What changed in this filing

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Item 1. Business

2024-03-13 compared with 2023-03-08 · 78 added, 87 removed, 213 unchanged (44% of the section changed)

We are a commercial stage bioelectronic medicine and wellness company dedicated to improving health through our 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.

nVNS is a platform bioelectronic technology that modulates neurotransmitters through its effects on both the peripheral and central nervous systems.

We are a commercial stage bioelectronic medicine and general wellness company dedicated to improving health and quality of life through our proprietary non-invasive vagus nerve stimulation (“nVNS”) technology platform.

nVNS modulates neurotransmitters through its effects on both the peripheral and central nervous systems.

Our 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.

Various scientific publications suggest that nVNS works through a variety of mechanistic pathways including the modulation of neurotransmitters.

Historically, vagus nerve stimulation or VNS, required an invasive surgical procedure to implant a costly medical device.

This limitation has generally limited VNS from being used by anyone other than the most severe patients.

Our medical devices and wellness products are self-administered and intended for regular or intermittent use over many years.

Our business is supported by our in-house capabilities spanning product development, regulatory affairs and compliance, sales and marketing, product testing, assembly, and fulfillment, and customer support.

We derive revenues from the sale of medical devices and wellness products in the United States and select overseas markets.

This generally limited VNS from being used by anyone other than the most severe patients.

Our non-invasive medical devices and general wellness products are self-administered and intended for regular or intermittent use over many years.

Our capabilities include product development, regulatory affairs and compliance, sales and marketing, product testing, assembly, fulfillment, and customer support.

We derive revenues from the sale of products in the United States and select overseas markets.

We have two principal product categories:

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

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

We believe our nVNS treatment may be used in the future to effectively treat additional medical conditions or improve human performance.

Handheld, personal use medical devices for the management and treatment of certain medical conditions such as primary headache;

Handheld, personal use consumer products utilizing nVNS technology to promote general wellness and human performance.

We believe our nVNS products may be used in the future to effectively treat additional medical conditions.

Primary Marketed Products and Business Strategy

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To achieve this, we offer multiple propositions:

gammaCore for the treatment of certain medical conditions such as primary headache;

Prescription gammaCore for the treatment of certain medical conditions such as primary headache;

Truvaga for the support of general health and wellbeing;

• TAC-STIM for human performance as defined by the United States Air Force Research Laboratory.

Our flagship model, gammaCore Sapphire, is a prescription medical device currently FDA cleared for a variety of primary headache conditions.

TAC-STIM for human performance.

Our flagship gammaCore Sapphire, is a prescription medical device that is 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 our facility in Rockaway, NJ.

After the initial prescription is filled, access to additional therapy can be refilled for certain of our 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.

Prescriptions are written by a health care provider and dispensed from a specialty pharmacy, through the patient’s healthcare system, or shipped directly to certain patients in the United States directly from our facility in Rockaway, NJ.

After the initial prescription is filled, access to additional therapy can be refilled for certain of our gammaCore products through the input of a prescription-only authorization.

Truvaga is a personal use consumer electronics general wellness product that does not require a prescription and is available direct-to-consumer from electroCore at www.truvaga.com.

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.

We are 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.

TAC-STIM products are available as a Commercial Off the Shelf (COtS) solution to professional organizations and are the subject of ongoing research and evaluation within the United States Air Force Special Operations Command, the United States Army 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.

We have generally focused most of our 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 our FDA cleared and CE marked product, gammaCore .

Guidance for Industry and FDA Staff, issued on September 27, 2019.” Truvaga and TAC-STIM products are not intended to diagnose, treat, cure, or prevent any disease or medical condition.

Our two largest customers by revenue are the United States Department of Veterans Affairs and United States Department of Defense, or VA/DoD, and the United Kingdom National Health Service or NHS utilizing our FDA cleared and CE marked product, gammaCore .

The United States Department of Veteran Affairs comprised 60.1 % of our revenue during the year ended December 31, 2023 .

We expect that a majority of our 2023 sales will be made pursuant to our qualifying contract under the Federal Supply Schedule or FSS, which was secured by us 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.

We intend to request an extension of the FSS from the United States Department of Veterans Affairs, but there is no assurance the FSS agreement will be renewed, if at all, or at terms favorable to us, which could have an adverse impact on our financial results.

Our sales function in this channel is comprised of employees and independent contractors.

Sales under the MTFM program for cluster headache in the UK comprised 15.1% of our revenue during the year ended December 31, 2022.

