Positive preliminary findings from ATI's neurostimulation system study on cluster headache

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable system for severe headaches, today announced positive preliminary findings from a study evaluating the safety and efficacy of the company's investigational neurostimulation system for the treatment of cluster headache. Jean Schoenen, M.D., coordinator of the Headache Research Unit at University of Liege in Liege, Belgium, presented the findings at a late breaking session today at the 15^th Congress of the International Headache Society in Berlin, Germany.

Cluster headache is a highly disabling neurologic condition characterized by intense stabbing pain in the area of one eye, often accompanied by swelling, tears and nasal congestion. Often called 'suicide headache,' the pain inflicted by the condition is recognized as amongst the most severe known to man. Sufferers can have headache attacks multiple times per day, each lasting 15 minutes to three hours. Approximately one in one thousand people suffer from cluster headaches.¹

Twenty-two of approximately 40 planned patients have been enrolled in the Pathway CH-1 study. Of those, stimulation data from the therapy 'titration' period are available for seven patients. The primary endpoint of Pain Relief within 15 minutes was met in 67 percent of headaches treated>

Importantly, more than 70 percent of patients experienced a reduction in the frequency of their headaches by 50 percent or more as compared to the four-week period prior to study enrollment. This effect was only seen once patients began using stimulation.

"These results are extremely encouraging," said Prof. Dr. Schoenen. "Chronic cluster headache sufferers are highly disabled by their condition, which causes immense pain and often prevents patients from leading a normal life. The investigators and I look forward to continuing to study this novel therapy in cluster headache, as well as future research in severe migraine."

"There are few treatment options today that serve cluster headache patients well," said Prof. Dr. Arne May, a neuroscientist at the University Hospital Hamburg-Eppendorf and president of the German Migraine and Headache Society. "Current treatments include preventive and acute abortive drugs, including expensive injectable medications and inhaled oxygen. Some patients are not candidates for these medications, and others experience significant side effects or have cardiovascular risk factors that place them at risk for taking them. I am hopeful that this novel approach might offer promise for many cluster headache patients."

"We are extremely pleased with these promising early results," said Ben Pless, president and chief executive officer of Autonomic Technologies. "We look forward to continued studies of our technology for cluster headache as well as for migraine, with the hope that our work may one day offer relief to millions of people."