Item 1A. Risk Factors 27
Item 1B. Unresolved Staff Comments 57
Item 2. Properties 57
Item 3. Legal Proceedings 57
Item 4. Mine Safety Disclosures 58
Part II
Item 6. Reserved 59
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 73
Item 8. Financial Statements and Supplementary Data 74
Item 9A. Controls and Procedures 102
Item 9B. Other Information 102
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 102
Part III
Item 10. Directors, Executive Officers and Corporate Governance 103
Item 11. Executive Compensation 109
Item 13. Certain Relationships and Related Transactions 115
Item 14. Principal Accountant Fees and Services 118
Part IV
Item 15. Exhibits, Financial Statement Schedules 119
-i-
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K contains forward-looking statements that reflect our current expectations and views of future events. The
forward-looking statements are contained principally in the sections entitled “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of Operations.” Readers are cautioned that known and unknown risks,
uncertainties and other factors, including those over which we may have no control and others listed in the “Risk Factors”
section of this Annual Report on Form 10-K, may cause our actual results, performance or achievements to be materially different from
those expressed or implied by the forward-looking statements.
You
can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,”
“anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,”
“is/are likely to,” “potential,” “continue” or other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections about future events that we believe may affect our financial condition,
results of operations, business strategy and financial needs.
These forward-looking statements include statements relating to:
● acceptance by the marketplace of the products and services that we market;
● our ability to retain key employees;
● our future financing plans; and
These
forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking
statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other
matters that we anticipate herein could be materially different from our expectations. Important risks and factors that could cause our
actual results to be materially different from our expectations are generally set forth in “Risk Factors,” “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” “Regulation” and
other sections in this Annual Report on Form 10-K. You should thoroughly read this Annual Report on Form 10-K and the documents that
we refer to with the understanding that our actual future results may be materially different from and worse than what we expect. We
qualify all of our forward-looking statements by these cautionary statements.
The
forward-looking statements made in this Annual Report on Form 10-K relate only to events or information as of the date on which the statements
are made in this Annual Report on Form 10-K. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read this Annual Report on Form 10-K and the documents that we refer to in
this Annual Report on Form 10-K and have filed as exhibits to this Annual Report on Form 10-K, completely and with the understanding
that our actual future results may be materially different from what we expect.
-ii-
SUMMARY
OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS
The
following is a summary of certain risks, uncertainties and other factors related to our company. These do not represent all of the risks
we face. You should carefully consider all of the risk factors presented in “Item 1A. Risk Factors” (some of which are not
summarized below) and all other information contained in this Report, including the financial statements which are a part of this Report,
in order to a more complete picture of the risk factors we face.
Risks
Related to Our Business and Industry
-iii-
Risks
Related to Our Products and Regulation
Risks
Related to Our Securities Generally
-iv-
PART
I
Item
1. Business
Overview
We are a revenue stage medical
technology company focused on the development and commercialization of a suite of innovative diagnostic and treatment modalities for
patients with dentofacial abnormalities and/or patients with mild to moderate obstructive sleep apnea (OSA) and snoring in adults. We
believe our proprietary oral appliances and associated protocols represent a significant improvement in the treatment of mild to moderate
OSA versus other treatments such as continuous positive airway pressure (or CPAP) or palliative oral appliance therapies. We call our
OSA treatment protocol The Vivos Method.
The
Vivos Method is an advanced therapeutic protocol, which often combines the use of customized oral appliance specifications and
proprietary clinical protocols developed by our company and prescribed by specially trained dentists in cooperation with their medical
colleagues. The Vivos Method features our proprietary clinical protocols combined with the following oral appliances:
We
believe The Vivos Method appliance technology and associated protocols represents the first non-surgical, non-invasive and
cost-effective treatment for people with dentofacial abnormalities and/or patients diagnosed with mild to moderate obstructive sleep
apnea (OSA) and snoring in adults. Combining technologies and protocols that alter the size, shape and position of the tissues of a
patient’s upper airway, The Vivos Method opens oral and airway space and may significantly reduce symptoms and conditions
associated with mild to moderate OSA.
Published
studies have shown that using our customized appliances and clinical protocols led to significantly lower Apnea Hypopnea Index scores
and improved other conditions associated with OSA, and The Vivos Method is estimated to be effective (within the scope of the U.S. Food
and Drug Administration (or FDA) cleared uses) in approximately 80% of cases of OSA where patients are compliant with clinical protocols.
Our patented oral appliances have been utilized in approximately 25,000 patients treated worldwide by more than 1,450 trained dentists.
