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Summit Technology, Inc. Announces FDA Approval to Initiate Custom Cornea Studies With Autonomous LADARVision System.


WALTHAM, Mass.--(BUSINESS WIRE)--July 27, 1999--

Summit Technology, Inc. (NASDAQ Symbol:BEAM) announced today that its Autonomous Technologies subsidiary had been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration to begin investigational feasibility studies for customized ablations using the combination of its patented CustomCornea(R) measurement device and its LADARVision(R) System. The Company believes that its CustomCornea(R) technology will provide surgeons with the ability to treat ocular aberrations that cannot be detected or compensated for by existing refractive systems. This application has the potential to provide outstanding results that consistently exceed 20/20 vision. The study will include the treatment of nearsightedness nearsightedness /near·sight·ed·ness/ (ner-sit´ed-nes) myopia.

near·sight·ed·ness (nîrs
 as well as farsightedness farsightedness /far·sight·ed·ness/ (fahr-sit´ed-nes) hyperopia.

far·sight·ed·ness (färs
 and astigmatism
compound astigmatism  that complicated with hypermetropia or myopia in all meridians.
corneal astigmatism  that due to irregularity in the curvature or refracting power of the cornea.
irregular astigmatism  that in which the curvature varies in different parts of the same meridian or in which refraction in successive meridians differs irregularly.
 with both photorefractive keratectomy (PRK PRK - Democratic People's Republic of Korea (ISO alpha-3 country code for North Korea)
PRK - Partia Republikane e Kosovës (Republican Party of Kosovo)
PRK - People's Republic of Kalifornia
PRK - People's Republic of Kampuchea
PRK - Photorefractive Keratectomy
PRK - Polyteknikkojen Radiokerho (student ham radio club at Helsinki University of Technology)
PRK - Primitive Recursive Kernel
) and laser in-situ keratomileusis laser-assisted in-situ keratomileusis  (LASIK) keratoplasty in which the excimer laser and microkeratome are combined for vision correction; the microkeratome is used to shave a thin slice and create a hinged flap in the cornea, the exposed cornea is reshaped by the laser, and the flap is replaced, without sutures, to heal back into position. (LASIK).

The results of the feasibility IDE study will provide the basis for an expanded U.S. clinical trial which is necessary for FDA approval. The study will include the treatment of a limited number of eyes using both PRK and LASIK and is scheduled to begin in August.

The Right Shape to Make

When performing laser vision correction, today's surgeons use a laser to flatten or steepen the curvature of the patients cornea to enhance the patients vision. However, the amount of change and final shape of the cornea is still largely dependent on the same nineteenth century trial lens technology used when a contact lens or spectacle prescription is measured.

"We believe that CustomCornea(R) will greatly improve the way in which the optimal cornea shape is determined and applied to the cornea. The goal of CustomCornea(R) is to set a new level of expectations for refractive outcomes and to provide a significant increase in visual quality for all refractive patients," said Randy Frey, President of Autonomous and Executive Vice President of Summit.

CustomCornea(R) represents the integration of advanced measurement technologies with the LADARVision(R) System, and is the result of three years of product development. CustomCornea(R) begins by pulsing a beam of light into the eye and onto the retina. The light pulse is then reflected back through the cornea, gathering individual properties of the optical path. The reflected light pulse is analyzed by CustomCornea(R) and used to develop a custom corneal shape. This custom shape is then applied to the cornea using the LADARVision(R) System. The LADARVision(R) System's unique small beam and active eye tracker enable it to precisely sculpt the cornea to the custom shape.

Founded in 1985, Summit Technology is a leading developer, manufacturer and marketer of ophthalmic laser systems and related products 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 excimer laser system for the correction of mild to moderate myopia in the U.S. Autonomous, a wholly owned subsidiary, is engaged in the design and development of next generation excimer laser instruments for laser refractive surgery. The Company's LADARVision system combines laser radar eye tracking Determining what a user looks at. Using sophisticated equipment, eye tracking follows the eye movements of a person looking at any visual such as a printed ad, an application's user interface or a page on a Web site. It is used to analyze the usability and effectiveness of the layout. with narrow beam shaping technology. 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 report 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. Among these risks and uncertainties are: competition from other manufacturers and vision correction technologies, delays in obtaining regulatory approvals, challenges to patents owned and licensed by the Company affecting per procedure revenues and adverse litigation results. For additional information and risks associated with the Company's business prospects, and future operating results, please refer to Summit's annual report on Form 10-K for the year ended December 31, 1998.
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Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jul 27, 1999
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