electroCore, Inc.

Item 1.

Our Business

Background and Overview

electroCore is a bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. Our two leading commercial products are gammaCore non-invasive vagus nerve stimulation, or nVNS, and Quell Fibromyalgia, or Quell. We also sell our Truvaga and TAC-STIM products, which are handheld, personal-use consumer products, developed to promote general wellness and human performance.

We believe that our proprietary nVNS technology, which works through a variety of mechanistic pathways including the modulation of neurotransmitters, and Quell for chronic pain are designed to address many of the limitations of traditional non-invasive approaches.

Our business generates revenues from the sale of prescription medical devices and non-prescription wellness products in the United States and select overseas markets. We have two principal product categories:

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

Marketed Products and Business Strategy

Our goal is to be a leader in non-invasive bioelectronic technologies delivering better health. To achieve this, we offer multiple propositions:

gammaCore

gammaCore, is a prescription, handheld, medical device that is FDA cleared for a variety of primary headache conditions. gammaCore products are available by prescription only and are portable, reusable, rechargeable with reloadable personal use options 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 directly from electroCore in the United States from our facility in Rockaway, New Jersey. After the initial prescription is filled, access to additional therapy can be refilled for certain of our gammaCore products with a prescription authorization. Additional information may be found at www.gammaCore.com.

Quell Fibromyalgia

Quell Fibromyalgia is an FDA-authorized, prescription only, wearable neuromodulation device that helps reduce the symptoms of fibromyalgia in adults with high pain sensitivity. It incorporates a collection of proprietary approaches designed to optimize the effectiveness of nerve stimulation. The Quell platform is comprised of (1) an electronic device that is placed in a flexible band worn on the upper calf; (2) disposable refillable electrodes that attach to the device and acts as the interface between the device and the skin; and (3) a smartphone app to control the device, and, visualize, understand, and optimize data relating to chronic pain and health. The app is integrated with the Quell Health Cloud which stores user data which may be used for data analytics and scientific research. Prescriptions are written by a health care provider and dispensed through the patient’s healthcare system, or directly from electroCore in the United States from our facility in Rockaway, New Jersey. Additional information may be found atwww.quell.com.

Truvaga

We offer Truvaga handsets for the support of general health and wellbeing. Truvaga products are available direct-to-consumer at www.truvaga.com, through certain online retailers, or through select employment benefit plans.

TAC-STIM

TAC-STIM is a non-prescription 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 handsets are available as a Commercial Off the Shelf (COtS) solution to active-duty military and 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. Additional information may be found at www.Tac-Stim.com.

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 handsets are not intended to diagnose, treat, cure, or prevent any disease or medical condition.

Quell Over-the-Counter (“Quell OTC”)

Quell OTC is a pain management therapeutic system for the symptomatic relief and management of chronic pain in the lower extremities. Quell OTC is a Class III medical device intended for the treatment of lower extremity pain and is FDA cleared as an over-the-counter device (no prescription required) with disposable electrodes and in conjunction with a mobile app that contains several convenient features. Quell OTC is no longer commercially available; however, replacement electrodes continue to be sold to existing Quell OTC customers. We may choose to relaunch the Quell OTC product in the direct-to-consumer business channel in the future, there can be no assurance that we will do so successfully, or at all.

Customers

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, both utilizing prescription products under qualifying agreements.

The United States Department of Veteran Affairs comprised 71.2% of our revenue during the year ended December 31, 2025. The majority of our 2025 sales were made pursuant to our qualifying contract under the Federal Supply Schedule, or FSS, which has an expiry date of June 14, 2030, as well as pursuant to open market sales to individual facilities within the government channels.

In August 2023, we signed a non-exclusive distribution agreement with Lovell Government Services, or Lovell, providing Lovell with the right to list and distribute certain electroCore products into the federal market. Lovell is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to federal healthcare providers. Listing 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.

