GammaCore ™ Non-Invasive Vagus Nerve Stimulation (nVNS) Receives Revolutionary Device Designation for Treatment of Post-Traumatic Stress Disorder (PTSD)

NVNS reduces PTSD symptoms by 31% in simulation-controlled study

ROCKAWAY, NJ, Jan. 12, 2022 (GLOBE NEWSWIRE) – electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that its gammaCore ™ nVNS device has received breakthrough designation from the US Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD) after showing a reduction in symptoms of PTSD by 31% compared to sham.

PTSD is a very common and disabling disorder with limited approved treatment options. According to the National Center for PTSD of the United States Department of Veterans Affairs, approximately 15 million adults in the United States suffer from PTSD each year. In the military and veterans administration alone, PTSD is reported to affect between 10-20% of veterans who served in every Operation Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm) and the Vietnam War. More than half of all PTSD patients report having a severely impaired quality of life in areas such as mood, social and family relationships, leisure activities, sense of well-being and life satisfaction .

The revolutionary device designation was supported, in part, by research from an Emory-Georgia technical team led by J. Douglas Bremner, MD, in the departments of Psychiatry and Radiology at the School of Medicine of the Emory University, and Omer T. Inan, Ph .D., School of Electrical and Computer Engineering and Coulter Department of Biomedical Engineering at Georgia Institute of Technology in Atlanta, Georgia. Their research, based on strong mechanistic rationale and animal studies, shows that nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD. 31% PTSD compared to a sham. stimulation.

Dr Douglas Bremner commented, “Current treatments for PTSD involving drugs and psychotherapy have limitations due to limited efficacy, possible side effects, and the reluctance of many PTSD patients to engage in therapy. therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from drugs or psychotherapy, which is safe, relatively free of side effects and does not involve expensive and invasive implantation procedures, like previous VNS devices approved by the FDA for the treatment of intractable depression.

“We appreciate the thorough and timely review by the FDA of our application for a revolutionary device for gammaCore for the treatment of PTSD,” commented Eric Liebler, senior vice president of neurology at electroCore. “The ability of nVNS to target several of the underlying causes of PTSD, such as autonomic dysfunction, stress and inflammation, effectively and safely supports its potential as a revolutionary treatment for PTSD. “

The Breakthrough Devices program is a voluntary program for certain medical devices and device-driven combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices program is to provide patients and healthcare providers with rapid access to essential medical devices by accelerating their development, evaluation and review, while preserving legal pre-market approval standards. Authorization 510 (k) and De Novo Marketing Authorization, consistent with the FDA’s mission to protect and promote public health.

About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes with its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of several conditions in neurology. The current indications of the company are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and cluster headache episodic, the acute and preventive treatment of migraine in the adolescent and paroxysmal hemicrania and continuous hemicrania in adults.

For more information, visit www.electrocore.com.

About gammaCore ™
gammaCore ™ (nVNS) is the first non-invasive portable medical treatment applied to the neck as an adjunct to treat migraine and cluster headaches of the face through the use of mild electrical stimulation of the vagus nerve that passes through the neck. skin. Designed as portable and easy to use technology, gammaCore can be self-administered by patients as needed without the potential side effects associated with commonly prescribed medications. When placed on a patient’s neck above the vagus nerve, gammaCore stimulates the afferent fibers of the nerve, which can lead to reduced pain in patients.

gammaCore (nVNS) is cleared by the FDA in the United States for adjuvant 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 adolescents (aged 12 years and older) and in adult patients, and paroxysmal hemicrania and continuous hemicrania in adult patients. gammaCore is CE marked in the European Union for the acute and / or prophylactic treatment of primary headache (migraines, cluster headache, trigeminal autonomic headache and continuous bleeding) and headache from drug abuse in adults.

gammaCore is contraindicated in patients if they:

  • Have an active implantable medical device, such as a pacemaker, hearing aid implant, or other electronic device implanted

  • Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck

  • Use another device at the same time (eg TENS unit, muscle stimulator) or any other portable electronic device (eg cell phone)

The safety and efficacy of gammaCore have not been evaluated in the following patients:

  • Adolescent patients with congenital heart problems

  • 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 (under 12 years old)

  • Pregnant women

  • Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia

The United States FDA has cleared the gammaCore Sapphire CV device under emergency use authorization for acute home or healthcare use to treat adult patients with known COVID-19 or suspected of suffering from exacerbation of asthma-related dyspnea and reduced air flow, and for whom approved pharmacological therapies are not tolerated or provide insufficient symptom relief as assessed by their doctor. healthcare provider, using non-invasive vagus nerve stimulation (nVNS) on either side of the patient’s neck.

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

More information can be found at:

Clearance letter: https://www.fda.gov/media/139967/download

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

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

GammaCore Instructions for Use: https://www.fda.gov/media/139970/download

Please refer to the gammaCore Instructions for Use for all 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. These forward-looking statements include, without limitation, statements regarding the activities of electroCore. prospects and plans for clinical and product development (including enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, results and impact of regulatory, clinical and commercial developments; the issuance of US and international patents providing extended IP coverage; the possibility of future business models and revenue streams of the company’s potential to use nVNS for post-traumatic stress disorder (PTSD), the potential of nVNS in general and gammaCore in particular and other statements that are not historical in nature, especially those which use terminology such as “anticipates”, “will”, “expects”, “believes”, “intends”, other words with similar meaning, derivations of these words and the use of future dates. Actual results could differ from those projected in forward-looking statements due to many factors. These factors include, but are not limited to, the ability to raise the additional funds necessary to continue pursuing business plans. activity and product development of electroCore, the inherent uncertainties associated with the development of new products or technologies, the ability to commercialize gammaCore ™, the impact and potential effects of CO VID-19 on the business of electroCore, the results of operations and financial performance of electroCore, and any actions that electroCore has and may take in response to COVID-19 and any expectations that electroCore may have in In this regard, 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 assumes no obligation to update any forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements. , unless Required by law. Investors should review all information set forth in this document and should also refer to the risk factor disclosure set forth in reports and other documents filed by electroCore with the SEC available at www.sec.gov.

Investors:
Rich rooster
CG Capital
404-736-3838
[email protected]

Where

Media contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

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