STAAR Surgical Gains Final Step in Regulatory Approval for Visian ICL With CentraFLOW In China

STAAR Surgical Company STAA a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, today announced that it has received the Approval Certification from CFDA to market its Visian ICL with CentraFLOW® technology in China effective November 3rd. The Visian ICL with CentraFLOW uses a proprietary port in the center of the ICL optic, KS-AquaPORT®, intended to optimize the flow of fluid within the eye without affecting the quality of vision. The CentraFLOW technology eliminates the need for surgeons to perform a YAG peripheral iridotomy procedure days before the ICL implant, simplifying the procedure and increasing patient comfort while providing the superior visual outcomes of the ICL. "China is currently the largest market in the world for refractive procedures and the approval of the Visian ICL with the CentraFLOW technology builds on the momentum of our already quickly growing line of ICL products in this important focus market" said Don Todd, President of the Asia Pacific Region. "We have seen a very positive impact in other markets with the introduction of the CentraFLOW technology. Visian ICL procedures today represent about 2% of the more than 875,000 annual refractive procedures in China. We now have the opportunity to further expand our share and growth in China, which included a 27% ICL revenue growth milestone in the most recent quarter. The first orders for the Visian ICL with CentraFLOW have been placed and will begin to ship this week." STAAR Surgical personnel in China began marketing the new technology on Monday. To date over 400 surgeons have been trained on the Visian ICL technology and additional surgeon training is already underway. The first orders for the Visian ICL with CentraFLOW were placed yesterday and leading ophthalmologists who were trained during the recent ESCRS meeting will begin utilizing the new technology. There will be a CentraFLOW training course in China for surgeons in November followed by two additional training courses before year end. Distributors in China were trained at a recent meeting in September and additional training will take place in November. The steps this year in the CentraFLOW's approval process in China started with a successful Experts Panel Meeting on May 15th which was followed by the Technical Recommendation from CMDE on September 24th and the Marketing Approval from the CFDA on October 29th. The approval includes both the Myopic ICL and the Toric ICL with expanded approval ranges for both myopia and astigmatism. This increases the potential number of patients that can be treated with the Visian ICL in China. The range of myopia correction approved is -0.5 diopters to -18.0 diopters versus the previous range of -2.5 diopters to -18.0 diopters equivalent in BSS. The range of astigmatism correction approved is +0.5 to +6.0 diopters versus the previous range of +0.75 to +4.75 diopters equivalent in BSS. The previously approved ICL was stored in sodium chloride while the Visian ICL with CentraFLOW will be stored in BSS.