ECOR US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

(Mark

One)

For

the fiscal year ended December 31, 2025

OR

FOR THE TRANSITION PERIOD

FROM TO

Commission

File Number 001-38538

electroCore,

Inc.

(Exact

name of Registrant as specified in its Charter)

(Address of principal executive offices) (Zip Code)

Registrant’s

telephone number, including area code: (973)290-0097

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol(s) Name of each exchange on which registered

Common Stock, Par Value $0.001 Per Share ECOR The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒

Indicate

by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒

Indicate

by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

Indicate

by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant

was required to submit such files). YES ☒ NO ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,

or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller

reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large, accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act by the registered public accounting firm

that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange

Act). YES ☐ NO ☒

The

aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price

of the shares of common stock on the Nasdaq Capital Stock Market on June 30, 2025 was $27,950,688.

The

number of shares of Registrant’s Common Stock outstanding as of March 13, 2026 was 8,083,558.

Table

of Contents

Page

PART I

Item 1. Business 4

Item 1A. Risk Factors. 14

Item 1B. Unresolved Staff Comments 91

Item 1C. Cybersecurity 91

Item 2. Properties 93

Item 3. Legal Proceedings 94

Item 4. Mine Safety Disclosures 94

PART II

Item 6. [Reserved] 95

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 103

Item 8. Financial Statements and Supplementary Data 103

Item 9A. Controls and Procedures 103

Item 9B. Other Information 104

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 104

PART III

Item 10. Directors, Executive Officers and Corporate Governance 105

Item 11. Executive Compensation 114

Item 14. Principal Accountant Fees and Services 127

PART IV

Item 15. Exhibits and Financial Statement Schedules 127

i

Cautionary

Note Regarding Forward-Looking Statements

This

Annual Report on Form 10-K, or Annual Report, contains forward-looking statements that involve substantial risks and uncertainties. All

statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results

of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements.

In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,”

“could,” “expects,” “intends,” “plans,” “anticipates,” “believes,”

“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other

comparable terminology. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those

described under the heading “Risk Factors” contained in Item 1A of this Annual Report. In light of these risks, uncertainties

and assumptions, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements

in this Annual Report and you should not place undue reliance on these forward-looking statements.

Any

forward-looking statements in this Annual Report reflect our current views with respect to future events or to our future financial performance

and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to

be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume

no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

References

to electroCore

In

this Annual Report, unless otherwise stated or the context otherwise indicates, references to “ECOR,” “electroCore,”

“the Company,” “we,” “us,” “our” and similar references refer to electroCore, Inc., a

Delaware corporation and its wholly owned subsidiaries, including NeuroMetrix, Inc., a Delaware corporation (“NeuroMetrix”

or “NURO”).

Risk

Factor Summary

The

following is a summary of certain important factors that may make an investment in our Company speculative or risky. You should carefully

consider the full risk factor disclosure set forth in Item 1A of this Annual Report, in addition to the other information herein, including

the section of this report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

and our financial statements and related notes.

● We may not be able to establish, strengthen, or protect our brands.

● As a publicly traded company, we are subject to activist investors.

Trademarks

and Tradenames

The

electroCore, gammaCore, Truvaga, TAC-STIM, NeuroMetrix, and Quell, names, logos, and other trademarks of electroCore, Inc. appearing

in this Annual Report on Form 10-K are the property of electroCore, Inc. All other trademarks, service marks and trade names in this

Annual Report on Form 10-K are the property of their respective owners. We have omitted the ® and TM designations, as applicable,

for the trademarks used in this Annual Report on Form 10-K.

Market

Data and Forecasts

Unless

otherwise indicated, information in this Annual Report on Form 10-K concerning economic conditions, our industry, and our markets, including

our general expectations and competitive position, market opportunity and market size, is based on a variety of sources, including information

from independent industry analysts and publications, and/or our own estimates and research.

Our

estimates are derived from industry and general publications, studies and surveys conducted by third parties, as well as data from our

own internal research. These publications, studies and surveys generally indicate that their information has been obtained from sources

believed to be reliable, although they do not guarantee the accuracy or completeness of such information, and we have not independently

verified industry data from such third-party sources. While we believe our internal research is reliable and that our internal estimates

are reasonable, such research has not been verified by any independent source and our internal estimates are based on our good faith

beliefs as of the respective dates of such estimates. We are responsible for all of the disclosure in this Annual Report on Form 10-K.

PART

I

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 at www.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 acute treatment of pain associated with episodic cluster headache;

● The acute treatment of pain associated with migraine headache;

● The preventive treatment of migraine headache in adult patients;

● Treatment of hemicrania continua and paroxysmal hemicrania in adult patients.

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