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 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.
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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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