Firm Markets Alternative to Dental X-Rays : Valencia: The FDA cleared Dolphin Imaging Systems’ non-radioactive DigiGraph machine two months ago for use in orthodontic treatment.

Suppose you want your teeth straightened. First, your orthodontist takes some X-rays of your mouth, then explains how various kinds of braces might be used, what your teeth ultimately would look like and how much it would cost.

Any questions?

Yes, says Dolphin Imaging Systems Inc. The Valencia company says dental patients are increasingly asking whether the X-rays expose them to unnecessary doses of radiation. To allay that concern, Dolphin has begun selling a machine that in many cases takes the place of an X-ray apparatus.

The $31,000 machine, called the DigiGraph, is the concept of Dr. Marc Lemchen, an orthodontist in New York City, and Gary Engel, a former orthodontic supplies executive, who formed Dolphin in 1988 to build the machine. After three years of development, the DigiGraph was cleared for sale two months ago by the U.S. Food and Drug Administration.

Now privately held Dolphin faces its next challenge: persuading the nation’s 7,500 orthodontists and some of its 100,000 dentists to largely abandon their X-ray machines--which typically cost between $15,000 and $40,000--and buy a DigiGraph to treat the 3 million Americans who each year wear braces or otherwise receive orthodontic treatment.

Dolphin, with FDA approval, earlier sold 55 machines at cost to the dental industry so that it could collect research data for the agency. Since it got FDA permission to sell the machine for a profit, the company has sold six systems to orthodontists in Utah, Florida and other states. It hopes to sell an additional 100 over the next year, said Derek Evans, Dolphin’s vice president of marketing. If that happened, Dolphin would haul in $3 million in sales.

But hoping to make those sales and actually ringing them up are two different things. The American Assn. of Orthodontists in St. Louis hasn’t yet taken “any particular stance on this equipment,” spokesman Mike Dillon said. Phil Weintraub, spokesman for the American Dental Assn. in Chicago, said, “We have not seen any technology out there . . . that is a clear-cut alternative to dental X-rays.”

Dr. Patrick K. Turley, an orthodontist at UCLA who said he has seen the DigiGraph demonstrated, said “the concept Dolphin has is a good one” because “we need to continue looking for an alternative” to X-rays. But the machine right now “is nowhere close to being able to replace the X-ray for diagnostic purposes,” he said.

Simply put, the DigiGraph doesn’t provide enough information about all of the bones and tissue in a patient’s head that are involved in orthodontics, Turley said. “There are landmarks on skeletal structures that you can’t get to with the Dolphin,” he said.

The company disagrees. “We think in the long run that every orthodontist who practices will have to have this kind of machine,” said Dolphin President Allen Lay, who also is a principal of Southern California Ventures in Los Angeles, one of the venture capital firms that funded Dolphin.

But even Evans acknowledged that “you have to go relatively slowly” in marketing such a device. “It’s not a consumer thing where you throw $100,000 of advertising at it and force the issue.”

Because Dolphin’s machine is being marketed primarily as an alternative to X-rays, it raises the question of just how dangerous dental X-rays are to patients. Although studies have produced varying answers, most everyone agrees that because X-rays emit low-level radiation, “X-rays should be used only when needed for proper care,” said Dillon, of the orthodontics association.

Turley said only one patient in his 11 years of practice asked to be treated without X-rays, and out of the 50 new patients he gets each year, two or three “seriously ask about it.” But Lemchen contended that patients will be drawn to orthodontists who give them the option of avoiding X-rays.

Dolphin’s machine basically works this way: When a wand is pointed at specific parts of the patient’s mouth or jaw, it emits sound waves that are picked up by microphone, sent to the machine’s computer and calculated into exact measurements. At the same time, the machine’s two cameras take pictures of the patient, which are digitized so they can be shown on the computer’s color monitor.

Then, the various lines that show the distances in the mouth or outlines of the teeth are superimposed over the patient’s picture on the monitor. So, instead of using an X-ray to see through the patient’s skin to the teeth and jaw inside, the DigiGraph superimposes the teeth and other mouth structures over the patient’s picture. It’s what the dental community calls a non-invasive examination.

“It’s just a big measuring system with imaging capability,” Evans said.

In addition, the computer can calculate how the patient’s appearance will change after orthodontic treatment and, using an electronic “cut-and-paste” system of video images, display the patient’s “new” look.

Lemchen, 45, said in a telephone interview from New York that he got the idea for the machine because the dental community already digitizes X-rays to reshow them on computer screens. “We said, ‘Why can’t we just put the patient’s head down there and measure directly from the patient?’ ” without using an X-ray, he recalled.

After he and Engel designed the computer software, they founded Dolphin and financed the development of their machine with $6 million from four venture capital firms, including Southern California Ventures and El Dorado Ventures in Pasadena. Together the four firms own about 90% of Dolphin’s stock and its employees own the rest, Evans said.

The company’s name was chosen because dolphins “use sonics to find distances and identify features,” and “it’s easy to spell,” Lemchen said.

Lemchen said that besides giving patients a non-X-ray option, his machine will help orthodontists’ businesses by enabling them to better show prospective patients what they will look like after treatment.

“Orthodontics tends to be an elective procedure” that can cost $3,000 or more and is generally not covered by health insurance, Evans said. Also, about half of all people who pay an initial visit to orthodontists don’t return for treatment, “so it’s incumbent on the orthodontist to communicate what the patient is going to get out of this,” he said.

Still, doesn’t Dolphin run the risk of annoying orthodontists by reminding the public of the X-ray danger?

“I don’t think we’re going to upset a significant portion of the dental community,” Lemchen said. “I believe we should respond to our patients’ concerns before they force us to respond.”