By Amy Reeves

Fans of "Star Trek" like to debate whether or when we might develop warp drives, transporters or holodecks.

And most folks watching the show probably have wondered at least once, "When are we gonna get those cool hypodermics with no needles?"

In fact, the basic technology already existed when "Star Trek" first went on the air in 1966.

It was used mostly in the military. But it wasn't until the 1990s that researchers refined it enough to be feasible for the mass market. Even today, makers of needle-free injectors (NFIs) are struggling to get a foothold in the U.S.

"We're primarily a name recognized in Europe," said Roger Harrison, chief executive of NFI maker Antares Pharma. (ANTR) "We need similar success here in the U.S."

The old NFIs were a long way from the "Star Trek" image. One model stood on the ground and fired a dose from a big metal gun. Other models suffered from reliability problems and could cause pain and bruising.

In recent years, no big medical device maker has wanted to touch the business. The technology has advanced through the work of small startups such as Aradigm, (ARDM) Equidyne (IJX) and Bioject Medical Technologies. (BJCT)

Those firms, along with Antares, still control almost all of the current market. But none has exactly set Wall Street abuzz.

The four combined for less than $44 million in revenue last year. None is profitable, and each has shares that can be bought on the cheap.

Still, each has worked to improve the technology from its early days. New devices have shrunk to pen size, and different NFIs are tailored to different drugs.

NFI makers target people who need to inject themselves frequently over long periods, such as diabetics and AIDS patients. Nearly all the products today are used to deliver insulin and human growth hormone.

Hunting An Edge

Because leading NFI makers are pretty small concerns, they need big partners. In particular they look to the makers of the injectable drugs, who might see the advantage in selling the drug and its delivery device together.

"Biotech companies look for the differentiation of their products through the use of innovative devices," Harrison said.

Bioject seemed to have hit a gold mine in 2000 when it cut a licensing deal with Amgen. (AMGN) But two years later Amgen changed its strategy and ended the deal.

Bioject has yet to recover. Its stock, which traded near 20 at the time of the deal, now hovers near 2. The stocks of the other three public players trade near or below 1.

Those in the business say they're still suffering for the mistakes of their forbears.

"(The challenge is) overcoming the perception that needle-free is not patient-friendly because of a lot of the historical devices being difficult to use (and) unreliable," said Toby King, senior director of research and development at Aradigm.

The technology has had an unusually "long gestation period," as Harrison puts it.

Improvements often haven't gone as fast as expected. King admits his project simply ran out of money before Aradigm bought it.

Still, the industry sees reasons for hope. Harrison says Antares and partner Ferring Pharmaceuticals have enjoyed success in Europe, mainly among children who fear needles.

In September, Antares landed a formidable ally when it entered into a licensing deal with pharmaceutical giant Eli Lilly. (LLY)

A Shot Of Convenience

Further variations on NFI devices might broaden their appeal. Antares and Aradigm are working on developing prefilled, disposable devices.

These would be ideal for emergency situations, such as a sudden allergic reaction. The patient could tear off the tip, inject himself with the right amount and throw it away.

NFIs must also be tailored to their particular patients, King says.

"If you're targeting (patients with) rheumatoid arthritis, you need to design a device that's simple to use, with nice big parts," he said. "Our device, because it's only three simple steps and you can't do them in the wrong order, is suitable for people who are visually impaired."

Harrison expects vaccines to become an important market as well. Many new therapeutic vaccines are due to launch, and many of those need to be delivered into the intradermal space between layers of skin.

That can be tricky with a needle, Harrison says, but NFIs can handle the job.

The challenge is finding more customers willing to buy the products. In the U.S., the NFI market remains tiny — $10.3 million in sales in 2002. New technologies and patients should help push the U.S. market to $425 million by 2007, Harrison says.

About 45% of that would belong to Bioject, 29% to Antares, 16% to Aradigm and 3% to Equidyne, with the rest split among smaller players.