10q10k10q10k.net

What changed in Vivos Therapeutics, Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Vivos Therapeutics, 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.

+669 added−528 removedSource: 10-K (2026-04-15) vs 10-K (2025-03-31)

Top changes in Vivos Therapeutics, Inc.'s 2025 10-K

669 paragraphs added · 528 removed · 357 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

181 edited+194 added−64 removed217 unchanged
Biggest changeJanuary 2023 Private Placement On January 9, 2023, we closed a private placement (the “January 2023 Private Placement”) with an institutional investor pursuant to which we agreed sell up to an aggregate of $8,000,000 of securities of the Company of units.
Biggest changeIn summary, under our new model, we expect to present Vivos treatment to more patients, close a higher percentage of cases into Vivos treatment, and potentially generate more revenue and profit per case. -28- January 2023 Private Placement On January 9, 2023, we closed a private placement (the “ January 2023 Private Placement ”) with an institutional investor pursuant to which we agreed sell up to an aggregate of $8,000,000 of our securities in a private placement consisting of 80,000 shares of our common stock, a pre-funded warrant to purchase up to an aggregate of 186,667 (the “ January 2023 PFW ”) shares of our common stock and a common stock purchase warrant to purchase up to an aggregate of 266,667 shares of our common stock (the “ January 2023 Warrant ”).
Pursuant to the HCW Engagement Agreement, the we have (i) paid the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds of the September 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the aggregate gross proceeds of the September 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.
Pursuant to the HCW Engagement Agreement, we have (i) paid the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds of the September 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the aggregate gross proceeds of the September 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.
It is highly efficient and has a sleep design which promotes space for the tongue to sit in the roof of the palate. ● VivoScore (from SleepImage), Rhinomanometry (from GM Instruments), Cone Beam Computerized Tomography or CBCT (from multiple vendors), Joint Vibration Analysis (from BioResearch) and other key diagnostic technologies play an essential role as part of The Vivos Method in patient assessment, proper clinical diagnosis, treatment planning, progress measurement, and optimal outcome facilitation.
It is highly efficient and has a sleep design which promotes space for the tongue to sit in the roof of the palate. -5- ○ VivoScore (from SleepImage), Rhinomanometry (from GM Instruments), Cone Beam Computerized Tomography or CBCT (from multiple vendors), Joint Vibration Analysis (from BioResearch) and other key diagnostic technologies play an essential role as part of The Vivos Method in patient assessment, proper clinical diagnosis, treatment planning, progress measurement, and optimal outcome facilitation.
See “ Risk Factors- The misuse or off-label use of The Vivos Method may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.” -19- The FDA has broad regulatory compliance and enforcement powers.
See “ Risk Factors- The misuse or off-label use of The Vivos Method may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.” The FDA has broad regulatory compliance and enforcement powers.
While the use of this designated HCPCS code is new there is a potential pathway for additional registrations with Vivos appliances on the PDAC list of oral appliances covered by and billable to Medicare. -12- In September 2024, the American Medical Association (AMA) issued new CPT Codes for billing medical insurance which apply only to Vivos C.A.R.E. appliances.
While the use of this designated HCPCS code is new there is a potential pathway for additional registrations with Vivos appliances on the PDAC list of oral appliances covered by and billable to Medicare. In September 2024, the American Medical Association (AMA) issued new CPT Codes for billing medical insurance which apply only to Vivos C.A.R.E. appliances.
We also believe that older oral appliances are typically less expensive, but do not reshape the upper airway like our C.A.R.E. appliances and therefore require nightly use over a lifetime and have a number of other disadvantages. -10- ● Intellectual property portfolio and research and development capabilities .
We also believe that older oral appliances are typically less expensive, but do not reshape the upper airway like our C.A.R.E. appliances and therefore require nightly use over a lifetime and have a number of other disadvantages. ● Intellectual Property Portfolio and Research and Development Capabilities .
Moreover, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (described below). Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved.
Moreover, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (described below). -22- Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved.
We believe that third parties seeking to compete directly with us have significant barriers to entry for the following reasons: competitors must offer a treatment modality with similar features, capabilities, research support, FDA regulatory clearances, and successful clinical outcomes in the market; then develop the systems and best practices required to successfully integrate diagnosis and treatment into a single-site, high-volume medical / dental practice offering substantially all options for OSA diagnosis and treatment; and finally, providing sleep testing and treatment centers with an attractive and mutually beneficial model that meets the needs of their business as well as their patients.
We believe that third parties seeking to compete directly with us have significant barriers to entry for the following reasons: competitors must offer a treatment modality with similar features, capabilities, research support, FDA regulatory clearances, and successful clinical outcomes in the market; then develop the systems and best practices required to successfully integrate diagnosis and treatment into a single-site, high-volume medical / dental practice offering substantially all options for OSA diagnosis and treatment; and finally, provide sleep testing and treatment centers with an attractive and mutually beneficial model that meets the needs of their business as well as their patients.
On June 18, 2020, our stockholders approved an amendment and restatement of the 2019 Plan to increase the number shares or our Common Stock available for issuance thereunder by 33,334 share of Common Stock such that, after amendment and restatement of the 2019 Plan, for a total of 46,667 shares of Common Stock available for issuance under the 2019 Plan.
On June 18, 2020, our stockholders approved an amendment and restatement of the 2019 Plan to increase the number shares or our common stock available for issuance thereunder by 33,334 shares of common stock such that, after amendment and restatement of the 2019 Plan, for a total of 46,667 shares of common stock available for issuance under the 2019 Plan.
We will continue to support our workforce to ensure safety and well-being. Corporate History Formation We were originally organized on July 7, 2016 in Wyoming as Corrective BioTechnologies, Inc. On September 6, 2016, we changed our name from Corrective BioTechnologies, Inc. to Vivos BioTechnologies, Inc.
We will continue to support our workforce to ensure safety and well-being. -26- Corporate History Formation We were originally organized on July 7, 2016 in Wyoming as Corrective BioTechnologies, Inc. On September 6, 2016, we changed our name from Corrective BioTechnologies, Inc. to Vivos BioTechnologies, Inc.
On July 30, 2020, prior to the transfer of our corporate domicile from Wyoming to Delaware, we implemented a one-for-three reverse stock split of our outstanding Common Stock pursuant to which holders of Vivos’ outstanding Common Stock received one share of Common Stock for every three shares of Common Stock held.
On July 30, 2020, prior to the transfer of our corporate domicile from Wyoming to Delaware, we implemented a one-for-three reverse stock split of our outstanding common stock pursuant to which holders of our outstanding common stock received one share of common stock for every three shares of common stock held.
Extensive online and in-person training, multiple touch point support systems, specific fabrication materials, customized appliance designs, and multi-disciplinary treatment modalities are all considered proprietary trade secrets and competitive advantages with no known counterparts. -13- FDA Regulatory Status The Vivos Method offers treatment modalities that uses nonsurgical, noninvasive, and cost-effective oral appliance technology prescribed by trained dentists and medical professionals to treat dentofacial abnormalities and/or mild to severe OSA and snoring.
Extensive online and in-person training, multiple touch point support systems, specific fabrication materials, customized appliance designs, and multi-disciplinary treatment modalities are all considered proprietary trade secrets and competitive advantages with no known counterparts. -15- FDA Regulatory Status The Vivos Method offers treatment modalities that uses nonsurgical, noninvasive, and cost-effective oral appliance technology prescribed by trained dentists and medical professionals to treat dentofacial abnormalities and/or mild to severe OSA and snoring.
Our website and the information on or that can be accessed through such website are not part of this Annual Report on Form 10-K. -31- Available Information We maintain a website at www.vivos.com .
Our website and the information on or that can be accessed through such website are not part of this Annual Report on Form 10-K. Available Information We maintain a website at www.vivos.com .
Our new business model has the combination of Vivos’ advanced proprietary diagnostic and evidence-based treatment technology, delivered by closely aligned medical and dental professionals using our state-of-the-art customized practice management and proprietary billing software and working together in a single, compliant dental service organization (DSO) and medical service organization (MSO) practice model to treat a large and growing volumes of new and existing OSA patients who seek to avoid or get off their CPAP machines.
Our new business model has the combination of Vivos’ advanced proprietary diagnostic and evidence-based treatment technology, delivered by closely aligned medical and other healthcare professionals using our state-of-the-art customized practice management and proprietary billing software and working together in a single, compliant dental service organization (DSO) and medical service organization (MSO) practice model to treat a large and growing volumes of new and existing OSA patients who seek to avoid or get off their CPAP machines.
Our appliances may require periodic adjustments, some of which can be performed by the patient and others that are typically rendered at the dental office where treatment was initiated. -7- Our Growth Strategy Our goal is to be the global leader in providing a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost alternative for patients with dentofacial abnormalities and/or mild to severe OSA and snoring in adults.
Our appliances may require periodic adjustments, some of which can be performed by the patient and others that are typically rendered at the dental office where treatment was initiated. -9- Our Growth Strategy Our goal is to be the global leader in providing a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost alternative for patients with dentofacial abnormalities and/or mild to severe OSA and snoring in adults.
These include: ● establishment registration and device listing with the FDA; ● Quality system Regulation (“QSR”) requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process; ● labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or off-label promotion is prohibited, and all claims must be substantiated; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; ● the federal Physician Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers; -18- ● state and federal Anti-Kickback Statute prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid.
These include: ● establishment registration and device listing with the FDA; ● Quality system Regulation (“ QSR ”) requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process; ● labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or off-label promotion is prohibited, and all claims must be substantiated; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; ● the federal Physician Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers; ● state and federal Anti-Kickback Statute prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid.
Currently, dentists can take courses individually in a customized fashion, learning at their own pace, and only learning the materials they need in order to serve their patients. -4- During 2023, we expanded our product portfolio by acquiring certain devices (now known as Vivos Vida , Vivos Versa and Vivos Vida Sleep ) from Advanced Facialdontics, LLC.
Currently, dentists can take courses individually in a customized fashion, learning at their own pace, and only learning the materials they need in order to serve their patients. -6- During 2023, we expanded our product portfolio by acquiring certain devices (now known as Vivos Vida , Vivos Versa and Vivos Vida Sleep ) from Advanced Facialdontics, LLC.
We fully recognize that breathing and sleep disorders, including OSA, are often complex conditions with multiple contributing factors that require more than a single solution.
We recognize that breathing and sleep disorders, including OSA, are often complex conditions with multiple contributing factors that require more than a single solution.
The Guides are FDA Class I registered product for orthodontic tooth positioning typically used by dentists in children to address malocclusions and promote proper guided growth and development of the mouth and jaws. ○ Vivos Versa TM is an FDA 510(k) cleared Class II device for treating mild to moderate OSA in adults.
The Tooth Positioners are FDA Class I registered product for orthodontic tooth positioning typically used by dentists in children to address malocclusions and promote proper guided growth and development of the mouth and jaws. ○ Vivos Versa TM is an FDA 510(k) cleared Class II device for treating mild to moderate OSA in adults.
In August and September 2016, we completed, by way of a share exchange, an agreement to acquire the business and operations of (1) BMS (now a wholly-owned subsidiary), which was engaged in the manufacture and sale of our patented DNA appliance ® and FDA cleared mRNA appliance ® (collectively with special proprietary treatment modalities that comprises The Vivos Method), and (2) First Vivos, Inc., a Texas corporation (“First Vivos”), which proposed to develop and operate a retail chain of Vivos Centers with specially trained dentists that offer The Vivos Method and corroborating physicians.
In August and September 2016, we completed, by way of a share exchange, an agreement to acquire the business and operations of (1) BMS (now a wholly-owned subsidiary), which was engaged in the manufacture and sale of our patented DNA appliance ® and FDA cleared mRNA appliance ® (collectively with special proprietary treatment modalities that comprises The Vivos Method), and (2) First Vivos, Inc., a Texas corporation (“ First Vivos ”), which proposed to develop and operate a retail chain of Vivos Centers with specially trained dentists that offer The Vivos Method and corroborating physicians.
To that end, we have broadened our product and services lines that comprise The Vivos Method to go beyond the proprietary technologies featured in our C.A.R.E. oral appliances and now offer providers far greater optionality in selecting a diagnostic or treatment solution that is best for their patients.
To that end, we have broadened our product and services lines that comprise The Vivos Method to go beyond the proprietary technologies featured in our C.A.R.E. oral appliances and now offer sleep health providers far greater optionality in selecting a diagnostic or treatment solution that is best for their patients.
The DNA appliance remains the only oral appliance of any kind that has been FDA cleared to treat children with OSA. -2- ○ Mandibular Repositioning Nighttime Appliance (or mRNA appliance ® ) has 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring and mild to moderate OSA in adults.
The DNA appliance remains the only oral appliance of any kind that has been FDA cleared to treat children with OSA. -4- ○ Mandibular Repositioning Nighttime Appliance (or mRNA appliance ® ) has 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring and mild to moderate OSA in adults.
The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics, medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or Children’s Health Insurance Program (“CHIP”), for payments and other transfers of value provided by them, directly or indirectly, to physicians (including physician family members), certain other healthcare providers, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics, medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or Children’s Health Insurance Program (“ CHIP ”), for payments and other transfers of value provided by them, directly or indirectly, to physicians (including physician family members), certain other healthcare providers, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device acquires a Class III designation, and a PMA must be approved before the device can be commercialized. The Vivos Guides are registered with the FDA as Class I devices for orthodontic tooth positioning.
If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device acquires a Class III designation, and a PMA must be approved before the device can be commercialized. The Vivos Tooth Positioners are registered with the FDA as Class I devices for orthodontic tooth positioning.
The purpose of the third trial was to evaluate the improvement of ADHD related symptoms in school-aged children ages 5 to 12 in treatment with Vivos Guides for SDB and establish a connection and treatment between children and behavior issues such as attention-deficit/hyperactivity disorder (known as ADHD), bed wetting, problems at school, crowded teeth that may be associated with lack of sleep and or teeth grinding with underdeveloped growth of the jaw and teeth positioning.
The purpose of the third trial was to evaluate the improvement of ADHD related symptoms in school-aged children ages 5 to 12 in treatment with Vivos Tooth Positioners for SDB and establish a connection and treatment between children and behavior issues such as attention-deficit/hyperactivity disorder (known as ADHD), bed wetting, problems at school, crowded teeth that may be associated with lack of sleep and or teeth grinding with underdeveloped growth of the jaw and teeth positioning.
CPAP is the “gold standard” treatment for over 90% of OSA patients, but no one wants to wear those devices to bed every night for life, rendering long-term compliance rates low. Traditional oral appliances can be effective over limited time frames but often create other problems with temporomandibular joint (or TMJ) dysfunction, open bites, infections, and more.
CPAP is the “gold standard” treatment for over 90% of OSA patients, but no one wants to wear those devices to bed every night for life, rendering long-term compliance rates low. Traditional oral appliances can be effective over limited time frames but often create other problems with TMJ dysfunction, open bites, infections, and more.
Reviewed by the Western Copernicus Group Institutional Review Board (WCG IRB) as non-significant controlled clinical trials, we conducted a clinical trial to evaluate the safety and efficacy of the Vivos Guides (which in this context we call the Vivos Grow and Vivos Way appliances) to reduce sleep disordered breathing (SDB) in children, including snoring, mild to moderate OSA, and Airway Resistance Syndrome (UARS).
Reviewed by the Western Copernicus Group Institutional Review Board (WCG IRB) as non-significant controlled clinical trials, we conducted a clinical trial to evaluate the safety and efficacy of the Vivos Tooth Positioners (which in this context we call the Vivos Grow and Vivos Way appliances) to reduce sleep disordered breathing (SDB) in children, including snoring, mild to moderate OSA, and Airway Resistance Syndrome (UARS).
We also issued to the Placement Agent or its designees (who are among the selling stockholders named herein) warrants (the “December 2024 PA Warrants”) to purchase up to 95,467 shares of Common Stock (or 7% of the number of shares sold in the December 2024 Offering) at an exercise price of $6.1688 per share of Common Stock, exercisable beginning upon issuance until two years following the issuance date.
We also issued to the Placement Agent or its designees (who are among the selling stockholders named herein) warrants (the “ December 2024 PA Warrants ”) to purchase up to 95,467 shares of common stock (or 7% of the number of shares sold in the December 2024 Offering) at an exercise price of $6.1688 per share of common stock, exercisable beginning upon issuance until two years following the issuance date.
The government may assert that claim includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statute; ● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA devices; ● medical device reporting (“MDR”) regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; ● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; ● complying with the new federal law and regulations requiring Unique Device Identifiers (“UDI”) on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database (“GUDID”); ● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and ● post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
The government may assert that claim includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statute; -20- ● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA devices; ● medical device reporting (“ MDR ”) regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; ● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; ● complying with the new federal law and regulations requiring Unique Device Identifiers (“ UDI ”) on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database (“ GUDID ”); ● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and ● post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
In October 2021, we announced that results from a peer-reviewed, published study by an independent dentist found a significant reduction of tooth decay in pediatric patients after undergoing treatment using our Vivos Guides.
In October 2021, we announced that results from a peer-reviewed, published study by an independent dentist found a significant reduction of tooth decay in pediatric patients after undergoing treatment using our Vivos Tooth Positioners.
Together with our network of trained dentists, we have developed a body of clinical and patient data, and benefits of The Vivos Method for its registered and 510(k) cleared use, spanning over approximately ten years from nearly 58,000 patients treated with our proprietary clinical treatments that demonstrates the safety, effectiveness, therapy adherence (patient compliance).
Together with our network of trained dentists, we have developed a body of clinical and patient data, and benefits of The Vivos Method for its registered and 510(k) cleared use, spanning over approximately ten years from nearly 75,000 patients treated with our proprietary and non-proprietary clinical treatments that demonstrates the safety, effectiveness, therapy adherence (patient compliance).
We also found a plateau of resolving or improvement of symptoms between the 2 to 3 months endpoint and the 4-6 months endpoint, but most profoundly, there is a high probability that 90% of children in MOA therapy with Vivos Guides will have SDB symptoms resolved or improved at the 7+ month endpoint.
We also found a plateau of resolving or improvement of symptoms between the 2 to 3 months endpoint and the 4-6 months endpoint, but most profoundly, there is a high probability that 90% of children in MOA therapy with Vivos Tooth Positioners will have SDB symptoms resolved or improved at the 7+ month endpoint.
In summary, under our new model, we expect to present Vivos treatment to more patients, refer a higher percentage of cases into Vivos treatment, and generate more revenue and profit per case.
In summary, under our new model, we expect to present OSA Vivos treatment options to more patients, refer a higher percentage of cases into Vivos treatment, and generate more revenue and profit per case.
We consider our relations with our employees to be good, but we do have a Whistleblower Hotline setup for employees to confidentially report concerns. As of December 31, 2024, no employees had used our Whistleblower Hotline.
We consider our relations with our employees to be good, but we do have a Whistleblower Hotline setup for employees to confidentially report concerns. As of December 31, 2025, no employees had used our Whistleblower Hotline.
We own two Canadian patents and one European patent that has been validated in Belgium, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029. Our U.S. trademark portfolio consists of 14 registered marks.
We own two Canadian patents and one European patent that has been validated in Belgium, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029. Our U.S. trademark portfolio consists of 14 registered marks and one pending published application.
We have seen an increase in the ability for reimbursement for our other FDA registered oral appliances such as the Vivos Guides for children and the DNA appliance for adults. During 2024, the FDA expanded the DNA’s clearance to treat children ages 6-17 for moderate to severe OSA in children with malocclusions.
We have seen an increase in the ability for reimbursement for our other FDA registered oral appliances such as the Vivos Tooth Positioners for children and the DNA appliance for adults. During 2024, the FDA expanded the DNA’s clearance to treat children ages 6-17 for moderate to severe OSA in children with malocclusions.
