Biolase’s Laser Approved for Use on Kids’ Cavities

Biolase Technology Inc. has received clearance from the Food and Drug Administration to market its Millennium dental laser to treat cavities in children, its president and chief executive officer said Tuesday.

“This is a very important approval,” that will spur sales, CEO Jeffrey W. Jones said.

The FDA clearance means “all classes of cavities in all age groups” can be filled using the device, he said. In October, the laser received its initial approval for use in drilling adult teeth.

Surveys show that dentists want to use lasers, but they like to have a range of uses to justify the investment, Jones said. The Biolase device, which uses hydrokinetic laser technology, retails in the U.S. for $44,900, he said.

The clearance for children also puts the Biolase laser on equal footing--from a regulatory standpoint--with a rival device made by Premier Laser Systems Inc. Irvine’s Premier uses a different technology, but competes in the marketplace against the Millennium.

Premier’s laser received FDA clearance last October for treating tooth decay in children, a dental industry first at the time.

Jones, who joined San Clemente’s Biolase in November, said the clearance is “a critical component” in helping the company reach its goal of surpassing $10 million in sales this year, equal to about 250 units. “We’re hoping to be profitable in the first quarter of 2000” and in subsequent quarters, he added.

Biolase posted a net loss of $670,000 in the first quarter this year on sales of $1.79 million. In 1998, losses totaled $10.4 million on sales of $1.5 million. The loss included a $5.1-million charge related to an acquisition.

Since November, Biolase has increased its U.S. sales force to 10 people from two, Jones said. In addition, the company has added three international sales managers with responsibility for dealer sales in Europe, Latin America and the Pacific Rim.

On Tuesday, the stock rose 28 cents a share to $2.25, on the Nasdaq Small-Cap market.