In 2023, we plan on continued expansion under this program, as well as continue to utilize distribution partners to commercialize our nVNS technology in territories outside the United States and United Kingdom.

In 2023, we expect 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 our ability to work with the National Health Service, or NHS, England on the MTFM program and could have an adverse impact on our financial results.

We believe there may be significant opportunities beyond these areas.

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

The m ajority of our 2023 sales were made pursuant to our qualifying contract under the Federal Supply Schedule or FSS, which was secured by us in December 2018, as well as open market sales to individual facilities within the government channels.

The initial term of our FSS contract was scheduled to expire on January 15, 2024.

On January 5, 2024, we obtained a modification to the initial contract, temporarily extending the term from January 15, 2024, to March 14, 2024 , and subsequently extended the term to June 14, 2024, while the U.S.

Department of Veteran Affairs VA Federal Supply Schedule Service reviews our follow-on offer application for a replacement contract.

Although we continue to work with the appropriate government personnel to replace our FSS contract, there can be no assurance that the VA/DoD will accept our follow-on application to replace our contract which may limit or eliminate our ability to sell certain gammaCore products into the government channel pursuant to our qualifying FSS contract or individual facilities that utilize our FSS contract number for open market purchases.

Between November 2023 and January 2024, certain gammaCore products were added to the Federal Supply Schedule (FSS), the DoD’s Distribution and Pricing Agreement (DAPA), GSA Advantage, and Defense Logistics Agency’s ECAT system procurement portals through the Lovell Government Services (“Lovell”) contract vehicles.

We expect that a portion of our 2024 U.S.

sales of gammaCore will be made pursuant to qualifying FSS, GSA, DAPA, ECAT contracts and open market sales to individual VA facilities.

Our sales function in this channel is comprised of employees and an increasing number of independent contractors.

Sales under the UK MedTech Funding Mandate, or MTFM, for cluster headache (CH) in the UK compris ed 7.5 % of our re venue during the year ended December 31, 2023.

In 2024, we plan on continued expansion under this program.

In 2023, NHS granted a two-year extension in which our prescription gammaCore therapy will continue to be listed in the NHS catalogue.

This extension is through March 17, 2026, with an option for us to extend an additional two years.

In 2024, we expect 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 our ability to work with NHS, England on the MTFM program and could have an adverse impact on our financial results.

We continue to utilize distribution partners to commercialize our nVNS technology in selected territories outside the United States and United Kingdom.

Primary Headache Market and Competition for our gammaCore Products’

In the United States, 39 million patients are affected by migraine, with more than 28 million being adult women.

Approximately 8 million Americans are seeing a professional about headache and approximately 2.5 million Americans have a prescription for migraine therapy.

Migraine attacks can be extremely disabling and more than 90% of migraine sufferers are unable to work or function normally while experiencing migraine.

According to a recent analysis, the annual economic burden of migraine in the United States is approximately $78 billion.

According to an analysis in The American Journal of Managed Care, the annual economic burden of migraine in the United States is approximately $78 billion.

Further, it is estimated that the annual total direct and indirect costs of all migraine-related health services are between $8,500 and $9,500 for an individual patient with chronic migraine.

In the United States and EU, research has found that the age of first diagnosis of migraine peaks in the early-to-mid teens and the disease continues to persist throughout adulthood for many of these sufferers, demonstrating that it is often a disorder of long duration.

The marketing landscape for the treatment and prevention of migraine is highly competitive with most migraine patients managing their conditions with over-the-counter therapies.

The triptan drug class is the current first line therapy for the acute treatment of migraine.

According to the U.S.

Pharmacist, a leading pharmacy publication, more than 60% of patients have reported dissatisfaction with, or have contraindications to, the current standard of care, such as triptan medications.

The market f or the treatment and prevention of migraine is highly competitive with most migraine patients managing their conditions with over-the-counter therapies.

The prescription triptan drug class is the generally considered first line therapy for the acute treatment of migraine.

There are many additional pharmaceutical approaches currently marketed and under development by third parties.

There are several neuromodulation devices that have been marketed for the treatment of migraine, including CEFALY (sold by CEFALY technologies sprl) and Nerivio (sold by Theranica Bioelectronics), as well as other neuromodulation devices that may be marketed for use in treating pain associated with primary headache.

Cefaly has been granted OTC clearance allowing it to be sold without a prescription and the impact of this clearance on the competitive landscape remains to be seen.

The estimated prevalence of CH in the United States ranges from 0.1 % to 0.2 % of the total population, with an estimated 400,000 patients.