Currently, Vivos is sponsoring a large independent prospective pediatric trial on the clinical effects of Vivos Guides with over 150 children currently enrolled. We expect to continue to enroll children ages 3-12 in the trial up to a total potential cohort of 500 children. We currently enroll approximately 20 new children per month.
Currently, Vivos is sponsoring a large independent prospective pediatric trial on the clinical effects of Vivos Tooth Positioners with over 150 children currently enrolled. We expect to continue to enroll children ages 3-12 in the trial up to a total potential cohort of 500 children. We currently enroll approximately 20 new children per month.
As noted above, since our landmark FDA clearances in 2023 and 2024, we have not yet seen a corresponding increase in enrollment of patients using our appliances.
As noted above, since our landmark FDA clearances in 2023 and 2024, we have not yet seen a corresponding increase in numbers of patients using our appliances.
Finally, with our new marketing and distribution model, our unique business model can appeal and adapt to the unique needs and demands of sleep testing clinics as well as patients seeking viable non-surgical solution to their chronic moderate to severe OSA. -9- ● Superior Economics of New Marketing and Distribution Business Model.
Finally, with our new marketing and distribution model, our unique business model can appeal and adapt to the unique needs and demands of sleep testing clinics as well as patients seeking viable non-surgical solution to their chronic mild, moderate and severe OSA. -11- ● Superior Economics of New Marketing and Distribution Business Model.
The amendment also restated in its entirety the definition of “Black Scholes Value” contained in the January 2023 Warrant with the intention of eliminating an embedded derivative liability associated with such warrant.
The amendment also restates in its entirety the definition of “Black Scholes Value” contained in the January 2023 Warrant with the intention of eliminating an embedded derivative liability associated with such warrant.
We also are subject to similar anticorruption legislation implemented in Europe under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions. Human Capital Resources As of December 31, 2024, we had 109 full-time employees. None of our employees are represented by a union.
We also are subject to similar anticorruption legislation implemented in Europe under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions. Human Capital Resources As of December 31, 2025, we had 268 full-time employees. None of our employees are represented by a union.
When preauthorizing and billing the Vivos Guides and DNA appliances, an undefined CPT code can be utilized only when medical necessity is present and documented properly. A dentist billing an undefined CPT code for a Class I or Class II oral appliance must proceed with caution.
When preauthorizing and billing the Vivos Tooth Positioners and DNA appliances, an undefined CPT code can be utilized only when medical necessity is present and documented properly. A dentist billing an undefined CPT code for a Class I or Class II oral appliance must proceed with caution.
The Vivos Method alters the size, shape and position of the tissues that surround and define the functional space known as the upper airway. Our treatment also improves nasal breathing, reduces mouth breathing, reduces Apnea Hypopnea Index (AHI) scores, and generally facilitates better breathing and sleep.
The Vivos Method alters the size, shape and position of the tissues that surround and define the functional space known as the upper airway. Our treatment also improves nasal breathing, reduces mouth breathing, reduces AHI scores, and generally facilitates better breathing and sleep.
Adoption of Stock and Option Award Plan On April 18, 2019, our stockholders approved the adoption of a stock and option award plan (the “2019 Plan”), under which 13,334 shares were reserved for future issuance for options, restricted stock awards and other equity awards.
Replacement of the 2019 Stock and Option Award Plan and Adoption of the 2024 Omnibus Plan On April 18, 2019, our stockholders approved the adoption of a stock and option award plan (the “2019 Plan”), under which 13,334 shares were reserved for future issuance for options, restricted stock awards and other equity awards.
Pursuant to the MSA, V-CO will provide certain management, consulting, and advisory services to us related to our new strategic marketing and distribution alliance with Rebis.
Pursuant to the MSA, V-CO will provide certain management, consulting, and advisory services to us related to our new strategic marketing and distribution alliance.
December 2024 Registered Direct Offering and Private Placement of the December 2024 Warrants On December 22, 2024, we entered into a securities purchase agreement (the “December 2024 SPA”) with certain institutional investors (who are the selling stockholders named herein) in connection with a registered direct offering, priced at-the-market under Nasdaq Stock Market rules, to purchase 709,220 shares of Common Stock and, in a concurrent private placement (collectively, with the registered direct offering, the “December 2024 Offering”), warrants (the “December 2024 Warrants”) to purchase up to 709,220 shares of Common Stock (the shares of Common Stock issuable upon exercise of the December 2024 Warrants, the “December 2024 Warrant Shares”).
December 2024 Registered Direct Offering and Private Placement of the December 2024 Warrants On December 22, 2024, we entered into a securities purchase agreement (the “ December 2024 SPA ”) with certain institutional investors (who are the selling stockholders named herein) in connection with a registered direct offering, priced at-the-market under Nasdaq Stock Market rules, to purchase 709,220 shares of common stock and, in a concurrent private placement (collectively, with the registered direct offering, the “December 2024 Offering”), warrants (the “ December 2024 Warrants ”) to purchase up to 709,220 shares of common stock (the shares of common stock issuable upon exercise of the December 2024 Warrants, the “ December 2024 Warrant Shares ”).
This study will test the hypothesis that treatment of the upper airway associated with functional improvements of sleep parameters in adults with mild to moderate OSA. ● Treatment of Sleep Disordered Breathing (SDB) with an intraoral device in a pediatric population.
This study will test the hypothesis that treatment of the upper airway associated with functional improvements of sleep parameters in adults with mild, moderate and severe OSA. ● Treatment of Sleep Disordered Breathing (SDB) with an intraoral device in a pediatric population.
We have filed with the SEC such registration statement registering the shares and warrants as described herein on Form S-3 (File No. 333-281090) on July 30, 2024 which was subsequently declared effective on August 7, 2024. -28- Management Services Agreement with V-CO Also on June 10, 2024, our company, Airway Integrated Management Company, LLC, a Colorado limited liability company and a wholly owned subsidiary of the Company (or “AIM”), and V-CO entered into a management services agreement (which we refer to herein as the “MSA”).
We have filed with the SEC such registration statement registering the shares and warrants as described herein on Form S-3 (File No. 333-281090) on July 30, 2024 which was subsequently declared effective on August 7, 2024. -30- Management Services Agreement with V-CO Also on June 10, 2024, our company, Airway Integrated Management Company, LLC, a Colorado limited liability company and a wholly owned subsidiary of the Company (or “ AIM ”), and V-CO entered into a management services agreement (which we refer to herein as the “ MSA ”).
We believe we are also the first to bring forth a go-to-market strategy that incorporates collaborating with DME companies, medical professionals and other non-traditional healthcare providers such as chiropractors and physical therapists to expand access by patients to our products and services. ● Differentiated products .
We believe we are also the first to bring forth a go-to-market strategy that incorporates collaborating with durable medical equipment companies, medical professionals and other non-traditional healthcare providers such as chiropractors and physical therapists to expand access by patients to our products and services. ● Novel and Differentiated products .
We currently own five design patents that expire between 2023 through 2029 and two utility patents expiring in 2029 and 2030. We also own two Canadian patents and a European patent that has been validated in Belgium, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029.
We currently own three design patents that expire between 2028 through 2029 and two utility patents expiring in 2029 and 2030. We also own two Canadian patents and a European patent that has been validated in Belgium, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029.
Such participation payment shall accrue and not be paid until our company on a consolidated basis is cash flow positive from operations, as reported in our Securities and Exchange Commission (“SEC”) filings.
Such participation payment shall accrue and not be paid until our company on a consolidated basis is cash flow positive from operations, as reported in our Securities and Exchange Commission (“ SEC ”) filings.
We have recently expanded our mission and product line positioning to extend the reach and scope of The Vivos Method beyond the dental profession and to allow for greater collaboration and mutual referrals from other healthcare practitioners, including primary care physicians, medical specialists, chiropractors, nutritionists, physical therapists, and others who see and treat patients with breathing and sleep disorders.
During 2024 and 2025, we expanded our mission and product line positioning to extend the reach and scope of The Vivos Method beyond the dental profession and to allow for greater collaboration and mutual referrals from other healthcare practitioners, including primary care physicians, medical specialists, chiropractors, nutritionists, physical therapists, and others who see and treat patients with breathing and sleep disorders.
DNA appliance ® an unprecedented clearance to treat children ages 6-17 for moderate to severe OSA. In addition, we offer our own specially designed pre-formed Vivos Guides, which the FDA considers Class I orthodontic devices for tooth positioning.
DNA appliance ® an unprecedented clearance to treat children ages 6-17 for moderate to severe OSA with malocclusions. In addition, we offer our own specially designed pre-formed Vivos Tooth Positioners, which the FDA considers Class I orthodontic devices for tooth positioning.
A second study was peer reviewed and published in 2022 showing a 97.4% resolution of nocturnal enuresis (bedwetting) in children within 60 days of starting treatment with Vivos Guides.
A second study was peer reviewed and published in 2022 showing a 97.4% resolution of nocturnal enuresis (bedwetting) in children within 60 days of starting treatment with Vivos Tooth Positioners.
Medicare reimbursement for the mmRNA appliance will vary by the Centers for Medicare and Medicaid Services (CMS) jurisdiction in the U.S. ● Body of published research and strong patient outcomes .
Medicare reimbursement for our mmRNA and Vida Sleep appliance will vary by the Centers for Medicare and Medicaid Services (CMS) jurisdiction in the U.S. ● Body of Published Research and Strong Patient Outcomes .
As of December 31, 2024, awards (in the form of options) for an aggregate of 1,020,487 shares of Common Stock have been issued under our 2024 Omnibus Plan.
As of December 31, 2025, awards (in the form of options) for an aggregate of 1,110,487 shares of common stock have been issued under our 2024 Omnibus Plan.
Our Mission Our mission is to rid the world of sleep apnea by being a leading technology platform and go-to resource for the latest and most effective treatment modalities, products, and clinical education available to healthcare providers of all specialties who treat patients suffering from breathing and sleep disorders and their comorbidities.
Our mission is to rid the world of OSA by being a leading technology platform and go-to services resource for the latest and most effective diagnostic tools, treatment modalities, products, and clinical education available to healthcare providers of all specialties who treat patients suffering from breathing and sleep disorders and their comorbidities.
We actively identify and develop strategic relationships and selective acquisitions of sleep clinics throughout the country. ● Expand the number of strategic marketing and sales alliances we have and cultivate active referral sources among physicians, sleep specialists, dentists and other healthcare providers. We have 12 individuals within our company dedicated to cultivating referral sources for our appliances.
We actively identify and develop strategic relationships and selective acquisitions of sleep clinics throughout the country. ● Expand the number of medical provider focused strategic marketing and sales alliances we have and cultivate active referral sources among physicians, sleep specialists, dentists and other healthcare providers. We have seven individuals within our company dedicated to cultivating referral sources for our appliances.
Our alliance marketing and distribution model provides sleep centers with whom we collaborate better alternatives to CPAP and surgery for patients diagnosed with mild to severe OSA.
Our medical-provider focused alliance marketing and distribution model provides sleep centers with whom we collaborate better alternatives to CPAP and surgery for patients diagnosed with mild to severe OSA.
With the change in business model to focus on alliance marketing and distribution of Vivos products through sleep centers, the MID has been renamed the M&A Group and their mission and focus has shifted to identifying and closing strategic alliances and / or acquisitions of sleep clinics and Vivos. ● MyoCorrect (Orofacial Myofunctional Therapy) Program .
With the change in business model to focus on medical-provider marketing and distribution of Vivos products through sleep centers, the MID has been renamed the M&A Group and their mission and focus has shifted to identifying and closing strategic alliances and / or acquisitions of sleep clinics and Vivos. ● MyoSync (formerly MyoCorrect) (Orofacial Myofunctional Therapy) Program .
September 2024 Registered Direct Offering On September 18, 2024, we entered into a securities purchase agreement (the “September 2024 SPA”) with certain institutional investors in connection with a registered direct offering (the “September 2024 Offering”), priced at-the-market under Nasdaq Stock Market rules, to purchase 1,363,812 shares of Common Stock at a purchase price of $3.15 per share.
September 2024 Registered Direct Offering On September 18, 2024, we entered into a securities purchase agreement (the “ September 2024 SPA ”) with certain institutional investors in connection with a registered direct offering (the “ September 2024 Offering ”), priced at-the-market under Nasdaq Stock Market rules, to purchase 1,363,812 shares of common stock at a purchase price of $3.15 per share.
We anticipate that the 1,600,000 shares will allow the 2024 Omnibus Plan to operate for several years, although this could change based on other factors, including but not limited to merger and acquisition activity.
We anticipate that the 4,100,000 shares will allow the 2024 Omnibus Plan to operate for several years, although this could change based on other factors, including but not limited to merger and acquisition activity.
As of December 31, 2024, we had five non-employee directors, two officers, 110 employees and three consultants, although we expect that, based on our current usage, awards will be generally limited to approximately five non-employee directors, two officers ten employees, and three consultants.
As of December 31, 2025, we had five non-employee directors, two officers, 268 employees and three consultants, although we expect that, based on our current usage, awards will be generally limited to approximately five non-employee directors, two officers, ten employees, and three consultants.
PMA Pathway Class III devices require PMA approval before they can be marketed although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process.
We do not have any Class III devices. -18- PMA Pathway Class III devices require PMA approval before they can be marketed although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process.
Accordingly, we have scaled back our VIP enrollments, and as a result, our in-house direct sales personnel and have asked our Practice Advisors to assume direct sales and marketing activities.
Accordingly, we have ceased our VIP enrollments, and as a result, our in-house direct sales personnel and have asked our Practice Advisors to assume direct sales and marketing activities.
The DNA appliance is thus the only oral appliance in the world that has been FDA cleared to treat OSA. ● The Vivos Guides are an FDA-registered Class I product for orthodontic tooth positioning.
The DNA appliance is thus the only oral appliance in the world that has been FDA cleared to treat children with OSA. ● Vivos Tooth Positioners are an FDA-registered Class I product for orthodontic tooth positioning.
February 2024 Warrant Exercise Transaction On February 14, 2024, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same institutional investor pursuant to which the investor agreed to exercise for cash the entirety of the Series B Warrant issued in November 2023 at a reduced exercise price of $4.02 per share (with such exercise price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market), resulting in gross proceeds to us of approximately $4.0 million.
February 2024 Warrant Exercise Transaction On February 14, 2024, we entered into a warrant inducement letter agreement (the “ February 2024 Inducement Agreement ”) with an institutional investor pursuant to which the investor agreed to exercise for cash the entirety of the November 2023 Series B Warrant at an exercise price of $4.02 per share (with such exercise price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market), resulting in gross proceeds to the Company of approximately $4.0 million.
However, President Biden revoked this Executive Order on January 28, 2021 (as part of President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act) and directed heads of departments to “consider whether to suspend, revise, or rescind - and, as applicable, publish for notice and comment proposed rules suspending, revising, or rescinding” actions taken by the Trump Administration which may hinder the operation of the Health Reform Laws. -23- Nevertheless, the core tenets of the Health Reform Laws remain in effect with several exceptions.
However, President Biden revoked this Executive Order on January 28, 2021 (as part of President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act) and directed heads of departments to “consider whether to suspend, revise, or rescind - and, as applicable, publish for notice and comment proposed rules suspending, revising, or rescinding” actions taken by the Trump Administration which may hinder the operation of the Health Reform Laws.
To our knowledge, we believe only The Vivos Method offers a truly differentiated, non-invasive treatment option that actually works on a common root cause of OSA.
To our knowledge, we believe only The Vivos Method offers a truly differentiated, non-invasive treatment option that actually works on a common root cause of OSA in both adults and children.
At this time, we do not have plans to continue further international expansion and will continue to focus and deploy resources primarily in the United States. -11- Insurance Reimbursement Insurance reimbursement is available across the full spectrum of Vivos appliances. Medical coverage and benefits are subject to medical necessity and payer guidelines.
At this time, we do not have plans to continue further international expansion beyond the MENA region and will continue to focus and deploy resources primarily in the United States. Insurance Reimbursement Insurance reimbursement is generally available across the full spectrum of Vivos appliances. However, medical coverage and benefits are subject to medical necessity, provider credentialing, and payer guidelines.
As word spreads among a broader array of professionals and their patients, we expect more people to come to know and understand the compelling advantages of The Vivos Method. We believe this will allow us to scale our business and grow our company more rapidly.
As word spreads among a broader array of professionals and their patients, we expect more people to come to know and understand the compelling advantages of The Vivos Method. We believe this will allow us to scale our business and grow our company, offering our OSA solutions to a large and growing number of patients.
We have a comprehensive patent portfolio to protect our intellectual property and technology, five design patents that expire between 2023 through 2029 and two utility patents expiring in 2029 and 2030.
We have a comprehensive patent portfolio to protect our intellectual property and technology, three design patents that expire between 2028 and 2029 and two utility patents expiring in 2029 and 2030.
The 2024 Omnibus Plan provides for the grant of options to purchase shares of our Common Stock, including stock options intended to qualify as incentive stock options (“ISOs”) under Section 422 of the Code and nonqualified stock options that are not intended to so qualify (“NQSOs”), stock appreciation rights (“SARs”), restricted stock awards, and other equity-based or equity-related awards including restricted stock units and performance units (each, an “Award”).
The 2024 Omnibus Plan provides for the grant of options to purchase shares of our common stock, including stock options intended to qualify as incentive stock options (“ ISOs ”) under Section 422 of the Code and nonqualified stock options that are not intended to so qualify (“ NQSOs ”), stock appreciation rights (“ SARs ”), restricted stock awards, and other equity-based or equity-related awards including restricted stock units and performance units (each, an “ Award ”).
Pursuant to the terms of the December 2024 SPA, we agreed not to effect or agree to effect any Variable Rate Transaction (as defined in the Purchase Agreement) until one year following the closing of the December 2024 Offering, subject to certain exceptions. Segment Information We manage our business within one reportable segment.
Pursuant to the terms of the December 2024 SPA, we agreed not to effect or agree to effect any Variable Rate Transaction (as defined in the Purchase Agreement) until one year following the closing of the December 2024 Offering, subject to certain exceptions.
Background on OSA OSA is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life. According to a 2019 article published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S. alone.
We also utilize Treatment Navigators in our SCN operations. Background on OSA OSA is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life. According to a 2019 article published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S. alone.
Certain other changes to an approved device require the submission of a new PMA application, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA application are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness. -17- Clinical Trials Clinical trials are typically required to support a Premarket Approval (PMA) application and in some cases, a 510(k) submission.
Certain other changes to an approved device require the submission of a new PMA application, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA application are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.
We therefore believe that effective diagnostic and treatment strategies are needed to minimize the negative health impacts of OSA and to maximize cost-effectiveness. -6- Based on our direct experience with our Vivos-trained providers performing approximately 53,000 VivoScore HSTs during 2024, we strongly believe the published estimates from available public information, which range from 12% to 20% of the population, seriously underestimate the extent of the condition and scope of the problem in the United States and Canada.
We therefore believe that effective diagnostic and treatment strategies are needed to minimize the negative health impacts of OSA and to maximize cost-effectiveness. -8- Based on our direct experience with our Vivos-trained providers performing nearly 60,000 VivoScore home sleep testes administered during 2025, we strongly believe the published estimates from available public information, which range from 12% to 20% of the population, seriously underestimate the extent of the condition and scope of the problem in the United States and Canada.
We also began a separate trial in March 2023 relating to our Vivos Guides.
We also began a separate trial in March 2023 relating to our Vivos Tooth Positioners.
In our pilot testing, which we conducted at over 45 separate locations around the United States during 2023 and 2024, our Vivos-trained personnel were able to consistently close over 70% of patients into some form of Vivos treatment.
In our pilot testing, which we conducted at over 45 separate locations around the United States during 2023 and 2024, our Vivos-trained personnel consistently experienced over 70% of patients choosing some form of Vivos treatment.
We are required to comply with the FCPA, which generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments to foreign officials for the purpose of obtaining or retaining business or other benefits.
Anti-Bribery and Corruption Laws We are subject to the Foreign Corrupt Practices Act (“ FCPA ”). We are required to comply with the FCPA, which generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments to foreign officials for the purpose of obtaining or retaining business or other benefits.

