What changed in electroCore, Inc.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of electroCore, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+110 added−1288 removedSource: 10-K (2026-03-19) vs 10-K (2025-03-12)
Top changes in electroCore, Inc.'s 2025 10-K
110 paragraphs added · 1288 removed · 66 edited across 2 sections
- Item 1. Business+102 / −1127 · 59 edited
- Item 1C. Cybersecurity+8 / −161 · 7 edited
Item 1. Business
Business — how the company describes what it does
59 edited+43 added−1068 removed37 unchanged
Item 1. Business
Business — how the company describes what it does
59 edited+43 added−1068 removed37 unchanged
2024 filing
2025 filing
Biggest changeRegulatory Clearances Prescription gammaCore, which is our prescription only, handheld device intended for regular or intermittent use over many years, is cleared by the FDA for use in the following indications: • The acute treatment of pain associated with episodic cluster headache ; • The acute treatment of pain associated with migraine headache; • Adjunctive use for the preventive treatment of cluster headache in adult patients; • The preventive treatment of migraine headache in adult patients; • The use of gammaCore by adolescent patients (between 12 and 17 years of age); and • Treatment of h emicrania c ontinua and paroxysmal hemicrania in adult patients. 4 The FDA clearances of our prescription gammaCore therapy to treat headache were facilitated by the FDA's creation of a new regulatory category: External Vagus Nerve Stimulator for Headache (21 CFR 882-5892).
Biggest changeRegulatory 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; ● Adjunctive use for the preventive treatment of cluster headache in adult patients; ● The preventive treatment of migraine headache in adult patients; ● The use of gammaCore by adolescent patients (between 12 and 17 years of age); and ● Treatment of hemicrania continua and paroxysmal hemicrania in adult patients.
If the FDA ultimately refuses admission, the 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.
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.
Some of the world’s 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 in the future develop products and technologies that may compete with our current or future products and technologies.
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.
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.
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.
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. 7 If FDA approves the PMA, the approved indications may be more limited than those originally sought.
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.
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.
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.
These include: • 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; • post-market surveillance regulations, which apply to Class II or III devices if the FDA has issued a post-market surveillance order and the failure of the device would be reasonably likely to have serious adverse health consequences, the device is expected to have significant use in the pediatric population, the device is intended to be implanted in the human body for more than one year, or the device is intended to be used to support or sustain life and to be used outside a user facility; • regular and for-cause inspections by FDA to review a manufacturer’s facility and its compliance with applicable FDA requirements; • the FDA’s recall authority, whereby it can ask, or order, device manufacturers to recall from the market a product that is in violation of applicable laws and regulations; and • the guidance document entitled “ General Wellness: Policy for Low-Risk Devices; Guidance for Industry and FDA Staff, issued on September 27, 2019” under which Truvaga and TAC-STIM are marketed under as general wellness devices.
These include: ● the FDA’s quality management system regulation, 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; ● post-market surveillance regulations, which apply to Class II or III devices if the FDA has issued a post-market surveillance order and the failure of the device would be reasonably likely to have serious adverse health consequences, the device is expected to have significant use in the pediatric population, the device is intended to be implanted in the human body for more than one year, or the device is intended to be used to support or sustain life and to be used outside a user facility; 11 ● regular and for-cause inspections by FDA to review a manufacturer’s facility and its compliance with applicable FDA requirements; ● the FDA’s recall authority, whereby it can ask, or order, device manufacturers to recall from the market a product that is in violation of applicable laws and regulations; and ● the guidance document entitled “General Wellness: Policy for Low-Risk Devices; Guidance for Industry and FDA Staff, issued on September 27, 2019” under which Truvaga and TAC-STIM are marketed under as general wellness devices.
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. Lovell is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to federal healthcare providers.
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.
There are several neuromodulation devices that have been marketed for the treatment of migraine, including CEFALY (sold by CEFALY Technologies sprl), Nerivio (sold by Theranica Bioelectronics), and Savi Dual (sold by eNeura, Inc.) as well as other neuromodulation devices that may be marketed for use in treating pain associated with primary headache.
