ElectroCore Receives Australian and Colombian Regulatory Approval for GammaCore Vagal Nerve Stimulation Therapy

* Reuters is not responsible for the content in this press release.

Tue Feb 19, 2013 9:00am EST

- GammaCore approved to treat primary headache in both countries

MORRIS PLAINS, N.J., Feb. 19, 2013 /PRNewswire/ -- ElectroCore®, a company
dedicated to developing effective, non-invasive Vagal Nerve Stimulation (nVNS)
therapies for serious medical conditions including primary headaches, announced
today that its GammaCore® therapy has been approved for commercial sale by the
Therapeutic Goods Administration in Australia and the National Institute of
Surveillance of Medicine and Foods in the Ministry of Health in Colombia.
GammaCore's non-invasive, non-pharmaceutical, neuromodulation therapy is
indicated for the acute and/or prophylactic treatment of primary headache
(migraine, cluster headache and Hemicrania Continua) and medication overuse
headache in adults.

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Monday 24th June 2013


Early results show potential for non-invasive vagal nerve stimulator as a novel, effective, and well-tolerated treatment for cluster headache


The results of an open label study presented at the INS (International Neuromodulation Society) 11th World Congress in Berlin showed that Non-Invasive Vagal Nerve Stimulation (nVNS) has meaningful clinical benefits both in the time to relief from an acute cluster headache as well as a decrease in the frequency of attacks.

The report on the open-label trial, run by the Royal Free London NHS Foundation Trust on behalf of two sites in the UK and Ireland was presented by Dr Alexander Nesbitt and Dr Juana Marin. The report included data from 21 patients, with five followed to twelve months of experience with nVNS, and concluded that nVNS delivered by electroCore’s gammaCore device appeared to be effective, safe and well-tolerated for up to twelve months. The report concluded that nVNS is useful for both acute and preventive treatment strategies and should be considered before surgically invasive neuro-stimulation. The authors concluded that this data strongly supports additional randomised studies of nVNS.

“Although the data is still early, these results are encouraging,” said Professor Peter Goadsby, Professor of Neurology at the University of California, San Francisco. “Acute cluster headache is a dreadfully painful condition, and can be utterly disabling. These results are likely to encourage further research into this new treatment which offers real hope to patients.”

Data Highlights

Acute Treatment of cluster headaches
• The researched showed that on average, 47 per cent of the treated attacks were terminated within 15 minutes.
• There was also a reduction in the use of concomitant therapies (hi-flow oxygen and injectable triptans).
Preventative Treatment
• The research showed that nVNS is useful for preventive treatment. On average the number of attacks within a 24 hour period was halved following treatment.
• Overall, 86% of the patients noted that they were satisfied or very satisfied with the treatment and would recommend it to others. Adverse events were mild and transient. Full data will be submitted for publication in a peer-reviewed medical journal.

JP Errico, Founder and CEO of electroCore commented, “We are pleased to see our gammaCore device provide such meaningful and sustained relief for people suffering from cluster headaches. We believe that nVNS therapy offers possible clinical benefits in a number of therapeutic areas and, as this study highlights, our novel technology takes this therapy out of the operating room and puts it into the hands of clinicians and patients in a way they can benefit from it on an on-going basis”

Cluster headaches are considered by many to be one of, if not the most painful of all headache conditions. Attacks can last anything from 15 minutes to three hours and can strike up to eight times a day. In the United States, only one product has been approved by the FDA for the treatment of acute cluster headaches and no products have been formally approved for reduction of cluster attacks.

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