electroCore Stock

electroCore, Inc. operates as a commercial stage bioelectronic medicine and wellness company.

The company's focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing non-invasive vagus nerve stimulation (nVNS) to promote general wellbeing and human performance in the United States and select overseas markets.

nVNS is a platform bioelectronic technology that modulates neurotransmitters through its effects on both the peripheral and central nervous systems. The company's nVNS treatment is delivered through a proprietary high-frequency burst waveform that safely and comfortably passes through the skin and stimulates therapeutically relevant fibers in the vagus nerve. Various scientific publications suggest that nVNS works through several mechanistic pathways, including the modulation of neurotransmitters.

The company's medical devices and wellness products are self-administered and intended for regular or intermittent use over many years. The company derives revenues from the sale of medical devices and wellness products in the United States and select overseas markets. The company has two principal product categories:

Handheld, personal use medical devices for the management and treatment of certain medical conditions; and

Handheld, personal use consumer product offerings utilizing nVNS technology to promote general wellbeing and human performance.

gammaCore, which is the company;s prescription only, handheld device intended for regular or intermittent use over many years, is cleared by the FDA for use in the following indications: the acute treatment of pain associated with each of migraine headache and episodic cluster headache in adults, or eCH; the preventive treatment of migraine headache and adjunctive use for the preventive treatment of cluster headache in adults, or CH; the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age; and the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age; and

The FDA clearances of the company's gammaCore therapy to treat headache were facilitated by the FDA's creation of a new regulatory category: External Vagus Nerve Stimulator for Headache (21 CFR 882-5892).

In January 2022, the FDA granted gammaCore Sapphire 'Breakthrough Device designation for the treatment of post-traumatic stress disorder or PTSD'.

The company is considering several additional medical indications for its nVNS technology which are being studied in several investigator-initiated trials, or IITs.

The company received a CE Certificate of Conformity for gammaCore for the treatment of primary headache from the British Standards Institution, a European Union notified body. This CE Certificate of Conformity allowed the company to affix the CE Mark on gammaCore and to commercialize it in the European Economic Area and other countries that recognize the CE Mark. In addition, the company received CE Certificates of Conformity on gammaCore covering four other indications for use, including reactive airway disease and gastric motility disorders.

Primary Marketed Products

The company offers multiple propositions: gammaCore for the treatment of certain medical conditions, such as primary headache; Truvaga for the support of general health and wellbeing; and TAC-STIM for human performance as defined by the United States Air Force Research Laboratory.

The company's flagship model, gammaCore Sapphire, is a prescription medical device FDA cleared for a variety of primary headache conditions. gammaCore is available by prescription only and Sapphire is a portable, reusable, rechargeable and reloadable personal use option for patients to use at home or on the go. Prescriptions are written by a health care provider and dispensed from a specialty pharmacy, through the patient's healthcare system, or fulfilled directly to certain patients in the United States directly from the company's facility in Rockaway, NJ. After the initial prescription is filled, access to additional therapy can be refilled for certain of the company's gammaCore products periodically through the input of a prescription-only authorization.

Truvaga is a personal use consumer electronics wellness product that does not require a prescription and is available direct-to-consumer from electroCore at www.truvaga.com. Truvaga is not intended for medical use. TAC-STIM is a form of nVNS for human performance and has been developed in collaboration with the United States Department of Defense Biotech Optimized for Operational Solutions and Tactics, or BOOST program. The company is exploring strategies to make this product offering available to other branches of the active-duty military and certain human performance professionals in the United States and abroad. TAC-STIM is available as a Commercial Off the Shelf (COtS) solution to professional organizations and is the subject of ongoing research within the United States Air Force Special Operations Command and at the United States Air Force Research Laboratory.

Truvaga and TAC-STIM are intended for general wellness in compliance with the FDA guidance document entitled 'General Wellness: Policy for Low-Risk Devices; Guidance for Industry and FDA Staff, issued on September 27 2019'. They are not intended to treat medical conditions.

The company has focused most of its historical sales efforts in two channels, the United States Department of Veterans Affairs and United States Department of Defense, or VA/DOD, and the United Kingdom utilizing its FDA cleared and CE marked product, gammaCore.

The United States Department of Veteran Affairs comprised 60.8% of the company's revenue during the year ended December 31, 2022. The company expects that a majority of its 2023 sales will be made pursuant to its qualifying contract under the Federal Supply Schedule or FSS, which was secured by it in December 2018, as well as open market sales to individual facilities within the government channels. The FSS is scheduled to expire on January 15, 2024. The company's sales function in this channel consists of employees and independent contractors.

Sales under the MTFM program for cluster headache in the U.K. comprised 15.1% of the company's revenue during the year ended December 31, 2022. In 2023, the company plans on continued expansion under this program, as well as continue to utilize distribution partners to commercialize its nVNS technology in territories outside the United States and the United Kingdom. In 2023, the company expects the National Institute for Health and Care Excellence, or NICE, to review the guidance document and any changes in recommendation or pricing may adversely impact the company's ability to work with the National Health Service, or NHS, England on the MedTech Funding Mandate (MTFM) program.

In 2023, therefore, the company plans to continue its investment in expanded commercial adoption of gammaCore with cash pay, physician dispense, and direct-to-consumer approaches, and continue its early efforts to begin building wellness and human performance propositions through Truvaga and TAC-STIM.

Intellectual Property

Patents and Patent Applications

As of February 1, 2023, the company held more than 200 patents and patent applications, including 128 issued U.S. patents, 37 U.S. patent applications, and 45 international patents and applications. All of the company's issued patents are projected to expire between 2026 and 2037.

Copyrights, Trademarks and Trade Secrets

As of February 1, 2023, the company's trademark portfolio consisted of six U.S. trademark registrations, including electroCore, gammaCore, and gammaCore Sapphire, 19 international trademark registrations, and 15 pending U.S. and international trademark applications.

Trademarks and Tradenames

The electroCore logo, gammaCore, Truvaga, TAC-STIM and other trademarks are the property of the company.

Government Regulation

The majority of the company's products are medical devices that are subject to extensive regulation by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, or FDCA, and the regulations promulgated thereunder, as well as by other regulatory bodies in the United States and abroad.

Before being introduced into the U.S. market, the company's medical devices must obtain marketing clearance or approval from FDA through the 510(k) pre-market notification process, the de novo classification process, or the pre-market approval (PMA) process, unless they are determined to be Class I devices or to otherwise qualify for an exemption from one of these available forms of pre-market review and authorization by the FDA.

The company received CE Certificate of Conformity in the European Economic Area, or EEA, for its gammaCore therapy to treat, primary headache, including migraine, CH, and hemicrania continua, as well as medication overuse headache in adults.

In the EEA and the U.K., gammaCore must comply with the essential requirements laid down in Annex I to Directive 93/42/EEC on the approximation of the laws of the member states relating to medical devices or the European Union (EU) Medical Devices Directive. The company has the necessary certificates for the MDR (EU Medical Device Regulation 2017/745). The company is subject to Federal Trade Commission, or FTC, regulatory oversight.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were $5.5 million.

History

electroCore, Inc., a Delaware corporation, was founded in 2005. The company was incorporated in 2005.