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.
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, t he FDA also has a policy, General Wellness: Policy for Low-Risk Devices , regarding general wellness products.
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.
In 2014 , we received CE Certificate of Conformity in the European Economic Area, or EEA, for our prescription gammaCore therapy to treat primary headache, including migraine, CH, and hemicrania continua, as well as medication overuse headache in adults.
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.
New employees are provided in dustry-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.
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.
Our prescription gammaCore therapy competes with numerous existing therapies from many different sources, including pharmaceutical, biotechnology, medical device and other healthcare companies, and therapies that may become available in the future.
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.
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.
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.
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 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.
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.
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 discussing the pathway for obtaining FDA clearance for treatment of PTSD by using gammaCore Sapphire.
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.
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.
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.
In January 2022, the FDA granted gammaCore Sapphire “Breakthrough Device designation for the treatment of post-traumatic stress disorder or PTSD.” PTSD is a highly prevalent and disabling disorder with limited approved treatment options.
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.
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 two wholly owned subsidiaries: electroCore UK Ltd. and electroCore Germany GmbH.
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.
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.
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.
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.
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.
The CBP also imposes its own regulatory requirements on the import of our products, including inspection and possible sanctions for noncompliance. 10 Human Capital Resources As of February 1, 2025, we emplo yed 73 full -time employees in the US and abroad. None of our employees are represented by a labor union or covered by a collective bargaining agreement.
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.
Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices. 6 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.
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.
General Wellness Truvaga and TAC-STIM are being marketed in the United States as general wellness and human performance devices pursuant to the FDA guidance document entitled “ General Wellness: Policy for Low-Risk Devices; Guidance for Industry and FDA Staff, issued on September 27, 2019.” They are not intended to diagnose, treat, cure, or prevent any disease or medical condition.
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.
Approximately 8 million Americans are seeing a professional about headache and approximately 2.5 million Americans have a prescription for migraine therapy. Migraine attacks can be extremely disabling and more than 90% of migraine sufferers are unable to work or function normally while experiencing migraine.
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.
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 Truvaga could be marketed in the future .
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. 12 Other Regulations We may also be subject to healthcare fraud and abuse regulation in the jurisdictions in which we conduct our business.
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.
The FDA also can require the company to cease marketing and/or recall the medical device in question until its regulatory status is resolved. 10 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.
Our flagship gammaCore Sapphire, is a prescription medical device that is FDA cleared for a variety of primary headache conditions. gammaCore is available by prescription only and Sapphire is a portable, reusable, rechargeable and reloadable personal use option for patients to use at home or on the go.
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.
In particular, injectables such as Botulinum toxin (Botox) and calcitonin gene-related peptides antagonists or CGRPs have gained significant adoption and market share, with oral CGRPs gaining more market share.
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.
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.
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.
Manufacturing We are the FDA-registered and ISO registered legal manufacturer of our nVNS products. We rely upon third-party contract manufacturers and suppliers, located both within and outside the United States, for substantially all the components of our nVNS products.
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.
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. U.S. Food and Drug Administration (FDA) Regulation Many of our products are medical devices that are subject to extensive regulation by the U.S.
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. 9 U.S.
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”.
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”.
All of our current issued patents are projected to expire between 2026 and 2037 . Copyrights, Trademarks and Trade Secrets 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.
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 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.
These indications include, post-traumatic stress disorder, concussion, and anxiety, among others. 8 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.
We have two principal product categories: • Handheld, personal use medical devices for the management and treatment of certain medical conditions such as primary headache; and • Handheld, personal use consumer products utilizing nVNS technology to promote general wellness and human performance. We believe our nVNS products may be used in the future to effectively treat additional medical conditions.
We have two principal product categories: ● Personal use prescription medical devices for the management and treatment of certain medical conditions such as primary headache and fibromyalgia; and ● Personal use consumer products that promote general wellness and human performance.
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.
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.
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 2025, we plan on continued use of this program.
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.
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 program.
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.
We derive a material portion of our revenue made pursuant to our qualifying contract under the Federal Supply Schedule or FSS, as well as open market sales to individual facilities within the government channels.
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.
The most frequently used acute treatments for CH attacks are subcutaneous sumatriptan and high flow rate inhaled oxygen. Alternative treatments include intranasal triptans and intravenous dihydroergotamine, or DHE. Galcanezumab, a calcitonin gene-related peptide was recently approved by the FDA for the treatment of episodic CH. Additional medications that are used by patients off-label include verapamil, lithium, and valproate.
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 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 .
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.
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 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 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.
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.
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.
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.
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.
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.
These laws include, without limitation, applicable anti-kickback, false claims, transparency and patient privacy and security laws and regulations.
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 are considering additional medical indications for our nVNS technology which are being studied in several investigator-initiated trials, or IITs.
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.
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.
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. 3 Market and Competition for our General Wellness Products 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 .
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.
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. 1 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.
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.
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. In 2024, we launched our next generation app-enabled consumer device under the Truvaga brand.
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.
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.
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.
Once applicable, the MDR may impose increased compliance obligations for us to access the EU market. In order to continue to sell gammaCore in Europe, we must maintain our CE Certificate of Conformity for the device and continue to comply with the Medical Devices Directive and with the MDR.
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.
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.
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.
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.
We continue to utilize distribution partners to commercialize our nVNS technology in selected territories outside the United States and United Kingdom. 5 Research and Development (“R&D”) and Clinical Programs Our R&D team has significant experience in developing and commercializing therapeutic devices and bioelectronic technologies.
Item 1. Business Our Business An Overview 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.
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.
In 2023, NHS granted a two-year extension in which our prescription gammaCore therapy will continue to be listed in the NHS catalogue. This extension is through March 17, 2026, with an option for us to extend an additional two years.
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.
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.
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).
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).
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.
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Our nVNS treatment is delivered through a proprietary high-frequency burst waveform that safely and comfortably passes through the skin and stimulates therapeutically relevant fibers in the vagus nerve. Various scientific publications suggest that nVNS works through a variety of mechanistic pathways including the modulation of neurotransmitters.
Added
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.
Removed
Historically, vagus nerve stimulation or VNS, required an invasive surgical procedure to implant a costly medical device. This generally limited VNS from being used by anyone other than the most severe patients. Our non-invasive medical devices and general wellness products are self-administered and intended for regular or intermittent use over many years.
Added
Our business generates revenues from the sale of prescription medical devices and non-prescription wellness products in the United States and select overseas markets.
Removed
Primary Marketed Products and Business Strategy 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 prescription FDA cleared medical conditions such as primary headache; • Truvaga for the support of general health and wellbeing; and • TAC-STIM for human performance.
Added
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.
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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.
Added
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.
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The United States Department of Veteran Affairs comprised 70.6 % of our revenue during the year ended December 31, 2024 . 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.
Added
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.
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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, 2025, while the U.S.
Added
Additional information may be found at www.quell.com . 4 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.
Removed
Department of Veteran Affairs VA Federal Supply Schedule Service reviews our follow-on offer application for a replacement contract.
Added
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.
Removed
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.
Added
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.
Removed
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.
Added
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.
Removed
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.
Added
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.
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In 2025, we expect the National Institute for Health and Care Excellence, or NICE, to review the guidance document and any changes in recommendation or pricing may adversely impact our ability to work with NHS, England on the MTFM program and could have an adverse impact on our financial results.
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Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
7 edited+1 added−154 removed13 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
7 edited+1 added−154 removed13 unchanged
2024 filing
2025 filing
Biggest changeIn furtherance of our cybersecurity policies and procedures, our IT team has a monthly IT Steering committee meeting, chaired by our Chief Financial Officer (“CFO”) and Chief Strategy Officer, where all new IT projects include a cybersecurity component.
Biggest changeIn furtherance of our cybersecurity policies and procedures, our IT team has a monthly IT Steering committee meeting, chaired by our Chief Financial Officer (“CFO”), where all new IT projects include a cybersecurity component. 91 Engage Third-Parties on Risk Management We engage a range of external experts, including consultants, auditors, and cybersecurity assessors, who assist us in evaluating and testing our cybersecurity systems and processes.
