What changed in this filing

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Item 1. Business

2025-03-12 compared with 2024-03-13 · 108 added, 62 removed, 229 unchanged (43% of the section changed)

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.

ElectroCore is a 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 and related product offerings .

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

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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.

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

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

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Primary Marketed Products and Business Strategy

Our goal is to be a leader in non-invasive neuromodulation by using our proprietary nVNS platform technology to deliver better health.

Our goal is to be a leader in non-invasive neuromodulation to deliver better health.

To achieve this, we offer multiple propositions:

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

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

Truvaga for the support of general health and wellbeing;

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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 shipped directly to certain patients in the United States directly from our facility in Rockaway, NJ.

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

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.

We offer two versions of our Truvaga products for the support of general health and wellbeing.

Truvaga 350 is a personal use consumer electronics general wellness product and Truvaga Plus, which was launched in April 2024, is our next generation, app-enabled general wellness product.

Neither product requires a prescription and is available direct-to-consumer from electroCore at www.truvaga.com, or through online retailers,

such as Amazon.com.

TAC-STIM handset 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

TAC-STIM handsets 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.” 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 .

Guidance for Industry and FDA Staff, issued on September 27, 2019.” Truvaga and TAC-STIM handsets 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, 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 70.6 % of our revenue during the year ended December 31, 2024 .

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 majority of our 2024 sales were made pursuant to our qualifying contract under the 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.

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, 2025, 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 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.

In August 2023, we signed a non-exclusive distribution agreement

with Lovell Government Services, or Lovell, providing Lovell the right to list

and distribute certain gammaCore products into the federal market.

Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and

pharmaceutical goods and services to federal healthcare providers.

products with Lovell is intended to streamline the sales process to a variety

of government procurement channels through Lovell’s compliance with contracting

regulations and its provision of logistical solutions connected directly into

government contracting portals, all of which are intended to help government

agencies meet their SDVOSB procurement goals.

Customers for these vehicles are federal

healthcare systems such as the Veterans Health Administration (VHA, which

includes the VA), the Military Health System (MHS), and Indian Health Services

(IHS), which we believe serve up to approximately 21

million patients combined.

Between November 2023 and January 2024, certain

gammaCore products were added to the FSS, the VA’s Distribution and Pricing

Agreement or DAPA, GSA Advantage, and Defense Logistics Agency’s ECAT system

procurement portals through the Lovell contract vehicles, enabling the purchase

of gammaCore products within the government channel and throughout the federal

markets, including, but not limited to, the VA.

The gammaCore products offered

through Lovell provide government customers with similar product configuration

options to those currently sold through our existing FSS contract and open

market sales made directly to individual VA facilities.

We expect a significant

portion of our 2025 sales to continue in the government channel broadly, and to

our largest customer the VA, specifically, pursuant to our FSS contract if

replaced and / or through our relationship with Lovell and its qualifying FSS,

GSA, DAPA, and ECAT contracts for which gammaCore has been added.

Sales under the UK MedTech Funding Mandate, or MTFM, for cluster headache (CH) in the UK compris ed 6.6 % of our re venue during the year ended December 31, 2024 .

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

In 2025, we plan on continued use of 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.

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

On December 17, 2024, we entered into a definitive agreement to acquire NURO.

NURO is a commercial stage healthcare company that develops and commercializes neurotechnology devices to address unmet needs in the chronic pain market through its Quell® platform:

a wearable, app and cloud-enabled neuromodulation platform that is indicated for the treatment of fibromyalgia symptoms (Quell Fibromyalgia) and lower-extremity chronic pain (Quell 2.0).

The transaction does not include NURO’s Japan-related DPNCheck® technology and business, which are expected to be divested by NURO prior to closing of the transaction.

Consummation of the transaction is subject to approval by holders of at least a majority of the outstanding shares of NURO common stock entitled to vote on the merger, and the filing with the SEC of NURO’s Form 10-K with respect to the fiscal year ended December 31, 2024, in addition to other closing conditions.

Primary Headache Market and Competition for our gammaCore Products’

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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 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.

According to an analysis cited in The American Journal of Managed Care, published in 2020, the annual economic burden of migraine in the United States is approximately $78 billion.

The analysis further provides an estimate of annual total direct and indirect costs of all migraine-related health services 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 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.

The prescription triptan drug class is 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.

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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 is a condition in which patients experience extremely painful headaches.

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.

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Market and Competition for our General Wellness Products

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.