We expect a significant portion of our 2026 sales to continue in the government channel broadly, and to our largest customer, the VA, specifically, pursuant to our FSS contract and / or through our relationship with Lovell and its qualifying FSS, GSA Advantage, VA Distribution and Pricing Agreement (DAPA), and Defense Logistics Agency’s ECAT system contracts to which our prescription devices have been added.

Sales under the U.K. MedTech Funding Mandate, or MTFM, for cluster headache (CH) in the United Kingdom comprised 4.4% of our revenue during the year ended December 31, 2025. In 2026, we plan on continuing to use this program. Our current agreement with the NHS, in which our prescription gammaCore therapy will continue to be listed in the NHS catalogue, expires in February 2028. We continue to utilize distribution partners to commercialize our nVNS technology in selected territories outside the United States and United Kingdom.

Research and Development (“R&D”) and Clinical Programs

Our R&D team has significant experience in developing and commercializing therapeutic devices and bioelectronic technologies. Our R&D team works closely with regulatory, engineering, marketing, and customers to design and support products that are focused on improving clinical outcomes.

The product development team is comprised of product development, engineering, and product management personnel to support new iterations of bioelectronic technologies, led by our Chief Executive Officer. We are developing future iterations of bioelectronic technology, including the use of our intellectual property around the delivery of smartphone-integrated and smartphone-connected non-invasive therapies.

Our clinical and medical program is led by our Chief Medical Officer who coordinates our clinical programs for potential future uses of our bioelectronic technologies and clinical education. 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 into new indications and markets.

Sales, Marketing, and Distribution

Demand for our prescription devices in the U.S. may be driven by clinical data and our increased presence in the field. Our field sales force is comprised of territory business managers who manage commission only sales agents and sub representatives. In addition, we have a small team seeking to accelerate adoption in managed care systems.

Demand for prescription devices outside the U.S. may be driven by similar factors, including the strength of our clinical and health economic data. We have two dedicated resources focused on generating sales outside the United States.

We sell our general wellness products direct-to-consumer through our ecommerce site, www.truvaga.com, and through select Truvaga retail and marketplace partners, including Best Buy and Rehabmart. We also partner with organizations such as Ben Greenfield Life, Perks at Work, True Medicine and a growing number of affiliates and influencers who promote Truvaga and support awareness and customer acquisition through promotional partnerships.

We sell the TAC-STIM handset for human performance to active-duty military and professional organizations.

Manufacturing and Supply

We are the FDA-registered and ISO registered legal manufacturer of our bioelectronic 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 products. In order to protect against risk of supply chain disruption, we seek to maintain adequate inventory and, safety stock and 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 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. 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 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, programmed, and packaged, along with appropriate labeling and accessories.

Market and Competition

nVNS for Primary Headache

Migraine affects roughly 12% of the U.S. population and 14% of the global population. In the United States, approximately 39 million patients are affected by migraine, with approximately 18% being women. Approximately eight million Americans are seeing a professional annually about headaches. 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 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.

The market for 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 generally considered first line therapy for the acute treatment of migraine. There are many additional pharmaceutical approaches currently marketed by third parties. 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 shortly after their initial U.S. approvals and commercial launches in early 2020.

Several neuromodulation devices 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.

Cluster Headache (“CH”) is a rare primary headache disorder compared with migraine and tension-type headache. The estimated prevalence of CH ranges from 0.05% to 0.07% of the total U.S. adult population, and roughly 0.1% of the global adult population. 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.

There are a variety of pharmaceutical, FDA-approved, and commercially available therapies for the acute treatment for CH. The most frequently used acute treatments for CH attacks are subcutaneous sumatriptan and high flow rate inhaled oxygen. Alternative treatments, both approved by the FDA and medications that are used by patients off label, exist for CH.

Our prescription gammaCore therapy competes with numerous existing therapies from many different sources, including pharmaceutical, biotechnology, medical device and other healthcare companies, as well as with 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.