The Audit Committee reports to the Board as necessary with respect to its activities, including making such reports and recommendations to the Board as it deems necessary and appropriate. 85 Risk Management Personnel Management’s role in assessing, monitoring and managing our material cybersecurity risks is primarily the responsibility of our CISO, reporting to our CFO.
The Audit Committee reports to the Board as necessary with respect to its activities, including making such reports and recommendations to the Board as it deems necessary and appropriate. Risk Management Personnel Management’s role in assessing, monitoring and managing our material cybersecurity risks is primarily the responsibility of our CISO, reporting to our CFO.
We maintain business continuity and disaster recovery capabilities to mitigate interruptions to critical information systems and/or the loss of data and services from the effects of natural or man-made disasters to our physical operations. Monitor Cybersecurity Incidents The CISO implements and oversees processes for the regular monitoring of our IT systems.
We maintain business continuity and disaster recovery capabilities to mitigate interruptions to critical information systems and/or the loss of data and services from the effects of natural or man-made disasters to our physical operations. 92 Monitor Cybersecurity Incidents The CISO implements and oversees processes for the regular monitoring of our IT systems.
They provide briefings to the Audit Committee on no less than an annual basis or on an ad hoc basis when needed. These briefings encompass: • Evaluation of existing cybersecurity risks; • Status of ongoing cybersecurity initiatives and strategies from the cybersecurity roadmap ; and • Incident reports and learnings from cybersecurity events. Item 2 .
They provide briefings to the Audit Committee on no less than an annual basis or on an ad hoc basis when needed. These briefings encompass: ● Evaluation of existing cybersecurity risks; ● Status of ongoing cybersecurity initiatives and strategies from the cybersecurity roadmap; and ● Incident reports and learnings from cybersecurity events.
This includes the deployment of security measures to identify potential vulnerabilities. In the event of a cybersecurity incident, the CISO runs an incident response plan. This plan includes actions to mitigate the impact and long-term strategies for remediation and prevention of future incidents. Reporting to Board of Directors The CISO regularly informs the CFO of cybersecurity risks and incidents.
This includes the deployment of security measures to identify potential vulnerabilities. In the event of a cybersecurity incident, the CISO runs an incident response plan. This plan includes actions to mitigate the impact and long-term strategies for remediation and prevention of future incidents.
Furthermore, significant cybersecurity matters, and strategic risk management decisions are escalated to the Board of Directors, which has oversight and may provide guidance on critical cybersecurity issues.
Reporting to Board of Directors The CISO regularly informs the Audit Committee and CFO of cybersecurity risks and incidents. Furthermore, significant cybersecurity matters, and strategic risk management decisions are escalated to the Board of Directors, which has oversight and may provide guidance on critical cybersecurity issues.
Oversee Third-party Risk As part of our evolving cybersecurity roadmap, we plan to implement and conduct security assessments of all third-party service providers before engagement and maintain ongoing monitoring to ensure compliance with relevant cybersecurity standards. Risks from Cybersecurity Threats We have not experienced any material cybersecurity incidents and the expenses we have incurred from any security incidents were immaterial.
Oversee Third-Party Risk As part of our evolving cybersecurity roadmap, we plan to implement and conduct security assessments of all third-party service providers before engagement and maintain ongoing monitoring to ensure compliance with relevant cybersecurity standards.
Removed
Engage Third-parties on Risk Management We engage a range of external experts , including consultants, auditors, and cybersecurity assessors, who assist us in evaluating and testing our cybersecurity systems and processes.
Added
Risks from Cybersecurity Threats The Company does not believe that it has experienced any material cybersecurity incidents and the expenses we have incurred from any security incidents were immaterial.
Removed
Properties Our principal office is approximately 22,557 square feet of office, warehouse and assembly space in Rockaway, New Jersey pursuant to a lease that expires in 2034 . Since the spring of 2020 , many of our employees have conducted business remotely. Management believes our facilities in Rockaway are currently suitable for their intended use.
