Wednesday, September 5, 2012

Clinical Success with STAAR Surgical Visian ICL™ CentraFLOW™ Technology Highlights the Upcoming ESCRS Congress

Clinical Success with STAAR Surgical Visian ICL™ CentraFLOW™ Technology Highlights the Upcoming ESCRS Congress

Product Introduction of Two New STAAR IOLs

Over 100 Presentations on the Visian ICL during ESCRS Week

MONROVIA, Calif., Sept. 5, 2012 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today provided a preview of the activities scheduled prior to and during the 2012 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) to be held in Milano, Italy, September 5 through 12, 2012.  During the Congress, the Company will officially introduce two key IOL products, the STAAR KS-SP Single Piece Preloaded Acrylic IOL and the nanoFLEX™ Toric IOL.  Both products are approved in Europe and other countries that accept CE Mark approvals, while the KS-SP is also approved in Japan. 

"Each year the presence of the Visian ICL at this meeting has increased and this will be the most exciting and productive ESCRS meeting in our history," said Hans Blickensdoerfer, President of Europe and Latin America for STAAR. "During the week there are 106 planned presentations on the Visian ICL technology.  We will also be celebrating the 1st anniversary of the latest Visian ICL approval with CentraFLOW technology in Europe, as well as the 10 year anniversary of the Toric ICL.  Ophthalmologists have now successfully implanted well over 75,000 Toric ICLs.  The Visian ICL is the fastest growing refractive technology in the world.  With the introduction of the Visian ICL CentraFLOW technology the Visian ICL and TICL can treat all LASIK eligible patients and more, while the procedure is as convenient for both the patient and surgeon, if not more so, than LASIK.  The CentraFLOW technology has now been implanted in over 6,500 eyes with excellent results and we are in the process of expanding the approval of the technology beyond Europe."

Beginning Thursday, STAAR will hold its 9th Annual Visian ICL Experts Symposium prior to the official opening of the ESCRS Congress.  This is a "by invitation only" meeting of key Visian ICL users, and over 130 surgeons from 30 countries are expected to attend.  The symposium will consist of 31 clinical presentations by surgeons from 16 different countries and five roundtable discussion sessions as well as a five free paper presentation sessions on the Visian ICL technology. 

The ESCRS Congress official program will begin on Saturday and includes over 65 presentations in which the Visian ICL technology will be highlighted.  These presentations include: papers presented from the podium, electronic poster presentations, surgeon presentations in the STAAR exhibition booth, instructional courses and a lunch symposium for members.  On Monday, STAAR will host the ESCRS Lunch Symposium entitled "Innovations in Premium Refractive Surgery."  This luncheon is expected to draw up to 400 surgeons and include six presentations by surgeons from five different countries sharing their experience with the Visian ICL technology, including the new Visian ICL with CentraFLOW technology.  Dr. Amar Agarwal from India will be the moderator of presentations by Dr. J.F. Alfonso from Spain, Dr. J. Aramberri from Spain, Dr. G. Baikoff from France, Dr. R. Rivera from the U.S., and Dr. Roberto Zaldivar from Argentina. 

The Visian ICL V4c, with STAAR's CentraFLOW proprietary technology, received CE Mark approval in April 2011. CentraFLOW eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure several days before the ICL implant. The result is more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon.  Since its approval, the Company has gained additional regulatory approvals including the Middle East markets.

At the Congress the premium nanoFLEX Collamer Toric IOL will be introduced in Europe and other countries that accept CE Mark approval. The nanoFLEX Toric IOL incorporates the Company's proprietary aspheric optic design, optimized for the natural curvature of the eye into this new toric design on the Collamer platform.  Market Scope estimates the 2012 global market for toric IOLs to be approximately $285 million with $70 million of this coming in Europe.  Its estimate of average selling price is above 400 USD. 

The KS-SP Single Piece Preloaded IOL is made from hydrophobic acrylic material. The lens is delivered into the eye through a 2.4 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.

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 300,000 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 60 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. 

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, statements about planned product launches, 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 effect of poor global economic conditions on sales, especially sales of products like the ICL used in non-reimbursed elective procedures; our limited resources to promote new products; the risk that product launches may be affected by unplanned delays or be less successful than we expect; government approval of our new products; the willingness of surgeons and patients to adopt a new product and procedure; the entrenched market position of laser-based procedures for many conditions treated by the Visian ICL; and patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

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SOURCE STAAR Surgical Company

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