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U.S. e-cigarette experiment inspires new medical device

By Toni Clarke

(Reuters) - When Noah Minskoff's mother died of lung cancer in 2007, e-cigarettes were just entering the U.S. market. Minskoff, who had just started medical school in Utah, wondered whether the devices might have saved his mother's life by helping her quit smoking. Later, he sent some samples to his boyhood friend Nathan Terry, a mechanical engineer, and asked for his opinion.

Terry, who was working in Germany for the French industrial firm Areva, took apart the products to see how they were made. What he found disturbed him: at the heart of the devices were heater wires of unknown quality wrapped around bundles of glass fibers and surrounded by steel wool, silicon, plastic, tape and adhesives.

Wires between the heater, circuit board and batteries were connected with lead solder and also housed in tape and plastic. Everything was close to the heat source, meaning consumers were at risk of inhaling fiber and metal particles as well as toxic fumes from hot plastic and lead.

"There were red flags everywhere," Terry said.

Still, he liked the concept and decided to design a version of his own, avoiding the use of fiberglass, plastic and solder and sourcing his materials entirely in the United States. In 2009 he reunited with Minskoff in California and formed a company, Thermo-Essence Technologies, to sell the product.

At $300 a piece, the e-cigarette serves a niche market, albeit one with a loyal following among medical marijuana patients and smokers looking for a high-end e-cigarette. As many as 30,000 have been sold.

But what began as a quest to develop a better e-smoke has broadened into an ambitious effort to design a new medical device: an inhaler that delivers measured doses of nicotine to help people quit smoking. The technology could also eventually be used as an abuse-resistant delivery device for other drugs, including opioid painkillers.

If successful, the inhaler could become the first new smoking-cessation product to emerge from the e-cigarette field and would compete with products such as GlaxoSmithKline Plc's nicotine gum and Pfizer Inc's antismoking drug, Chantix.

A STARTUP WITH BIOTECH FUNDING

To develop the inhaler, Terry formed a second company, Minusa LLC, which is based in Newtown, Connecticut. Minskoff left Thermo-Essence for family reasons and is not involved in Minusa. Terry himself is leaving Thermo-Essence, which is currently being sold, to concentrate on Minusa.

The new company obtained initial funding from Michael Breede, a commercial real-estate-turned-biotech investor whose father suffered from drug and alcohol addiction and who is eager to see an abuse-resistant painkiller device.

"This is in my wheelhouse," he said. "I think we can put a serious dent in this problem."

When Terry developed his e-cigarette he assumed the U.S. Food and Drug Administration would begin regulating the industry, as it has recently done, proposing a ban on sales to people under the age of 18 and requiring companies to register. Later it could impose product standard and quality controls.

Terry wanted to create a product that would pass any FDA inspection. He used a pure metal wire wrapped around a rod made from magnesia-stabilized zirconia, a highly durable ceramic material. Instead of meshes, tape and plastic he used novel porous ceramics and surgical-grade alloys, and instead of soldering parts together he connected them mechanically, fitting components together like Legos to complete the circuits.

He built on that design to create his drug-delivery device, known as Envi, a single-user, tamper-resistant, metered-dose inhaler.

Envi is about the size of a short cigar and comes with a spare in a case the size of a deck of playing cards.

The nicotine or other drug will come in a sealed cartridge that the patient will insert into the inhaler. To activate the device, the user will have to enter a code. The inhaler will be programed to deliver a certain amount of drug and then turn off.

When the device is returned to the case, which is required after each dose to activate it for the next dose, data on the patient's usage will be downloaded and available to be viewed electronically by the prescribing physician.

"It will only let you take your prescription," Terry said. "It will log your usage and transmit it in real time, and make it easier for the doctor to monitor and interact with the patient."

BUILDING A BETTER INHALER

Terry, 37, who grew up on an organic farm in Ohio to "hippy commune" parents and studied mechanical engineering at the University of Idaho, faces multiple challenges.

Inhalers are typically more expensive to develop than pills, and ensuring patients get the right dose is more complicated.

"I can see a lot of barriers, but the idea is certainly interesting," said Dr. Ben Forbes, a Reader in Pharmaceutics, broadly the equivalent of a U.S. professor, at King's College London who specializes in inhaled medications.

There needs to be a good reason to target a drug to the lungs, Forbes said. Drugs that are inhaled may work faster than pills, so a device that offered quick pain relief in an abuse-resistant form would be "brilliant" if it could be produced economically, he added.

"Changes in inhaler technology have been very incremental over the years, so maybe something like this would have a place."

In the meantime, big tobacco companies are developing alternative nicotine products they hope one day will carry a "modified risk" of harm. Some are dispensed through an inhaler.

Unlike Terry's smoking-cessation device, which he plans to file with the FDA's drug division, these products would be marketed as less risky alternatives to smoking and be processed through the FDA's tobacco division.

However smokers end up using the new products will be the subject of intense research by the FDA.

Terry believes he is creating a product that will survive any market configuration. Minusa has a long way to go, and human trials may be two years off. Eventually he hopes to partner with a big drug company.

"I think we can change how drugs are delivered."

(Reporting by Toni Clarke in Washington; Editing by Michele Gershberg and Prudence Crowther)

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