Next Safety (West Jefferson, North Carolina), primarily focused on developing powered respirators, out of those efforts has developed a device that it expects to alter the landscape of pulmonary drug delivery.

What's more, one of those "drugs" — and the first for which it will seek approval – is nicotine as a strategy to provide an aerosol designed to help smokers stop inhaling smoke, but still get the fix of the drug. That plan is not without those who protest such a use of a drug delivery device, saying it promotes addiction to nicotine, Lyndell Duvall, director of technology and product development and corporate vice president for Next Safety, told Medical Device Daily.

"The pulmonary delivery device kind of sprang out of an idea that we had during the development of the respirator," Duvall said. "Essentially our device is — we call it a mandible port — inserted between the respirator and the unit that delivers the air."

But he believes such a delivery device for nicotine would be more effective, and therefore more marketable, than other options like nicotine gum or patches because it delivers a more concentrated dose.

It is also expected to fulfill an unmet need for other drugs, particularly drugs now off-patent and considered generic in order to "revive their use," he said.

And although the "jury is still out on nicotine," the device would require a prescription for some of the other drugs being considered for use with it.

When the company begins clinical testing under an Institutional Review Board protocol soon, the drugs slated to be tested with the device will be antiobiotics such as tobramycin, the anti-nausea drug phenergen, albuterol and morphine.

"[The device] would be applicable to use similar to an inhaler," Duvall said. "The other embodiment of it, if you will, is including it in the air flow between the respirator and the wearer."

The company's hope is that it will be able ultimately to license the technology with a prototype and early test results, expected in July, Duvall said, since medical devices "that require FDA qualification" are not considered the company's "core business." Patents are pending on the delivery device currently.

"The fundamental nature of this development means that pulmonary delivery for a wide range of drug classes will be vastly improved or enabled," said Tom Stern, MD, assistant professor of medicine in the Department of Internal Medicine at Carolinas Medical Center (Charlotte, North Carolina) and a member of Next Safety's Medical advisory board.

Stern said, "To date, laboratory data suggests applications such as childhood asthma or home delivery of medicines previously requiring an IV will be equally benefited."

And while saying that further testing is needed, he suggested that "this fundamental breakthrough may eventually be seen as important as the invention of the syringe."

As for those drugs expected to undergo testing in the device, Duvall said "an easy example" where someone would prefer inhaling to an IV is morphine. Morphine delivered via the pulmonary delivery device would also "offer the potential for home healthcare."

Phenergen, an anti-nausea drug, is typically delivered orally also, but at a time when most people really don't feel like putting anything in their mouths, he said.

The "gist" of why the company believes its technology will be "more effective and more safe" is that it has more control over the droplets that are issued than most other inhalers, Duvall said.

"Things like metered dose inhalers and nebulizers … typically generate a massive cloud of droplets instantly, and it's a bulk process, which means that you have some variation in the droplet size with perhaps very small droplets that can be delivered deep in the lung to larger droplets that get deposited higher up in the airways," Duvall said.

Rather than that approach, the Next Safety-developed device uses a technology "to eject the droplets essentially one at a time, and those droplets are ejected through a nozzle that generates essentially the same droplet size every time."

The company is now taking orders for its bPure8000 respirator over the company web site, with manufacturing scheduled to begin later this month or in early July.

The respirator was Next Safety's first project, Duvall said.

"Essentially, what we did is design it to have the best run time, best filter efficiency and best air flow on the market," he said.

The company was founded by CEO C. Eric Hunter, who was also a co-founder of Cree Research (Durham, North Carolina).

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