… 359 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

80 edited+83 added−17 removed204 unchanged
Biggest changeComparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly based on many factors, including: ● our inability to attract demand for and obtain acceptance of The Vivos Method for the treatment of dentofacial abnormalities and/or mild to severe OSA and snoring by both medical professionals and their patients; ● the success of alternative therapies and surgical procedures to treat individuals, and the possible future introduction of new products and treatments; ● our ability to design, implement and as necessary modifying product pricing programs for existing VIPs; ● the expansion and rate of success of our marketing and advertising efforts to both consumers and dentists as well as other medical professionals, and the rate of success of our direct sales force in the United States and internationally; ● Failure of third-party contract manufacturers to deliver products or provide services in a cost effective and timely manner; ● our failure to develop, find or market new products; ● the successful completion of current and future clinical studies, and the possibility that the results of any future study may be adverse to our product and services, or reveal some heretofore unknown risk to patients from treatment in The Vivos Method; the failure by us to make professional presentation and publication of positive outcomes data from these clinical studies, and the increased adoption of The Vivos Method by dentists as a result of the data from these clinical studies; ● actions relating to ongoing FDA compliance; ● the size and timing of orders from dentists and independent distributors; ● our ability to obtain reimbursement for The Vivos Method (i.e., billable oral appliances and orofacial myofunctional therapy) in the future from third-party healthcare insurers; -35- ● the willingness of patients to pay out-of-pocket for treatment in The Vivos Method in the absence of reimbursement from third-party healthcare insurers, for; decisions by one or more commercial health insurance companies to preclude, deny, limit, reduce, eliminate, or curtain reimbursement for treatment in whole or part by The Vivos Method; ● unanticipated delays in the development and introduction of our current and future products and/or our inability to control costs; ● the effects of global or local pandemics or epidemics and governmental responses, such as COVID-19; ● seasonal fluctuations in revenue due to the elective nature of sleep-disordered breathing treatments for mild to severe OSA, as well as seasonal fluctuations resulting from adverse weather conditions, earthquakes, floods or other acts of nature in certain areas or regions that result in power outages, transportation interruptions, damages to one or more of our facilities, food shortages, or other events which may cause a temporary or long-term disruption in patient priorities, finances, or other matters; and ● general economic conditions as well as those specific to our customers and markets.
Biggest changeComparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly based on many factors, including: ● our inability to attract demand for and obtain acceptance of The Vivos Method for the treatment of dentofacial abnormalities and/or mild to severe OSA and snoring by both medical professionals and their patients; ● the success of alternative therapies and surgical procedures to treat individuals, and the possible future introduction of new products and treatments; ● our ability to design, implement and as necessary modifying product pricing programs for existing VIPs; ● the success of our sleep centers and other sleep centers we operate in a strategic alliance model, which are dependent on patient volume, insurance reimbursement rates, provider credentialing timelines, staff recruitment and retention, the time required for each Sleep Optimization team to reach full operational capacity, and other factors beyond our control; ● the expansion and rate of success of our marketing and advertising efforts to both consumers and dentists as well as other medical professionals, and the rate of success of our direct sales force in the United States and internationally; -40- ● Failure of third-party contract manufacturers to deliver products or provide services in a cost effective and timely manner; ● our failure to develop, find or market new products; ● the successful completion of current and future clinical studies, and the possibility that the results of any future study may be adverse to our product and services, or reveal some heretofore unknown risk to patients from treatment in The Vivos Method; the failure by us to make professional presentation and publication of positive outcomes data from these clinical studies, and the increased adoption of The Vivos Method by dentists as a result of the data from these clinical studies; ● actions relating to ongoing FDA compliance; ● the size and timing of orders from dentists and independent distributors; ● our ability to obtain reimbursement for The Vivos Method (i.e., billable oral appliances and orofacial myofunctional therapy) in the future from third-party healthcare insurers; ● the willingness of patients to pay out-of-pocket for treatment in The Vivos Method in the absence of reimbursement from third-party healthcare insurers, for; decisions by one or more commercial health insurance companies to preclude, deny, limit, reduce, eliminate, or curtain reimbursement for treatment in whole or part by The Vivos Method; ● unanticipated delays in the development and introduction of our current and future products and/or our inability to control costs; ● the effects of global or local pandemics or epidemics and governmental responses, such as COVID-19; ● seasonal fluctuations in revenue due to the elective nature of sleep-disordered breathing treatments for mild to severe OSA, as well as seasonal fluctuations resulting from adverse weather conditions, earthquakes, floods or other acts of nature in certain areas or regions that result in power outages, transportation interruptions, damages to one or more of our facilities, food shortages, or other events which may cause a temporary or long-term disruption in patient priorities, finances, or other matters; and ● general economic conditions as well as those specific to our customers and markets.
We have engaged in and will continue to pursue acquisitions of medical or dental practices or other complementary businesses or assets as well as licenses of technology to, among other things, expand the our marketing and distribution model and the scope of products and services we provide.
We have engaged in and will continue to pursue acquisitions of medical or dental practices or other complementary businesses or assets as well as licenses of technology to, among other things, expand our marketing and distribution model and the scope of products and services we provide.
The Patient Protection and Affordable Care Act, as amended (or the PPACA), amended the intent requirement of the federal Anti-Kickback Statute and, as a result, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it; -39- ● federal civil and criminal false claims laws, including, without limitation, the False Claims Act, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false statement to Avoid, decrease or conceal an obligation to pay money to the federal government.
The Patient Protection and Affordable Care Act, as amended (or the PPACA), amended the intent requirement of the federal Anti-Kickback Statute and, as a result, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it; ● federal civil and criminal false claims laws, including, without limitation, the False Claims Act, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false statement to Avoid, decrease or conceal an obligation to pay money to the federal government.
For us to be successful: ● our dentist customers and referring physicians must believe that The Vivos Method offers meaningful clinical and economic benefits for the treating provider and for the patient as compared to the other surgical and non-surgical procedures or devices currently being used to treat individuals with dentofacial abnormalities and/or mild to severe OSA and referring physicians must write a prescription for the use of a Class II Vivos appliance; and -34- ● our dentist customers must believe patients will pay for The Vivos Method out-of-pocket, and patients must believe that paying out-of-pocket for treatment in The Vivos Method is the best alternative to either doing nothing or entering into another treatment option.
For us to be successful: ● our dentist customers and referring physicians must believe that The Vivos Method offers meaningful clinical and economic benefits for the treating provider and for the patient as compared to the other surgical and non-surgical procedures or devices currently being used to treat individuals with dentofacial abnormalities and/or mild to severe OSA and referring physicians must write a prescription for the use of a Class II Vivos appliance; and ● our dentist customers must believe patients will pay for The Vivos Method out-of-pocket, and patients must believe that paying out-of-pocket for treatment in The Vivos Method is the best alternative to either doing nothing or entering into another treatment option.
In the event of a delisting, we would likely take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
In the event of a delisting scenario, we would likely take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
Such violations, or allegations of such violations, could disrupt our business and result in a material adverse effect on our financial condition, results of operations and cash flows -42- Risks Related to Our Products and Regulation We depend in large part on The Vivos Method technology, and the loss of regulatory approval or access to this technology would terminate or delay the further development of our products, injure our reputation or force us to pay higher fees.
Such violations, or allegations of such violations, could disrupt our business and result in a material adverse effect on our financial condition, results of operations and cash flows Risks Related to Our Products and Regulation We depend in large part on The Vivos Method technology, and the loss of regulatory approval or access to this technology would terminate or delay the further development of our products, injure our reputation or force us to pay higher fees.
We cannot predict the extent to which medical doctors will, in the future, endorse or recommend our protocol to their patients, even for those who are unwilling or unable to comply with other alternative therapies. We may not be able to protect our patents and proprietary technology and may become subject to intellectual property claims or litigation.
We cannot predict the extent to which medical doctors will, in the future, endorse or recommend our protocol to their patients, even for those who are unwilling or unable to comply with other alternative therapies. -42- We may not be able to protect our patents and proprietary technology and may become subject to intellectual property claims or litigation.
The misuse or off-label use of The Vivos Method or other Vivos products and services could result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
The misrepresentation, misuse or off-label use of The Vivos Method or other Vivos products and services could result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors. -38- In addition to patents, we rely on trademarks to protect the recognition of our company and product in the marketplace.
Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors. In addition to patents, we rely on trademarks to protect the recognition of our company and product in the marketplace.
In particular, the loss of sales personnel could lead to lost sales opportunities as it can take several months to hire and train replacement sales personnel. Uncertainty created by turnover of key employees could adversely affect our business. Members of our board of directors and our executive officers will have other business interests and obligations to other entities.
In particular, the loss of sales personnel could lead to lost sales opportunities as it can take several months to hire and train replacement sales personnel. Uncertainty created by turnover of key employees could adversely affect our business. -47- Members of our board of directors and our executive officers will have other business interests and obligations to other entities.
Any of these possibilities, to the extent available, may be on terms that result in significant dilution to our shareholders or that result in our investors losing all of their investment in our company. -32- Even if we are able to raise additional capital, we do not know what the terms of any such capital raising would be.
Any of these possibilities, to the extent available, may be on terms that result in significant dilution to our shareholders or that result in our investors losing all of their investment in our company. Even if we are able to raise additional capital, we do not know what the terms of any such capital raising would be.
On May 6, 2024, we received written notice from the Nasdaq staff indicating that the Company had regained compliance with the Equity Rule. On May 16, 2024, we received a further written notice from Nasdaq indicating that, as of March 31, 2024, we failed to comply with the Equity Requirement.
On May 6, 2024, we received written notice from the Nasdaq staff indicating that the Company had regained compliance with the Equity Requirement. On May 16, 2024, we received a further written notice from Nasdaq indicating that, as of March 31, 2024, we failed to comply with the Equity Requirement.
In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (or the Code), a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses (“NOLs”), carryforwards to offset future taxable income.
In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (or the Code), a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses (“ NOLs ”), carryforwards to offset future taxable income.
On June 27, 2024, we met with the Panel to discuss our past, current, and anticipated future compliance with the Equity Requirement, and requested the continued listing of its securities on Nasdaq.
On June 27, 2024, we met with the Panel to discuss our past, current, and anticipated future compliance with the Equity Requirement, and requested the continued listing of our securities on Nasdaq.
The inclusion of the projections in this Annual Report should not be regarded as an indication that we or our management or representatives considered or consider the projections to be a reliable prediction of future events, and the projections should not be relied upon as such. -49- If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.
The inclusion of the projections in this Annual Report should not be regarded as an indication that we or our management or representatives considered or consider the projections to be a reliable prediction of future events, and the projections should not be relied upon as such. -59- If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.
After analyzing contracts using the five-step process in ASC 606, we have determined that for both VIP enrollment contracts and Orofacial Myofunctional Therapy (MyoCorrect), modifications to our revenue recognition policies were required in order to identify the performance obligations and recognize the revenue as the performance obligations are satisfied or over the customer life as applicable.
After analyzing contracts using the five-step process in ASC 606, we have determined that for both VIP enrollment contracts and Orofacial Myofunctional Therapy (MyoSync), modifications to our revenue recognition policies were required in order to identify the performance obligations and recognize the revenue as the performance obligations are satisfied or over the customer life as applicable.
Moreover, given that our new sales, marketing and distribution model is at its very early stages, it is impossible to know with any certainty whether this new model will increase our revenues or ultimately lead to profitability. We have a history of operating losses and may never achieve cash flow positive or profitable results of operations.
Moreover, given that our medical-focused sales, marketing and distribution model is at its early stages, it is impossible to know with any certainty whether this new model will increase our revenues or ultimately lead to profitability. We have a history of operating losses and may never achieve cash flow positive or profitable results of operations.
These conditions include providing an update as to our plan to regain compliance with the Equity Rule as well as demonstrating compliance by March 19, 2024. On February 23, 2024 we presented our plan of compliance to the Hearings Committee.
These conditions include providing an update as to our plan to regain compliance with the Equity Requirement as well as demonstrating compliance by March 19, 2024. On February 23, 2024 we presented our plan of compliance to the Hearings Committee.
To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
To achieve compliance with Section 404 within the prescribed period, we engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizeable damage awards against us that may not be covered by insurance. -41- We have engaged in and will continue to pursue acquisitions of medical or dental practices or complementary businesses or technologies, which could divert the attention of management, and which may not be integrated successfully into our existing business.
Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizeable damage awards against us that may not be covered by insurance. -46- We have engaged in and will continue to pursue acquisitions of, or affiliations with, medical or dental practices or complementary businesses or technologies, which could divert the attention of management, and which may not be integrated successfully into our existing business.
To expand our marketing and distribution model, achieve increased revenue levels, complete clinical studies and develop future products, we believe that we will be required to periodically expand our operations, particularly in the areas of sales and marketing, clinical research, reimbursement, research and development, manufacturing and quality assurance.
To expand our medical provider-focused marketing and distribution model, achieve increased revenue levels, complete clinical studies and develop future products, we believe that we will be required to periodically expand our operations, particularly in the areas of sales and marketing, clinical research, reimbursement, research and development, manufacturing and quality assurance.
The PPACA provides, and recent government cases against medical device manufacturers support, the view that federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the False Claims Act; ● the federal Health Insurance Portability and Accountability Act of 1996 (or HIPAA), which created new federal criminal statutes that prohibit a person from knowingly and willfully executing a scheme or making false or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private); ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (or HITECH), and its implementing regulations, and as amended again by the final HIPAA omnibus Rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers, and their respective business associates; ● Federal transparency laws, including the federal Physician Payments Sunshine Act, which is part of the PPACA, that require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (or CMS), information related to: (i) payments or other “transfers of value” made to physicians and teaching hospitals; and (ii) ownership and investment interests held by physicians and their immediate family members; ● state and foreign law equivalents of each of the above federal laws, state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws that require medical device companies to comply with the specific industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; and ● state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The PPACA provides, and recent government cases against medical device manufacturers support, the view that federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the False Claims Act; ● the federal Health Insurance Portability and Accountability Act of 1996 (or HIPAA), which created new federal criminal statutes that prohibit a person from knowingly and willfully executing a scheme or making false or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private); ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (or HITECH), and its implementing regulations, and as amended again by the final HIPAA omnibus Rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers, and their respective business associates; ● Federal transparency laws, including the federal Physician Payments Sunshine Act, which is part of the PPACA, that require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (or CMS), information related to: (i) payments or other “transfers of value” made to physicians and teaching hospitals; and (ii) ownership and investment interests held by physicians and their immediate family members; ● state and foreign law equivalents of each of the above federal laws, state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws that require medical device companies to comply with the specific industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; and ● state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. -45- Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
There may be increased risk of injury or other side effects to patients if physicians attempt to use our appliances and associated treatments off label.
There may be increased risk of injury or other side effects to patients if physicians misrepresent, misuse or attempt to use our appliances and associated treatments off label.
We expect that sales of the component aspects of The Vivos Method and our services to our VIPs related to the use of such treatments will account for a significant majority of our prospective revenue for the foreseeable future.
We expect that sales of the component aspects of The Vivos Method and our services to our VIPs and affiliated sleep centers related to the use of such treatments will account for a significant majority of our prospective revenue for the foreseeable future.
Kirk Huntsman, our Chief Financial Officer, Brad Amman and Susan McCullough, our EVP of Operations, among others. Our business would be impeded or harmed if we were to lose their services.
Kirk Huntsman, our Chief Financial Officer, Brad Amman, Susan McCullough, our EVP of Operations, and Michael Bruhn, our EVP of Operations, East Coast, among others. Our business would be impeded or harmed if we were to lose their services.
While we believe that at December 31, 2023, we had taken great strides to complete the full remediation of all of our internal control deficiencies and associated material weakness by undertaking the plan described in Item 9A of this Report, we believe the additional review and testing in 2024 can affirmatively declare that the material weakness has been fully remediated as of December 31, 2024.
While we believe that at December 31, 2023, we had taken great strides to complete the full remediation of all of our internal control deficiencies and associated material weakness by undertaking the plan described in Item 9A of this Report, we believe our additional review and testing in 2024 had cured and fully remediated the material weakness as of December 31, 2024.
Currently, our primary product is The Vivos Method, inclusive of MyoCorrect and our SleepImage HST. Our secondary source of revenue is our clinical training and practice support programs, including Billing Intelligence Services, Airway Intelligence System and AireO 2 .
Currently, our primary product is The Vivos Method, inclusive of MyoSync and our SleepImage HST. Our secondary source of revenue is our clinical training and practice support programs, including Billing Intelligence Services and Airway Intelligence System.
If we fail to achieve ongoing compliance and our common stock is delisted by Nasdaq, such delisting would likely have a material adverse effect on our stock price, the ability of its stockholders to buy or sell their common stock, our ability to raise capital and on our reputation, all of which could make it significantly more difficult to operate. -46- If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.
If we fail to achieve ongoing compliance and our common stock is delisted by Nasdaq, such delisting would likely have a material adverse effect on our stock price, the ability of its stockholders to buy or sell their common stock, our ability to raise capital and on our reputation, all of which could make it significantly more difficult to operate.
We have received an FDA warning letter in the past when such a letter was received by our subsidiary BioModeling Solutions, Inc. (“BioModeling” or “BMS”) in January 2018 following a routine FDA audit.
We have received an FDA warning letter in the past when such a letter was received by our subsidiary BioModeling Solutions, Inc. (“ BioModeling ” or “ BMS ”) in January 2018 following a routine FDA audit.
At the Hearing on November 9, 2023, we presented our plan to regain compliance with the minimum stockholders’ equity requirement (the “Equity Rule”), which plan includes raising additional equity capital. On November 30, 2023, we received a letter from the Hearings Panel that, subject to certain conditions, the Hearings Panel granted our request to continue to be listed on Nasdaq.
At the Hearing on November 9, 2023, we presented our plan to regain compliance with the Equity Requirement, which included raising additional equity capital. On November 30, 2023, we received a letter from the Hearings Panel that, subject to certain conditions, the Hearings Panel granted our request to continue to be listed on Nasdaq.