CH is a condition in which patients experience extremely painful headache attacks that have been described by patients and physicians as some of the most painful known.

In particular, injectables such as Botulinum toxin (Botox) and calcitonin gene-related peptides antagonists or CGRPs have gained significant adoption and market share, with oral CGRPs gaining more market share.

There are several neuromodulation devices that have been marketed for the treatment of migraine, including CEFALY (sold by CEFALY Technologies sprl) Nerivio (sold by Theranica Bioelectronics), and Savi Dual (sold by eNeura, Inc.) as well as other neuromodulation devices that may be marketed for use in treating pain associated with primary headache.

Cefaly has been granted OTC clearance allowing its product to be sold without a prescription and the impact of this clearance on the competitive landscape remains to be seen.

The estimated prevalence of CH (Cluster Headache) in the United States ranges from 0.1 % to 0.2 % of the total population, with an estimated 400,000 patients.

CH is a condition in which patients experience extremely painful headache.

CH predominantly affects males in their prime earning ages of 20 to 50, and the attacks of pain occur in bouts, known as cluster periods, during which attacks are experienced at a frequency ranging from every other day to as often as eight times per day.

Individual attacks typically last from 15 minutes to as long as three hours.

Among CH patients, 85% to 90% experience eCH, with their cluster periods, or bouts, lasting from two to 12 weeks, followed by a remission period, often cycling into bouts twice per year.

According to a February 2020 published study in The American Journal of Managed Care, the overall average medical costs for eCH patients over a three -year period exceeded $ 22,500 , compared with $ 10,140 among non-headache sufferers.

Similarly, the overall average pharmacy costs per episodic CH patient during this period were $ 8,200 , which was nearly double that of the non-headache sufferers.

Participants in surveys of sufferers indicate that CH is associated with a large socioeconomic burden.

For example, research found that nearly 20 % of patients with CH reported loss of employment and approximately 8 % are unemployed or receiving disability services due to the disorder.

In the United Kingdom, the estimated prevalence of CH ranges from 0.1% to 0.2% of the total population, with approximately 66,000 affected patients.

Injectable sumatriptan (Imitrex) is an FDA-approved commercially available therapy for the acute treatment for CH.

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Additional medications that are used by patients off-label include verapamil, lithium, and valproate.

Our gammaCore therapy competes and will compete with numerous existing therapies from many different sources, including pharmaceutical, biotechnology, medical device and other healthcare companies, and therapies that may become available in the future.

Our prescription gammaCore therapy competes with numerous existing therapies from many different sources, including pharmaceutical, biotechnology, medical device and other healthcare companies, and therapies that may become available in the future.

We believe the key competitive factors affecting the potential success of our therapy are safety, efficacy, side effect profile, convenience, price, the availability of generic drugs and the availability of coverage and reimbursement from government and certain other third-party payers.

Market and Competition for our General Wellness Products

In April 2021, McKinsey & Company, or McKinsey estimated the global wellness market to be more than $1.5 trillion with annual growth of 5-10%, With the US market, spanning health, fitness, appearance, sleep, nutrition, and mindfulness, to be more than $450 billion and growing at great than 5% annually .

With the U.S.

market, spanning health, fitness, appearance, sleep, nutrition, and mindfulness, estimated to be more than $450 billion and growing at greater than 5% annually.

In a survey McKinsey conducted in August 2020 with roughly 7,500 customers in Brazil, China, Germany, Japan, the United Kingdom and the United States, 79% of the respondents said they believed wellness is important, and 42% considered it a top priority.

Around 37% of surveyed consumers expressed a desire for additional products and services in both the sleep and mindfulness categories, with almost 1/3 of customers wanting more across the remaining four wellness dimensions.

In April 2021, McKinsey & Company estimated the global general wellness market to be more than $1.5 trillion with annual growth of 5-10%, with the US market, spanning health, fitness, appearance, sleep, nutrition, and mindfulness, to be more than $450 billion and growing at greater than 5% annually .

The global stress management treatment market is expected to reach approximately $20 billion by 2024, with the US stress management market size valued at $2.4 billion in 2022 and expected to grow at a compound annual growth rate (CAGR) of 5.3% from 2023 to 2030.

Research and Development

We are developing future iterations of nVNS technology, including the use of our intellectual property around the delivery of smartphone-integrated and smartphone-connected non-invasive therapies.

We are supporting a variety of Investigator Initiated Trials (IIT) to evaluate additional indications and/or markets for our products.

During 2024, we plan on launching our next generation app-enabled consumer device under the Truvaga brand.