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We may in the future add new facilities or expand or relinquish existing facilities as our needs evolve, and we believe that should the need arise, suitable additional or substitute space will be available as needed to accommodate any expansion of our operations.
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On February 6, 2024, the Company entered into an amendment to the lease agreement (the"Rockaway Amendment") to extend its Rockaway, New Jersey lease for an additional 10 years . The Rockaway Amendment was effective May 1, 2024 , and expires on July 31, 2034 , with a tenant option to renew for an additional five years .
Removed
The increase in the term of the lease for the existing leased property was accounted for as a lease modification, and therefore, the associated operating lease right of use assets and operating lease liabilities for the existing space were remeasured as of February 6, 2024.
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The Rockaway Amendment also includes the expansion of leased property from 13,643 square feet to 22,557 square feet. Item 3 .
Removed
Legal Proceeding s On September 26, 2019, and October 31, 2019, purported stockholders of the Company served putative class action lawsuits in the United States District Court for the District of New Jersey captioned Allyn Turnofsky vs. electroCore, Inc ., et al., Case 3:19-cv-18400, and Priewe vs. electroCore, Inc., et al., Case 1:19-cv-19653, respectively.
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In addition to the Company, the defendants include present and past directors and officers, and Evercore Group L.L.C., Cantor Fitzgerald & Co., JMP Securities LLC and BTIG, LLC, the underwriters for the IPO. 86 The plaintiffs each seek to represent a class of stockholders who (i) purchased the Company’s common stock in the IPO or whose purchases are traceable to the IPO, or (ii) who purchased common stock between the IPO and September 25, 2019.
Removed
The complaints each alleged that the defendants violated Sections 11 and 15 of the Securities Act and Sections 10(b) and 20(a) of the Exchange Act, with respect to (i) the registration statement and related prospectus for the IPO, and (ii) certain post-IPO disclosures filed with the SEC. The complaints sought unspecified compensatory damages, interest, costs and attorneys’ fees.
Removed
The Priewe case was voluntarily dismissed on February 19, 2020. In the Turnofsky case, on November 25, 2019, several plaintiffs and their counsel moved to be selected as lead plaintiff and lead plaintiff’s counsel. On April 24, 2020, the Court granted the motion of Carole Tibbs and the firm Bragar, Eagel & Squire, P.C.
Removed
On July 17, 2020, the plaintiffs filed an amended complaint in Turnofsky. In addition to the prior claims, the amended complaint adds an additional director defendant and two investors as defendants, added a claim against us and the underwriters for violating Section 12 (a)( 2 ) of the Securities Act.
Removed
On September 15, 2020, we and the other defendants filed a motion to dismiss the amended complaint for failure to state a claim. On November 6, 2020, the plaintiffs filed their opposition to the motion to dismiss. The Company and the other defendants filed reply papers in support of the motion on December 7, 2020.
Removed
Argument of the motion to dismiss occurred on June 18, 2021. On August 13, 2021, the Court dismissed the amended complaint with leave to re-plead. On October 4, 2021, the plaintiffs filed a second amended complaint in the Turnofsky case. The defendants moved to dismiss, and briefing on the motion was complete on January 7, 2022.
Removed
On July 13, 2023, the court dismissed the second amended complaint with leave to re-plead. The plaintiffs did not file a third amended complaint. On August 23, 2023, the plaintiffs provided the court with an order of dismissal, and the court entered the order on August 24, 2023.
Removed
On September 8, 2023, plaintiff Carole Tibbs filed a notice of appeal to the United States Court of Appeals for the Third Circuit. The appeal has been docketed as number 23-2655. The principal brief of appellant and appendix were filed on January 5, 2024.
Removed
The appellees’ brief was filed on February 15, 2024, and the appellant’s reply brief was filed on March 15, 2024. On December 5, 2024, the Third Circuit issued an opinion affirming Judge Quraishi's August 24, 2024 dismissal of the case and entered Judgment to that effect.
