|Ben Pless, CEO of Autonomic Technologies|
Based: Redwood City, CA
The Scoop: Using an external remote controller similar to a large cell phone, patients deliver as-needed stimulation to an implant in the gum to relieve severe migraines or cluster headaches. The implant, placed closest to where the headaches take place, targets the sphenopalatine ganglion nerve bundle deep in the face. Once the headache is treated, patients can move the remote away from the cheek and the stimulation therapy is done. It all takes 5 to 10 minutes.
What Makes It Fierce: The tiny, minimally invasive device (smaller than an almond--about a half-cubic centimeter) addresses severe headache/migraine disorders in a more effective way than existing neurostimulators, which can simply cover up the pain with other sensations or drugs rather than combat it outright, Autonomic Technologies' CEO Ben Pless notes. "What we are doing," he says, is blocking the parasympathetic nerve flow, which … makes the reason for the pain go away."
"These patients we are treating today are the ones that have no other options," he explains. "They are miserable. Disability is high. And they are getting relief they would otherwise not be able to get."
Additionally, Autonomic Technologies' neurostimulation device is the only one on the market in Europe that is completely MRI-compatible, Pless said, in part because of its small size.
Investors ranging from Kleiner Perkins Caufield and Byers to InterWest Partners, Versant Ventures, Novartis Ventures Aberdare Ventures and the Cleveland Clinic have taken notice. (The company's basic intellectual property came out of the Cleveland Clinic, with the full therapy developed at Autonomic Technologies.) Autonomic Technologies has pulled in $57 million in venture funding so far, including a $32 million Series C round in October 2011. That funding round has help propel Autonomic Technologies overseas. Armed now with a CE mark, the company is ramping up for commercialization, with expectations to complete its first sales by year-end at "key centers." A broader commercial launch is on tap for next year.
Negotiations with U.S. regulators, meanwhile, are advancing. The FDA approved a feasibility trial investigational device exemption several months ago. But the company is now pursuing the possibility of going straight to a pivotal trial, based on European data. Either way, U.S. clinical trials should launch next year. Once complete, Autonomic Technologies will seek PMA approval for its tech as a Class III medical device, Pless says. If all goes well, Autonomic Technologies hopes to have approval in hand by 2016.
What To Look For: With its European commercialization plans and focus on U.S. regulatory development, Autonomic Technologies is eyeing at least one more funding round. Plans call for raising about $30 million in a round that would close in late 2013/early 2014, Pless says. Longer range, he sees the company continuing on its own but will entertain a variety of options.
"We have kind of an old-fashioned idea. We want to go out there and make money," he says. "If by doing that we create value and the opportunity to do a merger, we would consider it. But those kinds of things happen when they happen. Until then, we are building an organization to be a profitable business."
-- Mark Hollmer (Twitter | email)
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