electroCore has regulatory approval for the use of gammaCore therapy in the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache throughout the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil and Malaysia. In Canada the therapy is indicated for the acute and/or prophylactic treatment of cluster headache and for the treatment of migraine.
However, at this time, electroCore is focusing its commercial activities on migraine and cluster headache in particular markets through specialist physicians.
The therapy is not yet available in the US.
In the US, gammaCore will be evaluated by the CDRH division of the FDA for medical device use in cluster headaches as a De Novo application.
electroCore will be expanding the marketing of the therapy to other countries where it has the CE mark during 2014.