Premier Laser Systems Inc., which makes the first dental laser approved in the United States for use directly on teeth, said it has cleared a major hurdle to marketing the laser in Europe.
The move opens the door to a market of 125,000 dentists, roughly the same size as the U.S. dental market.
The company’s laser received the stamp of approval from the Geneva-based International Electrotechnical Commission. While the IEC clearance isn’t required for the Irvine-based company to sell the laser in Europe, it was considered critical to assuring dentists that the product is safe.
Premier Chief Executive Colette Cozean said the company now plans to kick off its marketing program in Europe this fall.
Premier has been the focus of nationwide attention since the announcement in May that the federal Food and Drug Administration had approved its laser to remove tooth decay. The FDA’s blessing was considered a major breakthrough in dentistry that could lead to a relatively painless replacement for the dreaded drill in repairing cavities.
In the past two months, Premier said, it has been swamped with orders from dentists all over the country. Cozean said the company also has received many calls from European dentists who are interested in the system.
Premier previously said it expects to manufacture as many as 400 of the dental laser systems by next March.
Analyst Scott Baily at BlueStone Capital Partners in New York estimated that as many as 50 of those could go to Europe. “I think we’re seeing just the tip of the iceberg of potential demand and market penetration out of Premier,” he said. “It’s just a matter of time.”
Premier’s stock, which soared to record levels following the FDA announcement, closed Wednesday at $10.94 a share, down 6 cents, in Nasdaq trading.