The
House of Delegates of the American Dental Association in 2017 adopted a policy statement describing the important role dentists can play
in helping identify patients at greater risk of sleep related breathing disorders. By focusing our business model around dentists, we
fulfil this role by training dentists and providing the support to use The Vivos Method with their patients that suffer from dentofacial
abnormalities and/or mild to moderate OSA and snoring. Our program to train dentists and offer them other value-added services
is called the Vivos Integrated Practice (VIP) program. The VIP program provides dentists with a strong economic incentive
to provide this treatment and prescribe The Vivos Method, together with practice support services.
Sleep
apnea 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, and according to
a 2016 report by Frost & Sullivan, OSA has an annual societal cost of over $149.6 billion. According to the study “Global
Prevalence of Obstructive Sleep Apnea (OSA)” conducted by an international panel of leading researchers, nearly 1 billion people
worldwide have sleep apnea, and as many as 80% remain undiagnosed. Research has shown that when left untreated, OSA can increase the
risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening
diseases.
In February 2021, we launched
our screening and home sleep test (“HST”) program (which we call our VivoScore Program) featuring SleepImage®
technology, a 510(k) cleared ring-based recorder and diagnostic platform for home sleep apnea testing. We market and distribute
our SleepImage HST in the U.S. and Canada pursuant to a licensing agreement with MyCardio LLC. We believe our SleepImage HST offers significant
commercial advantages over existing home sleep apnea products and technologies in the market and may enable healthcare providers to more
efficiently screen, diagnose and initiate treatment for OSA in their patients, which could result in more patients being treated through
The Vivos Method. Initially, we anticipated increased revenue from our HST based on an expected increase in total patients tested for
OSA and a corresponding increase in patient enrolment in Vivos Method treatment. Throughout 2021, we successfully conducted 15 training
sessions conducted by our personnel on the VivoScore Program and screening and home sleep testing using the SleepImage®
HST, which were attended by approximately 800 dentists and their staff.
In
January 2022, we announced significant increases across several key metrics for our SleepImage HST, including in particular, for the
three-months ended December 31, 2021, versus the three-months ended December 31, 2020: (i) an 18 times increase in the total number of
HSTs given across our VIP network, (ii) a 5.7 times increase in the number of VIPs administering HSTs via the VivoScore Program
and (iii) a 3 times increase in the average number of HSTs being administered per VIP. We believe this performance gain in home sleep
testing allowed us to renegotiate our commercial agreement with MyCardio LLC to lower costs and convert the entire diagnostic
program from a loss leader aimed primarily at stimulating new case starts with sleep apnea treatment using The Vivos Method to a potential
recurring revenue center. Under the revised agreement, we will lease out the SleepImage ring recorders to VIPs at a fixed price
that includes a full month’s worth of diagnostic sleep test reports. This potential new revenue center is as yet unproven, but
we believe we will see positive results during 2022.
Our
Mission
Our
mission is to rid the world of OSA. We believe we are well-positioned with what we consider to be a disruptive technology in The
Vivos Method aimed at treating dentofacial abnormalities and/or mild to moderate OSA and snoring, with a clear first-mover
strategy in penetrating the dental market as a means of treating dental conditions and OSA, compelling economics at each level
of the delivery chain, and a talented team of experienced professionals who are passionate about what we do and driven to deliver results.
Our
Market Opportunity
According to an August 2019 article published in the Lancet, an
estimated 936 million adults globally aged 30-69 years (men and women) have mild to severe obstructive sleep apnea, which includes 425
million adults aged 30-69 years who have moderate to severe obstructive sleep apnea. The number of affected individuals with OSA was highest
in China, followed by the U.S., Brazil, and India. The article indicated that 1 billion people (inclusive of children) are affected with
OSA, with prevalence exceeding 50% in some countries. We therefore believe that effective diagnostic and treatment strategies are needed
to minimize the negative health impacts of OSA and to maximize cost-effectiveness.
Estimates
from publicly available information vary as to the extent of obstructive sleep apnea in the United States, but we believe the market
is significant. According to a 2010 publicly available analysis from researchers at the Harvard Medical School Division of Sleep Medicine,
mild obstructive sleep apnea is defined by an apnea-hypopnea index (or AHI) of between 5 and 15 and has a prevalence of 8-11% of the
adult population in the United States. A 2004 study published in the Journal of the American Medical Association stated the prevalence
of mild obstructive sleep apnea is one in five adults. Based on our analysis of the available public information, we estimate that approximately
15% of the adult population in the United States and Canada suffers from OSA. Based on the estimated total adult population
of 284 million in the United States and Canada, we believe the total addressable United States and Canadian market is approximately 43
million adults. Our estimates set forth below relating to the intended uses of The Vivos Method are also based in part upon data found
in the study Oral Appliance Treatment for Obstructive Sleep Apnea: An Update, published publicly by the National Institutes of
Health in 2014. Targeted treatment projections identified by this method of sleep titration were found to result in effective treatment
in 87% of patients predicted to be successfully treated of OSA in an initial study. To be conservative and based on available data and
our internal market analysis, we estimate that over 80% of individuals diagnosed with OSA in the North American addressable market may
be candidates for The Vivos Method, leaving us with a total addressable consumer market of over 43.2 million adults.
