Printer Friendly

FDA ACCEPTS SUMMIT'S APPLICATION TO COMMERCIALLY MARKET EXCIMER LASER SYSTEMS FOR TREATMENT OF MYOPIA

 WALTHAM, Mass., Jan. 4 /PRNewswire/ -- Summit Technology, Inc. (NASDAQ: BEAM) announced today that the FDA has accepted for filing Summit's PMA application to commercially market and sell its excimer laser system in the United States for the treatment of nearsightedness. This acceptance represents a significant step in the FDA's product review process by signifying that the FDA has begin a full-scale evaluation of the data contained in the company's PMA application.
 The treatment, known as Photorefractive Keratectomy (PRK), uses the excimer laser to gently reshape the cornea with the result being most patients do not require the use of eyeglasses or contact lenses post- operatively. In the United States alone, there are approximately 60 million nearsighted people and it is believed that the majority of them are potential candidates for Summit's excimer laser PRK procedure.
 Summit's PMA application represents the culmination of over five years of United States clinical trials in which approximately 2,000 treatments have been performed using Summit's laser system. Concurrently, Summit's excimer laser system has been in commercial operation in many countries around the world and to date it is estimated that well over 60,000 procedures have been performed using Summit's systems.
 The PMA document consists of over 14,000 pages of clinical data and supporting technical information which has been compiled by the company's United States clinical investigators and its Regulatory and Clinical Affairs team.
 Summit Technology, Inc. is a worldwide leader in the development, manufacture and sale of ophthalmic laser systems designed to correct common refractive vision disorders such as nearsightedness, farsightedness and astigmatism.
 -0- 1/4/94 R
 /CONTACT: Paula Rainville, investor relations of Summit Technology, 617-890-1234/
 (BEAM)


CO: Summit Technology, Inc. ST: Massachusetts IN: MTC SU:

OP -- NE004R -- 8880 01/04/94 11:49 EST
COPYRIGHT 1994 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1994 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 4, 1994
Words:294
Previous Article:STATE WATER HEARING SET IN SAN LUIS OBISPO
Next Article:CARR GOTTSTEIN ANNOUNCES EXPANSION INTO JUNEAU
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters