New Products and Clinical Success with STAAR Surgical Visian ICL(TM) Technology Highlights the Upcoming ESCRS Congress
Introduction of the New Visian ICL Preloaded System
MONROVIA, Calif., Oct. 3, 2013 /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 2013 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) to be held in Amsterdam, The Netherlands October 5 – 9, 2013. During the week, STAAR will host several key activities where the new Visian ICL Preloaded System will be highlighted including: the Visian ICL Experts Meeting, an expanded presence in the ESCRS Exhibit area, a Speaker’s Forum in STAAR’s booth, and an Evening Refractive Symposium on preserving the cornea.
“STAAR’s presence at the ESCRS continues to increase each year and this will be the most exciting and productive one in our history,” said Hans Blickensdoerfer, President of Europe, Middle East and Latin America for STAAR. “During the week there are 111 planned presentations on the Visian ICL technology. We will also be celebrating over 375,000 successful implants of the Visian ICL, including over 28,000 implants of the CentraFLOW technology, as well as over 100,000 implants of the Toric ICL. The Visian ICL is the fastest growing refractive technology in the world while LASIK continues to be under downward pressure. The highlight for the meeting will be the introduction of the Visian ICL Preloaded System, which will include an enhanced optic design and the very popular CentraFLOW technology. This technology is designed to reduce the procedure time as well as make the delivery of the ICL even more consistent. We expect to begin a full launch of commercialization during the first quarter of next year.”
The Visian ICL Preloaded System is designed to make the procedure more efficient and provide an increased quality of vision. The CE Mark approval pathway is a two staged process with expected approval before year end. The first stage would be the approval of the new optic design. The enhanced optic is designed to increase the useful optical zone particularly for patients who have larger pupils. The data on the optic was submitted last month to the regulatory agency. The Company licensed patented delivery technology from a third party European company and enhanced the proprietary position by submitting new STAAR developed intellectual property for which patents are currently pending. This data for the second stage of the process on the new delivery system is expected to be submitted during October to our regulatory body which is expected to result in an approval of the entire system by year-end.
During the Experts Meeting and at the STAAR ESCRS booth surgeons, will share their experience and thoughts about the new Preloaded ICL technology. Dr. Juan Batlle, Medical Director, Centro Laser in the Dominican Republic will share results of ICL implants utilizing the new delivery technology. “The Visian ICL Preloaded System performed well during surgery, making the procedure more efficient for me as a surgeon, for the patient, and for the surgical team in the operating theatre,” said Dr. Batlle. “This is a major contribution to the fourth dimension; time. The post-operative results were excellent and I look forward to using the preloaded system on a regular basis,” concluded Dr. Batlle.
The ICL Preloaded System has been shown to reduce the operating time in preliminary time and motion studies which could reduce the total ICL procedure time to five minutes or less. “The Visian ICL Preloaded will allow me to focus more on the surgery itself and less on loading the lens,” said Dr. Erik Mertens, Medical Director and founder of the Medipolis Eye Centre in Antwerp, Belgium. “Experienced ICL users will gain additional time and efficiencies, and the learning curve for new ICL surgeons will be reduced,” concluded Dr. Mertens. During the meeting Dr. Mertens will present his results from a time and motion study utilizing the new delivery system.
STAAR is hosting its 10(th) Annual Visian ICL Experts Symposium prior to the official opening of the ESCRS Congress. The Symposium which began today is a “by invitation only” meeting of key Visian ICL users, and approximately 170 surgeons from 40 countries are expected to attend. The attendance of key surgeons represents a 50% increase over the 2012 ICL Experts Symposium. The symposium will consist of 27 clinical presentations and 12 roundtable discussion sessions on the Visian ICL technology. These sessions are being led by surgeons from 18 different countries. This evening a Gala Dinner event will be held where special recognition will be given to surgeons for their contributions to the Visian ICL technology.
The ESCRS Congress official program will begin on Saturday and includes 72 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 an evening symposium for ESCRS members.
On Saturday evening, STAAR will host the ESCRS Symposium entitled “Refractive Surgery and Preserving the Cornea for the Future.” This symposium is expected to attract up to 300 surgeons and include nine presentations by surgeons from seven different countries sharing their experience with the Visian ICL technology, including the Visian ICL with CentraFLOW and the Visian ICL Preloaded System. Dr. Amar Agarwal from India will be the moderator of presentations by Dr. Jose Alfonso from Spain, Dr. Jaime Aramberri from Spain, Dr. Alaa El-Danasoury from Saudi Arabia, Dr. Gero Krommes from Germany, Dr. Erik Mertens from Belgium, Dr. Tobias Neuhann from Germany, Dr. Rob Rivera from the U.S., and Dr. Roberto Zaldivar from Argentina.
During the past three months STAAR has added regulatory approval of the Visian ICL with its CentraFLOW proprietary technology in the key markets of Korea, India and Argentina. 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 approval in Korea, a few key refractive clinics have begun to offer same day ICL surgery which allows the surgeon to perform the procedure the same day the patient comes in for an initial exam.
At the Congress the premium nanoFLEX Collamer Toric IOL will be introduced to additional markets 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 2013 global market for toric IOLs to be approximately $289 million with $65 million of this coming in Europe. Its estimate of the global average selling price is above $400 per lens.
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.
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.
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SOURCE STAAR Surgical Company