We
currently charge clinicians an average sales price of approximately $1,600 per adult case for The Vivos Method. There are approximately
200,000 general dentists and dental specialists in the United States and another 30,000 in Canada who could potentially offer the Vivos
Method to their patients. Based on the addressable U.S. and Canadian consumer market described above and average sales price, we believe
the addressable consumer market for adults in the United States and Canada is approximately $69 billion.
According to a March 2021 Sleep
Apnea Devices Market Size & Share Report, “Sleep Apnea Devices Market Size, Share & Trends Analysis Report By Product
Type (Diagnostic Devices, Therapeutic Devices, Sleep Apnea Masks), By Region (North America, Europe, APAC, Latin America, MEA), And Segment
Forecasts, 2021 – 2028”, the global sleep apnea devices market size was valued at $3.7 billion in 2020 and is
expected to expand at a compound annual growth rate (CAGR) of 6.2% from 2021 to 2028. According to an American Sleep Association study
published in 2020, an estimated 50 million to 70 million people in the U.S. are suffering from some form of sleep disorders. Moreover,
according to Canadian Respiratory Journal in 2014, around 5.4 million adults in Canada were diagnosed with sleep apnea or were at higher
risk of developing OSA. According to a study conducted by ResMed in 2018, around 175 million people in Europe were suffering from sleep
apnea.”
Our
Treatment Alternative for OSA – The Vivos Method
The Vivos Method is a non-invasive,
non-surgical, non-pharmaceutical, multi-disciplinary treatment modality for the treatment of dentofacial abnormalities and/or mild to
moderate OSA and snoring. Proprietary and virtually painless, The Vivos Method may enhance and increase the upper airway and offers patients
what we believe to be an effective treatment alternative based on clinical retrospective data showing that some patients diagnosed with
mild to moderate OSA and snoring symptoms. are improving. Based on feedback from independent VIP and their patient we have received, we
believe initial therapeutic benefits from using the protocols and devices are often achieved relatively quickly (in days or weeks) and
final clinical results are typically achieved in 12 to 24 months), all at a relatively low cost to consumers ranging between $7,000 and
$10,000 for adults and $3,500 to $6,000 for children (costs vary by provider) when compared to other options such as surgery.
We believe that The Vivos Method
alters the size, shape and position of the tissues that surround and comprise the functional space known as the upper airway. This belief
is based on retrospective raw data with validated before and after sleep studies and Cone Beam Computerized Tomography (CBCT) scans from
treating clinicians and patient testimony. As The Vivos Method treatment process progresses, the airway expands, with many patients reporting
a significant reduction of their mild to moderate OSA and snoring symptoms. Our primary products used in The Vivos Method is our
mRNA appliance®, and our mmRNA appliance® which are specifically designed, custom oral appliance that
are worn primarily in the evening hours and overnight and are available for adults. The treatment time may range from 12 to 24 months.
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. Through the course of treatment with The Vivos Method, patients have reported a variety
of outcomes, including:
● Reduction of snoring;
● Reduction in AHI level and/or other indicators of mild to moderate OSA;
● Relief of mild to moderate OSA symptoms;
● Restoration and improvement of normal (nasal) breathing;
● Improvement in overall sleep quality;
● Reduction in the need for other lifetime treatment options such as CPAP;
● Restoration and maintenance of proper facial symmetry and alignment;
● Dentofacial and orthodontic improvement and/or correction;
● Resolution of TMJ pain, clicking, and locking; and
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 moderate OSA and snoring in adults. We believe the following
strategies will play a critical role in achieve this goal and our future growth:
Our
Revenue Model
Our
revenue is currently derived from the following primary sources:
Our
Competitive Strengths
We
believe that The Vivos Method has numerous advantages that, taken together, set us apart from the competition and position us for success
in the marketplace:
Sales
and Marketing
We
have established a methodical approach to market development which centers on active engagement directly with members of the medical
community, including general dentists and medical doctors who treat dentofacial abnormalities and/or mild to moderate OSA and
snoring, to educate them on The Vivos Method and its benefits. The goals of our sales and marketing efforts are (i) to secure new
VIP dentists and provide them with the tools to treat patients with our products and (ii) more broadly educate the medical community
regarding our products with a view towards expanding our number of VIPs as well as medical professionals who could refer patients to
our VIPs for treatment.
