electroCore Supports Results of Lancet Paper Highlighting the Benefits of Vagus Nerve Stimulation for Stroke Patients

May 18, 2021 at 08:56 AM EDT

electroCore anticipates results of the company’s two clinical studies on non-invasive vagus nerve stimulation for acute treatment of stroke

electroCore, Inc., a commercial-stage bioelectronic medicine company, commends the results of the VNS-REHAB study published in the April 24^th edition of The Lancet which demonstrated how vagus nerve stimulation (VNS) during rehabilitation can significantly improve arm function after an ischemic stroke. Effective treatments hold particular interest because stroke is the second highest cause of death and the third leading cause of disability globally, with ischemic stroke as the most common type of stroke. The results of the VNS-REHAB study build general excitement for the medical and scientific community’s ongoing efforts to find new and safe ways to treat the immediate or long-term disabilities faced by stroke patients.

In detail, the VNS-REHAB study showcases how surgically implanted VNS (iVNS), combined with motor rehabilitation, was able to continue to improve limb function years after a stroke. In this clinical trial, patients with moderate-to-severe arm impairment after ischemic stroke participated in rehabilitation for two years after the implantation of VNS. The results showed that VNS decreased motor impairment and improved function at a faster rate and progressed further than those treated with only the existing standard of care.

In general terms, VNS activates the body’s longest nerve which is connected to many major organs that are vital to cognitive, sensory and motor function, allowing the body to safely “correct” its own brain signals to address any clinical difficulties. The same edition of The Lancet also featured commentary on the VNS-REHAB trial from Professor Marieke Wermer and Dr. Anne van der Meij, which noted the “remarkable” success of iVNS to enhance post stroke rehabilitation and the “incredible” promise of VNS.

Prof. Wermer and Dr. Van Der Meij describe current research regarding the potential for non-invasive vagus nerve stimulation (nVNS) as another option for treating stroke, although no results are published yet. They highlight nVNS as potentially having broader clinical potential because of its rapid and practical administration. In fact, Prof. Wermer and Dr. Van Der Meij are currently leading the NOVIS study to investigate the acute treatment of ischemic stroke with nVNS.

Parallel to the NOVIS study, electroCore recently announced the completion of enrollment in its TR-VENUS study of nVNS with gammaCore^TM as a possible acute therapy for ischemic stroke.

“Treating stroke quickly and safely is imperative for reducing the amount of disability and in some cases, death,” states Peter Staats, MD, Chief Medical Offer of electroCore. “electroCore’s small, portable nVNS device, gammaCore Sapphire, offers the potential opportunity for rapid treatment after the onset of stroke, even as early as in the ambulatory setting before reaching the hospital. Because it does not require surgery and can be applied at any time after a stroke, this could potentially offer significant time savings that might lead to improved outcomes.”

gammaCore (nVNS) is currently available to treat a variety of significant conditions as a convenient, non-drug alternative. gammaCore Sapphire^TMis an established, FDA-cleared therapy in the headache space, for treating and preventing migraine and cluster headache, including migraine in COVID patients. Additionally, gammaCore Sapphire CV^TM received an emergency use authorization (EUA) from the FDA to treat patients with known or suspected COVID-19, who are experiencing exacerbation of asthma-related dyspnea and reduced airflow.

“We eagerly look forward to the results of the recently completed TR-VENUS study (NCT03733431) and the larger, on-going NOVIS study (NCT04050501), which are investigating the safety, feasibility and efficacy of nVNS for stroke patients,” concluded Eric Liebler, Senior Vice President of Neurology at electroCore.

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 current indications 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.

Forward-Looking Statements

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 the potential of VNS and nVNS generally and gammaCore in particular to treat stroke and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

About gammaCore^TM

gammaCore^TM (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 the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients 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 the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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 (less than 12 years of age)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

In the United States, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders, such as COVID-19-associated acute respiratory stress disorder. Refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.

The U.S. FDA has cleared the gammaCore Sapphire CV device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient's neck.

gammaCore Sapphire CV has not been cleared or approved for acute use in the home or healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient's neck during pandemic Coronavirus Disease 2019 (COVID-19).

gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:

Letter of authorization: https://www.fda.gov/media/139967/download

Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download

Patient information sheet: https://www.fda.gov/media/139969/download

Instructions for use of gammaCore https://www.fda.gov/media/139970/download