When used in this report, unless otherwise indicated, the terms “Avra,” “the
Company,” “we,” “us” and “our” refer to
Note Regarding Forward Looking Statements
This report contains forward-looking statements that reflect our current views
about future events. We use the words “anticipate,” “assume,” “believe,”
“estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,”
“could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,”
“goal” or the negatives of such terms or other similar expressions. These
statements relate to future events or our future financial performance and
involve known and unknown risks, uncertainties and other factors that may cause
our actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or
achievements expressed or implied by these forward-looking statements.
Overview
We are a medical robotics company developing a fully autonomous medical robotic
system using proprietary software which integrates Artificial Intelligence
(“AI”) and
enhanced software program, we are creating an intelligent robotic system that we
believe can “robotize” a wide range of medical procedures currently being
performed by human hands. We are concentrating our research and development
efforts to meet rising expectations of patients and practitioners alike for the
precision, safety and speed offered by an AI enhanced robotics platform system
that can be combined with proven medical devices, end-effectors and surgical
instruments.
We believe that progress in mechanical and software engineering has made
possible lightweight and relatively inexpensive robotic devices for difficult
procedures in various medical fields. Medical robots are already being
successfully employed in several areas of surgery, including Urology (Prostate),
Colo-Rectal, Gynecology, Thoracic, General Surgery, Orthopedics, and Neuro and
Spine Surgery. Robots are also being used for Telemedicine and assistive robotic
methods are addressing the delivery of healthcare in inaccessible locations,
ranging from rural areas lacking specialist expertise to post-disaster
scenarios, and battlefield areas. With the aging population dominating
demographics in the
technologies are being developed toward promoting improved function, lower
morbidity and improved overall outcomes.
We are developing a treatment-independent autonomous robotics system utilizing
our proprietary AI-driven precision guidance system, applicable to a variety of
minimally and non-invasive procedures, with an initial focus on skin resurfacing
aesthetic procedures utilizing several FDA approved skin enhancing techniques
robotized for superior performance and optimal results. Our medical robotic
system is being developed to deliver skin resurfacing treatments, such as
micro-needling and laser therapies with improved efficiency, accuracy and
precision over current procedures conducted by human hand, and only requiring
the doctor to input or just confirm treatment parameters. As a result, use of
our medical robotic system is expected to provide improved quality and safety as
well as improve patient throughput and workflow.
19
Our autonomous medical robotics system is being developed to be compatible with
available FDA approved surgical tools and end-effectors, enabling us to
initially penetrate a sizable and fast-growing aesthetics market, which includes
micro-needling and laser solutions. Our robotics system will allow doctors, and
anyone permitted to treat patients, defined at the State level, such as a
licensed aesthetician, to treat damaged skin autonomously by delivering, for
example, micro-needling to the skin. The micro-needling catalyzes the natural
process of collagen remodeling, consisting of formation of new collagen,
elastin, and vascularization in the papillary dermis, similar to the effect of
laser treatments.
We expect our robotic system to eliminate many of the common errors that occur
during handheld procedures, such as over- or under- exposure of the needles or
energy-based instruments that can have terrible cosmetic results and even injure
the patient. In addition, our system is being designed to continuously adjust
treatment parameters, such as penetration depth, time, and energy in order to
individualize the outcome based on our algorithms.
Our robotic system has been designed and developed through a seamless
collaboration of the surgeon, the engineer and the scientist. Since the medical
robotic industry has progressed greatly in miniaturization, adaptability and
lower costs, we believe that the Avra “brains” technology component can lead to
dramatic opportunities in all of medicine.
The advantages of robotizing already FDA approved aesthetic devices are many. In
contrast to a human using a handheld device, our aesthetics robotic system has
the potential to perform each and every procedure with unsurpassed precision
without constraint of age, proficiency, experience or fatigue. Likewise, in many
skin related treatments the amount of energy delivered, distance and/or depth of
the instrument to, or into, the skin, and treating only the affected area are
critical to the outcome. The robotic system can maintain these parameters with
unparalleled accuracy. The system can also replicate the same procedure time and
again precisely. Delivery of certain aesthetic treatments by robotic systems is
believed to be the most efficient option, requiring fewer visits per patient
while increasing patient throughput – a benefit for patients and practitioners
alike.
Advantages of using our medical robotic approach to procedures include:
? Reduced cost per treatment.
? Better treatment accuracy.
? Better treatment outcomes.
? Increased patient throughput and revenue generation for the physician.
? Easier multi-platform integration.
? Addresses shortfall of physicians/surgeons.
? Easier future integration of medical and technological advancements such
as molecular biologics.
We believe that our initial medical robotic system for the aesthetics market
should find rapid acceptance based on the aforementioned advantages of using the
attribute of robotics versus traditional manual applications. Furthermore, there
is general acceptance by consumers for fee-for-service cash payments in the
facial aesthetics market thereby avoiding medical insurance reimbursement
issues.
20
Our medical robotic system utilizes a robotic arm that has 7-degrees of freedom
integrated with our proprietary AI-driven control software and algorithms. The
robotic arm was designed and built under the required medical device standards
of the
integrate the robotic arm with FDA approved devices, which is expected to allow
for a more expedited approval of the integrated system. We believe that the FDA
approval process will primarily focus upon validation of the medical robotic
system’s software control. This could lead to a less onerous, more de-risked
regulatory path to approval, particularly if strong preclinical results are
achieved. Subsequent to the completion of the FDA preclinical work, estimated to
take six months, we believe that we will be able to additionally modify and
robotize certain non-invasive instruments that do not require FDA approvals and
proceed to the cosmetic treatments marketplace. This action could sharply reduce
the time to commercial operations and revenues.