We
sell the VIP Program to dentists through a direct sales force that primarily targets general dentists in the United States and Canada.
Our sales effort is developed through social media initiatives, and our new website with over 150 videos, and the production of over
350 new content creation projects. Our VIP program was developed to train independent dentists to identify and treat dental
conditions that may be associated with mild to moderate sleep apnea. Our sales program to target medical doctors is our MID
program, which was developed to assist VIP practices to establish clinical collaboration ties to local primary care physicians, sleep
specialists, ENTs, pediatricians, pulmonologists and other healthcare professionals who routinely see or treat patients with sleep and
breathing disorders.
In
countries outside of North America we typically offer a modified training and support program at a lower cost. We currently have approximately
25 direct sales representatives in the United States and Canada. Our direct sales force engages in sales efforts and promotional activities
focused on referring physicians, as well as directly to the over 200,000 professionally active general dentists in the United States
and 20,000 general dentists in Canada.
Our
current VIP sales organization is comprised of three teams consisting of:
Our
MID sales organization is comprised of a Senior Vice President that leads the MID sales efforts and one Senior Director of Business Development.
We plan on growing our MID sales organization by recruiting candidates that have extensive healthcare backgrounds, strong business development
experience setting up physician owned medical facilities/practices and significant healthcare regulatory knowledge.
We
utilize indirect and direct marketing channels to inform and educate dentists, medical doctors and healthcare professionals about The
Vivos Method. Our indirect marketing channels include strategic partners, industry key opinion leaders, trade shows and our own clinical
advisor network. In 2021, we made strides by establishing the following strategic partnerships aimed and broadening awareness
of and selling efforts for The Vivos Method:
Our
direct marketing channels include outreach to prospective VIPs using digital advertising platforms including Facebook and Google ad placements.
The objective of our indirect and direct marketing efforts are to bring dentists, medical doctors and healthcare professionals to our
educational and training websites to learn about OSA and its treatment alternatives.
We
further believe our dentist and medical doctor marketing efforts have been effective in facilitating contact via our Vivos introduction
and online training webinars, despite significant headwinds throughout our core customer base, mostly driven by COVID-19 Delta and
Omicron variant resurgences in the middle and latter part of the year.
Potential
Economics for Trained VIP Clinicians
Dentists
that enroll in our VIP program have the potential for compelling economics. The actual incidence of dental patients with OSA will vary,
but our conservative estimate would suggest that the average dental practice sees 400-500 adult patients a year with a high risk of suffering
from obstructive sleep apnea. Using these demographic figures, the economic potential per dentist may be calculated, based on a retail
adult case fee of approximately $9,000, fully burdened VIP provider costs of approximately $3,000, and net profit of approximately $6,000,
to be over $3.3 million in annual gross revenue potential annually with over $2.4 million in potential net profit. We believe, based
on our experience, that dentists have seen accretive economic additions to their practices by utilizing The Vivos Method, and thus participation
in the VIP program can likely add to the dentist’s take-home income.
In
terms of continuing training, our sales and clinical advisory dentists conduct training primarily in a highly personalized, deep immersion
workshop format at our Vivos Institute. The key topics covered in training include case selection, clinical diagnosis, treatment planning,
appliance design, adjunctive therapies, information on our productions and services, guidance on pricing, case acceptance, instruction
on insurance reimbursement protocols and interacting with our proprietary software system and the many other features of our website.
We present our training material in a manner we believe to be superior to most other dental training and experience, including preparatory
online courses, didactic lectures, hands-on training, specialized small group breakout sessions, and post training technical support
from assigned mentors. As a result, we are able to complete the initial training workshops, both online and in person, typically
within just 15 days spread out over several weeks. Our success in training approximately 1,450 dentists confirms our belief that
training represents a minimal barrier to adoption for most dentists.
Below
is an illustrative model depicting the total additional revenue a dentist might receive by treating patients with The Vivos Method. The
potential patients with dentofacial abnormalities and/or mild to moderate OSA is determined by using a calculation that results
in a conservative estimate that 30% of patients of a dental practice patient may suffer from OSA (according to a 2019 article published
in Chest Physician). The revenue treatment fee is estimated at $9,000 per patient. This illustration helps to explain why a dentist
might want to become a trained VIP and use The Vivos Method.
