Premier Laser receives FDA clearance to market Centauri Er:YAG system for hard tissue applications; first in nation.

IRVINE, Calif.--(BW HealthWire)--May 7, 1997--

170 million such procedures annually in U.S.; alternative to

high-speed drills

Premier Laser Systems Inc. (NASDAQ/NM:PLSIA) Wednesday announced that the FDA has granted the company the first-ever clearance to market a laser system throughout the United States for a new dimension in dentistry -- hard tissue procedures, including caries (decayed tissue) removal, cavity preparation and related applications.

The clearance was granted to Premier Laser for its Centauri(tm) Erbium Yttrium Aluminum Garnet (Er:YAG) laser system. With an estimated 170 million hard tissue procedures performed annually nationwide, the company believes it may sell as many as 10,000 to 15,000 Er:YAG systems for those applications within the next decade. The system will cost approximately $39,000. Shipments will begin later this quarter; systems will be in dentists' hands within the next 90 days.

Premier Laser Chairman, President and Chief Executive Officer Colette Cozean, Ph.D., said that clinicians in five states had developed data on more than 1,300 procedures for the final submittal to the Food and Drug Administration.

"Extensive pre-clinical and clinical studies, with a three-year follow-up, have shown that Centauri's overall performance and safety offer patient comfort and other significant advantages when compared with the traditional high-speed drill," she commented.

"We're especially proud to be the first company in the nation to receive this clearance," Cozean added. "Centauri completes our product line, which already features leading dental laser systems for soft tissue surgery and teeth whitening. We believe this new application will play a key role in the expansion of our marketing and distribution outside the U.S."

Richard T. Hansen, DMD, a Fullerton, Calif.-based practitioner and faculty member at the University of California at Los Angeles (UCLA) School of Dentistry, participated in the clinical tests. He said the results of his and other patient studies "underscored the fact that a laser for hard tissue procedure writes a new page in dental history. I believe it's a development patients have been waiting for, especially considering the public's familiarity with the success of medical lasers."

Hansen pointed to a number of practitioner benefits provided by the laser system. "We can pinpoint and excise diseased hard tissue with great precision, preserving the tooth's overall integrity," he said. "We can eliminate nonproductive time spent during the day waiting for anesthesia to take effect and we find the laser ideal for the newer tooth-colored restorative materials dentists increasingly use."

He added that, based on his and other practitioners' previous experiences with laser systems, the practice usually expands measurably, primarily by patient referrals. Hansen indicated that the Er:YAG laser system is already cleared for periodontal applications and that there is a possibility of future clearances "that might permit a variety of other applications, including root canal surgery and the cutting and shaping of bone."

Hansen's comments were echoed by James M. Pelagalli, DDS, founder of the Cleveland-based American Academy of High-Tech Dentistry and chief clinical investigator.

"There are also several patient advantages," he commented. "There's little or no pain and minimal discomfort, so in most cases there's no need for anesthesia or needles. The patient won't hear a high-speed drill, or feel its vibrations.

"My own clinical experience has clearly shown that the Er:YAG becomes a fascinating, even friendly instrument," Pelagalli said. "Now a trip to the dentist should no longer be fearsome for this or future generations."

Cozean herself underwent hard tissue procedure as part of the clinical testing. "I personally experienced the speed and ease with which the laser removed the decay, with no pain whatsoever," she said.

Cozean indicated that all practitioners choosing to purchase the Centauri will be required to undergo an intensive training program and will be provided continuing clinical updates via printed case studies and videotapes from the clinical testing participants and other dentists employing the system. Registration for training courses will begin immediately.

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, surgical and dermatological applications. The Centauri was previously cleared to market by the FDA for certain ophthalmic surgery applications. -0-

NOTE: The statements in this news release that relate to future plans, events or performance including future product introductions, future sales trends and amounts, public demand for laser dental treatment, the impact of new technologies on a dentist's practice, expected regulatory actions and future manufacturing capacity are forward-looking statements. These statements involve risks and uncertainties, including risks associated with uncertainties related to the exercise of regulatory discretion, contract cancellations, component availability and pricing, labor costs, 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 undue reliance on these forward-looking statements, which speak only as of the date hereof.

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