Premier Laser Receives FDA Clearance to Market Diode Laser for Removal of Dental Pulp in Pulpotomies and Root Canals; 14 Million Pulpal Procedures Annually.

IRVINE, Calif.--(BUSINESS WIRE)--Dec. 21, 1998--Premier Laser Systems Inc. (Nasdaq NM:PLSIA) Monday announced that the FDA has granted the company clearance to market its Aurora(TM) diode laser for the removal of coronal pulp in pulpotomies and as an adjunct to root canal procedures.

This clearance follows the announcement in August that the Pegasus Nd:YAG laser had been cleared for these procedures. This announcement is especially important since the Aurora(TM) diode laser is widely used for a range of FDA cleared soft tissue (gum) procedures including sulcular debridement (deep cleaning). The company also announced that Aurora will now include the new pulpotomy upgrade as standard equipment to enable dentists to perform this FDA approved procedure.

The feature will include a special optical coupler that enables the use of a 200 micron fiber and handpiece with Aurora, as well as enhanced software and other accessories. The list price of Aurora with the standard pulpotomy feature is $25,000 and deliveries of Aurora with the feature are planned to commence in January. Installed Aurora diode lasers can be upgraded in the field with the pulpotomy feature kit. List price of the field upgrade kit is $2,750, with deliveries also planned to start in January.

According to The American Academy of Endodontics Web site, more than 14 million pulpal procedures are performed each year in the United States. Conventional cleaning and shaping of the pulpal cavity in these endodontic procedures are performed using reamers and files or rotary instruments. With the advent of dental laser systems, these procedures can be cleaner and more comfortable for the patient, enhancing the overall patient experience. The cleared application cited clinical studies performed at dental research centers in the United States and Germany.

This clearance follows the October announcement of the FDA clearance to market the Centauri(TM) Er:YAG laser for use on children for such selected hard-tissue procedures as caries (decay) removal and cavity preparation. Centauri was already cleared to market by the FDA for hard-tissue procedures on adults in May 1997.

David W. Winn II, D.D.S., a Colorado Springs, Colo.-based practitioner and author of several articles related to laser dentistry commented: "The laser offers dentists a powerful new tool to further improve endodontics. When using current techniques, it is difficult to remove coronal tissues in a precise and aseptic manner; however, use of the laser for these procedures enhances the sterility and, ultimately, the tooth's chance for survival."

Dr. Winn went on to note that "The substitution of the laser for the drill in coronal pulp removal decreases the use of the low speed drill with its objectionable vibration, and is much appreciated by patients."

According to Premier Laser Chairman, President and Chief Executive Officer Colette Cozean, Ph.D.: "This clearance is especially important for the many existing laser dentists who currently use the Aurora for soft tissue procedures. With the new field installable pulpotomy feature kit, current Aurora users can expand the laser's use to a whole new class of application, giving them the opportunity to enhance their return on investment."

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

The statements in this release that relate to future events or performance, statements about growth, future regulatory clearances, levels of sales and market size and future manufacturing capacity and efficiencies are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to the development of markets for and commercial acceptance of the company's products and services, the availability of components, competitors' product introductions and other risks identified in the company's SEC filings. Actual results may differ from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof.