10-K
1
form10-k.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark One)
For the fiscal year ended December 31, 2020
OR
For
the transition period from to
Commission
File Number: 001-39796
Vivos
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
9137 Ridgeline Boulevard, Suite 135 Highlands Ranch, CO 80129
(Address of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (844) 672-4357
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of exchange on which registered
Common stock, $0.0001 par value VVOS Nasdaq Capital Market
Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X]
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes [ ] No [X]
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files). Yes [X] No [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer [X] Smaller reporting
company [X]
Emerging growth company [X]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 726(b)) by the registered
public accounting firm that prepared or issued its audit report. [ ]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [ ] No [X]
As
of June 30, 2020, the last business day of the registrant’s most recently completed second fiscal quarter, the registrant’s
securities were not publicly traded. The registrant’s common stock began trading on The Nasdaq Capital Market on December
11, 2020. The aggregate market value of the common stock outstanding, other than shares held by persons who may be deemed affiliates
of the registrant, computed by reference to the closing sales price for the common stock on December 31, 2020, as reported on
the Nasdaq Capital Market, was approximately $73 million. Common stock held by each officer and director and by each person known
to the registrant who owned 10% or more of the outstanding voting and non-voting common stock have been excluded in that such
persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for
other purposes.
As
of March 18, 2021, the registrant had 18,212,119 shares of common stock, $0.0001 par value per share, outstanding.
TABLE
OF CONTENTS
Page
Cautionary Note Regarding Forward-Looking Statements
Summary of Material Risks Associated with our Business
PART I
Item 1. Business 1
Item 1A. Risk Factors 28
Item 1B. Unresolved Staff Comments 51
Item 2. Properties 51
Item 3. Legal Proceedings 51
Item 4. Mine Safety Disclosures 51
PART II
Item 6. Selected Financial Data 52
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 61
Item 8. Financial Statements and Supplementary Data 62
Item 9A. Controls and Procedures 63
Item 9B. Other Information 63
PART III
Item 10. Directors, Executive Officers and Corporate Governance 64
Item 11. Executive Compensation 70
Item 13. Certain Relationships and Related Transactions 75
Item 14. Principal Accountant Fees and Services 78
PART IV
Item 15. Exhibits, Financial Statement Schedules 79
Signatures 80
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:
● the viability of our current intellectual property;
● acceptance by the marketplace of the products and services that we market;
● government regulations and our ability to comply with government regulations;
● 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.
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” and
all other information contained in this Report including the financial statements in order to a more complete picture of the risk
factors we face.
Risks
Related to Our Business and Industry
Risks
Related to Our Products and Regulation
Risks
Related to Our Securities Generally
PART
I
Item
1. Business
Overview
We
are a medical technology company focused on the development and commercialization of innovative treatment alternatives for patients
with sleep disordered breathing (SDB), including mild-to-moderate obstructive sleep apnea (OSA). We believe our products and technology
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 alternative and advanced treatment the Vivos
System.
The
Vivos System
The
Vivos System is an advanced therapeutic protocol, which combines the use of customized oral appliance specifications developed
by Vivos and prescribed by specially trained dentists in cooperation with their medical colleagues. We believe the Vivos System
technology represents the first non-surgical, non-invasive and cost-effective treatment for people with mild-to-moderate OSA.
Combining technologies and protocols that alter the size, shape and position of the tissues of a patient’s upper airway,
the Vivos System opens airway space and can 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 improve other conditions associated with OSA. Our patented oral appliances have proven effective (within the
scope of the U.S. Food and Drug Administration (or FDA) cleared uses) in over 15,000 patients treated worldwide by more than 1,200
trained dentists.
The
Vivos System consists of combination of our patented oral appliance (the mRNA appliance®) with multi-disciplinary
and proprietary clinical treatment protocols that has 510(k) clearance from the FDA as a Class II medical device for the treatment
of snoring, mild-to-moderate OSA and SDB. We also market a specially designed and patented FDA Class I customized oral appliance
(DNA appliance®) and a number of preformed pediatric oral appliances, which we call the Vivos
Guides. For the treatment of mild-to-moderate OSA, the Vivos System and other Vivos products are typically delivered to
patients by dentists specially trained to use the Vivos System to address certain craniofacial and morphological conditions commonly
associated with SDB and mild-to-moderate OSA.
Vivos DNA appliance Vivos mRNA appliance
Sleep
Apnea and the Role of Dentists in Treatment
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 fulfill this role by training dentists and providing the support to use the Vivos System with their patients that
suffer from mild-to-moderate OSA. Our program to train dentists and offer them other value-added services as described below 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 System, 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.
The
Vivos System is estimated to be effective in approximately 80% of cases of obstructive sleep apnea. Approximately 1 billion people
globally suffer from OSA, and as many as 80% remain undiagnosed. Research has shown that when left untreated, OSA increases the
risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia and other debilitating, life-threatening
diseases.
Obstructive
sleep apnea can range from mild to severe, based on a measurement system called the apnea-hypopnea index (AHI). The AHI is an
index of the number of partial or complete airway blockages lasting 10 seconds or longer that a patient experiences in an hour.
Studies have shown that the patented and proprietary technologies and protocols incorporated into the Vivos System technology
alter the size, shape and position of the tissues that comprise the human airway. In 17 published, peer-reviewed studies (on which
our founder and Chief Medical Officer was an author) that examined the impact of our technologies and protocols on the AHI scores
of patients with varying degrees of OSA, patient AHI scores were reduced from a low of 38% to a high of 98.6%, with the mean AHI
reduction shown in such studies being 67.4%. The results from published case reports and articles, together with patient-reported
outcomes, have shown that our Vivos System therapy provides a significant reduction in the severity of patients’ OSA (as
measured by industry standard indices such as the AHI among others), improvement in sleep-related quality of life, reduction in
snoring, as well as a high patient compliance rates and a strong safety profile.
The
treatment by a dentist of SBD and mild-to-moderate OSA with the Vivos System follows a required diagnosis of these conditions
(typically through the use of either a polysomnogram (or PSG) or home sleep apnea test (or HSAT) by a medical doctor which is
often provided by the sleep test provider.
VivoScoreTM
, Powered by SleepImage
In
February 2021, we launched VivoScoreTM Powered by SleepImage®, an FDA cleared diagnostic technology
for home sleep apnea testing featuring what we believe to be significant commercial advantages over existing HSAT products and
technologies in the market. We believe VivoScore 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 with our Vivos System. While we anticipate
increased revenue from VivoScore due to an expected increase in total patients tested and a corresponding increase in patient
enrollment in Vivos System treatment, in arriving at this conclusion, we are relying on the results of a pilot test we conducted
and other feedback from VIPs, which may or may not prove reliable on a broader scale.
VivoScore
is a comprehensive home sleep apnea test that utilizes proprietary cardiopulmonary coupling technology developed by MyCardio LLC
d/b/a SleepImage (“SleepImage”). VivoScore consists of a single-sensor ring recorder worn on the finger that works
with a mobile phone application which facilitates a seamless data capture and upload and proprietary cloud-based algorithms to
evaluate sleep quality and clinically diagnose sleep apnea. VivoScore test results have been shown to be comparable with overnight
in-lab PSG tests. VivoScore creates comprehensive proprietary sleep quality measures, such as the Sleep Quality Index (or SQI),
that go beyond a mere clinical diagnosis for sleep apnea to more effectively manage treatment benefit and improve patient outcomes.
With no consumables required, per test costs are significantly reduced, which is expected to allow for broad distribution and
multi-night sleep evaluations using VivoScore that are often required by insurance carriers.
The
SleepImage System, which is the underlining technology for VivoScore, is FDA cleared for the purpose of evaluating sleep quality
and to diagnose and manage sleep disordered breathing in both children and adults and may eliminate access and cost hurdles that
may exist with other competing HSAT technology. Current estimates show that 80% of sleep apnea sufferers remain undiagnosed and
untreated, creating a pressing need for an easy-to-use, clinical grade, low-cost HSAT for patients of all ages.
We
are bringing VivoScore to market under a Licensing, Distribution, and Marketing agreement with SleepImage. This agreement is exclusive
to our company with respect to white labeling of the VivoScore brand to the sleep dentistry market in the United States and Canada.