If any analyst who may cover us was to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.
If any analyst who may cover us was to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline. Item 1B. Unresolved Staff Comments. None.
Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance, and downward volatility in our public stock price could lead to investment losses by our stockholders. Our failure to meet the continuing listing requirements of The Nasdaq Capital Market could result in a delisting of our securities.
Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance, and downward volatility in our public stock price could lead to investment losses by our stockholders. -55- Our failure to meet the continuing listing requirements of The Nasdaq Capital Market, including the minimum stockholders’ equity requirement and minimum bid price requirements, could result in a delisting of our securities.
The 2024 pivot in our business model was accompanied by significant strategic, operational and staffing changes to our business. Therefore, there is very limited and evolving or differing historical operating data on which to evaluate the results of and prospects for our current business model.
The 2024 pivot in our business model was accompanied by significant strategic, financial, operational and staffing changes to our business, which we have continued to refine as we progress. Therefore, there is very limited and evolving or differing historical operating data on which to evaluate the results of and prospects for our current business model.
Since our inception, we have not been profitable and have incurred significant losses and cash flow deficits. For the fiscal years ended December 31, 2024 and 2023, we reported net losses of $11.1 million and $13.6 million respectively, and negative cash flow from operating activities of $12.7 million and $11.9 million, respectively.
Since our inception, we have not been profitable and have incurred significant losses and cash flow deficits. For the fiscal years ended December 31, 2025 and 2024, we reported net losses of $21.2 million and $11.1 million respectively, and negative cash flow from operating activities of $15.3 million and $12.7 million, respectively.
If we fail to satisfy the continuing listing requirements of Nasdaq, such as the corporate governance, stockholders equity or minimum closing bid price requirements, Nasdaq may take steps to delist our common stock.
If we fail to satisfy the continuing listing requirements of Nasdaq, such as the corporate governance, $2.5 million minimum stockholders’ equity (the “Equity Requirement”) or minimum closing bid price requirements, Nasdaq may take steps to delist our common stock.
This is particularly true because our VIP-focused business model only commenced in mid-2018. Furthermore, since the roll out of our VIP-focused business model, we have continued to refine or alter our strategies, including in 2024 to reduce our reliance on VIP enrollment revenue and instead pursue marketing and distribution alliances with, or acquisitions of, sleep clinics and other providers.
Furthermore, since the roll out of our VIP-focused business model, we have continued to refine or alter our strategies, including in 2024 to reduce our reliance on VIP enrollment revenue and instead pursue marketing and distribution alliances with, or acquisitions of, medical sleep clinics and other medical providers.
Modifications to appliances within The Vivos Method may require additional FDA approvals which, if not obtained, could force us to cease marketing and/or recall the modified device until we obtain new approvals.
In the end, we may be unable to develop marketable products. -49- Modifications to appliances within The Vivos Method may require additional FDA approvals which, if not obtained, could force us to cease marketing and/or recall the modified device until we obtain new approvals.
Further, if we or any third party have difficulty enrolling a sufficient number of patients in a timely or cost-effective manner to conduct clinical trials as planned, or if enrolled patients do not complete the trial as planned, we or a third party may need to delay or terminate ongoing clinical trials, which could negatively affect our business. -43- The results of our clinical trials may not support either further clinical development or the commercialization of any new product candidates or modifications to existing products.
Further, if we or any third party have difficulty enrolling a sufficient number of patients in a timely or cost-effective manner to conduct clinical trials as planned, or if enrolled patients do not complete the trial as planned, we or a third party may need to delay or terminate ongoing clinical trials, which could negatively affect our business.
However, while we remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
However, while we remain a non-accelerated filer and a smaller reporting company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
A material portion of our future revenue is expected to derive from sales of our appliances and other closely related diagnostic and therapeutic services to patients through dentists and other medical professionals, who are part of Dental Service Organization (DSO) we may form and other Medical Service Organization (MSO) which leaves us reliant on our ability to establish, staff, and operate such operations successfully across diverse and geographically dispersed markets.
A material portion of our future revenue is expected to derive from sales of our appliances and other closely related diagnostic and therapeutic services to patients through dentists and other medical professionals, who are part of various Vivos-supported Medical and Dental Service Organizations (MSOs / DSOs) which we intend to form in various states, and which leave us reliant on our ability to establish, staff, and operate such operations successfully across diverse and geographically dispersed markets.
Additionally, from 2022 and until 2023, we have reduced staff and eliminated or renegotiated certain vendor contracts, strategically reorganized our business and revamped our business model.
Additionally, beginning in 2022 we have periodically reduced staff and eliminated or renegotiated certain vendor contracts, strategically reorganized our business and revamped our business model.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. Certain provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control.
If we identify one or more material weaknesses in our internal control over financial reporting, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. Certain provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control.
Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404.
Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.
As of December 31, 2024, we had an accumulated deficit of approximately $104.2 million and ended the period with approximately $6.3 million in cash and cash equivalents. As of December 31, 2024, we had total liabilities of approximately $7.3 million.
As of December 31, 2025, we had an accumulated deficit of approximately $125.4 million and ended the period with approximately $2.0 million in cash and cash equivalents. As of December 31, 2025, we had total liabilities of approximately $26.7 million.
The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed.
Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed.
Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others.
Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. -43- However, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon by others.
A number of companies in the medical technology industry have suffered significant setbacks in advanced clinical trials despite promising results in earlier trials. In the end, we may be unable to develop marketable products.
A number of companies in the medical technology industry have suffered significant setbacks in advanced clinical trials despite promising results in earlier trials.
On July 5, 2024, we were notified that the Panel had granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended June 30, 2024, with the Securities and Exchange Commission by August 15, 2024, evidencing our compliance with the Equity Requirement.
On July 5, 2024, we were notified that the Panel granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended June 30, 2024, with the Securities and Exchange Commission by August 15, 2024, evidencing our compliance with the Equity Requirement. -56- We are working diligently to ensure continued compliance with the Equity Requirement, including exploring potential additional equity capital financing or financings to stay above the minimum threshold of the Equity Requirement.
We expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatment pursuant to our new strategic alliance and acquisition models, which leaves us reliant on the commercial viability of The Vivos Method and other associated products and services.
These efforts have taken, and will continue to take, material time and resources, and we may be unable to undertake such efforts effectively. -39- We expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatment pursuant to our new strategic alliance and acquisition models, which leaves us reliant on the commercial viability of The Vivos Method and other associated products and services.
These control deficiencies, aggregated, create a reasonable possibility that a material misstatement to the consolidated financial statements will not be prevented or detected on a timely basis. -33- In summary, as of December 31, 2022 we identified material weaknesses related to the operating effectiveness of our review controls in that we did not put the appropriate resources in place to be able to identify and account for technical accounting issues and perform review functions appropriately.
In summary, as of December 31, 2022 we identified material weaknesses related to the operating effectiveness of our review controls in that we did not put the appropriate resources in place to be able to identify and account for technical accounting issues and perform review functions appropriately.
Our success further depends on our ability to obtain and maintain trademark protection for our name and mark; to preserve our trade secrets and know-how; and to operate without infringing the intellectual property rights of others. -37- We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents We cannot assure you that any of our patents pending will result in issued patents, that any current or future patents will not be challenged, invalidated or circumvented, that the scope of any of our patents will exclude competitors or that the patent rights granted to us will provide us any competitive advantage or protect our products.
We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents We cannot assure you that any of our patents pending will result in issued patents, that any current or future patents will not be challenged, invalidated or circumvented, that the scope of any of our patents will exclude competitors or that the patent rights granted to us will provide us any competitive advantage or protect our products.
If we are successful in our efforts to obtain reimbursement for the billable procedures within The Vivos Method, any changes in this reimbursement system could materially affect our ability to continue to grow our business.
In addition, third-party healthcare insurers are increasingly challenging the prices charged for medical products and procedures. If we are successful in our efforts to obtain reimbursement for the billable procedures within The Vivos Method or otherwise impacting our business, any changes in this reimbursement system could materially affect our ability to continue to grow our business.
While both of these deficiencies were cleared by January 2023, we became subject to additional delisting from Nasdaq during 2023, one for failure to meet the minimum bid requirement and the other for failing to meet Nasdaq’s $2.5 million minimum stockholders’ equity requirement. -45- On September 21, 2023, we received a written notice from the Nasdaq staff confirming that since, as of that date, we failed to meet the minimum bid price requirement, and because as of the period ended June 30, 2023 we also failed the minimum stockholders’ equity requirement, Nasdaq would commence delisting proceedings against us.
On September 21, 2023, we received a written notice from the Nasdaq staff confirming that since, as of that date, we failed to meet the minimum bid price requirement, and because as of the period ended June 30, 2023 we also failed the minimum stockholders’ equity requirement, Nasdaq would commence delisting proceedings against us.
The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.
The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects.
To the extent a material number of patients who were treated with The Vivos Method were to be found to experience post-treatment relapse or regression, it could pose a significant risk to our brand, the willingness or ability of physicians to prescribe and dentists to use our products and the willingness of patients to engage in treatment with our products and could thus have a material adverse effect on our results of operations.
To the extent a material number of patients who were treated with The Vivos Method were to be found to experience post-treatment relapse or regression, it could pose a significant risk to our brand, the willingness or ability of physicians to prescribe and dentists to use our products and the willingness of patients to engage in treatment with our products and could thus have a material adverse effect on our results of operations. -50- Our medical-provider focused alliance marketing and distribution model under which will seek to acquire or create alliances with healthcare providers, may implicate federal and state laws involving the practice of medicine and related anti-kickback and similar laws.
Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on our business, financial condition and results of operations.
Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on our business, financial condition and results of operations. -44- Our relationships with VIPs, other healthcare providers, and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations.
We continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives. As a public company, and particularly after we are no longer an EGC, we will incur significant legal, accounting and other expenses that we did not incur as a private company.
We continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
Healthcare providers (including our VIPs and strategic alliances), physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation of The Vivos Method.
If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. Healthcare providers (including our VIPs and strategic alliances), physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation of The Vivos Method.
Pulmonologists or other sleep specialists typically administer a polysomnogram, or overnight sleep study, to diagnose the presence and severity of OSA. If an individual is diagnosed with OSA by a qualified medical doctor, CPAP is typically prescribed as the therapy of choice.
If an individual is diagnosed with OSA by a qualified medical doctor, CPAP is typically prescribed as the therapy of choice.
If we are not successful in anticipating and responding to changes in consumer preferences, our results of operations in future periods will be materially adversely impacted. Our business and results of operations may be impacted by the extent to which patients using The Vivos Method achieve adequate levels of third-party insurance reimbursement.
If we are not successful in anticipating and responding to changes in consumer preferences, our results of operations in future periods will be materially adversely impacted.
However, there is a risk that we will be unable to raise sufficient capital or generate sufficient revenue or positive operating results to maintain compliance with the Equity Requirement.
We anticipate that our medical provider-focused strategic marketing and distribution alliance will also positively impact our revenue growth and stockholders’ equity in upcoming fiscal quarters. However, there is a risk that we will be unable to raise sufficient capital or generate sufficient revenue or positive operating results to maintain compliance with the Equity Requirement.
These control deficiencies resulted in immaterial misstatements, some of which were corrected, in the consolidated financial statements as of and for the year ended December 31, 2022.
These control deficiencies resulted in immaterial misstatements, some of which were corrected, in the consolidated financial statements as of and for the year ended December 31, 2022. These control deficiencies, aggregated, create a reasonable possibility that a material misstatement to the consolidated financial statements will not be prevented or detected on a timely basis.
In addition, our bylaws provide that any person or entity purchasing or otherwise acquiring any interest in shares of our common stock is deemed to have notice of and consented to the Delaware Forum Provision and the Federal Forum Provision. -48- Section 27 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.
Section 27 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.
We recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware.
We note, however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. -58- We recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. -40- It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
We previously identified material weaknesses in our internal controls and may identify additional material weaknesses in the future or otherwise fail to operating effectiveness of our review controls, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations.
Further such steps, or even more, may be required before management is satisfied that we are positioned to succeed or even survive, and there is a risk that we will be unable to implement cost-cutting programs effectively. -38- We previously identified material weaknesses in our internal controls and may identify additional material weaknesses in the future or otherwise fail to operating effectiveness of our review controls, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations.
Risks Related to Our Business and Industry Our business has a limited operating history, and we continue to refine our business model, which makes it difficult to evaluate and compare our past performance with future prospects.
In that case, the trading price of our common stock could decline, and you may lose all or part of your investment. -37- Risks Related to Our Business and Industry Our business has a limited operating history, and we continue to refine our business model, which makes it difficult to evaluate and compare our past performance with both current performance and future prospects.
Our ability to generate revenue from additional sales of The Vivos Method for the treatment of dentofacial abnormalities and/or mild to severe OSA may be materially limited by the extent to which reimbursement of The Vivos Method is available in the future. In addition, third-party healthcare insurers are increasingly challenging the prices charged for medical products and procedures.
Our ability to generate revenue from additional sales of The Vivos Method for the treatment of dentofacial abnormalities and/or mild to severe OSA, as well as our potential revenues from MSO/DSO support fees, may be materially limited by the extent to which reimbursement of The Vivos Method or other treatments and testing offered by our supported providers is available in the future.
As a result, regulatory approvals for our products not yet approved or that we may develop in the future can take a number of years or longer to accomplish and require the expenditure of substantial financial, managerial and other resources.
As a result, regulatory approvals for our products not yet approved or that we may develop in the future can take a number of years or longer to accomplish and require the expenditure of substantial financial, managerial and other resources. -48- We cannot assure that we will be able to complete any required clinical trial programs successfully within any specific time period, and if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected.
If we are unable to achieve reimbursement approvals in international markets, it could have a negative impact on market acceptance of The Vivos Method and potential revenue growth in the markets in which these approvals are sought. -36- In an effort to help expand in-network insurance coverage for The Vivos Method, in December 2022, we announced a collaboration with Nexus which effectively combines our proprietary out-of-network Billing Intelligence Service with the Nexus’ in-network medical billing platform.
If we are unable to achieve reimbursement approvals in international markets, it could have a negative impact on market acceptance of The Vivos Method and potential revenue growth in the markets in which these approvals are sought.
Our products are currently recommended only by a relatively small minority of medical sleep specialists, who are integral to the diagnosis and treatment of sleep breathing disorders. The majority of patients being treated today for OSA, domestically and internationally, are initially referred to pulmonologists or other sleep specialists by their primary care physicians.
The majority of patients being treated today for OSA, domestically and internationally, are initially referred to pulmonologists or other sleep specialists by their primary care physicians. Pulmonologists or other sleep specialists typically administer a polysomnogram, or overnight sleep study, to diagnose the presence and severity of OSA.
Even if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient to support an application for marketing approval.
We have incurred, and we will continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot trial testing, clinical trials and regulated, compliant manufacturing processes. Even if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient to support an application for marketing approval.
Reimbursement and healthcare payment systems in international markets vary significantly by country and reimbursement for the billable procedures within The Vivos Method may not be available at all under either government or private reimbursement systems.
We have experienced challenges with these insurance processes in connection with establishing our SCN-related operations, causing delays in revenue generation and cash flow, and we expect to face these challenges with other sleep practices we may acquire or affiliate with. -41- Reimbursement and healthcare payment systems in international markets vary significantly by country and reimbursement for the billable procedures within The Vivos Method may not be available at all under either government or private reimbursement systems.
Before obtaining regulatory approvals for the commercial sale of any products, we must demonstrate through clinical trials the safety and effectiveness of our products. We have incurred, and we will continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot trial testing, clinical trials and regulated, compliant manufacturing processes.
Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the commercial sale of any products, we must demonstrate through clinical trials the safety and effectiveness of our products.
Pursuant to Section 404, we will be required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm if certain criteria are met.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, we are required to furnish a report by our management on our internal control over financial reporting.
The Securities and Exchange Commission (or SEC) has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks.
If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares. The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks.
Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so.
However, we will be faced with delisting proceedings which will distract management and cost resources to remedy, A delisting of our common stock from Nasdaq for any would very likely (i) damage our reputation, (ii) make it more difficult to manage our business and raise necessary capital, (iii) have a negative effect on the price of our common stock and (iv) impair your ability to sell or purchase our common stock when you wish to do so.
In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives.
The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of The Nasdaq Capital Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
No advice of counsel has been obtained with respect any potential operations of the M&A Group in Canada. -44- Risks Related to Our Securities Generally The market for our common stock is relatively new and may not develop to provide investors with adequate liquidity. We conducted our initial public offering in December 2020, and a follow-on offering in May 2021.
No advice of counsel has been obtained with respect any potential operations of the M&A Group in Canada. Risks Related to Our Acquisition of the Sleep Center of Nevada (“SCN”) In 2024 and 2025, we worked to pivot our sales, marketing distribution model, including via the acquisition of the Sleep Center of Nevada (the “SCN Acquisition”).
Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.
Moreover, these rules and regulations have increased our legal and financial compliance costs relative to prior years and will make some activities more time-consuming and costly. -57- For as long as we remain a smaller reporting company, we may take advantage of certain exemptions from various reporting requirements as described in the preceding risk factor.