To
facilitate the adoption of The Vivos Method, we market the VIP Program, and as part of that offering, we often partner with equipment
manufacturers to bundle training and equipment into a turn-key program financed by third party lenders for those dental practices who
need to purchase additional equipment. The VIP Program fees are also often financed by third party lenders separate from any equipment
purchases. Loan terms and payments will vary depending on the doctor’s credit, the interest rate, the amount financed, and the
term of the loan. Generally, payments on such financing range from about $600 to $2,500 per month.
Insurance
Reimbursement
Our
mRNA appliance® and mmRNA appliance® are custom fabricated appliances to treat mild to moderate
OSA and snoring in adults. The mRNA and mmRNA can be billed in and out of network to most commercial payers under the E0486 CPT
code. The E0486 is reimbursable by many major commercial medical payers following a medical diagnosis of OSA. Level of reimbursement
is approximately 50% (ranging from 5% to 70%), although medical insurance is never a guarantee of payment, and patient deductibles and
policy limitations may vary. A verification of benefits is required for all medical policies to check for validity of CPT code E0486
and oral appliance therapy (OAT). Pre-authorization may be required for reimbursement. Pre-Authorization requirements may vary based
on the payer policies and patient’s insurance coverage. Although many patients pay for treatment out of pocket on a fee for service
basis, the availability of health insurance coverage is an important consideration for many patients who desire treatment in The Vivos
Method. All medical policies have different reimbursement policies which may affect availability of reimbursement.
VIPs
typically remain out of network with commercial health insurance payers, but this depends on the individual practice and the commercial
payer guidelines in each state. As out of network providers, dentists can set their own fees and balance bill the patient for the cost
of care not covered by the patient’s health insurance. The American Medical Association will provide fee ranges for all billable
CPT codes. A dentist must set their own fees for the CPT codes billed in their office that are within their scope of practice.
Our
mRNA appliance® and our DNA appliance are not covered by Medicare or Medicaid as they do not meet the approved design
criteria by CMS. We made modifications to the mRNA appliance® to meet CMS criteria for the billing code E0486 to
Medicare. These slight modifications of the mRNA appliance® led to the creation of a new FDA cleared device,
the mmRNA appliance® (Modified Mandibular Repositioning Nighttime Appliance). In February 2021, we submitted a
510(k) for Class II clearance to the FDA for the mmRNA appliance with indications to treat mild to moderate OSA and snoring in
adults, which was approved by FDA in August 2021. In December 2021, we received acceptance from a Centers for Medicare &
Medicaid Services Pricing, Data Analysis and Coding (“PDAC”) contractor for our mmRNA applicable for treating mild to
moderate OSA and snoring in adults. This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and
billable to Medicare, making the benefits of the mmRNA device available to millions of Medicare beneficiaries. Notwithstanding this
important achievement, in general we have not found the lack of inclusion on the current CMS Medicare list of approved sleep
appliances to hinder market distribution or acceptance due to the fact that most dentists who work with The Vivos Method are out of
network with commercial payers and do not typically file for reimbursement under Medicare.
We
have seen an increase in the ability for reimbursement for our other FDA registered oral appliances such as the DNA appliance and the
Vivos Guides. These oral appliances are being pre-authorized and billed under an undefined CPT code only when medical necessity is present
and documented properly. Pre-authorization with medical director review is required with a “letter of medical necessity”
(LMN) to gain possible medical reimbursement. A dentist billing an undefined CPT code for a Class I or Class II oral appliance must proceed
with caution. Billing an undefined CPT code for OAT must be supported with documented medical necessity and is reviewed by the medical
director at the payor before being submitted for possible reimbursement. Typically, the dentist writes an LMN to explain the medical
necessity and the patient’s request for oral appliance therapy and submits the LMN for review to the medical directors at the payor.
The plan medical directors will then review the LMN, including any dentofacial abnormalities, CT images, comorbidities, and any medical
conditions the patient has be diagnosed with by a medical doctor. This documentation is how the dentist establishes medical necessity.
Once pre-authorization is gained, then OAT can be billed for a possible reimbursement from the medical payor. A dentist typically can
gain reimbursement for OAT by the medical insurance if the undefined code is valid and billable under their policy and there is
medical necessity present, supported, and documented.
Published
Research
There
are several studies in the medical literature on upper airway remodeling in pathologic conditions such as asthma, chronic obstructive
pulmonary disease and similar conditions. In contrast, there is a dearth of studies that have documented pneumatization and physiologic
upper airway remodeling. Advances in 3D digital technology, as well as an increased understanding of the human genome and epigenetics,
has allowed us to make further advances in the understanding of dentofacial phenomena. For example, while it was believed that sutures
undergo closure in early adulthood, according to published research, it is now thought that populations of stem cells may persist to
permit continued growth and development. Using this premise, the midfacial bone volume can be increased surgically or non-surgically.
