ati neurostimulation systemsPG stimulation for Cluster Headache

relieves Cluster attack Pain and Decreases attack Frequency

improves Patient Headache Disability and Quality of life

Patient-Controlled, on-Demand therapy

unique Design for neurostimulator longevity

www.ati-spg.com

www.ati-spg.comautonomic technologies, inc.

Until recently, there were limited options to treat cluster headache. SPG stimulation is a new therapy for cluster headache that was specifically designed for the treatment of severe headache.

SPG stimulation uses a very small, minimally invasive, implantable neurostimulator that stimulates the sphenopalatine ganglion (SPG). The SPG is a nerve bundle located behind the nose, within the pterygopalatine fossa. It is a large extracranial parasympathetic ganglion. The SPG contains autonomic, sensory, and motor neural components. The SPG has been studied over the past 100 years, and there is a significant amount of international, peer-reviewed medical scientific literature on its role in severe headache. 1, 2, 3

The miniaturized SPG neurostimulator is smaller than an almond. It is implanted through a small incision in the gum on the side that is usually affected by cluster headaches. The implant procedure leaves no externally visible scars.

After the device is programmed, the patient controls their own SPG therapy. To activate the therapy on-demand, the patient places a handheld remote controller over their cheek, near the implanted neurostimulator. To stop stimulation, the patient simply moves the remote controller away from their cheek.

sPG stimulation therapy for Cluster Headache

Why Choose sPG stimulation?

Clinical evidence on the efficacy and safety of SPG stimulation for cluster headache is supported by the largest, most rigorous implantable medical device study ever conducted in cluster headache: the Pathway CH-1 clinical study, a randomized, multicenter, placebo-controlled study.

Relieves Cluster Attack Pain and Decreases Attack Frequency 4

• 68% of patients were able to control their debilitating cluster headaches by using SPG stimulation. These patients successfully treated more than 50% of their cluster attacks, experienced more than a 50% reduction in frequency of cluster attacks, or both.

• 67% of attacks treated with full stimulation achieved pain relief at 15 minutes, compared with only 7% of attacks treated with sham stimulation (Therapeutic Gain = 60%).

• 43% of patients had an average cluster attack frequency reduction of 88%.

Improves Patient Headache Disability and Quality of Life 4

• 64% of patients experienced improvements in headache disability.• 75% of patients experienced improvements in quality of life.• Improvements in these metrics were both clinically significant and statistically

significant.• Because the therapy stimulates the SPG directly, it does not cause undesirable

systemic side effects that medications can cause.

Patient-Controlled, On-Demand Therapy• Using a simple handheld remote controller, the patient decides when and where

to use their SPG stimulation therapy.• To apply therapy, the patient places the remote controller over their cheek,

over the implanted device.• To stop therapy, the patient simply moves the remote controller away from

their cheek.

Unique Design for Neurostimulator Longevity• The miniaturized neurostimulator was specifically designed to fit the facial

anatomy and remain stable at the implant site to reduce the risk of lead migration.

• No need to surgically replace the implanted neurostimulator over time due to battery depletion.

• First and only neurostimulator with CE marked MR Conditional labeling for whole-body MRI.

• Rechargeable remote controller.

CE Marked Intended Use The ATI™ Neurostimulation System is intended to relieve the acute pain of cluster headache. In some patients the use of the System has been associated with a reduc-tion in the number of cluster headaches.

Contraindications The ATI™ Neurostimulation System should not be used in patients who, in the opinion of the doctor, have bony facial deformities, inappropriate surgical anatomy or have had facial surgery in the area of the planned surgery that would prevent the proper placement of the ATI™ Neurostimulator.

Additional Information For information on warnings, precautions, risks, and side effects, refer to the ATI™ Neurostimulation System Implant Manual. A prescription is required.

References [1] Sluder G. (1908). The role of the sphenopalatine ganglion in nasal headaches. NY State J Med 27: 8-13.[2] Goadsby P. (2002). Pathophysiology of cluster headache: a trigeminal autonomic cephalgia. Lancet Neurology 2002; 1: 251–57.[3] Ansarinia M, Rezai A, et al. (2010). Electrical Stimulation of Sphenopalatine Ganglion for Acute Treatment of Cluster Headaches. Headache 50: 1164–1174.[4] Schoenen J, May A, Jensen R, Láinez JM, Lantéri-Minet M, Gaul C, Goodman A, Caparso A. Pathway CH-1 Study: Sphenopalatine Ganglion (SPG) Stimulation for Acute Treatment of Chronic Cluster Headache (CCH). Presented at the European Headache and Migraine Trust (EHMTIC) International Congress in London, September 2012.

3698 Haven Avenue, Suite C Redwood City, CA 94063 United States

www.ati-spg.cominfo@ati-spg.com

Autonomic technologies tm

© 2012 Autonomic Technologies, Inc. All rights reserved. M120801A