“VANQUISH” Clinical Trial (n=40) suggests safety and efficacy of nVNS for the Treatment of Headache Associated with Subarachnoid Hemorrhage (SAH)
“NOVIS” Clinical Trial (n=150) of nVNS for the acute treatment of Ischemic Stroke will complete recruitment in 2023
ROCKAWAY, N.J., Oct. 10, 2023 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced top line data from two abstracts being presented at the 15th World Stroke Congress held October 10-12, 2023, in Toronto, Canada on the possible role of nVNS in the treatment of acute neurological injuries.
The nVNS research presented at the 2023 World Stroke Congress covers two recently completed trials as follows:
1. Non-Invasive Vagus Nerve Stimulation Is Safe and Efficacious In The Treatment Of Headache Associated With Subarachnoid Hemorrhage (VANQUISH)
In this study conducted at Northwell Health in New York, there was a significant reduction in the overall pain score with a therapeutic gain of − 0.5 points in favor of nVNS. (P<0.005). There was a 14% decrease in the Average Morphine Equivalent Dosage after two weeks of treatment as well as a trend towards a 3 day decrease in average hospital stay (p = 0.14) that did not reach significance, possibly due to the size of the study.
Dr. Tania Rebeiz, the primary investigator of the VANQUISH study and Assistant Professor, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell commented, “We are pleased to have successfully completed this first trial of nVNS as a possible treatment for the acute treatment of Subarachnoid Hemorrhage. Our data suggests that nVNS is safe and effective in reducing pain and potentially the use of other acute pain medications, including opioids in the immediate aftermath of a SAH. The potential for nVNS to help decrease the overall length of the hospital stay after SAH could offer significant patient and health care benefits.”
Subarachnoid hemorrhage (SAH) is a devastating condition, most commonly due to trauma and aneurysm rupture, and carries significant mortality and morbidity. About half of the survivors are left with some disability. Some of the known complications are aneurysm re-rupture, seizures, central fever, delayed cerebral ischemia (DCI), headache and hydrocephalus.
2. Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke (NOVIS)
NOVIS is a prospective randomized clinical trial with blinded outcome assessment being conducted at the Leiden University Medical Center (Leiden, The Netherlands). 150 patients with ischemic stroke are being randomly allocated (1:1) to nVNS for five days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day five as assessed with MRI. Dr. Anne van der Meij, from the Leiden University Medical Center, who is presenting the poster at the World Stroke Congress commented, “Our study will complete enrollment before the end of 2023 and our efficacy endpoints should provide greater definition, and possibly confirmation, of the efficacy of nVNS for the acute treatment of ischemic stroke.”
Stroke is ranked as the second leading cause of death worldwide with an annual mortality rate of about 5.5 million. The burden of stroke lies not only in its high mortality rate, but in the high morbidity rate as well with up to 50% of stroke survivors being chronically disabled.
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “We congratulate all the investigators, patients and sites that supported this research into the role of nVNS as an acute treatment for SAH and Ischemic Stroke. The strong mechanistic rational for nVNS as a potentially neuroprotective and anti-inflammatory treatment for acute neurological injury is further supported by this data showing the continued efficacy of nVNS for the treatment of pain. The ability of nVNS to potentially decrease the daily use of other acute pain medications and potentially even shorten the length of the hospital stay after a SAH is very exciting.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
This press release and other written and oral statements made by representatives of electroCore 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 including potential commercial applications of gammaCore and nVNS for treatment of headache and pain associated with Subarachnoid Hemorrhage and the acute treatment of ischemic stroke; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of U.S. and international patents, including patents related to non-invasive nerve stimulation with mobile devices, providing expanded IP coverage; the possibility of future business models, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
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