Since the roof of the mouth is the floor of the nose, the volume of the nasal airway can also be increased surgically or non-surgically.
Therefore, using our patented, non-surgical protocols we targeted oral conditions and upper airways to address dentofacial
abnormalities and/or mild to moderate OSA and snoring. Using various assessment techniques, we found surface area, volumetric and
functional changes of the upper airway.
Since
2009, our technology has been the subject of approximately 55 peer-reviewed articles in the medical, dental and orthodontic literature.
Of the 55 articles, 27 of these are journal papers, with Dr. G. Dave Singh, our founder and former Chief Medical Officer, as first author
on 22 of these papers. Of the 27 journal papers, 17 of these articles describe the studies that examine the impact of our technology
and protocols on the AHI scores of patients with varying degrees of OSA as described in “Overview” above. In addition, over
25 conference papers have been published as abstracts, with Dr. Singh as first author on 20 of these conference papers. Additionally,
there were 19 independent dentists and five different sleep physicians are co-authors on these publications as well. The results
published in these case reports and articles, together with patient-reported outcomes, have illustrated that The Vivos Method
therapy can provide a significant change in the severity of patients’ with dentofacial abnormalities and/or mild
to moderate OSA and snoring (as measured by industry standard indices such as the AHI, among others), improvement in oral conditions,
sleep-related quality of life, reduction in snoring, high patient compliance rates and a strong safety profile.
Intellectual
Property
To
establish and protect our proprietary rights, we rely on a combination of patents, trademarks, copyrights and trade secrets, including
know-how, license agreements, confidentiality procedures, non-disclosure agreements with third parties, employee disclosure and invention
assignment agreements, and other contractual rights. Our intellectual property is important in achieving and maintaining our position
in the market. 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. Our U.S. trademark portfolio consists of ten
registered marks and one pending trademark application. Extensive online and in-person training, multiple touch point support systems,
specific fabrication materials, customized appliance designs, and multi-disciplinary treatment protocols are all considered proprietary
trade secrets and competitive advantages with no known counterparts.
FDA
Regulatory Status
The Vivos Method offers treatment
protocol 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 moderate OSA and snoring. The Vivos Method includes a customized treatment
plan that may begin with a simple and easy at-home sleep apnea screening using proprietary HST technology from SleepImage. We
offer two Class II devices cleared by the FDA (mRNA and mmRNA) and one Class I device registered with the FDA (DNA). We offer
our own pre-formed Vivos Guides. The regulatory status of our products is as follows:
We
are conducting two separate Western Copernicus Group Institutional Review Board (WCG IRB) approved pediatric clinical trials
with eight private dental sites around the country. The purpose of the first study is to evaluate the safety and efficacy of an intraoral
device (the DNA) to reduce sleep-disordered breathing (SDB) in children, including: snoring, mild to moderate obstructive sleep apnea
(OSA), and Upper Airway Resistance Syndrome (UARS). The child subjects enrolled in this study will be using the DNA appliance to correct
orthodontic issues. They will also present with midfacial hypoplasia suitable for palatal expansion. During orthodontic treatment and
palatal expansion, the device will be studied to determine whether it can also reduce symptoms of sleep disordered breathing in children.
The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment. If they
meet the inclusion and exclusion criteria, then they will be included in the study. The purpose of the second study is to evaluate the
safety and efficacy of an intraoral device (the Vivos Grow and/or Vivos Way appliances) to reduce sleep-disordered breathing (SDB) in
children, including: snoring, mild to moderate obstructive sleep apnea (OSA), and Upper Airway Resistance Syndrome (UARS). The child
subjects enrolled in this study will be using the Vivos Grow/Vivos Way appliance to correct orthodontic issues. They will also present
with midfacial hypoplasia suitable for palatal expansion. During orthodontic treatment and palatal expansion, the devices will be studied
to determine whether they can also reduce symptoms of sleep disordered breathing in children. The study will recruit pediatric subjects
who have already elected to utilize the study device for their orthodontic treatment. If they meet the inclusion and exclusion criteria
they can be included in the study. Upon completion of these WIRB pediatric clinical trials (expected to be completed in the next 6
to 12 months), we plan to submit two separate 510(k) applications to the FDA requesting pediatric clearances and indications of use
for the DNA appliance® as well as the Vivos Guides.
