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STAAR SURGICAL IMPLANTABLE CONTACT LENS IDE

This article was originally published in The Gray Sheet

Executive Summary

STAAR SURGICAL IMPLANTABLE CONTACT LENS IDE application will be filed by the end of 1993, Staar Chairman and Chief Operating Officer LaMar Laster said during a March 29 conference call for stock brokers. The product was developed by the Moscow Research Institute for Eye Microsurgery, which has granted Staar marketing rights in Western countries for the lens and the material of which it is composed. Staar also expects to file an investigational device exemption application before the end of 1993 for a foldable intraocular lens made of the same material. Staar describes the material as a biocompatible substance with a high refractive index that has been synthesized using an organic and an inorganic compound. Staar says that the material, which it has patented, "is superior in optical characteristics to all other materials used today." The foldable implantable contact lens (ICL) can be implanted behind the eye's lens using Staar's injector technology and is designed to correct hyperopia and myopia. The device has been implanted in over 600 patients in Russia during the last three years. Staar expects to begin marketing the product overseas through its Swiss subsidiary Staar AG in mid-to-late 1993. The firm says it has one distributor in each European country. The firm claims that the ICL has several advantages over the treatments such as refractive or photorefractive keratotomy. ICL insertion yields immediate visual acuity and minimal postoperative pain, Staar says. The results of the reversible procedure also are predictable in that they do not depend on how the cornea heals, according to Staar. Staar is looking to license the material used in the lens product to companies not involved with eye-care products. The company says that no negotiations currently are under way. Staar believes the material may be useful in the manufacture of mechanical heart valves, breast implants, finger joints and access ports. For example, the firm says it thinks there would be less hemolysis associated with use of its material in heart valves than there is with the use of pyrolytic carbon. Laster predicted that Staar's sales for the year ending Jan. 31, 1994 will double to approximately $20 mil. as compared with sales of $10.2 mil. for the year ended Jan. 31, 1993. These figures reflect the firm's estimate of existing product sales and do not include any figures for the new technology. Laster also noted that Staar will double its domestic manufacturing capacity by mid-1994 to approximately 60,000 square feet.

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