In January 2024, McKinsey & Company estimated the global general wellness market to be more than $1.8 trillion with the US market, spanning health, fitness, appearance, sleep, nutrition, and mindfulness, to be more than $480 billion and growing at greater than 5% annually .

According to Grand View Research, 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.

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

In 2024, we launched 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.

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

Regulatory Clearances

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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 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.

We received a CE Certificate of Conformity for gammaCore for the treatment of primary headache from the British Standards Institution, a European Union notified body.

The Company is currently discussing the pathway for obtaining FDA clearance for treatment of PTSD by using gammaCore Sapphire.

We are considering 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, sleep, mood, fatigue and memory retention among others.

We received a CE Certificate of Conformity for gammaCore for the treatment of primary headache from the British Standards Institution, which was at the time a European Union notified body.

This CE Certificate of Conformity allowed us 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, we received CE Certificates of Conformity on gammaCore covering four other indications for use, including reactive airway disease and gastric motility disorders.

Post-Brexit, these CE Certificates of Conformity remain valid in the UK and EU.

BSI has established a Netherlands entity, which remains a notified body, and BSI in the UK has equivalent status as a “UK approved body”.

Under current guidance, CE marked medical devices may be placed on the UK market up until the sooner of the expiry of the CE Certificate of Conformity or June 30, 2028.

After that date, we will need to obtain UKCA marking (the UK replacement for CE marking) for commercialization of our gammaCore products in the UK.

In 2019, NICE published a Medical Technology Guidance document recommending the use of gammaCore for CH within NHS of England and Wales.

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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

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

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:

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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.

In order to protect against risk of supply chain disruption, we seek to maintain adequate inventory and have qualified an approved secondary contract manufacturer.

In order to protect against risk of supply chain disruption, we seek to maintain adequate inventory and, if necessary, there is adequate safety stock to qualify a secondary contract manufacturer when any supply chain disruption is identified.

Additionally, we retain the internal expertise and capabilities to perform all assembly aspects of our commercial product.

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.

These measures include purchasing what we consider to be 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 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.

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Copyrights, Trademarks and Trade Secrets

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.

As of February 1, 2025, our trademark portfolio consisted of 12 US trademark registrations, including electroCore, gammaCore, gammaCore Sapphire, gammaCore Emerald and TAC-STIM, 23 international trademark registrations, and 13 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.

Some of the software related to our Truvaga Plus product which was launched 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

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The FDA classifies medical devices into one of three classes based on the risks associated with the medical device and the controls deemed necessary to reasonably ensure the device’s safety and effectiveness.

Those three classes are:

These three classes are:

Class I, the lowest risk products, which require compliance with medical device general controls, including labeling, establishment registration, device product listing, adverse event reporting and, for some products, adherence to good manufacturing practices through the FDA’s quality system regulations;

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the FDA’s QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other good manufacturing practice and quality assurance procedures during all aspects of the manufacturing process (unless a device category is exempt from this requirement by the FDA, such as in the case of many Class I devices);

correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and device recalls or removals if undertaken to reduce a risk to health by the device or to remedy a violation of the FDA caused by the device that may present a risk to health;

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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.

In the EEA and UK, gammaCore must currently 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 EU Medical Devices Directive.

In the EEA and UK, gammaCore must currently comply with the essential requirements in Annex I to Directive 93 / 42 /EEC, or the Essential Requirements, relating to the approximation of the laws of the member states concerning medical devices or the EU Medical Devices Directive (UK law, implemented through the Medical Devices Regulations 2002, continues to be based on these requirements).

Compliance with these requirements is a prerequisite to be able to affix the CE mark to gammaCore, without which they cannot be marketed or sold in the EEA.

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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.

Under current guidance, CE marked medical devices may be placed on the UK market up until the sooner of the expiry of the CE Certificate of Conformity or June 30, 2028.

After that date, we will need to obtain UKCA marking (the UK replacement for CE marking) from a UK approved body (the new equivalent of an EU notified body) for commercialization of our gammaCore products in the UK.

See “Item 1 – Business – Regulatory Clearances” for additional information.

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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The MDR became applicable on May 26, 2021, with the transition period intended to end on May 26, 2024.

While progress has been made on the transition from the MDD to the MDD, a European Commission proposal published on January 6, 2023, stated that the overall number and capacity of conformity assessment (a.k.a., ‘notified’) bodies remains insufficient to carry out the tasks required of them.

While progress has been made on the transition from the MDD to the MDR, a European Commission proposal published on January 6, 2023, stated that the overall number and capacity of conformity assessment or notified bodies remains insufficient to carry out the tasks required of them.