We are cooperating with a variety of Investigator Initiated Trials (“IIT”) to evaluate additional indications and/or markets for our products.

If successful, we believe these trials will provide marketing support for future expansion of our business to new indications and markets.

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gammaCore, which is our 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;

• the treatment of Paroxysmal Hemicrania , or PH, and Hemicrania Continua, or HC, in adults.

The FDA clearances of our gammaCore therapy to treat headache were facilitated by the FDA's creation of a new regulatory category:

The acute treatment of pain associated with episodic cluster headache ;

The acute treatment of pain associated with migraine headache;

Adjunctive use for the preventive treatment of cluster headache in adult patients;

The preventive treatment of migraine headache in adult patients;

The use of gammaCore by adolescent patients (between 12 and 17 years of age);

Treatment of h emicrania c ontinua and paroxysmal hemicrania in adult patients.

The FDA clearances of our prescription 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).

Based on this category’s description, we anticipate that some additional label expansions may be possible through the pathway under Section 510(k) of the Federal Drug and Cosmetic Act.

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

PTSD is a highly prevalent and disabling disorder with limited approved treatment options.

Based on this category’s description, we anticipate that some additional label expansions may be possible through the pathway under Section 510(k) of the Federal Drug and Cosmetic Act or through de novo classifications relating to uses of External Vagus Nerve Stimulators.

In January 2022, the FDA granted gammaCore Sapphire “Breakthrough Device designation for the treatment of post-traumatic stress disorder or PTSD.” PTSD is a highly prevalent and disabling disorder with limited approved treatment options.

The FDA’s Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or condition.

We also are considering several additional medical indications for our nVNS technology which are being studied in several investigator-initiated trials, or IITs.

We are considering several additional medical indications for our nVNS technology which are being studied in several investigator-initiated trials, or IITs.

These indications include, post-traumatic stress disorder, opioid use disorders, symptoms of Parkinson's disease, stroke, concussion, attention, nausea, mood, fatigue and memory retention among others.

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NHS England awarded gammaCore a place on the Innovation Technology Payment, or ITP, program for treatment of patients with refractory (severe) cluster headache, a reimbursement pathway that opened in April 2019.

Effective April 1, 2021, gammaCore was listed on the NHS England MedTech Funding Mandate (MTFM) Policy.

Effective April 1, 2021, gammaCore was listed on the MTFM Policy.

gammaCore is still listed in the policy, which requires commissioners fund the therapy from their existing allocations.

Non-Prescription

During 2022, we launched the Truvaga product line for consumer wellness applications.

During 2022, we launched the TAC-STIM product line designed for active-duty military personnel.

Truvaga and TAC-STIM are being marketed in the United States as wellness and human performance devices pursuant to the FDA guidance document entitled “ General Wellness:

Truvaga and TAC-STIM are being marketed in the United States as general wellness and human performance devices pursuant to the FDA guidance document entitled “ General Wellness:

Policy for Low-Risk Devices;

Guidance for Industry and FDA Staff, issued on September 27 2019”.

Guidance for Industry and FDA Staff, issued on September 27, 2019.” They are not intended to diagnose, treat, cure, or prevent any disease or medical condition.

Manufacturing

We are the FDA-registered and ISO registered manufacturer of our nVNS products.

We are the FDA-registered and ISO registered legal manufacturer of our nVNS products.

We rely upon third-party contract manufacturers and suppliers, located both within and outside the United States, for substantially all the components of our nVNS products.

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These measures include purchasing what we consider to be a sufficient advanced supply of key components to reasonably assure that no component shortages will interrupt our ability to manufacture and deliver our products to patients on a timely basis.

All the electronic components used in our products are either high-volume, non-custom commodity components, or are readily available from multiple vendors.

All the electronic components used in our products are either high-volume, non-custom commodity components, or alternate components are available.

Volumes of internationally sourced components have been increased due to geopolitical tensions that might temporarily have longer lead times .

The majority of these components have multiple sources, and the few with single sources have been purchased with sufficient reserves to permit continued production while simple product design modifications can be made.

We rely upon third parties, however, for the design function for new and modified devices.

We rely upon certain qualified third parties, from time to time, for engineering, design and validation of new and modified devices.

At our facility in Rockaway, NJ, we inspect inbound component parts to ensure they meet our design and manufacturing specifications prior to assembly.

This quality process involves physical inspection and electrical performance testing.

After successful completion of this inspection, each unit is then assembled, packaged, along with appropriate labeling and accessories.

