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Cervel Announces Successful Depression Clinical Study Results

Primary and Secondary Endpoints Achieve Statistical and Clinical Significance

REDWOOD CITY, CA -- (Marketwired) -- 09/03/14 -- Cervel Neurotech, Inc., a privately held company pioneering a non-invasive and non-pharmacologic treatment for depression, pain and other conditions, today announced the achievement of primary and secondary endpoints in a feasibility study of its multicoil repetitive transcranial magnetic stimulation (rTMS) system for patients suffering from depression. The Hamilton Rating Scale for Depression (HAMD), a scientifically validated tool for measuring depression severity and widely considered the gold standard, was used to assess the clinical endpoints in the randomized, sham-controlled, double blind study.

"We are extremely pleased with the results from our feasibility study as it supports the effectiveness of our multicoil approach for treating specific brain circuits responsible for depression symptoms," said Eric Meier, chief executive officer of Cervel Neurotech. "The Cervel System produced a fast and strong antidepressant effect.

Depression is a devastating condition for patients and their loved ones, and medication therapy alone is either not effective or poorly tolerated for a significant percentage of patients," continued Meier. "Our immediate focus will be completion of a pivotal study and the other requirements for marketing clearance."

The primary endpoint was the average change in HAMD scores from treatment start to finish, comparing patients receiving real rTMS and those receiving sham (placebo) treatment. Data analyzed from 86 patients at five sites demonstrated a statistically significant advantage in average score improvement for the rTMS group. Throughout the study, there were no serious device-related adverse events.

As a secondary study endpoint, the proportion of patients responding well to treatment was measured in each group, with treatment responders defined as patients whose HAMD depression symptoms were reduced by at least 50 percent. In the Cervel study, the proportion of patients receiving real rTMS who met the responder definition was almost twice that of the sham group. Moreover, the difference in response rates between the real and sham rTMS groups achieved statistical significance.

Certain central nervous system conditions, such as depression and pain, are thought to occur because of disordered metabolic activity in a network of regions within different brain circuits. TMS involves using pulsed magnetic fields to create small electrical currents that stimulate those areas to restore metabolism. Cervel's proprietary approach uses multiple magnetic fields, generated by coils placed on a patient's scalp, to selectively stimulate both superficial and deeper brain regions, to relieve the symptoms of the associated condition.

Depression remains one of the most common and disabling mental illnesses affecting 16 million adults in the United States (US) alone, according to the National Institute of Mental Health. Despite undergoing treatment with antidepressant medications, approximately four-and-a-half million people either do not respond to or cannot tolerate the side effects of their medications. The Cervel feasibility study included subjects from both of these classifications.

About the Cervel Neurotech System
The Cervel System is an investigational device, limited by US law to investigational use only. Visit www.cervel.com for more information.

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