Redwood City, CA (March 9, 2017) Autonomic Technologies, Inc. announced today that it has received an expanded indication (CE mark) in Europe for the Pulsante® SPG Microstimulator System to include pain relief for highly disabled migraine patients. Autonomic Technologies is a global medical device company focused on the development and commercialization of innovative therapies for the treatment of cranial autonomic disorders, initially severe headache.
The Pulsante® SPG Microstimulator System is the first implantable neurostimulation therapy to receive CE Mark for pain relief in both cluster headache and certain types of migraine. Specifically, the Pulsante® SPG Microstimulator System is now also indicated for pain relief in migraine patients for whom standard of care treatment is inadequate or contraindicated, and who are disabled by attacks (with or without aura) with one or more of the following characteristics: predominately unilateral orbital or temporal pain, pain free periods between typical attacks, the presence of cranial autonomic symptoms. The expansion in indication was based on clinical data from a feasibility study.
“We are delighted to receive this expansion of our CE mark for the use of the Pulsante® SPG Microstimulator System for people suffering from migraine,” said Niamh Pellegrini, President and CEO of Autonomic Technologies. “With this new indication, we will partner with clinicians to better understand the efficacy of Pulsante® therapy for migraineurs and look forward to continued study.”
In 2012, the Pulsante Microstimulator System received CE mark for acute pain relief of cluster headache, a disabling neurological condition characterized by intense, stabbing pain, typically on one side and often accompanied by swelling, tears, and nasal congestion. The Pulsante System provides acute pain relief for cluster headache using on-demand stimulation of a nerve bundle behind the nose known as the sphenopalatine ganglion (SPG). The CE mark for acute pain relief of cluster headache was based on robust clinical evidence from the Pathway CH-1 study1, and to date, more than 400 patients have received the therapy. Recently published, long-term follow-up data2 reaffirms the effectiveness of the therapy, with more than 60 percent of the patients enrolled in the study maintaining their therapeutic response and decreased use of medication at 24 months.
About the Pulsante® SPG Microstimulator System
The Pulsante Microstimulator System offers on-demand stimulation of the sphenopalatine ganglion (SPG), which is known to play a critical role in headaches with autonomic features, such as cluster headache and migraine. The Pulsante® SPG Microstimulator is activated using an external remote controller, allowing patients to deliver as-needed stimulation to relieve the attack. Backed by excellent, long-term2 clinical data, Pulsante has received CE mark for pain relief in cluster headache and certain types of migraine.
Migraine is a primary headache disorder that poses a significant burden in terms of the impact on patients’ daily lives and represents an area of significant unmet need. The Migraine Trust estimates that the disease affects approximately 1 in 7 people worldwide. In its 2013 Global Burden of Disease Study,the World Health Organization found that migraine is globally the sixth leading cause of years lost due to disability. Some migraine patients who are highly disabled, either by the intensity or frequency of their attacks and/or the symptomology associated with those attacks (including the presence of tearing (lacrimation), eyelid edema, and nasal congestion), do not respond to current abortive or acute treatments. It is just such patients who may benefit from emerging therapies such as SPG stimulation to lessen the burden of their condition.
About Autonomic Technologies
Autonomic Technologies, Inc. (ATI®) is a medical device company headquartered in the San Francisco Bay Area with an office in Germany, focused on the development and commercialization of innovative therapies for the treatment of autonomic disorders, particularly severe headache. The company’s initial product, the Pulsante® Microstimulator, is CE marked in Europe for acute pain relief of cluster headache and pain relief for highly disabled migraine patients. The device (also known as Autonomic Technologies, Inc. (ATI®) Neurostimulation System) is under an IDE study in the US for the treatment of chronic cluster headache. ATI is backed by world-class European and US investors including Edmond de Rothschild Investment Partners, Forbion Capital Partners, HBM Healthcare Investments, Kleiner Perkins Caufield and Byers, InterWest Partners, Aberdare Ventures, Novartis Venture Funds, Capital Royalty Group and Cleveland Clinic. For more information, please visit: www.pulsante.eu or www.ati-spg.com.
- Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJA, Gaul C, Goodman AM, Caparso A, May. A. Stimulation of the shenopalatine ganglion (SPG) for cluster headache Pathway CH-1: A randomized, sham-controlled study. Cephalalgia 2013;33:816-30.
- Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache: Tim P Jürgens, Mads Barloese, Arne May, Jose Miguel Láinez, Jean Schoenen, Charly Gaul, Amy M Goodman, Anthony Caparso, and Rigmor Højland Jensen, Cephalalgia, 2016. (http://www.ati-spg.com/europe/en/atineurostimulation-system/publications/)
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