visian ICL in Latin America. The population in Brazil is known to be more open to cosmetic and elective surgery than other countries and our ICL offers competitive advantages in terms of quality of vision and comfort that we believe will be well-received. We are now reviewing our sales and marketing organization in order to maximize the return in key adjoining markets like Argentina, Chile, Columbia and Mexico."

STAAR owns the ICL registration in Brazil. While the recent approval there is for the Visian ICL V4, the Company expects to move forward to the upgraded V4c design in the months ahead. STAAR plans to launch the Visian ICL in Brazil early in the third quarter.

"With the new product approvals we have obtained during the first five months of this year, we are positioned for a very busy and productive second half of 2011," said STAAR Surgical CEO Barry G. Caldwell. "During the second half of 2011 we will launch the following new products:
  • As we complete the rollout of the Visian ICL V4b in Europe, we will begin to market the newly approved Visian ICL V4c in Europe during the third quarter.
  • The nanoFLEX IOL which just received CE Mark Approval during April.
  • The Visian ICL V4 in Brazil.
  • The KS-SP Preloaded Single Piece Hydrophobic Acrylic IOL in Europe and in Japan, as previously announced.
These are exciting times for STAAR as we just completed the first truly profitable quarter in ten years and the pathway is clear for both revenue and income growth over the next several quarters. I want to congratulate our team and we look forward to reporting our success throughout the rest of the year."

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: 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 or call 626-303-7902.

Collamer® is the registered trademark for STAAR's proprietary biocompatible collagen copolymer lens material.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about the effect of new product approvals on our business, 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: our need to compete against much larger and better financed companies in selling IOLs; our limited resources to promote new products and the risk that product launches may be affected by unplanned delays or be less successful than we anticipate; our reliance on a third party supplier for the acrylic hydrophobic single piece lens, the effect of the global recession on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the entrenched position of laser-based refractive surgical procedures in Brazil and other markets, and the willingness of surgeons and patients to adopt a new product and procedure.. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

Source: STAAR Surgical

Issuer of this News Release is solely responsible for its content.
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