ATI commences European trial of neurostimulation system for migraine

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable stimulator for severe headaches, today announced initiation of a study in Europe to evaluate the safety and efficacy of the company's investigational neurostimulation system for the treatment of high frequency, high disability migraine. The multi-center, randomized Pathway M-1 study will enroll 30 patients initially at leading headache centers in Denmark, Belgium, Spain, France and Germany.

Migraine is the most common disabling headache, affecting 11% of the population in Western Europe and the United States. It is marked by pulsating, moderate to severe pain lasting from 4-72 hours, and may be associated with nausea and sensitivity to light or sound. According to the World Health Organization, severe migraine is associated with the highest level of disability (Class VII), higher than that of Congestive Heart Failure, Parkinson's and Alzheimer diseases.

"Current migraine treatments include preventive and acute abortive drugs, but these are not effective for all migraine sufferers," said Prof. Dr. Rigmor Hoejland Jensen, Director of the Danish Headache Center at Glostrup Hospital in Denmark and study Principal Investigator. "Some patients cannot use these medications because of cardiovascular risk factors or side effects, and others do not achieve effective relief. There is a clear need for an effective therapy for the most severely affected migraineurs who do not find relief from medications."

The ATI Neurostimulation System is also currently being evaluated in the Pathway CH-1 study for the treatment of cluster headache, an extremely severe headache disorder. Interim results of this study were presented at the North American Neuromodulation Society meeting in December 2011 by Prof. Dr. Jean Schoenen, coordinator of the Headache Research Unit at University of Liege in Belgium. These interim results demonstrated pain relief in 59% of headaches treated. An important additional finding was a ≥50% reduction in headache frequency in 63% of patients treated.

"Building on our therapy's promising results in cluster headache, ATI and our investigator team are excited to begin clinical work with migraine patients," said Ben Pless, President and Chief Executive Officer of Autonomic Technologies. "We hope that our work may one day offer relief to tens of thousands of severe headache sufferers."