electroCore, Inc. Announces Johns Hopkins University School of Medicine Study of Non-Invasive Vagus Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders

Rhea-AI Summary

electroCore, Inc. (Nasdaq: ECOR) announced an investigator-initiated trial by Johns Hopkins University School of Medicine. The study will explore non-invasive vagus nerve stimulation (nVNS) using their gammaCore device to treat nausea in patients with gastroparesis and related disorders (NCT04857281). Approximately 6 million Americans suffer from gastroparesis, leading to significant quality of life impacts and economic burdens. The gammaCore device aims to provide an alternative to traditional invasive treatments, potentially reducing the need for rescue medications.

Positive

• Initiation of a clinical trial for gammaCore in treating nausea related to gastroparesis, potentially expanding the market for the product.
• The gammaCore device offers a non-invasive alternative to traditional gastric electrical stimulation, which may attract patients concerned about surgical risks.

Negative

• The trial's outcome is uncertain, and there is a risk that it may not demonstrate significant efficacy, potentially affecting future product adoption.
• Dependence on the trial's success may indicate limited commercial viability if results are not favorable.

ROCKAWAY, NJ, April 26, 2021 (GLOBE NEWSWIRE) --  -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Johns Hopkins University School of Medicine is starting an investigator-initiated trial of non-invasive vagus nerve stimulation (nVNS) using the Company’s proprietary gammaCore device to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders (NCT04857281).

Many gastrointestinal disorders can cause nausea and vomiting, of which the most well-known is gastroparesis, a digestive disorder in which the stomach empties slowly.¹ The symptoms of gastroparesis can range from mild to severe, requiring prolonged hospitalizations and interventions, and causing life-threatening complications which can significantly affect the quality of life in affected individuals. It is estimated that close to 6 million Americans suffer from gastroparesis which is more common in women than men.² The economic impact of gastroparesis can be substantial, with studies reporting 11% of patients disabled due to their gastroparesis symptoms, while another 28.5% reported a loss of yearly income. ³

Nausea without slow gastric emptying may be even more common and has been referred to by many names, including chronic unexplained nausea and vomiting (CUNV), gastroparesis-like syndrome (GLS), functional vomiting, and vomiting of unexplained etiology (VUE). Many of these patients can be classified as having functional dyspepsia (FD) which is a disorder that may affect 10% of the US population.⁴

“The vagus nerve plays a key role in the regulation of nausea and vomiting,” commented Dr. Jay Pasricha, Professor of Medicine and Neurosciences and Director of the Johns Hopkins Center for Neurogastroenterology and principal investigator of the study. “Vagal modulation is currently thought to be a major component of the treatment benefit from an implanted gastric electrical stimulation (GES) device in patients with symptoms of gastroparesis and the planned proof of concept study explores whether a non-invasive hand-held device for vagal modulation can also be effective in reducing the need for traditional rescue medications for patients with unexplained nausea and vomiting.”

“We appreciate Dr. Pasricha and his team selecting gammaCore (nVNS) for their study,” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore (nVNS) is the first non-invasive, handheld medical device proven to activate the vagus nerve by providing a patented mild electrical stimulation through the skin, and offers a potential alternative to GES that could eliminate significant risks of injury or illness associated with implantation.”

For more information, visit clinicaltrials.gov.

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 for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

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 with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• 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 (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders 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.

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¹ Camilleri, M; Parkman HP; Shafi MA; Abell T; Gerson L. Clinical guideline: management of gastroparesis. 2013 Jan; 108 (1): 18-37.
² Rey E, Choung RS, Schleck CD, Zinsmeister AR, Talley NJ, Locke GR III. Prevalence of hidden gastroparesis in the community: the gastroparesis“iceberg”. J Neurogastroenterol Motil. 2012;18:34–42.
³ Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg LJ. Gastroparesis: quality of life and health care utilization. J Clin Gastroenterol. 2018; 52: 20–24.
⁴ Harer, K; Pasricha PJ. Chronic Unexplained Nausea and Vomiting or Gastric Neuromuscular Dysfunction (GND) An Update on Nomenclature, Pathophysiology and Treatment and Relationship to Gastroparesis. 2016 Dec; 14 (4): 410-419.

FAQ

What is the purpose of the new clinical trial involving gammaCore by electroCore?

The trial aims to evaluate the effectiveness of gammaCore, a non-invasive vagus nerve stimulation device, in treating nausea associated with gastroparesis.

Who is conducting the trial for gammaCore?

The trial is conducted by Johns Hopkins University School of Medicine.

How many Americans suffer from gastroparesis?

Approximately 6 million Americans are affected by gastroparesis.

What are the potential economic impacts of gastroparesis?

Gastroparesis can lead to significant economic burdens, with 11% of patients potentially disabled and 28.5% reporting lost yearly income.

What kind of device is gammaCore?

gammaCore is a handheld, non-invasive medical device designed to stimulate the vagus nerve to treat conditions like migraine, cluster headache, and now nausea.