MONROVIA, Calif., Jan. 14 STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today it has named Don Fagen to the position of Vice President of Sales for North America, a newly created position, effective immediately. Mr. Fagen, (55) will report directly to STAAR Surgical President and CEO, Barry G. Caldwell.
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"Don brings some 21 years of industry experience and a real passion for ophthalmology to STAAR at a time when we have the opportunity to capitalize on several growth initiatives in the U.S. market," said Mr. Caldwell. "I've had the opportunity to work with Don and see firsthand his sales leadership experience generate strong results. During his career, he spent 12 years dedicated to the refractive surgery market, and his very strong relationships with leading ophthalmologists will be very beneficial to our company as we execute our plans to build sales and U.S. market share."
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"STAAR is reemerging as a technology leader in the ophthalmic surgical marketplace. I am very excited about the Company's technology and look forward to joining the STAAR team," said Mr. Fagen. "Over the past 18 months, the Company has obtained three New Technology Intraocular Lens (NTIOL) approvals, launched two new IOL injector systems and released benchmarking data on the nanoFLEX IOL by the Collamer Accommodating Study Team (CAST). I look forward to leading the North American sales team as we focus on customer growth in 2010," Mr. Fagen added.
"STAAR's short term product development pipeline includes the Preloaded Silicone IOL, which has been submitted to the FDA for approval, and the Toric Collamer IOL, which is undergoing clinical studies," said Mr. Caldwell. "The Company is also awaiting word from the FDA on the Visian Toric Implantable Collamer Lens (ICL) approval submission. Additionally, for our longer term product development pipeline, we have submitted to the FDA the clinical protocol for studies to validate the visual findings of the CAST on the current nanoFLEX IOL as well as data for the agency to evaluate some new designs to the lens. We believe these minor design modifications may enhance the already impressive visual results of the current lens noted by the CAST. The Company is also working on enhanced designs for the Visian ICL products," concluded Mr. Caldwell.
Mr. Fagen's experience in the ophthalmic surgical industry includes the management of cataract surgical equipment and disposable sales, including IOLs. His strong refractive surgery industry experience includes six years at VISX as V.P. of Sales, four years as V.P. of Sales and Marketing at Clear Vision/Hillside Group, and two years as Director of Excimer Sales at Alcon.
More recently, Mr. Fagen was the Founder and Director of RedLetter Medical Sales Partners, a company specializing in the interpersonal relationship building of management teams and field sales organizations for medical equipment, implant and disposable products companies. He was also the Vice President of Sales, North America for Syneron Medical, an Israel-based manufacturer and distributor of medical aesthetic devices and disposables.
Mr. Fagen received his Bachelor of Science in Education and Sociology from Texas State University with additional training at the Graduate School of Business at both Stanford University and Columbia University as well as the Graduate School of Management at UCLA.
About STAAR Surgical
STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. Collamer® is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available 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 future sales or other financial items, the success of existing or planned products, the prospects for FDA approval of the Visian Toric ICL, the Silcone Preloaded Injector or any other product, any of the other plans, strategies, and objectives of management, 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 our limited capital resources and limited access to financing, the fact that our public accounting firm has expressed doubt about our ability to continue as a going concern in their opinion on our financial statements, the broad discretion of the FDA in approving any medical device and the inherent uncertainty that new devices will be approved, the likelihood of administrative delays, the need in certain future FDA submissions to satisfy additional and potentially costly requirements such as third party audits, the cost of defending pending litigation and satisfying the recent adverse judgment, for which we have taken no reserve, the negative effect of the global recession on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance and to demonstrate to the agency that its past concerns have been resolved, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
STAAR's current data on the accommodating properties of the Collamer material derive from the reports of individual independent clinicians and have not been subjected to large scale clinical studies. STAAR's nanoFLEX IOL does not have an FDA labeling claim for accommodation. STAAR cannot assure that its further research will support a claim that either its current Collamer lenses or future designs restore the eye's ability to accommodate. If clinical research does not support these claims, or supports only a narrow range of accommodation, STAAR's Collamer accommodation project may not result in increased sales. New lens designs may require clinical research studies and applying for the FDA's premarket approval, which are expensive and could result in delay or denial of approval.
CONTACT: Investors Media EVC Group EVC Group Barbara Domingo, 415-896-6820 Chris Gale, 646-201-5431 Douglas Sherk, 415-896-6820
SOURCE STAAR Surgical Company