Quell

Chronic pain affects nearly 20% of adults in the United States and globally. According to estimates from U.S. health economic studies, the estimated incremental impact of chronic pain on health care costs in the United States is over $250 billion per year, and lost productivity is estimated to exceed $300 billion per year. Specifically, Fibromyalgia is estimated to affect about 2% to 4% of patients in the United States and globally, depending on diagnostic criteria study methods and population surveys.

The most common approach to chronic pain management is pain medication. This includes over the counter internal and external analgesics as well as prescription pain medications, including both non-opioid and opioids. The approach to treatment is individualized, drug combinations may be employed, and the results are often inadequate. Side effects, including potential for addiction are substantial. As a result of the complexity of treating chronic pain, it is believed that inadequate relief leads 25% to 50% of pain sufferers to seek alternatives to prescription pain medications. These alternatives include nutraceuticals, acupuncture, chiropractic care, non-prescription analgesics, electrical stimulators, braces, sleeves, pads and other items. In total, these pain relief products and services account for approximately $15 billion in annual out-of-pocket spending in the United States.

Our Quell technology falls within the crowded transcutaneous electrical nerve stimulation (“TENS”) category, which encompasses a wide number of neurostimulation devices. However, we believe there is no direct competition to our Quell technology with the level of power, sophistication, and user-friendly features for the symptomatic relief of chronic pain. The most common approach to chronic pain, including fibromyalgia, is pain medication. This includes OTC drugs (such as Advil and Motrin), and prescription (“Rx”) drugs including anti-convulsants (such as Lyrica, Savella, and Neurontin) and anti-depressants (such as Cymbalta and Elavil). Topical creams may also be used (such as Zostrix and Bengay). With severe pain, narcotic or opioid pain medications may be prescribed (such as codeine, fentanyl, morphine, and oxycodone).

Nerve stimulation is an established treatment for chronic pain. It is available through implantable spinal cord stimulation; however, this approach requires surgery and has attendant risks. Historically, although non-invasive approaches to neurostimulation, specifically TENS, have achieved limited success due to device limitations, inadequate dosing and low patient adherence. We believe our Quell wearable technology is in a unique neurostimulation category for both fibromyalgia and other lower extremity chronic pain conditions.

General Wellness

The global wellness economy was valued at about $6.8 trillion in 2024, according to research by the Global Wellness Institute (GWI). It is projected to continue growing toward nearly $10 trillion by the end of 2030.

According to Grand View Research, the global stress management treatment market is expected to reach approximately $20 billion by 2030, with the U.S. 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.

Some of the largest technology companies that have not historically operated in the general wellness and/or medical device spaces, such as Alphabet Inc., Amazon.com, Inc., Apple Inc., Samsung Electronics Co., Ltd., and others have notably developed, or may develop, products and technologies that may compete with our current or future products and technologies. Such companies have substantially greater capital, research and development, and sales resources than we have.

Regulatory Clearances

Prescription gammaCore

gammaCore, our prescription only, handheld device, is cleared by the FDA for use in the following indications:

The FDA clearances of our prescription gammaCore therapy to treat primary 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 or through de novo classifications relating to uses of External Vagus Nerve Stimulators.

In January 2022, the FDA granted gammaCore “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. The Company is currently considering a pathway for obtaining FDA clearance for treatment of PTSD by using gammaCore.

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, concussion, and anxiety, among others.

In 2011, 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 United Kingdom and European Union. British Standards Institution , or BSI, has established a Netherlands entity, which remains a notified body, and BSI in the United Kingdoms has equivalent status as a “U.K. approved body”. Under current guidance, CE marked medical devices may be placed on the U.K. market until the sooner of the expiration of the CE Certificate of Conformity or June 30, 2028. After that date, we will need to obtain U.K.CA marking (the U.K. replacement for CE marking) for commercialization of our gammaCore products in the United Kingdom, unless the United Kingdom implements the proposed amendments to the U.K. Medical Device Regulation (U.K. MDR) permitting the United Kingdom to indefinitely recognize devices that comply with the E.U. Medical Device Regulation (E.U. MDR). BSI is currently reviewing the Company’s technical file as part of the transition to E.U. MDR and U.K. MDR. Upon successful completion of this review, BSI is expected to issue an updated CE certification.