Removed
The Plaintiffs did not move for rehearing, and the mandate of the Court of Appeals has issued. The plaintiffs did not pursue any further appeal and the time to do has now expired. On March 4, 2021, purported stockholder Richard Maltz brought a purported stockholder derivative action in the United States District Court for the District of New Jersey.
Removed
The action is captioned Richard Maltz , derivatively on behalf of electroCore, Inc., vs. Francis R. Amato , et al., Case 3 : 21 -cv- 04135 . The defendants include present and past directors and officers of the Company.
Removed
The plaintiff purports to pursue derivative claims on behalf of the Company in connection with the IPO and actions occurring between the IPO and September 25, 2019. The complaint alleges that demand on the board of directors is excused.
Removed
The complaint purports to allege claims against the defendants for violating Section 14 (a) of the Exchange Act, breaching fiduciary duties, unjust enrichment and waste of corporate assets.
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The complaint also purports to allege claims for contribution in connection with the Turnofsky case described above, pursuant to Section 11 (f) of the Securities Act and Sections 10 (b) and 21 D of the Exchange Act.
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The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to our Bylaws and Certificate of Incorporation.
Removed
O n March 8, 2021, purported stockholder Erin Yuson brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Erin Yuson, derivatively on behalf of electroCore, Inc., vs. Francis R. Amato, et al . , Case 3 : 21 -cv- 04481 .
Removed
The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with a 2019 proxy statement and actions occurring from the IPO through September 25, 2019. The complaint alleges that demand on the board of directors is excused.
Removed
The complaint purports to allege claims against the defendants for violating Section 14 (a) of the Exchange Act and breaching fiduciary duties. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to our Bylaws and Certificate of Incorporation.
Removed
The plaintiffs in the Maltz and Yuson derivative actions agreed to consolidate and stay those actions. The actions are stayed until and through the resolution of any motion for summary judgment in the Turnofsky federal securities class action.
Removed
A stipulation to that effect was filed by the plaintiffs on April 14, 2021, and ordered by the court on April 30, 2021. On June 9, 2023, the cases were administratively dismissed without prejudice. The Company has and intends to the extent necessary to continue to vigorously defend itself if these matters are revived.
Removed
However, in light of, among other things, the preliminary stage of these litigation matters, the Company is unable to determine the reasonable probability of loss or a range of potential loss.
Removed
Accordingly, the Company has not established an accrual for potential losses, if any, that could result from any unfavorable outcome, and there can be no assurance that these litigation matters will not result in substantial defense costs and/or judgments or settlements that could adversely affect the Company’s financial condition.
Removed
We are subject to various claims, complaints and legal actions in the normal course of business from time to time. The Company is not aware of any further currently pending litigation for which it believes the outcome could have a material adverse effect on its operations or financial position.
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The Company expenses associated legal fees including those relating to the stockholder litigation described in this Item 3 in the period they are incurred. Item 4 . Mine Safety Disclosures Not applicable. 87 PAR T II Item 5 .
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is traded on the Nasdaq Capital Market under the symbol “ECOR.” Stockholders As of March 6, 2025 , there were 404 stockholders of record, which excludes stockholders whose shares are held in nominee or street name by brokers.
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Dividend Policy We do not anticipate paying any cash dividends in the foreseeable future. Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.
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Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report. Use of Proceeds from Registered Securities Not applicable. Item 6 . [ Reserved] Not applicable. Item 7 .
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Management’s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
Removed
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Annual Report, including those set forth under Item 1 A. “Risk Factors” and under “Forward-Looking Statements” in this Annual Report.
Removed
Note: Information concerning the shares of our common stock and related share prices in this Item 7 has been adjusted to reflect the 1 -for- 15 reverse split of our common stock that was made effective on February 15, 2023.
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(See, “Item 8 – Notes to consolidated financial statements – Note 2 - Basis of Presentation”). 88 Overview 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.
Removed
Our nVNS treatment is delivered through a proprietary high-frequency burst waveform that safely and comfortably passes through the skin and stimulates therapeutically relevant fibers in the vagus nerve. Various scientific publications suggest that nVNS works through a variety of mechanistic pathways including the modulation of neurotransmitters.