Our mRNA appliance®
and mmRNA appliance® are cleared by the FDA as Class II sleep appliances to treat mild to moderate OSA and snoring
in adults. Patients undergoing treatment are seeing improvement in the said cleared indications of use, but clinicians have also reported
that they are seeing other comorbidities and medical conditions improve due to treatment. These appliances (which are central to The
Vivos Method) and other Vivos appliances are made available to trained clinicians who exercise their independent clinical judgment with
respect to their use and suitability as a part of an overall treatment protocol created for each individual patient.
In
September 2017 our subsidiary, BMS, was the subject of its first routine FDA audit. That audit resulted in findings that required BMS
to remediate certain deficiencies such as: (i) inadequate documentation of certain FDA-required procedures (i) not keeping certain records
and materials in paper format and in triplicate, and (iii) the use of certain descriptive words and phrases on its website and in marketing
materials that were not approved in advance by FDA. We immediately hired a highly qualified FDA consultant and legal counsel with FDA
expertise to assist BMS in preparing both a written response and a plan for regaining and maintaining compliance with FDA regulations
and guidelines. In good faith, and based on documents provided by BMS, we believed BMS had filed its response to the original audit in
a timely manner with FDA which was due on [ ]. However, in January 2018 BMS received a request for a response to an FDA Warning Letter
(the “Warning Letter”) that had been posted online at the FDA website. The Warning Letter stated that BMS failed to reply
in a timely manner and address the findings of the September audit. We believed that we had filed out response to the FDA on September
27, 2017. The local BMS office in Portland, Oregon was closed down as of September 30, 2017 pursuant to a share exchange agreement which
made BMS a subsidiary of our company (and which transaction was accounted for as a merger as disclosed in the consolidated financial
statements). This transaction was disclosed to the FDA, and neither we nor BMS ever received any further notices from FDA after September
2017.
Immediately
upon becoming aware of the miscommunication and deficiency, we notified the FDA of the error and provided the FDA with full documentation
of our substantial efforts to fully comply with FDA rules and regulations. The FDA completed a second audit in April 2018, which examined
our responses to the initial deficiencies and our compliance plan. We believe that this matter has been satisfactorily resolved, although
no definitive statement to that effect has been made by FDA, nor has the Warning Letter been taken down from the FDA website. The FDA
also audited our company (then known as Vivos BioTechnologies, Inc.) and issued one minor observation, to which we have responded and
addressed.
In
August of 2020, we underwent our 2-year FDA regulatory inspection. This inspection resulted in our receipt of an FDA Form 483 with two
observations. These observations were corrected and responded to according the Code of Federal Regulations. Upon the review of the 483
responses, the FDA delivered a letter to us requesting additional information. We responded to the letter, and thereafter learned that
the FDA was satisfied with our responses.
Manufacturing
and Supply
We rely on third-party suppliers
and manufacturers on a per order, or per item basis. Outsourcing manufacturing reduces our need for capital investment and reduces operational
expenses. Additionally, outsourcing provides expertise and capacity necessary to scale up or down based on demand for our appliances.
We select our manufacturing labs so we can ensure that our appliances are safe and effective, adhere to all applicable regulations, are
of the highest quality, and meet our supply needs. We also rely on third-party carriers and freight forwarders for product shipments,
including shipments to and from our manufactures’ distribution facilities and customer distribution facilities.
Our
Ongoing Clinical Research
We
are committed to ongoing research and development, and we intend to invest in our business to further improve our products and
clinical outcomes, increase patient acceptance and comfort and broaden the patient population that can benefit from The Vivos Method.
Government
Regulation
Our
products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States,
as well as comparable authorities in the European Economic Area (“EEA”). Our products are subject to regulation as medical
devices under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA. The FDA regulates the development,
design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping,
premarket clearance or approval, import, export, adverse event reporting, advertising, promotion, marketing and distribution, and import
and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses
and otherwise meet the requirements of the FDCA.
In
addition to U.S. regulations, we are subject to a variety of regulations in the EEA governing clinical trials and the commercial sales
and distribution of our products. Whether or not we have or are required to obtain FDA clearance or approval for a product, we will be
required to obtain authorization before commencing clinical trials and to obtain marketing authorization or approval of our products
under the comparable regulatory authorities of countries outside of the United States before we can commence clinical trials or commercialize
our products in those countries. The approval process varies from country to country and the time may be longer or shorter than that
required for FDA clearance or approval.
