Summit Technology Press Release
Summit Technology, Inc. Receives 510k Clearance To Market Krumeich-Barraquer Microkeratome
In The United States
Waltham, MA, December 23, 1998 - Summit Technology, Inc. (NASDAQ: BEAM) announced today that on December 22, 1998 the company received a 510K concurrence letter from the FDA permitting the company to market the Krumeich-Barraquer microkeratome in the United States. Summit acquired the Krumeich-Barraquer microkeratome in October and since then the Company has been marketing the device in international markets.
"When we acquired the Krumeich-Barraquer microkeratome we knew that we had an exciting new product to offer refractive surgeons and we are pleased that the FDA has responded so quickly to our 510K application," stated Robert J. Palmisano, Chief Executive Officer of Summit. "Following the acquisition we displayed and demonstrated the microkeratome during the American Academy of Ophthalmology and we were gratified by the overwhelmingly positive response from doctors attending the Academy. Doctors were particularly enthusiastic about the possibilities for customization utilizing the system," Palmisano continued. "We think that this product will be very attractive to all refractive surgeons," he finished.
Summit plans to commercially launch the Krumeich-Barraquer microkeratome during the first quarter of 1999. With this approval, Summit is now the only FDA approved laser manufacturer to also offer a microkeratome.
Founded in 1985, 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 excimer laser system for the correction of mild to moderate myopia in the U.S. In addition, through its wholly owned subsidiary, Lens Express, Summits 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 Companys 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 Companys business prospects and future operating results, please refer to Summits annual report on Form 10-K for the year ended December 31, 1997
Created January 28, 2000