TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
Despite seeing good growth in 2019, with net sales jumping to almost $2.4 million vs. $993,000 over the previous year, Electrocore Inc. has suspended its guidance due to uncertainty over COVID-19. The company previously said full-year revenue should be in the range of $7 million to $9 million.