… 100 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

5 edited+0 added−0 removed8 unchanged
Biggest changeWe utilize a seasoned and mature artificial intelligence-based security system that learns and monitors the actions of individuals that have access to our networks and systems, including location of access (notably from international locations), email, and SAAS platforms that we do not host.
Biggest changeOur approach is based on the premise that any cybersecurity incident could result in material harm to our company. -60- We utilize a seasoned and mature artificial intelligence-based security system that learns and monitors the actions of individuals that have access to our networks and systems, including location of access (notably from international locations), email, and SAAS platforms that we do not host.
We also have processes to oversee and identify material cybersecurity risks associated with our use of third-party service providers, including performing diligence on certain third parties that have access to our systems, data or facilities that store such systems or data, continually monitoring cybersecurity threat risks identified through such diligence -50- Under our framework, cybersecurity issues, including those involving vulnerabilities introduced by our use of third-party software, are analyzed by subject matter experts for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of impact.
We also have processes to oversee and identify material cybersecurity risks associated with our use of third-party service providers, including performing diligence on certain third parties that have access to our systems, data or facilities that store such systems or data, continually monitoring cybersecurity threat risks identified through such diligence Under our framework, cybersecurity issues, including those involving vulnerabilities introduced by our use of third-party software, are analyzed by subject matter experts for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of impact.
If a threat is detected, our system automatically notifies our internal information systems management (“ISM”) team of all activities and ranks those activities based on their level of threat to the system and/or deviation of behavior from normal. Severe threats notify the ISM team via text message, regardless of hours of operation.
If a threat is detected, our system automatically notifies our internal information systems management (“ ISM ”) team of all activities and ranks those activities based on their level of threat to the system and/or deviation of behavior from normal. Severe threats notify the ISM team via text message, regardless of hours of operation.
Given the lack of material cybersecurity incidents relating to our company, we have not been required to escalate any matters to our board of directors, although management keeps the board of directors periodically informed of cybersecurity matters.
Given the lack of material cybersecurity incidents relating to our company, we have no t been required to escalate any matters to our board of directors, although management keeps the board of directors periodically informed of cybersecurity matters.
It is difficult to assign a monetary materiality assessment to these risks or to the impact if we were to sustain a breach of our systems. Our approach is based on the premise that any cybersecurity incident could result in material harm to our company.
It is difficult to assign a monetary materiality assessment to these risks or to the impact if we were to sustain a breach of our systems.

Item 2. Properties

Properties — owned and leased real estate

0 edited+4 added−1 removed4 unchanged
Removed
This facility was built primarily as a training facility where providers are trained. We believe that these facilities are adequate for our current and near-term future needs.
Added
This facility was built primarily as a training facility where providers are trained. As part of the acquisition of SCN, we acquired seven additional leases in Nevada with approximately 53,208 rentable square feet of office space for the sleep centers. The lease expirations varies from beginning of 2026 to end of 2034.
Added
The terms of the leases provide for an aggregate rent base payments of approximately $63,000 per month. Effective August 20, 2025, we entered into a lease of approximately 3,690 rentable square feet of office space from an unaffiliated third party for our Detroit operations. This lease expires in December 2030.
Added
The terms of the lease provide for a base rent payment of $5,535 per month. We also lease approximately 8,996 rentable square feet of office space for our treatment center located in Las Vegas, Nevada. This lease expires in October 2031. The terms of the lease provide for a base rent payment of $16,902 per month.
Added
Lastly, we lease approximately 8,113 rentable square feet of office space for our sleep center and treatment center in Henderson, Nevada. The lease expires in January 2033. We believe that these facilities are adequate for our current and near-term future needs. -61-