Our agreement with SleepImage has an initial term of two (2) years and is subject to automatic one (1) year extensions, subject
to the right of the parties to terminate the agreement prior to an extension. Either party also has the right to terminate the
agreement (subject to applicable notice and cure periods) for customary matters such as breach of the Agreement or bankruptcy
of a party. SleepImage also has the right to terminate the agreement under certain other circumstances, including a change of
control of our company.
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 our Vivos System aimed at treating mild-to-moderate OSA, with a clear first-mover strategy in penetrating the dental market
as a means of treating 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
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 AHI 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 mild-to-moderate 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
System 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 System, 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 System. There are approximately
160,000 qualified general dentists in the United States and Canada who could potentially offer the Vivos System to their patients.
Based on the addressable US 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.
In
addition, another published study, titled “Global Prevalence of Obstructive Sleep Apnea (OSA),” conducted by
an international panel of leading researchers in 2007, reported that nearly 1 billion people worldwide have sleep apnea. Accordingly,
we believe there is a substantial market opportunity for us outside the United States and Canada.
Our
Treatment Alternative for OSA – the Vivos System
The
Vivos System is a non-invasive, non-surgical, non-pharmaceutical, multi-disciplinary treatment modality for the treatment of mild
to moderate OSA. The proprietary and virtually painless Vivos System enhances and increases 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, snoring and SDB symptoms are improving.
Based on VIP and patient feedback we have received, we believe initial therapeutic benefits from using the device 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 System 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 System treatment process
progresses, the airway expands, with many patients reporting a significant reduction of their mild-to-moderate OSA symptoms. Our
primary product used in the Vivos System is the mRNA appliance®, a specifically designed, custom oral appliance
that is worn primarily in the evening hours and overnight and is available for adults. The total treatment time can range from
12 to 24 months with 18 months being the approximate mean treatment time. Our appliances 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.
Patients
who undergo treatment in the Vivos System will typically receive a customized mRNA appliance fitted to both the upper and lower arches.
Alternatively, the VIP may prescribe an upper arch DNA appliance with the possibility of adding a lower arch DNA appliance later-on in
treatment. Each case is priced accordingly, and patient fees are set by the treating dentist. It is not common for a given patient to
be prescribed both an mRNA appliance and a DNA appliance. Irrespective of the Vivos device prescribed, each patient is given specific
protocols and instructions for wear and maintenance, including the expected duration of daily wear (typically 14-16 hours per day including
overnight). In addition to the oral appliance treatment, the patient may be referred for treatment by an orofacial myofunctional
therapist, a chiropractor, an ear, nose and throat physician (“ENT”), and/or other healthcare providers for adjunctive therapy,
as necessary. Each of these providers contributes to the overall treatment outcomes within the scope of their individual licensures.
The Vivos System is a multi-specialty system that is collaborative with several related healthcare specialties such as those just listed.
Through
the course of treatment with the Vivos System, 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,
● Craniofacial and orthodontic correction,
● Resolution of TMJ pain, clicking, and locking, and
The
Vivos System has been specifically designed to promote the proper growth and development of the hard and soft tissues surrounding
and comprising the oral cavity, nasal cavity, upper and lower jaws, and other tissues which together form and shape the airway.
As these areas develop more fully using the Vivos System, a patient’s airway typically widens and expands (a process we
call Pneumopedics®), enabling them to breathe properly through their nose. With a more open and less-obstructed
airway and easier nocturnal breathing, the symptoms of SDB often diminish over time and patients often report no longer suffering
from the adverse impacts of SDB or mild-to-moderate OSA. Use of the Vivos System is variable and case dependent but is typically
recommended to be worn daily for 12 to 16 hours starting in the early evening and continuing overnight. During use, patients can
typically talk (with minor difficulty), drink and swallow, but the device must be removed to eat. An example of the impact of
Vivos System treatment on an upper airway is shown in the figures below depicting scans of the airway before and after treatment.
30-Year-Old
Male | 14 Months
30-Year-Old
Male – 14 Months Treatment. Before minimum airway area: 31.4mm2 – After minimum airway area: 111.6mm2.
Before total airway volume: 13.22c – After total airway volume 26.5cc. (Imaging performed with no oral appliance in the
mouth)
Often
the cause of OSA is abnormal anatomical features of soft tissues and/or structures of the maxillomandibular skeleton that cause
a disproportionate anatomy of the airway. Correcting the maxillo-mandibular skeletal and oral soft tissue structures can reduce
obstruction of the upper airway, as shown above.
The
Vivos System works to treat OSA as follows:
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 sleep disordered breathing, including mild-to-moderate OSA. We believe the following strategies
will play a critical role in achieve this goal and our future growth:
Our
Revenue Model
Our
revenue is derived from three primary sources, namely (1) VIP enrollment and training fees (comprised of one-time, up-front fees,
as well as optional renewal fees after 12 months); (2) recurring Vivos System and Vivos Guides sales; (3) recurring monthly subscription
fees from our Billing Intelligence Services (BIS); and (4) MID one-time development and recurring management fees.
VIP
office training and enrollment fees. We derive revenue from one-time enrollment and training fees charged to new VIPs,
which are dental practices specially trained by us in the use of the Vivos System. We have three VIP program pricing options which
we refer to as Tier 1, Tier 2 and Tier 3. Our Tier 1 fees are currently set at $50,000 for the main practice provider plus $10,000
for each associate doctor (although such fees for the main practice provider can be discounted to $40,000, while the associate
fees are not typically discounted and are the same across all tiers). Tier 2 pricing reflects a one-time enrollment fee of $25,000
coupled with a 30% price premium on appliances, and Tier 3 pricing reflects a $12,500 one-time enrollment fee coupled with a 50%
price premium on appliances. The one-time enrollment fee provides VIPs with extensive clinical and business integration training,
including training on matters such as billing and marketing. For additional subscription fees described further below, VIPs can
sign up for our Billing Intelligence Services (BIS) under which the VIPs outsource their medical credentialing, pre-authorizations,
billing, and payer collections functions to us. On average, our revenue from VIP enrollment fees currently is approximately $28,000
per VIP.
Recurring
Vivos System and Guide sales. Trained VIPs pay us an average adult case fee of approximately $1,600 per case, and $400
for a pediatric Guide case. We maintain average gross margins in excess of 70% on both adult and pediatric cases. In turn, VIP
offices typically charge adult patients fees ranging from $7,000 to $10,000, and $3,500 to $6,000 for pediatric cases. We estimate
that fully burdened costs to the VIP practice range from between $1,500 (pediatric Guides) and $3,000 (adult mRNA appliance®)
per case.
Billing
Intelligence Services (BIS). This complete billing solution includes a comprehensive integrated revenue cycle management
software system that allows dentists to focus on running their practice and delivering the best care for their patients. Our medical
billing service generates recurring subscription fees from participating VIPs (Silver Package: $795 setup fee and $795 per month,
Gold Package: $1,800 setup fee and $895 per month, or Platinum Package: $2,800 set up fee and $995 per month) This important adjunctive
service is priced competitively and allows VIP offices to outsource a key back-office function without adding one or more full
time employees.
Medical
Integration Division (MID). In addition, in 2020, we launched our MID 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. The primary objective of our MID is to promote the Vivos
System to the medical profession and thus facilitate the potential for more SDB and OSA patients gaining access to the Vivos System,
which we believe can improve quality of life and can reduce overall health risks experienced these patients. The MID seeks to
fulfill that objective by meeting with VIP dentists and physicians in their local areas to establish physician practices using
the trademarked name “Pneusomnia Craniofacial Sleep Medicine Center” (Pneusomnia Center). These independent medical
practices will be set up as LLCs or subchapter S corporations owned by a small group of independent physicians, co-located in
the dental practice of the VIP dentist, and managed by our company under a management and development agreement. We believe our
early market response from MID activities has been promising, and in March 2021 we announced the opening of the first Pneusomnia
Center in Del Mar, California as well as plans to open additional Pneusomnia Centers in several other cities in the U.S. However,
it remains too early to predict the eventual impact on our overall revenue. If successful, the MID is expected to enhance the
overall practice level economics for independent VIP offices and generate additional lines of recurring revenue for us.
Vivos
Centers. Finally, we derive a relatively small amount of revenue from the management of two (2) clinics in Colorado (which
we call the Vivos Centers) where dentists and other healthcare professionals treat patients using the Vivos System. As a company,
we are not in the business of treating patients per se, as this occurs only through dentists and other professionals, operating
within the scope of their respective licenses, who, among other services, prescribe and treat patients using the Vivos System
and/or Vivos Guides. We thus have no direct control over patient intake or clinical care at our Vivos Centers. Our role is limited
to training and educating dentists and their staff, and to fulfilling orders placed for the Vivos System and/or Vivos Guides.
While
operating Vivos Centers through licensed dentists and other healthcare professionals was the main aspect of our business model
prior to July 2018, the Vivos Centers are not currently our core business, but rather a means by which we derive hands-on assessments
and field intelligence from the use and practice of the Vivos System in actual clinical settings. As such, we may dispose of one
or more of the Vivos Centers in the future, as was the case in October 2019 when we sold one Vivos Center located in Orem, Utah.
In our current business model, our core revenue drivers are enrollment and renewal fees from VIP clinical education and office
training, sales of the Vivos System and other appliances, and subscription fees from BIS services as described above.
Patient
Advantages
We
believe the Vivos System offers the following patient advantages:
● Non-invasive, non-surgical and non-pharmaceutical treatment of OSA
● Comfortable and easy to wear and to comply with treatment protocols
● Average treatment is 12 to 24 months for most cases
● Treatment effective (for its FDA cleared uses)
● Restoration and maintenance of craniofacial symmetry
● Near term benefits (no waiting for months to see improvements)
● U.S. patented 3D axial springsTM and screw mechanism for patient adjustment
During
the course of treatment with our Vivos System, patients have reported the following adverse effects that include, but are not
necessarily limited to:
● TMJ or bite changes
Patient
Treatment Process
Most
potential patients learn they may be a possible candidate for OSA therapy through physician referral, education and advertising
campaigns, and/or dentist examinations. Some useful predictive information can be obtained from self-reported questionnaires given
to the patient in advance of a formal evaluation, and this procedure may simplify the clinical assessment of patients. The most
widely used of such questionnaires are the Berlin Questionnaire and the Multivariable Apnea Prediction Index.
If
a VIP dentist determines that a patient may have OSA, they will refer the patient to complete either a VivoScore or other home
sleep apnea test (which could be our VivoScore test) or a full polysomnography, which provides detailed information on sleep state,
respiratory behavior and gas exchange abnormalities, in addition to a range of other variables including body position, heart
rate and rhythm, and muscle tone and activity. The sleep test will be reviewed, and a diagnosis of the test will be given by a
medical doctor; usually by a doctor that specializes in sleep, a pulmonologist or a cardiologist.
If
a patient is diagnosed with sleep apnea from the reading of the home sleep apnea test or polysomnography test and is a candidate
for oral appliance therapy, additional data will be recorded including a CBCT imaging scan. After obtaining a prescription from
a physician, the VIP dentist will design a treatment plan and present the case to the patient. Upon treatment acceptance, the
financial arrangements will be organized including insurance pre-authorization and/or any deposits and payment plan agreements.
The VIP dentist will design the appliance(s) based upon treatment protocol and order the appliance through our cloud-based portal
that we call Vivos Aire.
Fabrication
of the Vivos System appliances usually takes between two to four weeks for delivery. Upon receipt of appliance(s) by the VIP dentist,
the patient will visit the dentist for an appliance seating and delivery appointment. Routine follow-up lasts for the 12 to 24
months of treatment.
Upon
determination of treatment completion, the patient will take a post-treatment home sleep apnea test, such as VivoScore, or a polysomnography
test. Post treatment CBCT imaging will be taken to compete the patient’s treatment and records profile.
Competition
Our
industry is subject to significant competition and rapid change from the introduction of new products and technologies and other
activities of industry participants. We compete as a first-line therapy in the OSA treatment market for patients with mild to
moderate OSA. There are several treatment options for patients with OSA depending on the level of severity of the disease, ranging
from lifestyle changes to surgery. The goals of therapy are to resolve signs and symptoms of OSA, improve sleep quality, normalize
and reduce the AHI, and generally increase SpO2 (blood oxygen saturation) levels. CPAP therapy is typically considered
the first-line standard of care of therapy for adults with OSA; however, decreased patient adherence lessens the benefits of CPAP
therapy. Common reasons cited for lack of adherence is trouble getting used to wearing the CPAP device, difficulty tolerating
forced air, dry and stuffy nose, feeling claustrophobic, skin irritation, pressure sores, leaky mask, dry mouth, bothersome noise,
chronic bacterial and respiratory infections, and lack of intimacy. According to published research, many patients with mild-to-moderate
OSA, who prefer not to use CPAP, use mandibular advancement devices (or MAD) oral appliances as an alternative therapy; however,
treatment with MADs comes with its own set of adverse side effects, including dry mouth, dental caries, TMJ pain and sounds, soft
tissue and tongue irritation, excessive salivating, occlusal changes, damage to teeth or restorations, and tooth mobility, among
other effects.
CPAP
is a therapy often prescribed by medical doctors for patients with OSA. CPAP is delivered through a face or nasal mask that connects
through a hose to a bedside air compressor. The CPAP machine forces air into the nasal passages at pressures high enough to overcome
obstructions in the airway and facilitate normal breathing. The effectiveness of CPAP has been limited by low patient compliance
due to claustrophobic sensations, discomfort with the constant air pressure, irritation from an ill-fitting mask, embarrassment
in front of a bed partner, machine noise, skin irritation, dry mouth, sinus infections, nausea, acid reflux, and depression about
having a sleep disorder. CPAP therapy is a palliative solution to OSA. It can relieve symptoms but does not address the underlying
cause. When CPAP therapy is discontinued, patients typically revert back to having OSA.
Another
palliative solution to OSA is a mandibular advance device. MADs are oral appliances used to treat mild-to-moderate OSA. MADs are
used with the intent of moving the lower jaw and tongue base forward and/or preventing the tongue from moving back into the throat
or the oropharynx. This specific action has the effect of opening the airway, thereby minimizing or preventing snoring and/or
airflow compromise leading to OSA. Forward jaw posturing, maintained over several hours repeated daily, however, is not normal,
and can lead to a number of adverse side effects, including but not limited to, dental caries, dry mouth, tooth discomfort, temporomandibular
joint dysfunction (TMD or TMJD), craniofacial pain, muscular discomfort, malocclusion (bite changes), tooth movement, and more.
CPAP,
MADs and other products on the market that non-surgically address SDB and OSA are palliative therapies that temporarily treat
the symptoms only, which may worsen over time. We believe these therapies are not designed or intended to address or resolve the
tissue obstruction(s) which, in the opinion of some researchers, constitutes the potential root cause(s) of the disorder in up
to 98% of patients with OSA. CPAP and MADs require lifetime nightly use to be effective. Conversely, a number of published studies
show that by addressing the potential root cause of OSA in many patients, we believe the Vivos System may offer patients the very
real hope of a more effective solution to their OSA that can be accomplished in about 12 to 24 months.
The
follow graphic depicts what we believe to be the competitive landscape for the Vivos System:
We
believe that the leading SDB and OSA treatment modalities fall into the following categories:
We
consider our primary competition, both within and outside of the United States, to be both CPAP and other oral appliance products
(all of which represent variations on the same mandibular advancement device platform) typically delivered by licensed dentists,
such as SomnoMed, DynaFlex, TAP, EMA, and Herbst (which are FDA cleared) as well as ALF, Homeoblock and FAGGA (which are not FDA
cleared). According to the American Sleep Apnea Association, over 100 different oral appliances are FDA cleared for the treatment
of snoring and OSA. We believe other emerging businesses are in the early stages of developing mandibular advancement or other
oral appliance devices which incorporate novel technologies.
To
a lesser extent, we also compete with surgical therapies such as Uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement
(MMA), robotic tongue reduction surgery, and Inspire Medical implants. While we compete with CPAP in general as an alternative
treatment for mild-to-moderate OSA, we believe the Vivos System is a superior alternative given its relative safety, comfort,
ease of use and the potential to resolve underlying conditions. In addition, the Vivos System is suitable for patients who cannot
tolerate CPAP or for whom CPAP has not been effective. In certain cases, clinicians may temporarily treat patients using a combination
of the Vivos System and CPAP.
As
highlighted in the chart above, a patient who is diagnosed with OSA faces two primary treatment pathways—non-surgical and
surgical. The Vivos System, CPAP, and mandibular advancement oral appliances are examples of non-surgical treatment options. Inspire
Medical Systems implants, UPPP surgery, and Maxillomandibular Advancement surgery are examples of surgical treatment options.