Quell

In 2021, Quell received Breakthrough Device designation from the FDA for a fibromyalgia indication. A pivotal double-blind, randomized, sham-controlled clinical study of Quell Fibromyalgia was completed, and a De Novo marketing authorization was obtained from the FDA in 2022. Quell Fibromyalgia is indicated for use as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. This Rx product was introduced to the domestic market in late 2022.

Quell also received FDA Breakthrough Device designation in early 2022 for the treatment of chronic Chemotherapy Induced Peripheral Neuropathy (CIPN). Similar approaches to other possible disease indications involving chronic pain could include fibromyalgia-like long COVID, chronic low back pain, and chronic overlapping pain conditions (COPC).

In July 2014, the Quell OTC device received 510(k) clearance for over-the-counter use and in November 2014, our Quell OTC disposable electrode received 510(k) clearance for over-the-counter use. In January 2016, a number of new features were added to Quell OTC and received 510(k) clearance, most notably use with an optional mobile app that contains several convenience features. The intended use of the Quell OTC pain management therapeutic system is the symptomatic relief and management of lower extremity pain.

General Wellness

Truvaga and TAC-STIM are being marketed in the United States as general wellness and human performance products 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, and subsequently updated on January 6, 2026. They are not intended to diagnose, treat, cure, or prevent any disease or medical condition.

Intellectual Property

Patents and Patent Applications

As of December 31, 2025, we held more than 215 patents and patent applications, including 170 issued U.S. patents, 39 U.S. patent applications, and 80 international patents and applications. All of our current issued patents are projected to expire between 2026 and 2039.

Copyrights, Trademarks and Trade Secrets

As of December 31, 2025, our trademark portfolio consisted of 23 U.S. trademark registrations, including electroCore, gammaCore, gammaCore Sapphire, gConcierge, TAC-STIM, NeuroMetrix, and Quell, over 40 international trademark registrations, and 9 pending U.S. 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 employment or term of service.

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

U.S. Food and Drug Administration (FDA) Regulation

Several 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. 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. These three classes are:

Before being introduced into the U.S. market, our medical devices must obtain marketing clearance or approval from FDA through the 510(k) pre-market notification process, the de novo classification process (summarized below under De Novo Classification Process), or the 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. To date, our products have all been classified as Class II, moderate-risk medical devices and have been subject to the 510(k) review and clearance process.

Additionally, the FDA also has a policy, General Wellness: Policy for Low-Risk Devices, regarding general wellness products. Under this policy, the FDA does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FDCA or, if they are devices, whether they comply with the relevant regulatory requirements for devices (e.g., establishment registration, pre-market review). The policy defines general wellness products as products that meet the following two factors: (1) are intended for only general wellness use, as defined in the policy, and (2) present a low risk to the safety of users and other persons. We market Truvaga and TAC-STIM as general wellness products pursuant to this policy.

510(k) Pre-Market Notification Process

Class II devices typically require pre-market review and clearance by the FDA, which is accomplished through the submission of a 510(k) pre-market notification before the device may be marketed. To obtain 510(k) clearance, we must demonstrate that a new device is substantially equivalent to another device with 510(k) clearance or grandfathered status, or to a device that was reclassified from Class III to Class II or Class I - this device to which the new device is compared is called the “predicate device.” In some cases, we may be required to perform clinical trials to support a claim of substantial equivalence. If clinical trials are required, we may be required to submit an application for an investigational device exemption, or IDE, which must be cleared by the FDA prior to the start of a clinical investigation, unless the device and clinical investigation are considered non-significant risk by the FDA or are exempt from the IDE requirements. Whether or not an IDE is required for a clinical study involving a medical device, an appropriate Institutional Review Board (IRB) must review and approve the study protocol before it is initiated. It generally takes three months from the date of the pre-market notification submission to obtain a final 510(k) clearance decision from the FDA, but it can be significantly longer.