FDA
Premarket Clearance and Approval Requirements
Unless
an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket
notification or pre-market approval (PMA). Under the FDCA, medical devices are classified into one of three classes—Class I, Class
II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory
control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for
which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance
with the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful
and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls,
and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can
include performance standards, post-market surveillance, patient registries and FDA guidance documents. While most Class I devices are
exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a
premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Under
the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially
equivalent” to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28,
1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared
to through the 510(k) process. The FDA has 90 days from the date of the pre-market equivalence acceptance to authorize or decline commercial
distribution of the device. However, similar to the PMA process, clearance may take longer than this three-month window, as the FDA can
request additional data. 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. The DNA appliance® is registered
with the FDA as a Class I device for expansion and is currently used by Vivos-trained clinicians accordingly.
Devices
deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have
a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed
in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified but are subject to the FDA’s premarket
notification and clearance process in order to be commercially distributed. We do not have any Class III devices.
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.
In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported
by extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of
the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.
Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a substantive review.
If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA application, although in
practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from
outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability
of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a preapproval
inspection of the applicant or its third-party manufacturers.
The
FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA application constitute
valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA
may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device, including,
among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients
in the clinical study that supported a PMA approval or requirements to conduct additional clinical studies post-approval. The FDA may
condition a PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional
safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be
required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those
patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of
the approval.
Certain
changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the
design performance specifications, which affect the safety or effectiveness of the device, require submission of a new PMA application
or a PMA supplement. PMA supplements often require submission of the same type of information as a PMA application, except that the supplement
is limited to information needed to support any changes from the device covered by the original PMA application and may not require as
extensive clinical data or the convening of an advisory panel. 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.
Clinical
Trials
Clinical
trials are almost always required to support a PMA application and are sometimes required to support a 510(k) submission. All clinical
investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s
investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational
device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If
the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit
an IDE application to the FDA, which must become effective prior to commencing human clinical trials. A significant risk device is one
that presents a potential for serious risk to the health, safety, or welfare of a patient and either is implanted, used in supporting
or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment
of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate
data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol
is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies us that
the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires
modification, the FDA may require a response on such deficiencies or permit a clinical trial to proceed under a conditional approval.
In
addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical
site. The IRB is responsible for the initial and continuing review of the IDE, and may pose additional requirements for the conduct of
the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of
investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-significant risk to the
patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval
from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators
obtain informed consent, and labeling and record-keeping requirements. Acceptance of an IDE application for review does not guarantee
that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data
derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials. An IDE supplement
must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may
affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.
During
a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting
clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping
and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them. The clinical investigators
in the clinical study are also subject to FDA regulations and must obtain patient informed consent, rigorously follow the investigational
plan and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,
including a belief that the risks to study subjects outweigh the anticipated benefits.
Post-market
Regulation
After
a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:
● establishment registration and device listing with the FDA;
We
may be subject to similar foreign laws that may include applicable post-marketing requirements such as safety surveillance. Our manufacturing
processes are required to comply with the applicable portions of the quality system regulation (“QSR”), which cover the methods
and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging,
distribution, installation, and servicing of finished devices intended for human use. The QSR also requires, among other things,
maintenance of a device master file, device history file, and complaint files. As a manufacturer, our facilities, records, and
manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain compliance with
the QSR or other applicable regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations
and the recall or seizure of our products. The discovery of previously unknown problems with any of our products, including unanticipated
adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of
its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal
of the product from the market or voluntary or mandatory device recalls or a public warning letter that could harm both our reputation
and sales. Any potential consequences of off-label use of the DNA appliance are the responsibility of the treating independent
dentist; however, we may face consequences related to such off-label use. 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. If the FDA determines that we failed to comply with applicable regulatory
requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:
● recalls, withdrawals, or administrative detention or seizure of our products;
● operating restrictions or partial suspension or total shutdown of production;
● withdrawing 510(k) clearances or PMAs that have already been granted;
● refusal to grant export or import approvals for our products; or
● criminal prosecution.
Regulation
of Medical Devices in the EEA
There
is currently no premarket government review of medical devices in the EEA (which is comprised of the 28 Member States of the EU plus
Norway, Liechtenstein and Iceland). However, all medical devices placed on the market in the EEA must meet the relevant essential requirements
laid down in Annex I of Directive 93/42/EEC concerning medical devices, or the Medical Devices Directive. There is also a directive specifically
addressing Active Implantable Medical Devices (Directive 90/385/EEC). The most fundamental essential requirement is that a medical device
must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety
and health of users and others. In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured
and packaged in a suitable manner. The European Commission has adopted various standards applicable to medical devices. These include
standards governing common requirements, such as sterilization and safety of medical electrical equipment, and product standards for