Removed
Historically, vagus nerve stimulation or VNS, required an invasive surgical procedure to implant a costly medical device. This has generally limited VNS from being used by anyone other than the most severe patients. Our non-invasive medical devices and general wellness products are self-administered and intended for regular or intermittent use over many years.
Removed
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.
Removed
We have two principal product categories: • Handheld, personal use medical devices for the management and treatment of certain medical conditions such as primary headache; and • Handheld, personal use consumer products utilizing nVNS technology to promote general wellness and human performance. We believe our nVNS products may be used in the future to effectively treat additional medical conditions.
Removed
Our goal is to be a leader in non-invasive neuromodulation to deliver better health. To achieve this, we offer multiple propositions: • Prescription gammaCore medical devices for the treatment of certain prescription FDA cleared medical conditions such as primary headache; • Truvaga for the support of general health and wellbeing; and • TAC-STIM for human performance.
Removed
Our flagship gammaCore Sapphire is a prescription medical device that is FDA cleared for a variety of primary headache conditions. gammaCore is available by prescription only and Sapphire is a portable, reusable, rechargeable and reloadable personal use option for patients to use at home or on the go.
Removed
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 from our facility in Rockaway, NJ.
Removed
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. We offer two versions of our Truvaga products for the support of general health and wellbeing.
Removed
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.
Removed
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 program.
Removed
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.
Removed
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.
Removed
We are exploring strategies to make our TAC-STIM product available to other branches of the active-duty military, first responders, elite athletes and certain human performance professionals in the United States and abroad. Our TAC-STIM product is not a medical device and is not intended to diagnose, cure, mitigate, prevent, or treat a disease or condition.
Removed
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 . 89 The VA comprised 70.6 % of our revenue during the year ended December 31, 2024 .
Removed
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.
Removed
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.
Removed
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.
Removed
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. Lovell is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to federal healthcare providers.
Removed
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.
Removed
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.
Removed
Between November 2023 and January 2024, certain gammaCore products were added to the FSS, the DoD’s Distribution and Pricing Agreement (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.
Removed
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.
Removed
We expect a portion of our U.S. 2025 sales of gammaCore to continue to 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.
Removed
Sales under the UK Med Tech Funding Mandate, or MTFM, for CH in the UK comprised 6.6 % of our revenue during the year ended December 31, 2024 . In 2025, we plan on continued use of this program.
Removed
In 2023, NHS granted a two-year extension in which our prescription gammaCore therapy will continue to be listed in the NHS catalogue. This extension is through March 17, 2026, with an option for us to extend an additional two years.
Removed
In 2025, we expect NICE to review the guidance document and any changes in recommendation or pricing may adversely impact our ability to work with NHS England on the MTFM program and could have an adverse impact on our financial results.
Removed
We continue to utilize distribution partners to commercialize our nVNS technology in selected territories outside the United States and United Kingdom. We believe there may be significant opportunities beyond these two areas.
Removed
Specifically, we believe there may be a large commercial opportunity for our gammaCore medical device with additional insurance covered lives, cash pay, physician dispense, and direct-to consumer approaches, along with wellness and human performance propositions through our Truvaga and TAC-STIM handsets. Therefore, we will continue our investments to expand our efforts in these channels and markets in 2025 .
Removed
On December 17, 2024, we entered into a definitive agreement to acquire NURO.
Removed
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).
Removed
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.
Removed
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.
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We face a variety of challenges and risks that we will need to address and manage as we pursue our strategies, including our ability to develop and retain an effective sales force, achieve market acceptance of our gammaCore medical device among clinicians, patients, and third-party payers, expand the use of our gammaCore medical device to additional therapeutic indications, and to develop our nascent wellness and human performance business including the planned launch of Truvaga Plus, our next generation app-enabled device under the Truvaga brand.
Removed
Because of the numerous risks and uncertainties associated with our commercialization efforts, as well as research and product development activities, there may be uncertainty regarding our ability to achieve or maintain profitability.
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