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

8 edited+5 added−8 removed7 unchanged
Biggest changeOral Argument is scheduled for March 18, 2025. -51- On July 22, 2020, Ortho-Tain, Inc. filed a complaint in the United States District Court for the Northern District of Illinois against the Company, our Chairman and Chief Executive Officer, R. Kirk Huntsman, Benco Dental Supply Co., Dr. Brian Kraft, Dr. Ben Miraglia, and Dr.
Biggest changeOur amended complaint sought permanent injunctive relief to prevent what we believe are defamatory statements and interference with our business relationships by Ortho-Tain. On July 22, 2020, Ortho-Tain, Inc. filed a complaint in the United States District Court for the Northern District of Illinois against the Company, our Chairman and Chief Executive Officer, R.
The complaint in the Illinois Ortho-Tain Case alleges violation of the Lanham Act and an alleged civil conspiracy among the defendants to violate the Lanham Act by an alleged false designation of origin related to a presentation given by Dr. Brian Kraft at an event sponsored by us and Benco Dental.
The complaint in the Illinois Ortho-Tain Case alleged violation of the Lanham Act and an alleged civil conspiracy among the defendants to violate the Lanham Act by an alleged false designation of origin related to a presentation given by Dr. Brian Kraft at an event sponsored by us and Benco Dental.
Ortho-Tain also alleges that the actions of the defendants diverted sales from Ortho-Tain, deprived Ortho-Tain of advertising value and resulted in a loss of goodwill to Ortho-Tain. Ortho-Tain further alleges two separate breach of contract actions against Dr. Brian Kraft and Mr. Huntsman. Ortho-Tain’s allegation of breach of contract against Mr.
Ortho-Tain also alleged that the actions of the defendants diverted sales from Ortho-Tain, deprived Ortho-Tain of advertising value and resulted in a loss of goodwill to Ortho-Tain. Ortho-Tain further alleges two separate breach of contract actions against Dr. Brian Kraft and Mr. Huntsman. Ortho-Tain’s allegation of breach of contract against Mr.
(“ Ortho-Tain ”) in the United States District Court for the District of Colorado seeking relief from certain false, threatening, and defamatory statements to our business affiliate, Benco Dental (“ Benco ”). We believe such statements have interfered with its business relationship and contract with Benco, causing harm to our reputation, loss of goodwill, and unspecified monetary damages.
(“ Ortho-Tain ”) in the United States District Court for the District of Colorado seeking relief from certain false, threatening, and defamatory statements to our business affiliate, Benco Dental (“ Benco ”). We believed such statements have interfered with our business relationship and contract with Benco, causing harm to our reputation, loss of goodwill, and unspecified monetary damages.
On October 22, 2024, the District Court ordered the parties to exchange Rule 26(a)(1) initial disclosures by November 22, 2024 and Initial Written Discovery to Be Issued by the same date, which the parties completed. The parties provided a status report to the court on January 6, 2025 and February 24, 2025.
On October 22, 2024, the District Court ordered the parties to exchange Rule 26(a)(1) initial disclosures by November 22, 2024 and Initial Written Discovery to Be Issued by the same date, which the parties completed.
On September 9, 2020, we moved to dismiss the claims against it in the Illinois Ortho-Tain Case. On October 23, 2020, we filed a motion requesting, in the alternative, that if the case is not dismissed, it be transferred to the Colorado action described above or stayed.
On October 23, 2020, we filed a motion requesting, in the alternative, that if the case is not dismissed, it be transferred to the Colorado action described above or stayed.
Mark Musso (the “ Illinois Ortho-Tain Case ”). The complaint in the Illinois Ortho-Tain Case addresses the same events as the suit we filed against Ortho-Tain in June 2020 as described above.
Kirk Huntsman, Benco Dental Supply Co., Dr. Brian Kraft, Dr. Ben Miraglia, and Dr. Mark Musso (the “Illinois Ortho-Tain Case”). The complaint in the Illinois Ortho-Tain Case addressed the same events as the suit we filed against Ortho-Tain in June 2020 as described above.
Huntsman, relates to a Non-Disclosure Agreement entered into in October 2013 with Mr. Huntsman’s prior entity, Xenith Practices, LLC, which Non-Disclosure Agreement expired pursuant to its terms in October 2016. We continue to evaluate the allegations, although we believe they lack merit and believe Ortho-Tain will be unable to establish actionable damages.
Huntsman, relates to a Non-Disclosure Agreement entered into in October 2013 with Mr. Huntsman’s prior entity, Xenith Practices, LLC, which Non-Disclosure Agreement expired pursuant to its terms in October 2016. On September 9, 2020, we moved to dismiss the claims against it in the Illinois Ortho-Tain Case.
Removed
Our amended complaint seeks permanent injunctive relief to prevent what we believe are defamatory statements and interference with our business relationships by Ortho-Tain. We further seek declaratory relief to refute the defendant’s false allegations, as well as monetary damages. Prior to filing the suit, we worked collaboratively with legal counsel at Benco to address and resolve this matter.
Added
The parties continued with discovery and have provided additional status reports to the District Court on January 6, 2025, February 24, April 7, May 5, June 11, July 9, August 6, 2025, August 26, 2025, and September 16, 2025.
Removed
Such efforts were unsuccessful. On February 26, 2021, Ortho-Tain, Inc. filed a motion to dismiss the amended complaint. We opposed the motion. On June 21, 2022, the Tenth Circuit entered an order and judgment. Pursuant to such order, the appeal was terminated, and the case was remanded to the U.S. District Court for the District of Colorado for further proceedings.
Added
On October 23, 2025, the parties attended a mediation in an effort to resolve their disputes and agreed upon principal terms of a confidential settlement. On March 13, 2026, we entered into a confidential joint settlement and release agreement (the “Settlement Agreement”) with Ortho-Tain.
Removed
On July 13, 2022, the Clerk of Court for the Tenth Circuit transferred jurisdiction back to the District of Colorado. On February 14, 2024, the District Court of Colorado issued an order denying Ortho-Tain’s motion to dismiss after analyzing the issue of litigation privilege under the standard ordered by the Tenth Circuit.
Added
The Settlement Agreement resolved any claim for relief that was, or could have been alleged in the foregoing litigation matters.
Removed
In response, Ortho-Tain filed a notice of appeal of the District Court of Colorado order on February 14, 2024. The appeal has been docketed in the Tenth Circuit, and the record has been completed. On March 5, 2024, we filed a motion to dismiss the appeal for lack of jurisdiction.
Added
Pursuant to the Settlement Agreement, we will pay Ortho-Tain a confidential sum and, among other considerations, not make use of the phrase “Guide” or “Guides” in the formal product name of any of our oral appliance products and cease direct solicitation and training of independent dental professionals in the use of any Vivos pre-formed tooth positioner products that are competitive with Ortho-Tain.
Removed
Ortho-Tain filed its response to the motion to dismiss on March 19, 2024. Our reply in support of the motion to dismiss was filed on March 26, 2024.
Added
Item 4. Mine Safety Disclosures. Not applicable. -62- PART II
Removed
On March 20, 2024, the Court ordered that our motion to dismiss for lack of jurisdiction would be referred to the panel of judges to be assigned to the appeal, and that no ruling on the motion to dismiss would be issued at that time. Ortho-Tain filed its opening brief on April 29, 2024.
Removed
We filed an Answer Brief on May 29, 2024. Ortho-Tain filed its response brief on June 20, 2024. On October 31, 2024, the Tenth Circuit ordered additional briefing on two discrete issues and that briefing was filed on November 21, 2024.
Removed
The District Court set a deadline of May 16, 2025 to amend pleadings and July 30, 2025 to complete fact discovery. Item 4. Mine Safety Disclosures. Not applicable. -52- PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+1 added−34 removed6 unchanged
Biggest changeThe December 2024 Warrants are immediately exercisable upon issuance, will expire two years following the issuance date and have an exercise price of $4.81 per share Securities Authorized for Issuance under Equity Compensation Plans The following table summarizes the outstanding number of awards granted under the 2017 Plan, the 2019 Plan and the 2024 Omnibus Plan as of December 31, 2024.
Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans The following table summarizes the outstanding number of awards granted under the 2017 Plan, the 2019 Plan and the 2024 Omnibus Plan as of December 31, 2025.
Our board of directors and stockholders have approved a total reserve of 1,600,00 shares for issuance under the 2024 Omnibus Plan. -55- Dividend Policy As of the date of this Annual Report on Form 10-K, we have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Our board of directors and stockholders have approved a total reserve of 1,600,00 shares for issuance under the 2024 Omnibus Plan. -63- Dividend Policy As of the date of this Annual Report on Form 10-K, we have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Plan category: Number of Securities to be issued Upon Exercise of Outstanding Options, Warrants, and Rights (a) Weighted Average Exercise Price of Outstanding Options (b) Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in column (a)) (c) Equity compensation plans approved by stockholders 2017 Plan (1) 53,333 $ — — 2019 Plan (2) 174,380 $ — — 2024 Omnibus Plan (3) 1,600,000 $ — 579,513 Total 1,827,713 $ 57.35 579,513 (1) The 2017 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
Plan category: Number of Securities to be issued Upon Exercise of Outstanding Options, Warrants, and Rights (a) Weighted Average Exercise Price of Outstanding Options (b) Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in column (a)) (c) Equity compensation plans approved by stockholders 2017 Plan (1) 53,333 $ — — 2019 Plan (2) 174,380 $ — — 2024 Omnibus Plan (3) 1,600,000 $ — 489,513 Total 1,827,713 $ 6.83 489,513 (1) The 2017 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
Holders of Record On March 31, 2025, we had approximately 8,150 stockholders of record. On March 31, 2025, there were 5,889,520 shares of our common stock issued and outstanding. In addition, we believe that a significant number of beneficial owners of our common stock hold their shares in street name.
Holders of Record On March 31, 2026, we had approximately 8,150 stockholders of record. On March 31, 2025, there were 13,486,006 shares of our common stock issued and outstanding. In addition, we believe that a significant number of beneficial owners of our common stock hold their shares in street name.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “VVOS”. On March 28, 2025, the last reported sale price of the shares of our common stock as reported on NASDAQ was $3.11 per share.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “VVOS”. On April 14, 2026, the last reported sale price of the shares of our common stock as reported on NASDAQ was $1.35 per share.
Removed
Recent Sales of Unregistered Securities The following is a summary of transactions by us within the past three years involving sales or our securities that were not registered under the Securities Act.
Added
Recent Sales of Unregistered Securities Except for sales of unregistered securities that have been previously reported by the Company in either its Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, there were no sales of unregistered securities of the Company during the period covered by this report.
Removed
All of the sales listed below were made pursuant to an exemption from registration afforded by Section 4(a)(2) of the Securities Act and/or Regulation D thereunder in that (i) none of the offers and sales constituted a public offering of securities and/or (ii) the securities were only offered and sold to accredited investors.
Removed
On February 25, 2022 we issued 11,600 stock options to certain employees and officers with an exercise price of $81.75 per share, one-fifth vested on the date of grant, and one-fifth vests annually through February 25, 2026.
Removed
Additionally, we issued warrants to purchase 3,200 shares of the Company’s common stock to certain consultants for sales consulting services with an exercise price of $81.75 per share, vesting monthly over one year term of the agreement. These warrants may be exercised only for cash, and the exercise price is subject to customary, stock-based anti-dilution protection.
Removed
On May 12, 2022, we issued 10,600 stock options to certain employees and officers with an exercise price of $32.25 per share, one-fifth vested on the date of grant, and one-fifth vests annually through May 12, 2027.
Removed
Additionally, we issued warrants to purchase 5,200 shares of the Company’s common stock to certain consultants for sales consulting services with an exercise price of $32.25 per share. 1,600 of these warrants vested immediately upon issuance, 2,400 of these warrants vest monthly over a six month term and 1,200 of these warrants vest monthly over one year term of the agreement.
Removed
These warrants may be exercised only for cash, and the exercise price is subject to customary, stock-based anti-dilution protection. On July 8, 2022, we issued 600 stock options to a certain employee with an exercise price of $36.25 per share, one-fifth vested on the date of grant, and one-fifth vests annually through July 8, 2027.
Removed
On December 23, 2022,we issued 56,167 stock options to certain employees and officers with an exercise price of $12.00 per share, 31,500 of these options vested one-fifth on the date of grant, and one-fifth vests annually through December 23, 2026, 6,400 of these options vested 50% on the date of grant, and 25% vest on March 23, 2023, and the remaining 25% vest on June 23, 2023, and 18,267 of these options vested immediately upon issuance.
Removed
Additionally, we issued warrants to purchase 34,000 shares of the Company’s common stock to certain consultants for sales consulting services with an exercise price of $12.00 per share. 22,300 of these warrants vested immediately upon issuance, 1,100 of these warrants vest quarterly over one year term, 4,600 of these warrants vest quarterly over two year term of the agreement, 2,000 of these warrants vest annually over two year term, and 4,000 of these warrants exercisable upon the achievement of pre-determined performance metrics.
Removed
These warrants may be exercised only for cash, and the exercise price is subject to customary, stock-based anti-dilution protection. On January 9, 2023, we closed a private placement (the “Private Placement”) pursuant to which we agreed to sell up to an aggregate of $8,000,000 of securities of the Company of units.
Removed
Each unit consists of one share of the Company’s common stock, $0.0001 par value (or a pre-funded warrant to purchase one share of Common Stock) (the “Pre-Funded Warrants”) and one warrant exercisable for one share Common Stock (the “Common Stock Purchase Warrants” and together with the Pre-Funded Warrants, the “Warrants”). No actual units will be issued in the Private Placement.
Removed
Pursuant to the Purchase Agreement, we agreed to issue and sell in the Private Placement 80,000 Shares, Pre-Funded Warrants to purchase up to an aggregate of 186,666 shares of Common Stock and Common Stock Purchase Warrants to purchase up to an aggregate of 266,667 shares of Common Stock (collectively with the shares of Common Stock underlying the Pre-Funded Warrants and the Warrants, the “Warrant Shares”).
Removed
The purchase price per Share and associated Common Stock Purchase Warrant was $30.00, and the purchase price per Pre-Funded Warrant and associated Common Stock Purchase Warrant was $29.9998. -53- Each Common Stock Purchase Warrant entitles the holder, for a period of five years and 6 months, to purchase one share of Common Stock at an exercise price of $30.00 per share.
Removed
Each Pre-Funded Warrant entitles the holder, for a period until all Pre-Funded Warrants are exercised, to purchase one share of Common Stock at an exercise price of $0.0001 per share. The Warrants also contain customary beneficial ownership limitations that may be waived at the option of each holder upon 61 days’ notice to the Company.
Removed
On November 2, 2023, we closed a private placement (the “November 2023 Private Placement”) with an institutional investor pursuant to which we sold an aggregate of $4,000,003 of securities in a private placement consisting of (i) 130,000 shares of Common Stock, (ii) a pre-funded warrant to purchase 850,393 shares of Common Stock at an exercise price of $0.0001 per share, (iii) a five-year Series A Common Stock Purchase Warrant to purchase up to 980,393 shares of Common Stock with an exercise price of $3.83 per share and (iii) an 18-month Series B Common Stock Purchase Warrant (the “Series B Warrant”) to purchase up to 980,393 shares of Common Stock with an exercise price of $3.83 per share.
Removed
On February 14, 2024, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same institutional investor pursuant to which the investor agreed to exercise for cash the entirety of the Series B Warrant issued in November 2023 at a reduced exercise price of $4.02 per share (with such exercise price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market), resulting in gross proceeds to us of approximately $4.0 million.
Removed
The resale of the shares of Common Stock underlying the Series B Warrant has been registered pursuant to a Registration Statement on Form S-1 (File No. 333-275726), which became effective with the SEC on December 1, 2023.
Removed
Pursuant to the Inducement Agreement, in consideration for the immediate exercise of the Series B Warrant in full, we agreed to issue to the investor the two Inducement Warrants in a new private placement transaction. The Inducement Warrants are identical to each other, other than their dates of expiration, and are substantially identical to the Series B Warrant.
Removed
The Inducement Transaction closed on February 20, 2024. On June 10, 2024, we entered into a securities purchase agreement (the “June 2024 SPA”) with V-CO Investors LLC, a Wyoming limited liability company (“V-CO”). V-CO is an affiliate of Seneca, a leading independent private equity firm.
Removed
Pursuant to the June 2024 SPA, we sold to V-CO in a private placement offering: (i) 169,498 shares of our Common Stock, (ii) a pre-funded warrant (which we refer to herein as the Pre-Funded Warrant) to purchase 3,050,768 shares of Common Stock (which we refer to herein as the Pre-Funded Warrant Shares), and (iii) a Common Stock Purchase Warrant (which we refer to as the June 2024 Warrant) to purchase up to 3,220,266 shares of Common Stock (which we refer to herein as the June 2024 Warrant Shares).
Removed
V-CO paid a purchase price of $2.329 for each share and Pre-Funded Warrant Share and associated June 2024 Warrant, with such price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market LLC. The private placement closed on June 10, 2024. We received gross proceeds of $7,500,000 from the private placement.
Removed
No placement agent was used in connection with the private placement. The June 2024 Warrant has a five-year term, an exercise price of $2.204 per share and became exercisable immediately as of the date of issuance.
Removed
The Pre-Funded Warrant has a term ending on the complete exercise of the Pre-Funded Warrant, an exercise price of $0.0001 per share and became exercisable immediately as of the date of issuance.
Removed
The June 2024 Warrant and the Pre-Funded Warrants also contain customary stock-based (but not price-based) anti-dilution protection as well as beneficial ownership limitations that may be waived at the option of the holder upon 61 days’ notice to us.
Removed
On June 20, 2024, we issued 85,000 stock options to certain employees and officers with an exercise price of $2.38 per share, 17,000 of these options vested one-fifth on the date of grant, and one-fifth vests annually through June, 20, 2028.
Removed
Additionally, we issued 20,000 stock options to board members with an exercise price of $2.38 per share, 10,000 of these options vested 50% on the date of grant, and 25% vest on September 30, 2024, and the remaining 25% vest on December 31, 2024.
Removed
Lastly, we issued warrants to purchase 4,000 shares of the Company’s common stock to a certain consultant for business developments services with an exercise price of $2.38 per share, these warrants vested immediately upon issuance.
Removed
These warrants may be exercised only for cash, and the exercise price is subject to customary, stock-based anti-dilution protection. -54- On September 7, 2024 (the “Grant Date”), we granted 1,020,487 stock options, to certain employees, consultants and officers with an exercise price of $2.64 per share, such grant was made under but subject to stockholder approval of the Company’s 2024 Omnibus Equity Incentive Plan and such grant at our 2024 Annual Meeting.
Removed
Such meeting was held, and such stockholder approval was obtained, on November 26, 2024.
Removed
Stock options shall vest and become exercisable in three installments on the first, second and third anniversaries of the Date of Grant subject to achievement of the following three performance metrics: (1) quarter over quarter revenue growth of at least 15% over the same prior year quarter, (2) total stockholder return from date of grant of 3X or greater, and (3) positive cash flow for two consecutive quarters.
Removed
On September 18, 2024, we entered into a securities purchase agreement (the “September 2024 SPA”) with certain institutional investors in connection with a registered direct offering (the “September 2024 Offering”), priced at-the-market under Nasdaq Stock Market rules, to purchase 1,363,812 shares of Common Stock at a purchase price of $3.15 per share.
Removed
No common stock purchase warrants were offered or issued to investors in the September 2024 Offering.
Removed
On December 22, 2024, we entered into a securities purchase agreement (the “December 2024 SPA”) with certain institutional investors (who are the selling stockholders named herein) in connection with a registered direct offering, priced at-the-market under Nasdaq Stock Market rules, to purchase 709,220 shares of Common Stock and, in a concurrent private placement (collectively, with the registered direct offering, the “December 2024 Offering”), warrants (the “December 2024 Warrants”) to purchase up to 709,220 shares of Common Stock (the shares of Common Stock issuable upon exercise of the December 2024 Warrants, the “December 2024 Warrant Shares”).
Removed
The combined purchase price per share and each of the December 2024 Warrants is $4.935.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

