STAAR Surgical Gains Regulatory Approval in India for Its Visian® ICL™ with CentraFLOW™

MONROVIA, Calif., Aug. 19, 2013 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, today announced that it has received regulatory approval to market its Visian® Implantable Collamer® Lens (ICL™) with CentraFLOW™ technology from the CDSCO in India.

"Following our recent approval in Korea, we are delighted to add India to the growing list of markets in which we now have the CentraFLOW technology to help drive market share growth in the Asia Pacific region," said Don Todd, President of the Asia Pacific Region for STAAR Surgical. "During the first half of this year, the Visian ICL with CentraFLOW contributed to the 54% growth in European markets.  During the past four years, the Compound Annual Growth Rate (CAGR) for the Visian ICL has been 48% in India.  Our marketing partner, Spica Medical, has seen a lot of anticipation in the market for the CentraFLOW technology as inquiries from surgeons and clinics over the past few weeks have been tremendous. With this approval in India, we can now leverage this growing acceptance to further penetrate a significantly large market."

Several key refractive surgeons in India have expressed their excitement about the new technology.  Dr. Sri Ganesh, Chairman and Managing Director of Nethradhama Hospital, said, "STAAR has just made an excellent product better.  The Visian ICL with CentraFLOW is a very innovative design which improves patient safety and efficiency for the surgeon. The patient experience now with the Visian ICL CentraFLOW technology will be as good as or even better than LASIK."

Dr. Kasu Prasad Reddy, founder of Maxivision Eye Hospitals who has conducted over 45,000 refractive procedures, added, "A little hole in the Visian ICL optic, which eliminates a surgical peripheral iridotomy procedure, is a brilliant step towards surgical ease and patient comfort."

According to a Market Scope 2013 Comprehensive Report on The Global Refractive Surgery Market, India has a population of approximately 1.2 billion and approximately 149,000 refractive procedures were performed last year.  The demand for refractive surgery in India is lower than other markets based upon a couple of key factors which make the Visian ICL procedure an attractive option.  The investments required to purchase and maintain an excimer laser are high and there are documented studies that the population of India generally has thinner corneas making LASIK a more challenging procedure for treatment. The Market Scope estimate for 2012 is that overall refractive procedures grew 5% while the Visian ICL grew 26%.  The Company believes the Visian ICL has over a 4% market share of all refractive procedures in India.

The Visian ICL CentraFLOW technology was launched from a marketing perspective at two major meetings in India during the past few weeks. The first meeting was the Intraocular Implant and Refractive Society, India (IIRSI) meeting which was held on July 6 and 7 in Chennai, India.  During the Congress meeting on July 6^th, Dr. M. Alaa El Danasoury, Chief Medical Officer at Magrabi Hospitals and past President of the International Society of Refractive Surgery, performed live bilateral toric surgery utilizing the Visian ICL CentraFLOW technology. On July 7^th,a Visian ICL User's Meeting was held with leading ICL surgeons including: Dr. Alaa, Dr. Ganesh, Dr. Paul (Butch) Harton from the U.S., and Dr. Rajesh Fogla and Dr. Matthew Kurian from India. The Moderators for the Visian User's Meeting were Dr. Partha Biswas and Dr. Anand Parthsarathy, both from India.

The IIRSI meeting attracted a record attendance of approximately 1,500 ophthalmologists to Chennai.  The India Minister of Health, K.C. Veeranani, spoke to the delegates about the state government's high priority for eye care.  During this Inauguration Session, STAAR CEO, Barry G. Caldwell and President of Asia/Pacific, Don Todd, presented Dr. Amar Agarwal, Secretary General of the IIRSI, a model of an enlarged Visian ICL with CentraFLOW technology which was designed for the presentation.  Dr. Agarwal then gave the model to the Minister of Health representing the official launch of the CentraFLOW technology to India.

The second major meeting was the XXI Annual Conference of the Bombay Ophthalmologists Association, August 2-4, in Mumbai.  Over 1,400 delegates registered for the Conference.  During this Conference, on August 2, Dr. Sri Ganesh performed live surgery with the Visian ICL CentraFLOW to demonstrate the features and benefits of the technology to the audience.  In addition, there was a dedicated Visian ICL session at the Conference on August 3.  The speakers and moderators of the ICL session were leading surgeons from around India.  Presenting at the session were Dr. Sri Ganesh, Dr. Keiki Mehta, Dr. Anand Parthasarath, Dr. D. Ramamurthy, and Dr. Purendra Bhasin.  The moderators were Dr. Anand Shroff and Dr. Partha Biswas.

The CentraFLOW™ technology utilizes the KS-AquaPORT™, or KS-AP™, in the center of the ICL optic, to optimize the flow of fluid within the eye.  This proprietary technology eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant, thus eliminating an additional procedure and office visit.  This results in more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon.  The Visian ICL, which is currently the fastest growing refractive technology, has demonstrated an even greater growth rate with this enhancement.  Nearly 25,000 implants of the Visian CentraFLOW technology have been successfully performed in Europe.

This approval expands the market opportunity for the Visian ICL as the range of refractive errors treatable has significantly increased. The expanded range for the Visian ICL with CentraFLOW will now go from -0.5 diopter to -18.0 diopters on the myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.

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." Over 375,000 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 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 any statements about the effect of new product approvals on our business, market size, product performance, or product acceptance, any statements of belief 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 December 28, 2012, 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: our need to compete against much larger and better financed companies in selling refractive surgical procedures; 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; 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 many 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 Company