In addition, many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period.

This is threatening the availability of medical devices on the EU market.

According to an estimation presented by notified bodies to the Medical Device Coordination Group on November 17, 2022, the number of certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance remains the same with no changes to current conditions.

Notified bodies estimate that the transition of all Directives’ certificates to MDR certificates could possibly be completed by December 2027.

The European Commission’s “ Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, Brussels, 1.6.2023 intends” to extend the transition period from May 26, 2024 until December 31, 2027 for high-risk Class III and Class IIb implantable devices, and until December 31, 2028 for medium and lower risk Class IIb and Class IIa devices.

The gammaCore products (gammaCore Sapphire, gammaCore-S) are EU Class IIa devices.

This was threatening the availability of medical devices on the EU market.

The European Commission extended the transition period from May 26, 2024 until December 31, 2028 for Class IIa devices, which includes the gammaCore products (gammaCore Sapphire, gammaCore-S).

Once applicable, the new regulations will among other things:

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establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

i mprove the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

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We have the necessary certificates for the MDR.

On March 29, 2017, the United Kingdom formally notified the EU of its intention to withdraw from the Union pursuant to Article 50 of the Lisbon Treaty, commonly referred to as Brexit.

The United Kingdom and EU have agreed on the terms of the exit deal, which included a transitional period following the United Kingdom’s exit which occurred on January 31, 2020.

The transitional period ended on December 31, 2020.

The effects of Brexit will be determined by the EU–UK Trade and Cooperation Agreement which was agreed on December 24, 2020 and ratified by the UK Parliament on December 30, 2020 and was “provisionally” applied by the EU from December 31, 2020.

On March 29, 2017, the United Kingdom formally notified the EU of its intention to withdraw from the Union pursuant to Article 50 of the Lisbon Treaty, commonly referred to as Brexit, and completed a transitional period on December 31, 2020.

Following Brexit, EU law and the EU Court of Justice no longer have supremacy over British laws or its Supreme Court.

The United Kingdom's European Union (Withdrawal) Act 2018 retains relevant EU law as domestic law, which can be amended or repealed.

The United Kingdom’s withdrawal from the EU could lead to legal uncertainty and potentially divergent national laws and regulations in the EU and the United Kingdom.

Given the lack of comparable precedent, it is unclear what Brexit’s financial, regulatory, and legal implications will be and how it will affect us.

However, potentially changing regulatory schemes and tariffs engendered by Brexit may add additional complexity, cost and delays to the operations of electroCore UK Ltd., and in marketing or selling our products in both the United Kingdom and the EEA.

For medical devices, the key changes are that:

- UK “notified bodies” have lost this status, and are no longer able to issue CE certificates.

Some, including BSI, have set up an EU entity as a new notified body to issue CE certificates.

- the UK is replacing the EU CE marking system with “UKCA” marking.

The transition period has been extended, and currently CE marked medical devices may be placed on the UK market up until the sooner of the expiry of the Certificate of Conformity or June 30, 2028.

After this date, manufacturers will need UKCA marking to place medical devices on the UK market.

Medical devices sold in the UK and EU will need both CE and UKCA marking.

The United Kingdom’s national laws and regulations for medical devices are currently based on retained EU legislation, but may diverge in future.

Potentially changing regulatory schemes and tariffs engendered by Brexit may add additional complexity, cost and delays to our UK operations, and in marketing or selling our products in both the United Kingdom and the EEA.

Our revenue and profit, supply and demand for our products, and customer retention and acquisition in both the long term and short term could be adversely affected.

CE Certificates of Conformity issued by a notified body accredited in the EU may no longer be recognized in the United Kingdom.

Similarly, notified bodies accredited in the United Kingdom will no longer be able to issue CE Certificates of Conformity.

Obtaining new CE Certificates of Conformity or certification for the United Kingdom may have a significant impact on our activities.

Finally, Brexit may also disrupt the way that the United Kingdom interprets obligations under CE Certificates of Conformity.

Federal Trade Commission

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Other Regulations

We may also be subject to healthcare fraud and abuse regulation in the jurisdictions in which we will conduct our business.

We may also be subject to healthcare fraud and abuse regulation in the jurisdictions in which we conduct our business.

These laws include, without limitation, applicable anti-kickback, false claims, transparency and patient privacy and security laws and regulations.

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

Our Internet website address is www.electrocore.com.

Our primary Internet website address is www.electrocore.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.

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

Available Information

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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