STAAR Surgical Visian® ICL™ Preloaded System Receives CE Mark Approval

MONROVIA, Calif., July 1, 2014 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA) a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, announced that it has received CE Mark approval for its new Visian® ICL™ Preloaded System.  The Preloaded ICL provides a number of benefits to both surgeons and their patients during the delivery of STAAR's Implantable Collamer Lens (ICL) into the eye.  STAAR plans the official launch of the Preloaded System at the Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London during September 2014.  Preceding this meeting, key European refractive surgeons will utilize the technology in surgery to gain experience that will enable them to lead in podium activities during the ESCRS meeting.

The Preloaded ICL reduces overall procedure time; shortens the learning curve for new surgeons to perform ICL procedures and enables more consistent ICL lens delivery in the eye.  New intellectual property developed by the STAAR R&D team has been incorporated into the Preloaded Injector design.  Additional intellectual property includes a new hydrophilic coating technology, nanoCOAT™, which allows for the smooth transition of the ICL through the injector system to the small incision for the ICL procedure.

The Preloaded ICL also includes an enhanced optic design that increases the useful optic zone size.  This optic design may provide patients with the benefit of further enhanced quality of vision making the ICL even more competitive to LASIK.  Depending on the ICL power the optical surface could increase up to 20%, potentially enhancing night vision.  Each new advancement of the Visian ICL technology incorporates the previous improvements, so the highly successful Visian ICL CentraFLOW® technology will also be utilized in the Preloaded ICL System.

"The new Visian Preloaded ICL is part of our rapid cadence of new products under development at STAAR," said Hans Blickensdoerfer, President of EMEA at STAAR Surgical.  "This technology advancement is in response to feedback from surgeons to simplify the procedure by reducing the number of steps to deliver the ICL into the patient's eye.  We believe the benefits that have been designed into Preloaded ICL will play a role in continued ICL market share expansion where approved.  We anticipate a pricing premium for this technology advancement.  CE Mark approval enables us to market the Preloaded in the European Union as well as other countries that recognize the CE Mark approval."    

"In the time and motion study done at our facility with the Visian ICL Preloaded System, lens preparation time was reduced by 68%," added Dr. Erik Mertens, Medical Director and founder of the Medipolis Eye Centre in Antwerp, Belgium.  "I look forward to the availability of the Visian ICL Preloaded System.  I expect this system will increase the adoption of Visian ICL use, as well as add additional efficiencies and reproducibility to the implantation procedure"

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 and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." More than 425,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 335 full time employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company's website at www.staar.com. 

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections of revenue, statements regarding newly approved products, including but not limited to, expectations for market acceptance of new products; statements of belief, including as to intellectual property or market acceptance or growth as a result of new products, and any statements of assumptions underlying any of the foregoing.  Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company's Annual Report on Form 10-K for the year ended January 3, 2014, under the caption "Risk Factors," which is on file with the Securities and Exchange Commission and available in the "Investor Information" section of the company's website under the heading "SEC Filings."

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 willingness of surgeons and patients to adopt a new or improved product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive procedure market, and a general decline in the demand for refractive surgery particularly in the U.S. and the Asia Pacific region, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and current economic condition.  The Visian ICL Preloaded System is not yet approved for sale in the United States.

SOURCE STAAR Surgical Company

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