STAAR Surgical's two new lens products receive CE Mark approval

STAAR Surgical CompanyJun 1 2011

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.