Summit Technology Press Release - Astigmatism
FDA Approves Summit's Emphasis Disc
to Treat Myopic Astigmatism
Waltham, Massachusetts (March 12, 1998) - Summit Technology, Inc. (NASDAQ: BEAM) today announced that the U.S Food and Drug Administration (FDA) has approved the Summit SVS Apex Plus Excimer Laser Workstation and the emphasis disc for treating low to moderate myopic astigmatism.
This approval dramatically boosts the utility of Summit's equipment for its customers. Industry estimates suggest that millions of people suffer from some degree of astigmatism, a significant portion of which fall into the approved treatment range. Summit's Apex Plus and emphasisx disc technology have been used successfully for more than two years outside the U.S. for the treatment of astigmatism and hyperopia, as well as myopia with excellent clinical results. Summit is pursuing FDA approval for the treatment of hyperopia with its SVS Apex Plus Workstation and emphasisx disc, and is awaiting FDA action on its previously submitted PMA application for the treatment of high myopia.
Robert J. Palmisano, Chief Executive Officer, stated,
"We have our regulatory team in high gear and we do not intend to slow down. This approval is an important milestone not only because of the benefit astigmatism treatment brings to potential patients and to our customers, but also because it ushers in a new era of laser vision correction technology. FDA approval of Summit's unique emphasisx disc platform allows the US consumer and professional community access to this advanced technology, which should ultimately enable practitioners to perform as wide if not a wider range of refractive treatments as any other technology. This advantage derived, in part, from the disc's capacity for customization, meaning that for difficult or unusual cases the treatment can be tailored to the patients' individual condition."
Summit Technology is a leading developer, manufacturer and marketer of ophthalmic laser systems designed to correct common vision disorders such as nearsightedness, farsightedness and astigmatism. In 1995, Summit was the first excimer laser company to receive FDA approval for its Apex excimer laser system for the correction of mild to moderate myopia in the U.S. In addition, through its wholly-owned subsidiary, Lens Express, Summit sells contact lenses and related products.
Cautionary Statement: Under "Safe Harbor" Provisions of The Private Securities Litigation Reform Act Of 1995: Statements made in this news release contain information about the Company's future business prospects. These statements may be considered "forward-looking". These statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by such forward-looking statements. For further information regarding cautionary statements and factors affecting future operating results, please refer to Summit's annual report on Form 10-K for the year ended December 31, 1996 and Form 10-Q for the quarter ended September 30, 1997.
Created May 15, 1998