Each treatment option offers patients potential benefits and risks at a different price point.
We
believe the Vivos System offers patients several important advantages. Treatment in the Vivos System is typically limited to a
defined period of time (12-24 months), whereas both CPAP and oral appliance therapy require lifetime nightly use to be effective.
Treatment in the Vivos System also addresses the underlying anatomical cause of the OSA, whereas both CPAP and oral appliances
are palliative and effective only for temporary relief of symptoms while the devices are being used. Neither treatment purports
to correct the underlying tissue and structural anomalies that give rise to the OSA condition in the first place. Long-term compliance
in both alternative non-surgical protocols can be challenging. Yet once treatment in the Vivos System is complete, no further
intervention is necessary, in most cases.
Inspire
Medical Systems’ primary treatment for OSA involves surgical implant devices that seek to temporarily remove airway obstruction
by moving the tongue forward via an electrical stimulation. These devices relieve OSA symptoms and lower AHI scores, but pose
the added cost and risks of surgery, and must be used nightly over the patient’s lifetime in order to be effective. The
Vivos System avoids the cost and risk of surgery, and is less costly for both patients and insurance carriers than surgical options.
The Vivos System is thus far less dependent on insurance reimbursement for patients to be able to afford treatment.
We
believe that the primary competitive factors in the OSA treatment market are:
● company, product and brand recognition;
● product efficacy, safety, reliability and differentiation;
● third party medical / dental insurance reimbursement availability;
● dedicated practice development and clinical training teams;
● procedure costs to patients;
● quality and volume of clinical data;
● education of patients, dentists, physicians and sleep centers;
● sales force experience and access;
● technological innovation, product enhancements and speed of innovation; and
● pricing and revenue strategies.
Most
of the other OSA treatments against which we compete have a greater penetration into the OSA treatment market. Mandibular advancement
oral appliances and a variety of surgical treatments are better known to ENT physicians, sleep centers, dentists, and the other
physicians on whom we may rely for referrals, but we believe dentist and physician awareness of our Vivos System therapy is increasing.
Our
Competitive Strengths
We
believe that the Vivos System has numerous advantages that, taken together, set us apart from the competition and position us
for success in the marketplace:
● Compelling economics at all levels of the product and service delivery chain:
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 SDB and OSA, to educate them on the Vivos System and its benefits.
The goals of our sales and marketing efforts are (i) secure new VIP dentists 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 SBD and OSA 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 VIP program was developed to train dentists to identify and treat conditions associated with SDB and mild-to-moderate
sleep apnea. Our sales program to target medical doctors is our recently launched 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.
We
sell our VIP program to dentists in the United States and Canada. In countries outside of North America we typically offer a modified
training and support program at a lower cost. We currently have approximately 10 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 147,000 professionally active general dentists in the United States and the 13,000 general dentists in
Canada.
Our
current VIP sales organization is comprised 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 System. Our indirect marketing channels include strategic partners, industry key opinion leaders, trade shows and our
own clinical advisor network. Our direct marketing channel includes 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 SDB, OSA and treatment alternatives.
We
believe our dentist and medical doctor marketing efforts have been effective in facilitating contact via our Vivos introduction
and online training webinars, particularly during the COVID-19 epidemic.
Potential
Economics for Trained VIP Clinicians
Dentists
that enroll in our VIP program have favorable economics. The actual incidence of dental patients with OSA will vary, but our conservative
estimate would suggest the average dental practice sees 400-500 adult patients 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 $3,300,000 in annual gross revenue potential annually with over $2,400,000 in potential net profit. We believe based
on our experience that dentists have seen accretive economic additions to their practices with the Vivos System, and thus the
VIP program can likely add to the doctor’s take-home income. Our sales and clinical advisory dentists conduct training primarily
in a highly personalized, deep immersion workshop format at our Institute for Craniofacial Sleep Medicine. The key topics covered
in training include case selection, clinical diagnosis, treatment planning, appliance design, adjunctive therapies, instructions
on ordering Vivos products, 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. 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
1,200 dentists confirms our belief that training represents a minimal barrier to adoption for most dentists.