After successful completion of this inspection, each unit is then assembled, programmed, and packaged, along with appropriate labeling and accessories.

Intellectual Property

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Copyrights, Trademarks and Trade Secrets

The software programs associated with gammaCore and our proprietary ecosystem, are protected by U.S.

As of February 1, 2023, our trademark portfolio consisted of six US trademark registrations, including electroCore, gammaCore, and gammaCore Sapphire, 19 international trademark registrations, and 15 pending US and international trademark applications.

As of February 1, 2024, our trademark portfolio consisted of 12 US trademark registrations, including electroCore, gammaCore, and gammaCore Sapphire, 23 international trademark registrations, and 12 pending US and international trademark applications.

We also rely upon trade secrets, know-how and continuing technological innovation, and may pursue licensing opportunities in the future, to develop and maintain our competitive position.

We seek to protect our proprietary rights through a variety of methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have access to proprietary information, under which they are bound to assign to us inventions made during the term of their employment or term of service.

Some of the software related to our Truvaga Plus product which we expect to launch in 2024 is licensed from third-parties, and we rely entirely on third-party software developers for the design of the software for this product.

Food and Drug Administration (FDA) Regulation

The majority of our products are medical devices that are subject to extensive regulation by the U.S.

Many of our products are medical devices that are subject to extensive regulation by the U.S.

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.

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Policy for Low-Risk Devices;

Guidance for Industry and FDA Staff, issued on September 27 2019” under which Truvaga and TAC-STIM are marketed under as wellness devices.

Guidance for Industry and FDA Staff, issued on September 27, 2019” under which Truvaga and TAC-STIM are marketed under as general wellness devices.

Our international sales are subject to regulatory requirements in the countries in which our products are sold.

The regulatory review process varies from country to country and may in some cases require the submission of clinical data.

In 2014 , we received CE Certificate of Conformity in the European Economic Area, or EEA, for our gammaCore therapy to treat, primary headache, including migraine, CH, and hemicrania continua, as well as medication overuse headache in adults.

In 2014 , we received CE Certificate of Conformity in the European Economic Area, or EEA, for our prescription gammaCore therapy to treat primary headache, including migraine, CH, and hemicrania continua, as well as medication overuse headache in adults.

The CE Certificate of Conformity was extended to additional indications, including for the treatment or prevention of symptoms of reactive airway disease, which includes asthma, bronchoconstriction, exercise induced bronchospasm, and COPD in adults.

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The notified body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements.

This Certificate entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

This CE Certificate of Conformity entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.

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Human Capital Resources

As of March 1, 2023, we emplo yed 62 full -time employees in the US and abroad None of our employees are represented by a labor union or covered by a collective bargaining agreement.

As of February 1, 2024, we emplo yed 68 full -time employees in the US and abroad.

None of our employees are represented by a labor union or covered by a collective bargaining agreement.

We consider our relationship with our employees to be good.

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Employee health and safety in the workplace is one of our core values.

The ongoing COVID- 19 pandemic has underscored for us the importance of keeping our employees safe and healthy.

In response to the pandemic, the Company has taken actions aligned with best practices so our employees can continue to safely and effectively perform their work.

For example, since the advent of the pandemic in the first half of 2020, the majority of our employees previously based in our then headquarters in Basking Ridge, NJ have generally conducted business remotely, which has allowed us to reduce our real estate space requirements.

Company History

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The Company has ceased its operations in Germany, although sales to Germany are still supported by electroCore UK Ltd.

In addition, an affiliate, electroCore (Aust) Pty Limited, or electroCore Australia, was subject to electroCore’s control on a basis other than voting interests and is a variable interest entity, or VIE, for which electroCore was the primary beneficiary.

This VIE has been inactive since May 2017 and was terminated in 2021 .

Our Internet website address is www.electrocore.com.

We also maintain websites at www.gammacore.com , www.gammacore.co.uk, and www.truvaga.com .

We also maintain websites at www.gammacore.com , www.gammacore.co.uk, www.truvaga.com, and www.tac-stim.com .

The content reflected on our websites are not incorporated by reference herein unless expressly noted.

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Within the Investors section of our website, we provide information concerning corporate governance, including our Corporate Governance Guidelines, board committee charters, Code of Conduct and other information.

A copy of the Code of Conduct may be provided to any person without charge upon written request to:

electroCore, Inc., Attn:

Corporate Secretary, 200 Forge Way, Suite 205, Rockaway, NJ 07866.

The content reflected on any website reflected in this Form 10-K is not incorporated by reference herein unless expressly noted.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business