electroCore Provides Update on COVID-19 Clinical Initiatives
Randomized controlled investigator-initiated trial (IIT) of non-invasive vagus nerve stimulation (nVNS) therapy currently enrolling COVID-19 patients in
Peer-reviewed paper, “Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience,” accepted for publication in the journal Neuromodulation: Technology at the Neural Interface
The company announced today that an investigator-initiated, randomized, controlled clinical trial of nVNS therapy has commenced enrolling COVID-19 patients in
Multiple US institutions have expressed interest in conducting additional controlled clinical studies of nVNS’ potential utility in treating COVID-19 patients. A second investigator-initiated randomized, controlled trial protocol (SAVIOR-2) was recently approved by the
“COVID 19 is causing a worldwide pandemic, the likes of which we have not seen before. Worldwide data indicate that COVID 19 causes a lethal cytokine storm in a small percentage of people who contract the virus, so strategies directed at blocking cytokine release hold promise,” commented
The company also announced today that a paper, entitled, “Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience,” has gone through peer review and been accepted for publication by the highly-regarded journal Neuromodulation: Technology at the Neural Interface. The paper will be made available via open access when published online in the near future.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s initial targets are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is FDA cleared in
- Safety and efficacy of gammaCore have not been evaluated in the following patients:Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
• Patients should not use gammaCore if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including potential human trials for the study of nVNS in COVID-19 patients in