After a medical device receives a 510(k) clearance letter, which authorizes commercial marketing of the new device for one or more specific indications for use, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires the submission of a new 510(k) notification or could require de novo classification or a PMA. The FDA allows each company to make this determination, but the FDA can review the decision as part of routine compliance audits of the company. If the FDA disagrees with a company’s decision not to seek prior FDA authorization, the FDA may require the company to seek additional 510(k) clearance or pre-market approval. The FDA also can require the company to cease marketing and/or recall the medical device in question until its regulatory status is resolved.

De Novo Classification Process

If the FDA determines that a new, previously unclassified medical device or its intended use is not substantially equivalent to a predicate device, the device is automatically placed into Class III, requiring the submission of a PMA. Devices that cannot be cleared through the 510(k) process due to lack of a predicate device but would be considered low or moderate risk (in other words, they do not rise to the level of requiring the approval of a PMA because any risks associated with the device could be mitigated through general controls and/or special controls) may be eligible for the 510(k) De Novo classification process. If a product is classified as Class II through the De Novo classification process, then that device may serve as a predicate device for subsequent 510(k) pre-market notifications.

FDA has issued a Guidance document that formally codifies requirements for the medical device De Novo process and the procedures and criteria for product developers to file a De Novo classification request.

PMA Application Process

If a medical device does not qualify for the 510(k)-pre-market notification process and is not eligible for classification as a low or moderate-risk device through the De Novo process, the device is deemed to be Class III and a company must submit a PMA application to seek authorization for its commercial sale. A PMA requires more extensive pre-filing testing than is required in the 510(k) application and is more costly, lengthy and uncertain. The PMA review and approval process can take one to three years or longer, from the time the PMA application is filed with the FDA. Under a PMA, the company must demonstrate to the FDA that the new medical device is safe and effective for its intended purpose. A PMA typically includes extensive pre-clinical and clinical trial data, and information about the device, its design, manufacture, labeling and components. Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with the FDA’s quality system regulation, or QSR.

If FDA approves the PMA, the approved indications may be more limited than those originally sought. In addition, FDA’s approval order may include post-approval conditions that the FDA believes necessary to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution and post-market study requirements. Failure to comply with the post-approval conditions can result in adverse enforcement or administrative actions, including the withdrawal of the approval. Approval of a new PMA application or a PMA supplement may be required before making certain types of modifications to the device, including to its labeling, intended use or indication, or manufacturing process, especially when such modifications have the potential to affect safety and effectiveness.

Post-Marketing Compliance Obligations

Regardless of which pre-market pathway a medical device uses to reach the U.S. market, after a device is placed on the market, numerous regulatory requirements continue to apply. These include:

International Regulation

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 2011, 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.

Outside the United States, we market gammaCore in the United Kingdom and, to a limited extent, in the European Economic Area (EEA), and other jurisdictions through distribution partners. Sales in these markets currently represent an immaterial portion of our total revenue. To market gammaCore in the EEA and United Kingdom, we must comply with applicable medical device regulations and maintain CE Certificates of Conformity issued by a notified body. Our CE Certificates allow us to affix the CE mark to gammaCore for sale in the EEA. In the United Kingdom, CE marked devices may currently be placed on the market until the earlier of expiration of the CE Certificate or June 30, 2028, after which we will need UKCA marking to continue sales in the U.K.

The EU Medical Devices Regulation 2017/745 (MDR) replaced the prior Medical Devices Directive and imposes additional compliance requirements. The European Commission extended the MDR transition period until June 30, 2028 for Class IIa devices, which includes our gammaCore products. We have obtained the necessary certificates for MDR compliance through June 30, 2028. On December 16, 2025, the European Commission, or EC, published a proposal to revise the MDR. The proposal introduces several measures that would have a significant impact on the medical device industry, including:

The proposal will undergo the ordinary legislative procedure and be examined by the European Parliament and the Council, which may introduce amendments to the text proposed by the EC.

