Premier Laser responds to FDA queries in regard to hard tissue dentistry submittal

Business Wire, Feb 6, 1997

IRVINE, Calif.--(BUSINESS WIRE)--Feb. 6, 1997--Premier Laser Systems (NASDAQ NM:PLSIA) announced today that it received a letter containing a brief list of queries from the US Food & Drug Administration (FDA) regarding its pending submittal to market Erbium:YAG laser systems for certain procedures in hard-tissue dentistry.

Chairman, President and Chief Executive Officer Colette Cozean, PhD, said that the company responded in a straightforward fashion to all queries within 48 hours of receiving the FDA letter.

Cozean said that the letter informed the company that the FDA considers the submittal to have a very high priority.

There can be no assurances that the FDA will act with regard to the hard-tissue submittal, or that the FDA's action will be favorable to the company's products. But Cozean said that if the submittal is cleared for market, the company would provide the broadest line of dental lasers in the world.

The company already markets several laser systems to the dental marketplace, including Diode and Erbium:YAG lasers for soft-tissue procedures and individual and multiple-operatory Argon lasers for teeth whitening and composite curing. Premier Laser announced in a news release on January 16 that its sales had more than doubled in a year-to-year comparison, primarily due to sales of Diode, Argon and Erbium:YAG lasers for dentistry. The company also said it had a record backlog of orders for these laser systems entering its fiscal fourth quarter ending March 31, 1997.

Premier Laser Systems develops, manufactures and markets several lines of proprietary medical lasers, fiber optic delivery systems and associated products for a variety of dental, ophthalmic, surgical and dermatological applications. -0-

NOTE: The statements in this press release that relate to future plans, events or performance, including statements concerning actions by the FDA, are forward-looking statements that involve risks and uncertainties, including risks associated with the inability to predict FDA regulatory actions, uncertainties related to contract cancellations, manufacturing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the company's products and services and other risks identified in the company's SEC filings.

Actual results, events and performance may differ materially. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT: Marty Tullio (investors)

Owen Daley (media)

Allen & Caron Inc

714/252-8440