electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of Stroke
Primary objective to assess the safety of nVNS in the setting of acute stroke by examining decreases in arterial blood pressure, severe bradycardia, progression of neurological deficits and death
ROCKAWAY, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that full enrollment has been achieved for the TR-VENUS study of non-invasive vagal nerve stimulation (nVNS) for the acute treatment of stroke. TR-VENUS is a double blind, randomized, sham-controlled, multi-center clinical trial, conducted at nine major medical centers across Turkey, supported by the Turkish Neurological Society and partially funded through an unrestricted research grant from electroCore.
Stroke is the second highest cause of death and the third leading cause of disability globally. Ischemic stroke, caused by arterial occlusion, is the most common type of stroke. The effectiveness of current management strategies (e.g. rapid reperfusion with intravenous thrombolysis and endovascular thrombectomy) is dependent on time to treatment. Treating stroke quickly and safely is imperative for maximizing the therapeutic benefits of therapy. electroCore’s small and portable nVNS device, gammaCore Sapphire, offers the opportunity for administration rapidly after the onset of stroke. The scientific hypothesis supporting the TR-VENUS study is based, in part, on preclinical evidence from studies conducted in the lab of Ilknur Ay at Massachusetts General Hospital, Harvard Medical School suggesting that vagus nerve stimulation (VNS) results in a protective effect against ischemic brain injury1.
The TR-VENUS study recruited a total of 60 subjects with ischemic stroke and eight subjects with hemorrhagic stroke. The primary objective was to assess the safety of nVNS in the setting of acute stroke by examining decreases in arterial blood pressure, severe bradycardia, progression of neurological deficits and death. Feasibility was also assessed by determining the proportion of allocated stimulation doses that could be administered. Secondary efficacy outcomes evaluated neurologic deficits and infarct growth. Top-line data will be reported once available and full results will be published in a peer reviewed medical journal later this year.
The lead investigators of the study, Professors Ethem Murat Arsava and Mehmet Akif Topcuoglu of the Department of Neurology, Hacettepe University in Ankara, Turkey, commented, “We are very pleased to have successfully completed enrollment of this Phase 2 trial to assess the safety and feasibility of nVNS for the acute treatment of stroke. We are hopeful that nVNS might be a viable option to improve the treatment of acute stroke.”
“We congratulate and thank the investigators, patients and families that all supported the successful completion of study enrollment and we look forward to the data readout and what it tells us about nVNS’ potential as an acute treatment for stroke,” said Eric Liebler, Senior Vice President of Neurology at electroCore.
For complete details on the study design please see clintrials.gov: https://clinicaltrials.gov/ct2/show/NCT03733431?term=NCT03733431&draw=2&rank=1
gammaCore™ (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, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in 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. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.
- 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.
The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA.
gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.
gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
Further information is available at:
Authorization Letter: https://www.fda.gov/media/139967/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download
Fact Sheet for Patients: https://www.fda.gov/media/139969/download
Instructions for gammaCore use https://www.fda.gov/media/139970/download
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.
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, sales and marketing, and product development plans, future cash flow projections, anticipated costs, its pipeline or potential markets for its technologies, the availability and impact of payer coverage, the potential product use for other indications, the results of TR-VENUS study and the potential use of gammaCore for the acute treatment of 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, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore™, 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.
1 Ay I, Nasser R, Simon B, Ay H. Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Ischemic Injury in Rats. Brain Stimul. 2016 Mar-Apr;9(2):166-73. doi: 10.1016/j.brs.2015.11.008. Epub 2015 Dec 1. PMID: 26723020; PMCID: PMC4789082.