78 edited+25 added−47 removed67 unchanged
Biggest changeOther income relates to the excess warrant fair value and change in fair value of warrant liability. -61- Results of Operations Comparison of Years ended December 31, 2024 and 2023 Our consolidated statements of operations for the years ended December 31, 2024 and 2023 are presented below (dollars in thousands): 2024 2023 Change Revenue Product revenue $ 7,874 $ 6,270 $ 1,604 Service revenue 7,157 7,531 (374 ) Total revenue 15,031 13,801 1,230 Cost of sales (exclusive of depreciation and amortization shown separately below) 6,012 5,530 482 Gross profit 9,019 8,271 748 Gross profit % 60 % 60 % Operating expenses General and administrative 17,878 22,479 (4,601 ) Sales and marketing 1,731 2,467 (736 ) Depreciation and amortization 581 621 (40 ) Operating loss (11,171 ) (17,296 ) 6,125 Non-operating income (expense) Other expense (110 ) (212 ) 102 Excess warrant fair value - (6,453 ) 6,453 Change in fair value of warrant liability, net of issuance costs of $645 - 10,231 (10,231 ) Other income 145 147 (2 ) Net loss $ (11,136 ) $ (13,583 ) $ 2,447 Revenue Revenue increased approximately $1.2 million, or 9%, to approximately $15.0 million for the year ended December 31, 2024 compared to $13.8 million for the year ended December 31, 2023.
Biggest changeResults of Operations Comparison of Years ended December 31, 2025 and 2024 Our consolidated statements of operations for the years ended December 31, 2025 and 2024 are presented below (dollars in thousands): 2025 2024 Change Revenue Product revenue $ 6,487 $ 7,874 $ (1,387 ) Service revenue 10,956 7,157 3,799 Total revenue 17,443 15,031 2,412 Cost of sales (exclusive of depreciation and amortization shown separately below) 6,901 6,012 889 Gross profit 10,542 9,019 1,523 Gross profit % 60 % 60 % Operating expenses General and administrative 27,727 17,878 9,849 Sales and marketing 1,400 1,731 (331 ) Depreciation and amortization 1,309 581 728 Operating loss (19,894 ) (11,171 ) (8,723 ) Non-operating income (expense) Other expense (1,481 ) (110 ) (1,371 ) Other income 145 145 - Net loss $ (21,230 ) $ (11,136 ) $ (10,094 ) Net loss attributable to non-controlling interest 60 - (60 ) Net loss attributable to stockholders $ (21,170 ) $ (11,136 ) $ (10,034 ) -68- Revenue Revenue increased approximately $2.4 million, or 16%, to approximately $17.5 million for the year ended December 31, 2025 compared to $15.0 million for the year ended December 31, 2024.
These include the following: 1) Discount for cash paid in full 2) Conference or trade show incentives, such as subscription enrollment into the SleepImage ® home sleep test program, or a free trial period for the SleepImage ® lease program -67- 3) Negotiated concessions on annual enrollment fee 4) Credits/rebates to be used towards future product orders such as lab rebates The amount of the discount is determined up front prior to the sale.
These include the following: 1) Discount for cash paid in full 2) Conference or trade show incentives, such as subscription enrollment into the SleepImage ® home sleep test program, or a free trial period for the SleepImage ® lease program 3) Negotiated concessions on annual enrollment fee 4) Credits/rebates to be used towards future product orders such as lab rebates The amount of the discount is determined up front prior to the sale.
If we fail to achieve ongoing compliance and its common stock is delisted by Nasdaq, such delisting would likely have a material adverse effect on our stock price, the ability of our stockholders to buy or sell their common stock, our ability to raise capital and on our reputation, all of which could make it significantly more difficult to operate.
If we fail to achieve ongoing compliance and our common stock is delisted by Nasdaq, such delisting would likely have a material adverse effect on our stock price, the ability of our stockholders to buy or sell their common stock, our ability to raise capital and on our reputation, all of which could make it significantly more difficult to operate.
We believe VIPs can recoup their investment in VIP enrollment with approximately eight Vivos Method case starts, but as noted above, many VIPs start and also maintain their case starts at a significantly slower rate. We presently have a concentration of active VIPs who regularly start new Vivos Method treatment cases.
We believe VIPs can recoup their investment in VIP enrollment with approximately eight Vivos Method case starts, but as noted above, many VIPs start and also maintain their case starts at a significantly slower rate. We presently have a low concentration of active VIPs who regularly start new Vivos Method treatment cases.
On September 21, 2023, we received a written notice from the Nasdaq staff confirming that since, as of that date, we failed to meet the Minimum Bid Requirement, and because as of the period ended June 30, 2023 we also failed the Minimum Stockholders’ Equity Requirement, Nasdaq would commence delisting proceedings against us.
On September 21, 2023, we received a written notice from the Nasdaq staff confirming that since, as of that date, we failed to meet the Minimum Bid Requirement, and because as of the period ended June 30, 2023 we also failed the Equity Requirement, Nasdaq would commence delisting proceedings against us.
On June 25, 2024, we reported in a Current Report on Form 8-K that it believed it had stockholders’ equity of at least $2.5 million as of the date of the filing of such report as a result of our closing of a $7.5 million equity private placement on June 10, 2024.
On June 25, 2024, we reported in a Current Report on Form 8-K that we believed we had stockholders’ equity of at least $2.5 million as of the date of the filing of such report as a result of our closing of a $7.5 million equity private placement on June 10, 2024.
In general, revenues are separated between durable medical equipment (product revenue) and education and training services (service revenue). Treatment of Discounts and Promotions From time to time, we offer various discounts to its customers.
In general, revenues are separated between durable medical equipment (product revenue) and education and training services (service revenue). -73- Treatment of Discounts and Promotions From time to time, we offer various discounts to its customers.
The evaluation of asset impairment requires us to make assumptions about future cash flows over the life of the asset being evaluated. These assumptions require significant judgment and actual results may differ from assumed and estimated amounts. There were no quantitative or qualitative indicators of impairment that occurred for the year ended December 31, 2024, accordingly no impairment was required.
The evaluation of asset impairment requires us to make assumptions about future cash flows over the life of the asset being evaluated. These assumptions require significant judgment and actual results may differ from assumed and estimated amounts. There were no quantitative or qualitative indicators of impairment that occurred for the year ended December 31, 2025, accordingly no impairment was required.
Published studies have shown that using our customized appliances and clinical treatments led to significantly lower Apnea Hypopnea Index scores and have improved other conditions associated with OSA. Nearly 58,000 patients have been treated to date worldwide with our entire current suite of products by more than 2,000 trained dentists.
Published studies have shown that using our customized appliances and clinical treatments led to significantly lower Apnea Hypopnea Index scores and have improved other conditions associated with OSA. Nearly 75,000 patients have been treated to date worldwide with our entire current suite of products by more than 2,000 trained dentists.
We also offer our VIPs the ability to provide MyoCorrect to the VIP’s patients as part of treatment with The Vivos Method. The program includes packages of treatment sessions that are sold to the VIPs and resold to their patients. Revenue for MyoCorrect services is recognized over the 12-month performance period as therapy sessions occur.
We also offer our VIPs the ability to provide MyoSync to the VIP’s patients as part of treatment with The Vivos Method. The program includes packages of treatment sessions that are sold to the VIPs and resold to their patients. Revenue for MyoSync services is recognized over the 12-month performance period as therapy sessions occur.
Service Revenue VIP Enrollment Revenue We review its VIP enrollment contracts from a revenue recognition perspective using the 5-step method outlined above. All program enrollees, irrespective of their level of enrollment, are commonly referred to as VIPs, unless it is necessary to specify their particular program.
Service Revenue VIP Enrollment Revenue We review our VIP enrollment contracts from a revenue recognition perspective using the 5-step method outlined above. All program enrollees, irrespective of their level of enrollment, are commonly referred to as VIPs, unless it is necessary to specify their particular program.
These incentives are recorded as a liability at issuance and are deducted from the related product sale at the time the credit is used. -68- Intangible Assets, Net Goodwill is the excess of acquisition cost of an acquired entity over the fair value of the identifiable net assets acquired.
These incentives are recorded as a liability at issuance and are deducted from the related product sale at the time the credit is used. -74- Goodwill and Intangible Assets, Net Goodwill is the excess of acquisition cost of an acquired entity over the fair value of the identifiable net assets acquired.
Also, in October 2023, we announced an exclusive distribution agreement with NOUM DMCC, a Dubai-based company focused on diagnostic testing and treatment product distribution for healthcare providers and hospital networks treating obstructive sleep apnea patients throughout the Middle East-North Africa region. With regulatory approvals pending, there was no revenue from this collaboration in 2024.
Also, in October 2023, we announced an exclusive distribution agreement with NOUM DMCC, a Dubai-based company focused on diagnostic testing and treatment product distribution for healthcare providers and hospital networks treating obstructive sleep apnea patients throughout the Middle East-North Africa region. With regulatory approvals pending, there was no revenue from this collaboration in 2024 or 2025. Inflation .
Given that our alliance-based marketing and distribution model is very new and has yet to generate significant revenues, we are in the process of developing and implementing our revenue recognition plan for revenues derived from this model.
Given that our alliance-based marketing and distribution model is relatively new and has yet to generate significant revenues, we are in the process of developing and implementing our revenue recognition plan for revenues derived from this model.
In addition, an important aspect of our strategy to increase product revenues relates to the products and related intellectual property we acquired in March 2023 from Advanced Facialdontics, LLC (“AFD”), including a custom single arch device with an FDA 510(k) clearance for treating TMD and/or Bruxism (teeth grinding or clenching).
In addition, an important aspect of our strategy to increase product revenues relates to the products and related intellectual property we acquired in March 2023 from Advanced Facialdontics, LLC (“ AFD ”), including a custom single arch device with an FDA 510(k) clearance for treating TMD and/or Bruxism (teeth grinding or clenching).
Following the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) and the applicable provisions of ASC Topic 842 , Leases (“ASC 842”), we determine revenue recognition through the following five-step model, which entails: 1) identification of the promised goods or services in the contract; 2) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; 3) measurement of the transaction price, including the constraint on variable consideration; 4) allocation of the transaction price to the performance obligations; and 5) recognition of revenue when, or as we satisfy each performance obligation.
Following the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ ASC 606 ”) and the applicable provisions of ASC Topic 842 , Leases (“ ASC 842 ”), we determine revenue recognition through the following five-step model, which entails: 1) identification of the promised goods or services in the contract; 2) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; 3) measurement of the transaction price, including the constraint on variable consideration; 4) allocation of the transaction price to the performance obligations; and 5) recognition of revenue when, or as we satisfy each performance obligation.
However, inflationary pressures (including increases in the price of raw material components of our appliances) made it necessary for us to adjust our standard pricing for our appliance products in 2022 and will be revisited in 2025.
However, inflationary pressures (including increases in the price of raw material components of our appliances) made it necessary for us to adjust our standard pricing for our appliance products in 2022 and will be revisited in 2026.
The relative standalone price method is based on the proportion of the standalone selling price of each performance obligation to the sum of the total standalone selling prices of all the performance obligations in the contract. -66- The right to sell is similar to a license of intellectual property because without it the VIP cannot purchase appliances from us.
The relative standalone price method is based on the proportion of the standalone selling price of each performance obligation to the sum of the total standalone selling prices of all the performance obligations in the contract. -72- The right to sell is similar to a license of intellectual property, because without the right, the VIP cannot purchase appliances from us.
Income Taxes We account for income taxes in accordance with Accounting Standards Codification (“ASC”) 740, Income Taxes, under which deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of assets and liabilities given the provisions of enacted tax laws.
Income Taxes We account for income taxes in accordance with Accounting Standards Codification (“ ASC ”) 740, Income Taxes, under which deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of assets and liabilities given the provisions of enacted tax laws.
Product Revenue In addition to revenue from services, we also generate revenue from the sale of our line of oral devices and preformed guides (known as appliances or systems) to our customers, the VIP dentists, or to OSA patients directly now in our strategic alliance model.
Product Revenue In addition to revenue from services, we also generate revenue from the sale of our line of oral devices and preformed tooth positioners (known as appliances or systems) to our customers, the VIP dentists, or to OSA patients directly now in our strategic alliance model.
GAAP”). All significant intercompany balances and transactions have been eliminated in consolidation.
All significant intercompany balances and transactions have been eliminated in consolidation.
We contract with VIPs for the sale of the appliance and are not involved in the sale of the products and services from the VIP to the VIP’s patient. We utilize third party contract manufacturers or labs to produce its patient-customized, patented appliances and its preformed guides.
We contract with VIPs for the sale of the appliance and are not involved in the sale of the products and services from the VIP to the VIP’s patient. We utilize third party contract manufacturers or labs to produce its patient-customized, patented appliances and its preformed tooth positioners.
As such, we have raised equity capital in late 2023 and throughout 2024 and will be required to obtain additional financing to satisfy our cash needs and bolster our stockholders’ equity for Nasdaq compliance purposes, as management continues to work towards increasing revenue to achieve cash flow positive operations in the foreseeable future.
As such, we raised equity capital throughout 2024 and 2025 and will be required to obtain additional financing to satisfy our cash needs and bolster our stockholders’ equity for Nasdaq compliance purposes, as management continues to work towards increasing revenue to achieve cash flow positive operations in the foreseeable future.
There were no quantitative or qualitative indicators of impairment that occurred for the year ended December 31, 2024, accordingly no impairment was required.
There were no quantitative or qualitative indicators of impairment that occurred for the year ended December 31, 2025, accordingly no impairment was required.
We have implemented cost savings measures that lead to reduced impact to cash used in operations. However, sales did not grow in the year ended December 31, 2023 or in 2024 as anticipated, as our product offerings and distribution strategies continue to be improved and refined.
We have implemented cost savings measures that have reduced cash used in operations. However, sales did not grow in the year ended December 31, 2024 or in 2025 as anticipated, as our product offerings and distribution strategies continue to be improved and refined.
“Item 1A. Risk Factors’’ and elsewhere in this Annual Report on Form 10-K. We are a revenue stage medical technology company focused on the development and commercialization of innovative treatment alternatives for patients with dentofacial abnormalities and/or patients diagnosed with mild to severe obstructive sleep apnea (“OSA”) and snoring in adults.
“Item 1A. Risk Factors’’ and elsewhere in this Annual Report on Form 10-K. We are a revenue stage medical technology and healthcare services company focused on the development and commercialization of innovative treatment alternatives for patients with dentofacial abnormalities and/or patients diagnosed with mild to severe obstructive sleep apnea (“ OSA ”) and snoring in adults.
Performance obligations with respect to appliance sales are typically satisfied by shipping or delivering products to our VIPs or to the sleep clinic, through our new strategic alliance model, in the case of enrollment or service revenue, upon our satisfaction of performance obligations associated with VIP enrollments.
Performance obligations with respect to appliance sales are typically satisfied at a point in time by shipping or delivering products to our VIPs or to the sleep clinic, through our new strategic alliance model. In the case of enrollment or service revenue, upon our satisfaction of performance obligations associated with VIP enrollments.
The slow acceptance rate Vivos appliances with providers lead Vivos to consider other business models including the alliance marketing and distribution model announced in 2024 to sell additional product.
The slow acceptance rate Vivos appliances with providers lead Vivos to consider other business models including the medical provider-focused alliance marketing and distribution model announced in 2024 to sell additional product.
As of December 31, 2024, we had approximately $6.3 million in cash and cash equivalents, which will not be sufficient to fund operations and strategic objectives over the next twelve months from the date of issuance of these financial statements. Without additional financing, these factors raise substantial doubt regarding our ability to continue as a going concern.
As of December 31, 2025, we had approximately $2.0 million in cash and cash equivalents, which will not be sufficient to fund operations and strategic objectives over the next twelve months from the date of issuance of these financial statements. Without additional financing, these factors raise substantial doubt regarding our ability to continue as a going concern.
General and administrative (“G&A”) expenses consist primarily of personnel costs for our administrative, human resources, finance and accounting employees, and executives. General and administrative expenses also include contract labor and consulting costs, travel - related expenses, legal, auditing and other professional fees, rent and facilities costs, repairs and maintenance, and general corporate expenses. Depreciation and amortization expense.
General and administrative (“ G&A ”) expenses consist primarily of personnel costs for our administrative, human resources, finance and accounting employees, and executives. General and administrative expenses also include contract labor and consulting costs, travel - related expenses, legal, auditing and other professional fees, rent and facilities costs, repairs and maintenance, and general corporate expenses. Depreciation and amortization expense.
At the Hearing on November 9, 2023, we presented our plan to regain compliance with the minimum stockholders’ equity requirement (the “Equity Rule”), which plan includes raising additional equity capital. On November 30, 2023, we received a letter from the Hearings Panel that, subject to certain conditions, the Hearings Panel granted our request to continue to be listed on Nasdaq.
At the Hearing on November 9, 2023, we presented our plan to regain compliance with the Equity Requirement, which included raising additional equity capital. On November 30, 2023, we received a letter from the Hearings Panel that, subject to certain conditions, the Hearings Panel granted our request to continue to be listed on Nasdaq.
Net cash provided by financing activities of $17.9 million for the years ended December 31, 2024, is attributable to proceeds of $19.2 million from the issuance of Common Stock and Warrants, net of approximately $1.4 million of professional fees and other issuance costs, in our February warrant inducement, as well as the June, September and December private placements.
This compares to net cash provided by investing financing for the year ended December 31, 2024 of $17.9 million, attributable to proceeds of $19.2 million from the issuance of common stock and warrants, net of approximately $1.4 million of professional fees and other issuance costs, in our February 2024 warrant inducement, as well as the June, September and December 2024 private placements.
The other, lower priced enrollments were piloted in fiscal quarters prior to second quarter of 2023, and on a limited basis. They were officially adopted during the second quarter of 2023.
Prior to the second quarter of 2023, the majority of VIP enrollments were Premier VIPs. The other, lower priced enrollments were piloted in fiscal quarters prior to second quarter of 2023, and on a limited basis. They were officially adopted during the second quarter of 2023.
Cost of Sales and Gross Profit Cost of sales increased by approximately $0.5 million, or 9%, to approximately $6.0 million for the year ended December 31, 2024, compared to approximately $5.5 million for the year ended December 31, 2023.
Cost of Sales and Gross Profit Cost of sales increased by approximately $0.9 million, or 15%, to approximately $6.9 million for the year ended December 31, 2025, compared to approximately $6.0 million for the year ended December 31, 2024.
We believe our technologies and conventions represent a significant improvement in the treatment of mild to severe OSA versus other treatments such as continuous positive airway pressure (“CPAP”) or palliative oral appliance therapies. Our alternative treatments are part of The Vivos Method .
We believe our technologies and conventions represent a significant improvement in the treatment of mild to severe OSA versus other treatments such as CPAP or palliative oral appliance therapies. Our alternative treatments are part of The Vivos Method .
Approximately 36% of our VIPs initiated a new case as of December 31, 2024. As noted, we believe that reducing our reliance on VIPs and increasing the number of strategic marketing and distribution alliances (or acquiring medical or dental practices) will provide us with a better opportunity to drive appliance sales going forward.
As noted, we believe that reducing our reliance on VIPs and increasing the number of strategic marketing and distribution alliances (or acquiring medical or dental practices) will provide us with a better opportunity to drive appliance sales going forward.
An additional inflation-related risk is the Federal Reserve’s response, which up to this point has been to raise interest rates. Such actions have, in times past, created unintended consequences in terms of the impact on housing starts, overall manufacturing, capital markets, and banking.
An additional inflation-related risk is the Federal Reserve’s response, which up to this point has been to slightly decrease interest rates, however, the perceived decrease was lower than what was expected. Such actions have, in times past, created unintended consequences in terms of the impact on housing starts, overall manufacturing, capital markets, and banking.
As of December 31, 2024, we had total liabilities of approximately $7.3 million as compared with $10.3 million as of December 31, 2023.
As of December 31, 2025, we had total liabilities of approximately $26.7 million as compared with $7.3 million as of December 31, 2024.
On July 5, 2024, we were notified that the Panel had granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended June 30, 2024, with the Securities and Exchange Commission by August 15, 2024, evidencing our compliance with the Equity Requirement.
