Irvine Firm’s Dental Lasers Win FDA’s OK

IRVINE —  In a development that could revolutionize dentistry and virtually eliminate the pain of having a cavity filled, the Food and Drug Administration on Wednesday approved the first laser system to treat tooth decay.

The laser, made by Premier Laser Systems Inc. in Irvine, could usher in a new era in dentistry in which the often painful procedures involving the use of drills to remove tooth decay and prepare cavities for fillings will be replaced by relatively pain-free laser methods.

Previously, dental lasers were approved only for use on soft tissue such as gums.

“Use of lasers in dentistry is medicine for the 21st century,” said Bruce Burlington, director of the FDA’s Center for Devices and Radiological Health.

“This will give dentists and patients a significant new option for treating decay and doing other related procedures,” he said.

Company-sponsored studies showed that Premier’s laser is as safe and effective as a high-speed drill, the FDA said, and that fewer patients required anesthetic for pain. It also approved the laser to roughen enamel for bonding procedures.

Premier will begin marketing its laser systems immediately and could have them in dentists’ hands within 90 days, although there will be some delay as dentists undergo training, said Colette Cozean, Premier’s chairman and chief executive.

Some of the doctors in the studies charged higher prices for the laser procedures, but insurers so far have been willing to pick up the additional cost, she said.

For now, the laser system is approved only for adults. The company hopes that clearance for those 18 and younger will come as soon as it is able to demonstrate that the laser poses no risk to the larger sensitive interior of a child’s tooth.

Analysts were upbeat Wednesday about the laser’s potential. “It’s a sea change in the world of dentistry,” said Scott Baily, a senior analyst at BlueStone Capital Partners in New York.

The laser system is called the Centauri Er:YAG, which stands for erbium (a crystal that generates the wavelength), yttrium, aluminum and garnet (metals and crystals that help control the laser beam). It consists of a box-like console and a fiber-optic cable with a dental hand piece at the end.

The hand piece looks like a standard dental drill, and--like drills--uses water or air to cool and clean the tooth during treatment. Dentists and patients will be required to wear goggles during procedures to shield their eyes.

The company began the first of two studies in 1993 when more than 500 teeth with decay were treated with the laser. The FDA said that it detected no damage to the nerve and blood supply to the tooth.

In a second study, about half of the 125 patients enrolled were treated with a laser and the others were treated with a drill. The laser was just as safe and effective as the drill, the FDA said.

Cozean said she was surprised by the FDA announcement, which she had expected later in the week. In a telephone interview squeezed in amid a whirlwind of television appearances Wednesday, the 38-year-old biomedical engineer said she was “very excited about it, primarily because I know what it’s going to do for the patient.”

“It’s been a long time in coming.”

The feature that sets Premier’s laser apart from others, Cozean said, is that it operates at a particular wavelength that allows it to penetrate the tooth and slice away decay with extreme precision, preserving more of the healthy tooth.

Cozean said the company submitted data on more than 1,300 procedures to the FDA. Only three patients in the entire study were given pain medication, and that was probably because of sensitivity to cold water, she said.

The company also hopes that its lasers will be cleared for other applications, such as root canal surgery and the cutting and shaping of bone.

The Premier laser is superior to drills because it better sterilizes the area of the tooth where the decay is removed, which could also inhibit future decay, said David Winn, a Colorado Springs, Colo., dentist who participated in Premier’s clinical trials.

Perhaps more significant, he said, is that the reduced noise, vibration, and particularly the relative painlessness of the laser procedure could induce about 50% of the public that avoids dentists to seek treatment.

“Those are the three big reasons people hate coming to the dentist,” he said.

Robert Pick, a Chicago dentist and spokesman for the American Dental Assn., said the new laser system is one of a series of advances in the past few years that has thrust dentistry ahead by “quantum leaps.”

They include dental implants that have replaced full dentures, the regeneration of diseased gum and bone tissue, high-tech plastics for bonding, and--most recently--genetic testing to determine if someone is predisposed to periodontal disease.

“Unfortunately, people still have the perception of a person with a shoe on their chest yanking out a tooth,” he said.

But with the new laser system, he said, “I see a lot of people less fearful of the dentist.”

The FDA approval could catapult tiny Premier into a major company, analysts said.

With 170 million tooth-drilling procedures done each year, Cozean figures that Premier can capture $45 million in sales if it gets just 1% of that market. The company projects sales of 10,000 to 15,000 of the systems in the next 10 years.

Founded in 1989 as a division of drug giant Pfizer, Premier was bought out by management in 1991 and went public in a stock offering in November 1994. It also makes ophthalmic and surgical lasers, but its focus has been on bringing its dental laser to market. It lost $5.59 million on net sales of $5.53 million in the fiscal year ended March 31.

Premier’s stock rose $1.625 a share Wednesday to close at $8.375 in Nasdaq trading. Potentially, Premier is looking at a $3.9-billion market, analyst Baily estimated. He said Premier has at least a year and a half lead on other companies that are hoping to win FDA approval for lasers to be used in removing tooth decay.

But the biggest obstacle may be the hefty price tag. A Premier laser system runs $39,000, about 10 times what a drill might cost. Cozean said it will offer leasing and financing deals to dentists.

“We’re not going to rid the world of drills overnight,” Winn said. He expects that some dentists, conservative by nature, will balk at the new technology and its high cost.

But in time, he believes that the laser will turn dentistry “upside down.”

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No Needles, No Drills

Recently approved laser technology replaces the dreaded dental drill with a quiet, painless method of treating cavities. How it works:

1. Erbium laser vaporizes damaged portion of tooth and kills cavity-causing bacteria.

2. Laser clears away small amount of tooth structure to create space for filling material that matches tooth color.

Average amount of time required to this point: 60 seconds

3. Filling applied and hardened by an argon laser.

Laser’s Advantages

* No drill: Painful heat, vibration and anxiety-producing whine are eliminated; test patients report only a tingling feeling and a slight popping sound.

* No shots: No anesthesia required in most cases.

* No secondary decay: Laser-treated area is free of cavity-causing bacteria; decay cannot resume beneath filling.

* Quicker: No waiting for anesthesia to take affect; no time-consuming drilling.

* More precise: Less of surrounding healthy tooth structure is removed.

****

“There’s little or no pain and minimal discomfort, so in most cases, no need for anesthesia or needles . . . now a trip to the dentist should no longer be fearsome for this or future generations.”

--Dr. James M. Pelagalli, founder of the American Academy of High-Tech Dentistry and chief clinical investigator

Source: Premier Laser Systems

Researched by JANICE L. JONES / Los Angeles Times

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Premier Laser Systems

* Headquarters: Irvine

* Chairman/CEO: Colette Cozean

* Products: Develops and manufactures medical lasers and fiber-optic delivery systems used in dentistry, ophthalmology and various surgical procedures

* Incorporated: 1991

* Went public: 1994

* Exchange: Nasdaq

* Fiscal 1997 sales: $5.5 million

* Wednesday closing stock price: $8.38, up $1.63

Source: Premier Laser Systems , Researched by JANICE L. JONES / Los Angeles Times