- FDA has granted emergency use authorization to electroCore for a handheld, noninvasive vagus nerve stimulator to treat COVID-19 patients with asthma-related breathing difficulties and reduced airflow.
- The portable, rechargeable gammaCore Sapphire CV transmits a low-voltage electrical signal through the skin on either side of the patient's neck. It may be effective for acute emergency use at home or in a medical setting when standard drug therapy provides insufficient symptom relief or cannot be tolerated, FDA said in its EUA letter for the product, dated Friday.
- The agency authorized use of the device during the COVID-19 pandemic based on preliminary data from two prospective studies that showed improvements in asthma patients' scores for forced expiratory volume and dyspnea, or breathing difficulty, electroCore said Monday. The device was not tested in COVID-19 patients. Shares of the small Basking Ridge, New Jersey-based medtech more than doubled in value to close at $1.78 Monday on the Nasdaq.
A high level of aggressive, prolonged inflammation of the airways has been reported in patients with COVID-19 infections, FDA said. The problem is expected to worsen symptoms significantly in asthma patients.
There are no adequate approved device alternatives for the intended use of the gammaCore product. The device may help patients struggling with reduced airflow by inhibiting airway constriction and relaxing the smooth muscles, the agency said.
The device received Europe's CE mark in 2011 for treating respiratory indications including reactive airway disease, which includes asthma, bronchoconstriction, exercise induced bronchospasm and chronic obstructive pulmonary disease (COPD).
In the U.S., electroCore has focused on indications for preventing as well as treating pain associated with cluster headache episodes. The device is also indicated to treat migraine headache pain and in March received an expanded indication to include prevention of migraine.
The tiny company generated $734,000 in net sales in the first quarter, up from $410,000 the year before. Its net loss from operations narrowed to about $7.9 million, from a loss of $13.8 million the year before.
Receiving FDA's EUA could be a first step toward developing evidence to support expansion of noninvasive vagus nerve stimulation into reactive airway disease, the company's initial area of research, JP Errico, an electroCore board member and co-founder, said in the company's latest announcement.
In April, electroCore said it had begun enrolling COVID-19 patients in Spain in an investigator-initiated, controlled clinical trial to evaluate the effect on respiratory symptoms due to the virus. That study is designed to assess how well noninvasive vagus nerve stimulation can decrease the number of hospitalized COVID-19 patients needing ventilator support.
Data suggest COVID-19 causes a cytokine storm in a small percentage of people who contract the virus, so strategies aimed at blocking cytokine release hold promise, electroCore Chief Medical Officer Peter Staats said at the time.
Early pilot studies in respiratory indications such as asthma and bronchoconstriction, and literature demonstrating that vagus nerve stimulation blocks the cytokine storm in animals, support the hypothesis that the company's device may improve outcomes in patients with COVID-19, Staats said.
In its earnings release in May, the company said an institution in Pittsburgh, Pennsylvania, will conduct an investigator-initiated clinical study of the device's potential for treating COVID-19 patients.