On July 5, 2024, we were notified that the Panel granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended June 30, 2024, with the Securities and Exchange Commission, evidencing our compliance with the Equity Requirement. We made such filing in a timely manner.
On May 6, 2024, we received written notice from the Nasdaq staff indicating that the Company had regained compliance with the Equity Rule. On May 16, 2024, we received a further written notice from Nasdaq indicating that, as of March 31, 2024, we failed to comply with the Equity Requirement.
On May 16, 2024, we received a further written notice from Nasdaq indicating that, as of March 31, 2024, we failed to comply with the Equity Requirement.
See Note 1 to the accompanying financial statements for additional background information on our Company and current product and service offerings. -56- Material Items, Trends and Risks Impacting Our Business We believe that the following items and trends may be useful in better understanding our results of operations. VIP Enrollments (Service Revenue).
Business of this Report for additional background information on our Company and current product and service offerings. Material Items, Trends and Risks Impacting Our Business We believe that the following items and trends may be useful in better understanding our results of operations. VIP Enrollments (Service Revenue).
As such, while we will continue to recognize some VIP enrollment revenue going forward, such revenue will become increasing less important to us. We recognize revenue on VIP enrollments once the contract is executed, payment is received, and as our performance obligations are satisfied in accordance with ASC 606. Product Sales Revenue.
As such, while we will continue to recognize some VIP enrollment revenue through 2026, we believe such revenue will become immaterial. We recognize revenue on VIP enrollments once the contract is executed, payment is received, and as our performance obligations are satisfied in accordance with ASC 606. Product Sales Revenue.
We have incurred losses since inception, including $11.1 and $13.6 million for the years ended December 31, 2024 and 2023, respectively, resulting in an accumulated deficit of approximately $104.2 million as of December 31, 2024. Net cash used in operating activities amounted to approximately $12.7 and $11.9 million for the years ended December 31, 2024 and 2023, respectively.
We have incurred losses since inception, including $21.2 million and $11.1 million for the years ended December 31, 2025 and 2024, respectively, resulting in an accumulated deficit of approximately $125.4 million as of December 31, 2025. Net cash used in operating activities amounted to approximately $15.3 and $12.7 million for the years ended December 31, 2025 and 2024, respectively.
We do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources. -64- Cash Flows The following table presents a summary of our cash flow for the years ended December 31, 2024 and 2023 (in thousands): 2024 2023 Net cash provided by (used in): Operating activities $ (12,691 ) $ (11,946 ) Investing activities (568 ) (853 ) Financing activities 17,876 10,923 Net cash used in operating activities of approximately $12.7 million for the year ended December 31, 2024 is an increase of approximately $0.7 million compared to net cash used in operating activities of approximately $11.9 million for the year ended December 31, 2023.
We do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources. -70- Cash Flows The following table presents a summary of our cash flow for the years ended December 31, 2025 and 2024 (in thousands): 2025 2024 Net cash provided by (used in): Operating activities $ (15,263 ) $ (12,691 ) Investing activities (7,526 ) (568 ) Financing activities 18,558 17,876 Net cash used in operating activities of approximately $15.3 million for the year ended December 31, 2025 which represents an increase of approximately $2.6 million compared to net cash used in operating activities of approximately $12.7 million for the year ended December 31, 2024.
Late 2024, our clinical study conducted in collaboration with Stanford University and evaluating the DNA and CPAP for the treatment of OSA, was placed on hold by Stanford University.
Late 2024, our clinical study conducted in collaboration with Stanford University and evaluating the DNA and CPAP for the treatment of OSA, was placed on hold by Stanford University. The decision to pause the study was made due to low recruitment into the study.
If such funds are not available in the future, or that if our new model does not result in the patient volume and financial results within the expected timelines, we may also be required to delay, significantly modify or terminate some or all of our operations, all of which could have a material adverse effect on us and our stockholders.
If such funds are not available in the future, or the SAA or similar alliances or acquisitions do not result in the patient volume, appliance sales and financial results within the timeframes we expect, we may be required to delay, significantly modify or terminate some or all of our operations, all of which could have a material adverse effect on us and our stockholders.
For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority.
For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. We recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
For the year ended December 31, 2024, net cash used in investing activities consisted of capital expenditures for software of $0.6 million related to the development of software for internal use, expected to be placed in service in 2025.
This compares to net cash used in investing activities for the year ended December 31, 2024 of $0.6 million due to capital expenditures for the development of software for internal use.
We recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. -69- Warrant Accounting We account for our warrants and financial instruments as either equity or liabilities based upon the characteristics and provisions of each instrument, in accordance with ASC 815, Derivatives and Hedging and ASC 480, Distinguishing Liabilities from Equity .
Warrant Accounting We account for our warrants and financial instruments as either equity or liabilities based upon the characteristics and provisions of each instrument, in accordance with ASC 815, Derivatives and Hedging and ASC 480, Distinguishing Liabilities from Equity .
During the year ended December 31, 2024, we enrolled 112 VIPs and recognized VIP enrollment revenue of approximately $2.5 million, a decrease of approximately 37% in enrollment revenue, compared to the year ended December 31, 2023, when we enrolled 150 VIPs for a total of approximately $3.9 million.
During the year ended December 31, 2025, we enrolled no VIPs and recognized VIP enrollment revenue of approximately $0.5 million, a decrease of approximately 80% in enrollment revenue due to the pivot to the new business model, compared to the year ended December 31, 2024, when we enrolled 112 VIPs for a total of approximately $2.5 million.
During 2023, we entered into distribution collaborations with third parties to expand access of our products to potential patients. We hope that these strategic initiatives will lead to revenue growth opportunities for us in 2024 and beyond, and our ability to capitalize on these initiatives is expected to be a material aspect of our sales and marketing program going forward.
We hope that these strategic initiatives will lead to revenue growth opportunities for us in 2024 and beyond, and our ability to capitalize on these initiatives is expected to be a material aspect of our medical provider-focused sales and marketing program going forward.
Depreciation and amortization expense is comprised of depreciation expense related to property and equipment, amortization expense related to leasehold improvements, and amortization expense related to identifiable intangible assets. Other income.
Depreciation and amortization expense is comprised of depreciation expense related to property and equipment, amortization expense related to leasehold improvements, and amortization expense related to identifiable intangible assets. Other income. Other income relates to the excess warrant fair value and change in fair value of warrant liability.
For the year ended December 31, 2024, gross profit increased by approximately $0.7 million to $9 million. This increase was attributable to an increase in revenue of approximately $1.2 million offset by an increase in cost of sales of approximately $0.5 million.
This increase was attributable to an increase in revenue of approximately $2.4 million, offset by an increase in cost of sales of approximately $0.9 million. Gross margin remained constant at 60% for the year ended December 31, 2025, and 2024.
The increase is directly attributable to a 71% decrease in discounts offered during the same period, with less than $0.2 million in discounts offered during the year ended December 31, 2024 when compared to approximately $0.7 million of discounts offered during the year ended December 31, 2023, coupled with an increase in Guide sales, which are lower revenue generating products when compared to Vivos appliances.
The revenue decrease is directly attributable to an increase in discounts offered during the same period, with $1.6 million in discounts offered during the year ended December 31, 2025 when compared to approximately $0.2 million of discounts offered during the year ended December 31, 2024, coupled with an increase in tooth positioner sales, a lower price point product when compared to Vivos appliances.
As previously reported, we are currently subject to two Nasdaq Stock Market (“Nasdaq”) listing deficiencies, one related to Nasdaq’s $1.00 minimum bid price requirement (the “Minimum Bid Requirement”) and a second related to Nasdaq’s $2,500,000 minimum stockholders’ equity requirement (the “Minimum Stockholders’ Equity Requirement”).
We have been subject to two Nasdaq listing deficiencies, one related to Nasdaq’s $1.00 minimum bid price requirement (the “Minimum Bid Requirement”) and a second related to the Equity Requirement.
Liquidity and Capital Resources The financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern.
Depreciation and amortization increased due to an increase in depreciable assets related to the new sleep center asset acquisition and affiliations. Liquidity and Capital Resources The financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern.
A significant majority of our revenues are generated from enrolling dentists as either (i) Guided Growth and Development VIPs; (ii) Lifeline VIPs; (iii) combined Guided Growth and Development and Lifeline VIPs; or Premier Vivos Integrated Providers (“Premier VIPs”). Prior to the second quarter of 2023, the majority of VIP enrollments were Premier VIPs.
Revenue Recognition We generate revenue from the sale of products and services. Historically, a significant majority of our revenues are generated from enrolling dentists as either (i) Guided Growth and Development VIPs; (ii) Lifeline VIPs; (iii) combined Guided Growth and Development and Lifeline VIPs; or Premier Vivos Integrated Providers (“ Premier VIPs ”).
As disclosed in Note 1, the accompanying consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries (BioModeling, First Vivos, Vivos Therapeutics (Canada) Inc., Vivos Management and Development, LLC, Vivos Del Mar Management, LLC, Vivos Modesto Management, LLC, Vivos Therapeutics DSO LLC, a Colorado limited liability company, and Vivos Airway Alliances, LLC, a Colorado limited liability company), are prepared in conformity with generally accepted accounting principles in the United States of America (“U.S.
As disclosed in Note 1, the accompanying consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries (BioModeling, First Vivos, Vivos Therapeutics (Canada) Inc., Vivos Management and Development, LLC, Vivos Therapeutics DSO LLC, a Colorado limited liability company, Vivos Airway Alliance, LLC, a Colorado limited liability company, Vivos Providers Network, LLC, a Colorado limited liability company, Airway Integrated Management Company, LLC and Airway Intelligence Center, LLC.
The costs paid to MyoCorrect, Lyon Dental and AFD for patents and intellectual property are amortized over the life of the underlying patents, which approximates 15 years. Impairment of Long-lived Assets We review and evaluate the recoverability of long-lived assets whenever events or changes in circumstances indicate that an asset’s carrying amount may not be recoverable.
The identifiable intangible assets acquired are amortized using the straight-line method over the estimated life of the assets, which ranges between five and 15 years (See Note 6). Impairment of Long-lived Assets We review and evaluate the recoverability of long-lived assets whenever events or changes in circumstances indicate that an asset’s carrying amount may not be recoverable.
Revenue during the year ended December 31,2024 was impacted by an increase of approximately $1.6 million in product revenue, coupled with a decrease of approximately $0.4 million in service revenue.
The increase in revenue during the year ended December 31, 2025 was offset by the decline in product revenue attributable to a decrease of approximately $1.4 million in appliance sales to VIPs, followed by an increase of approximately $1.0 million in tooth positioner sales to VIPs.
For example, the Suez Canal blockage earlier in 2021 caused some delay in shipments of SleepImage ® rings from China. Overall, however, as our appliances are made in the U.S., we have not experienced significant supply chain issues as a result of COVID-19 or otherwise, although this may change in future periods. -59- War in Ukraine and Middle East Hostilities.
Overall, however, as our appliances are made in the U.S., we have not experienced significant supply chain issues as a result of COVID-19 or otherwise, although this may change in future periods. Middle East Hostilities. In addition, geopolitical instability in the Middle East continues to create uncertainty in global economic conditions and commercial activity.
We anticipate that our new strategic marketing and distribution alliance model will also positively impact our revenue growth and stockholders’ equity in upcoming fiscal quarters. However, there is a risk that we will be unable to raise sufficient capital or generate sufficient revenue or operating results to maintain compliance with the Equity Requirement.
However, there is a risk that we will be unable to raise sufficient capital, reduce costs sufficiently or generate sufficient revenue or operating results to maintain compliance with the Equity Requirement.
In addition to enrollment service revenue, we offer additional services, such as our Billing Intelligence Services offering, and MyoCorrect orofacial myofunctional therapy services, which was introduced in April 2021. Revenue for these services is recognized as our performance obligations are satisfied in accordance with ASC 606.
VIPs have the ability to start generating revenue for us and themselves after this training. In addition to enrollment service revenue, we offer additional services, such as our Billing Intelligence Services offering, and MyoSync (formally MyoCorrect) orofacial myofunctional therapy services, which was introduced in April 2021.
Approximately $1.7 million in revenue was attributable to breakage during the year December 31, 2024, when compared to approximately $0.7 million during the year ended December 31, 2023. -62- For the year ended December 31, 2024, we sold 16,182 oral appliance arches and guides for a total of approximately $7.9 million, a 26% increase in revenue from the year ended December 31, 2023, when we sold 8,240 oral appliance arches and guides for a total of approximately $6.3 million.
For the year ended December 31, 2025, we sold 25,441 oral appliance arches and tooth positioners for a total of approximately $6.5 million, a 18% decrease in revenue from the year ended December 31, 2024, when we sold 16,182 oral appliance arches and tooth positioners for a total of approximately $7.9 million.
The decision to pause the study was made due to low recruitment into the study. -57- We are actively working with Stanford University to address the concerns that led to the hold and has continued engaged discussions with the university.
The study is still on hold as of 2025. -65- We are working with Stanford University to address the concerns that led to the hold and has continued engaged discussions with the university.
Additionally, our revenue was lowered by a sales strategy shift and focus toward sleep center affiliations, coupled with lower enrollments in late 2023 and all of 2024, which resulted in lower service revenue for the year ended December 31, 2024.
Over the last year, our reliance on VIP enrollment revenue has diminished significantly as such revenues have decreased due to our pivot. Our revenue was impacted by the sales strategy shift and focus toward sleep center affiliations, coupled with lower enrollments in 2024 and 2025, which resulted in lower service revenue for the year ended December 31, 2025.
Until a state of cash flow positivity is reached, management is reviewing all options to obtain additional financing to fund operations. This financing is expected to come primarily from the issuance of equity securities in order to sustain operations until we can achieve profitability and positive cash flows, if ever.
Until we attain positive cash flow, our management is reviewing all options to obtain additional financing to fund our operations. We financed the SCN acquisition from the issuance of senior secured debt and equity securities.
This compares to net cash used in investing financing for the year ended December 31, 2023 of $10.9 million, attributable to gross proceeds of $12.0 million from the issuance of Common Stock, net of approximately $1.1 million of professional fees and other issuance costs, from our private placement in January and November 2023.
Net cash provided by financing activities of $18.6 million for the years ended December 31, 2025, is attributable to proceeds of approximately $5.6 million from the issuance of common stock, approximately $10.7 million from the issuance of debt, approximately $2.3 million from the issuance of warrants, and approximately $0.9 million from the exercise of warrants, net of approximately $0.8 million of professional fees and other issuance costs.
Sales and Marketing Sales and marketing expense decreased by $0.7 million to approximately $1.7 million for the year ended December 31, 2024, compared to $2.5 million for the year ended December 31, 2023.
In addition, approximately $1.6 million related to professional fees, approximately $0.8 million associated with salaries and wages and Vivos personnel and infrastructure costs of approximately $0.6 million when compared to the year ended December 31, 2024. -69- Sales and Marketing Sales and marketing expense decreased by $0.3 million to $1.4 million for the year ended December 31, 2025, compared to approximately $1.7 million for the year ended December 31, 2024.
Emerging Growth Company Status We are an “emerging growth company” (an “EGC”), as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and as a result, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs.
Refer to Note 3. -71- Emerging Growth Company Status Effective January 1, 2026, the Company is no longer an “emerging growth company” (an “EGC”), as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and must comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).
We made such filing in a timely manner. -60- We are working diligently to ensure our continued compliance with the Equity Requirement, including exploring a potential additional equity capital financing or financings to stay above the minimum threshold of the Equity Requirement.
We are working diligently to ensure our continued compliance with the Equity Requirement, including additional equity capital financing or financings and cost reductions to stay above the minimum threshold of the Equity Requirement. We anticipate that our new medical provider-focused strategic marketing and distribution alliance model will also positively impact our revenue growth and stockholders’ equity in upcoming fiscal quarters.
Revenue consists of the gross sales price, net of estimated allowances, discounts, and personal rebates that are accounted for as a reduction from the gross sale price. Cost of sales. Cost of goods sold primarily consists of direct costs attributable to the purchase from third party suppliers and related products.
For the treatment centers, the intercompany account is used to fulfil the account payable obligation and recognize the expense of the goods and services in cost of sales. Cost of sales. Cost of goods sold primarily consists of direct costs attributable to the purchase from third party suppliers and related products.
The increase in product revenue is attributable to an increase of approximately $2.1 million in Guide sales to VIPs, followed by a decrease of approximately $0.5 million in C.A.R.E. appliance sales to VIPs. Additionally, we had a decrease in service revenue of approximately $1.4 million in our VIP enrollment revenue, and a decrease of approximately $0.3 million from Myofunctional revenue.
Additionally, we had a decrease in service revenue of approximately $2.0 million in our VIP enrollment revenue, a decrease of approximately $0.7 million in sponsorship, conference and training related revenue, and a decrease of approximately $0.3 million in Myofunctional therapy and $0.2 million in BIS revenue.
Depreciation and Amortization Depreciation and amortization expense was approximately $0.6 million for the years ended December 31, 2024 and 2023.
This decrease was primarily driven by a $0.2 million decrease in commissions, as well as a $0.1 million decrease in conventions and tradeshow expenses. Depreciation and Amortization Depreciation and amortization expense was approximately $1.3 million for the year ended December 31, 2025, compared to approximately $0.6 million for the year ended December 31, 2024.
This was offset by an increase of approximately $1.3 million in sponsorship, conference and training related revenue. BIS revenue decreased by $0.1 million to approximately $0.8 million, which was offset by an increase of $0.1 million from sleep testing services to approximately $1.3 million for the year ended December 31, 2024.
This was primarily due to approximately $1.1 million in higher costs in diagnostic services related to new sleep center affiliations, and an increase of approximately $0.5 million related to additional staff associated with the sleep center affiliations. For the year ended December 31, 2025, gross profit increased by approximately $1.5 million or 17% to $10.5 million.
If an economic recession or depression commences and is sustained, it could have a material adverse effect on our business as demand for our products could decrease. Capital markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise capital when needed. Potential Nasdaq Delisting .
These developments, combined with the ongoing effects of Russia’s invasion of Ukraine that began in February 2022, have intensified supply chain constraints, increased commodity price volatility, disrupted international trade flows, creating. If an economic recession or depression commences and is sustained, it could have a material adverse effect on our business as demand for our products could decrease.
Intangible assets consist of assets acquired from First Vivos and costs paid to (i) MyoCorrect, from whom we acquired certain assets related to its OMT service in March 2021, (ii) Lyon Management and Consulting, LLC and its affiliates (“Lyon Dental”), from whom we acquired certain medical billing and practice management software, licenses and contracts in April 2021 (including the software underlying AireO2) for work related our acquired patents, intellectual property and customer contracts and (iii) AFD, from whom we acquired certain U.S. and international patents, trademarks, product rights, and other miscellaneous intellectual property in March 2023.
Intangible assets consist of assets acquired from First Vivos, costs paid to (i) MyoSync, (ii) Lyon Management and Consulting, LLC and its affiliates (“Lyon Dental”), (iii) AFD, and (iv) SCN, from whom we acquired tradenames and referral relationships.
These conditions include providing an update as to our plan to regain compliance with the Equity Rule as well as demonstrating compliance by March 19, 2024. On February 23, 2024 we presented our plan of compliance to the Hearings Committee.
On February 23, 2024 we presented our plan of compliance to the Hearings Committee. On May 6, 2024, we received written notice from the Nasdaq staff indicating that we had regained compliance with the Equity Requirement.
Removed
VIPs have the ability to start generating revenue for us and themselves after this training. To entice dentists to enroll as VIPs, we have worked with different marketing programs (which we generally call a “discovery track”) with respect to the payment of VIPs enrollment fee, including discounts and payment plans.
Added
In June 2025, we acquired all assets, including operating assets such as sleep testing, diagnostics, and treatment centers of SCN. The Acquisition marked a milestone in the pivot to our medical provider-focused sales, marketing distribution model for our innovative OSA appliances.

… 70 more changes not shown on this page.

Other VVOS 10-K year-over-year comparisons