Following Brexit, U.K. medical device regulations are based on retained EU legislation but may diverge in the future. These regulatory changes could add complexity and cost to our limited U.K. and EEA operations.

Federal Trade Commission

We are subject to Federal Trade Commission, or FTC, regulatory oversight. Under the Federal Trade Commission Act (FTC Act), the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress and other relief for conduct injurious to consumers; and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce. The FTC has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties, including civil penalties, or injunctions affecting the manner in which our products could be marketed in the future.

Other Regulations

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.

Advertising and Promotion

Advertising and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the FTC and by federal and state regulatory and enforcement authorities, including the Department of Justice, the Office of Inspector General of the Department of Health and Human Services, and various state attorneys general. Although physicians are permitted to use their medical judgment to use medical devices for indications other than those cleared or approved by the FDA, we may not promote our products for such “off-label” uses and can only market our products for cleared or approved uses. Other companies’ promotional activities for their FDA-regulated products have been the subject of FTC enforcement actions brought under healthcare reimbursement laws and consumer protection statutes. FTC enforcement actions often result in consent decrees that constrain future actions. In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims.

Import and Export Requirements

To import a device, the importer must file an entry notice and bond with the United States Bureau of Customs and Border Protection (CBP). All devices are subject to FDA examination before release from CBP. Any article that appears to be in violation of the FDCA may be refused admission and a notice of detention and hearing may be issued. If the FDA ultimately refuses admission, CBP may issue a notice for redelivery and, if a company fails to redeliver the goods or otherwise satisfy CBP and the FDA with respect to their disposition, may assess liquidated damages for up to three times the value of the lot. The CBP also imposes its own regulatory requirements on the import of our products, including inspection and possible sanctions for noncompliance.

Human Capital Resources

As of February 1, 2026, we employed 83 full-time employees. 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.

We believe our success depends on our ability to attract, develop and retain key personnel. The skills, experience and industry knowledge of key employees significantly benefit our operations and performance. Our board of directors and management oversee various employee initiatives. New employees are provided industry-relevant compliance training and are introduced to our Code of Business Conduct and Ethics to which all employees are required to annually confirm compliance.

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

Company History

electroCore, Inc. was founded in 2005 as a limited liability company, which converted into a Delaware corporation pursuant to a statutory conversion effective June 21, 2018. The Company is headquartered in New Jersey and has three wholly owned subsidiaries: electroCore U.K. Ltd., electroCore Germany GmbH, and NeuroMetrix. The Company has ceased its operations in Germany, although sales to Germany are still supported by electroCore U.K. Ltd.

On May 1, 2025 (the “NURO Closing Date”), the Company completed its previously announced acquisition of NeuroMetrix pursuant to the terms of the Agreement and Plan of Merger dated as of December 17, 2024 (the “Merger Agreement”) by and among the Company, NURO, and Nexus Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub”). Pursuant to the Merger Agreement, on the NURO Closing Date, Merger Sub merged with and into NURO, with NURO surviving as a wholly-owned subsidiary of the Company (the “Merger”).

Our primary internet website address is www.electrocore.com. We also maintain websites at www.gammacore.com, www.gammacore.co.u.k., www.gammacore.com/ca/, gammacore.com/lt/, www.truvaga.com, www.tac-stim.com, www.quellrelief.com, www.quellfibromyalgia.com, www.neurometrix.com, . The content reflected on our websites is not incorporated by reference herein unless expressly noted.

Available Information

Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and proxy statements, and all exhibits and amendments thereto, are available free of charge on our Internet website. These reports are posted on our website as soon as reasonably practicable after such reports are electronically filed with the SEC. The public may read and copy any materials that we file with the SEC electronically through the SEC website (www.sec.gov). The information contained on the SEC’s website is not incorporated by reference into this Form 10-K and should not be considered to be part of this Form 10-K. 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.