For Marijuana Inhaler That Won’t Get You High, Regulation Could Be a Bad Trip

Source: Syqe Medical

Cannabis processed into the inhaler. Close

Cannabis processed into the inhaler.

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Source: Syqe Medical

Cannabis processed into the inhaler.

Perry Davidson thinks he can sell a 3-D printed marijuana piece that can reduce patients’ pain but won’t make them stoned. What is he smoking?

The challenge isn’t necessarily a lack of demand, though you can imagine there are more than a few purists who’d rather smoke their pot the old-fashioned way. Davidson’s company Syqe wants to go after the U.S., which has a $1.4 billion legal market that’s expected to reach $10 billion by 2018, according to Arcview Market Research. Syqe will need regulatory approval to do it, and that won’t be easy to get for the Jaffa, Israel, startup.

"Without cover from U.S. federal government, the Food and Drug Administration is pretty gun-shy in approving anything controversial," says Jason Wittes, an analyst at Brean Capital, which does not have a relationship with Syqe. “Otherwise, it's a pretty straightforward product."

Syqe (pronounced "psyche") says its cannabis-inhalation device can administer a measured dose of tetrahydrocannabinol, or THC, that will mollify a patient's pain without the psychoactive effects. This could make medicinal marijuana a viable option for children and people who are sensitive to the effects of being high. Founded by Davidson, a recreational pot smoker in his youth, Syqe uses 3-D printers to produce its inhalers, which come packaged with cannabis cartridges. Syqe procures its marijuana from Bedrocan in Veendam, Holland, where cannabis is also "very regulated," says Davidson.

Source: Syqe Medical

Syqe Medical's metered-dose pharmaceutical grade medical Cannabis inhaler. Close

Syqe Medical's metered-dose pharmaceutical grade medical Cannabis inhaler.

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Source: Syqe Medical

Syqe Medical's metered-dose pharmaceutical grade medical Cannabis inhaler.

Though cannabis remains a Schedule 1 substance under U.S. federal law — a category reserved for drugs that have "no currently accepted medical use" and thus are illegal — more than 20 states have enacted laws to legalize the drug for medical purposes since California first did in 1996. The number of U.S. medical marijuana users is estimated at more than a million. Two U.S. states, Washington and Colorado, voted to legalize the sale of marijuana for recreational use in 2012.

Beyond the regulatory maze facing Syqe's expansion plans, the company should expect pushback from doctors, says Raphael Mechoulam, professor of medicinal chemistry at the Hebrew University of Jerusalem. Mechoulam conducted groundbreaking research on the marijuana component cannabidiol in the 1960s, which helped physicians understand the drug’s medicinal benefits.

"Inhalation and smoking is more efficient than taking it orally,” Mechoulam says. "But physicians are never happy to give a mixture of compounds. It has to be quantitative and measured."

Syqe General Manager James Amihood says the industry is underdeveloped, leaving an opportunity for companies like his to chart the path forward. "Everything is new, and nothing is fully known in this business,” Amihood says. "With the right solution, we can pave the way."

The company hasn’t decided how much to sell its device for. Syqe is seeking to raise $20 million by the end of March, says Davidson. Syqe has raised $3.5 million to date, including $1 million from Israel's Office of the Chief Scientist.

Though marijuana is illegal in Syqe’s home country, Israel is home to 20,000 medical marijuana users, and that number is expected to more than triple by 2018, according to Davidson. Israel's Health Ministry approved Syqe's device for hospital use in October. Davidson has been involved in the medical cannabis campaign in Israel since its early stages.

"I have a lot of experience with ministers and doctors, and have sat in parliamentary meetings,” Davidson says. "The trouble is how to scale the industry, how to reach all the patients."

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