REDWOOD CITY, Calif.--(BUSINESS WIRE)--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.1 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.2
“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.”
About the ATI Neurostimulation System
The investigational ATI Neurostimulation System is a novel, rechargeable system, with a miniaturized implantable stimulator approximately the size of an almond that is designed for the treatment of severe headache, including cluster headache and migraine. The neurostimulator is delivered through a surgical incision in the gum, leaving no external scars. The lead tip of the implant is placed at the sphenopalatine ganglion (SPG) nerve bundle deep in the face on the predominant side of the headache. For years clinicians have targeted the SPG to relieve severe headache, primarily by applying lidocaine and other agents to achieve a nerve block.
Using an external remote controller similar in size to a large cell phone, patients deliver as-needed stimulation to relieve the headache. After the headache is treated, the remote controller is simply moved away from the cheek, turning off stimulation therapy.
ATI anticipates European CE mark for use of the ATI Neurostimulation System for the treatment of cluster headache in the near future.
The US Food and Drug Administration (FDA) has approved investigational use of the ATI Neurostimulation System in the United States for treatment of cluster headache.
About the Pathway M-1 Study
The multi-center, randomized Pathway M-1 study will begin in leading headache centers in Denmark, Belgium, Spain, France and Germany. Additional European centers will be added later in the year. The study will enroll at least 30 patients who have a minimum of 4 migraine attacks per month and experience migraine pain on at least 8 days per month. For more information about the study and participating centers, visit www.ati-spg.com/m1/en1.
About Autonomic Technologies
Autonomic Technologies, Inc. (ATI) is a San Francisco Bay Area based medical device company backed by blue chip investors Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures, and the Cleveland Clinic. For more information, visit www.ati-spg.com.
1 Goadsby, P. J., Lipton, R. B., et al. (2002). "Migraine--current understanding and treatment." N Engl J Med 346(4): 257-270.
2 The Global Burden of Disease: 2004 Update. World Health Organization.
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