We previously retained the services of
consulting firm experienced in securing
for medical devices, in order to initiate the regulatory process. Working with
HPG, we prepared and filed an application with the FDA for our initial medical
robotic system and in
the FDA. We believe that this is the first of a series of meetings where the
Avra system and its regulatory requirements will be discussed in ever-increasing
specificity. This should allow for a more focused regulatory process, saving
both resources and time. The robotic arm that we intend to utilize for our
system has already been granted approval in the EU and received a CE mark. We
have begun implementing a quality and regulatory system that will serve as the
foundation for
market access for our medical robotic system. The Medical Device Single Audit
Program(“MDSAP”), which we plan to employ, is a single inspection that, when
completed, is expected to support market access to these six most important
medical device marketplaces.
Since 2016, we had a research partnership with the
(“UCF”) to develop a prototype intelligent medical robotic system. UCF is
recognized particularly for its work in the area of medical robotic research and
design, with a focus on the guidance systems. Avra has paid UCF a one-time fee
for outright ownership of work developed by UCF in the collaboration. The
Research Agreement was extended several times and expired on
further the depth of our research and development we also began a partnership in
2021 with
developing our system. Avra recently brought in two Associate Professors and a
graduate to join Avra’s engineering development team. Effective
2021
payments of
2022.
On
agreement with
Air
and automation employing software and AI for applications in various industries
and has more recently expanded to the development of air sanitizing devices to
help address such pathogens as COVID-19. Our CEO is also an owner of
will seek to develop software and AI systems for robots that are relevant to the
field of medical treatment or diagnostics. As part of the collaboration,
Air
royalty-free license to commercialize any technology (including any patents)
developed by
agreement as well as existing technology of AVRA AIR in the field of medical
robotics. This license survives termination of the agreement.
On
made with
restricted shares of our common stock valued at
the investment. Avra received (a) a 49.8% limited liability company membership
interest in
provisional patent that Avra did not yet control. In addition, Avra also agreed
to pay
for two years from the date that a first kit that uses the patent is sold. On
the acquisition of its interest in
prototype portable air de-contaminant system which it plans to market soon.
Our senior leadership team and advisory boards have broad and deep experience in
clinical practice, medical research, innovation and development in the medical
robotics field. We believe that our team, which has been active in the medical
robotics field for many years, brings the necessary skills and experience to
develop and commercialize intelligent medical robotic systems, as well as in
marketing, supply chain management, and the implementation of all other aspects
of our planned business operations.
21
We believe we can rapidly develop and commercialize its initial medical robotic
system in the aesthetic skin resurfacing market because of the following
advantages and progress made to date, including:
? Our team is experienced in medical robotic engineering.
? We are working in conjunction with preeminent physicians, engineers and
scientific institutions.
? We have substantially completed the design phase and are ready to complete
a final, integrated prototype for the regulatory approval process which
has been initiated.
? Our robotic arm was built under the required medical device standards of
the FDA and has already received a CE Mark in Europe .
? Our strategy is to integrate the robotic arm with FDA approved devices for
skin resurfacing, which we anticipate will allow for a more expedited
regulatory approval, with the FDA approval process primarily focused upon
validation of the medical robotic system's software control. We held a
pre-collaboration meeting with the FDA in August 2019 , which should allow
us to better focus on only the meaningful required activities, saving both
resources and time.
? We have begun implementing a quality and regulatory system that will serve
as the foundation for U.S. , Canadian, European, Australian, Japanese, and
Brazilian market access for AVRA's medical robotic system. MDSAP, which we
plan to employ, is a single inspection that, when completed, is expected
to support market access to the six most important medical device
marketplaces.
? We believe that our treatment-independent medical robotics platform system
will be compatible with currently and yet to be approved end-effectors
and/or surgical tools enabling rapid entry into the skin resurfacing and
other markets with new and improved devices.
Results of Operations
Introduction
The financial statements appearing elsewhere in this report have been prepared
assuming the Company will continue as a going concern. The Company was recently
formed and has not established sufficient operations or revenues to sustain the
Company. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern.
The following table provides selected balance sheet data for our Company at
30, 2021
Balance Sheet Data: As of As of
June 30, December 31,
2021 2020
Cash $ 307,565 $ 160,709
Total Assets $ 440,038 $ 317,870
Total Liabilities $ 1,297,971 $ 1,186,919
Total Stockholders' Deficit $ (857,933 ) $ (869,049 )
To date, the Company has relied on debt and equity raised in private offerings
and shareholder loans to finance operations and no other sources of capital has
been identified. If we experience a shortfall in operating capital, we could be
faced with having to limit our research and development activities.
22
Three months ended
2020
Revenues. We had no revenues during either the three months ended
or the three months ended
Research and Development Expenses. Research and development expenses during the
three months ended
General and Administrative Expenses. We incurred
and administrative expenses during the three months ended
30, 2020
other professional expenses related to the Company’s filings as a public company
with the
Compensation Expense. We had compensation expense of
during three months ended
include compensation for the management staff and stock-based compensation
expense related to the Company’s 2016 Stock Incentive Plan.
Other Income/Expenses. We have
2021
30, 2020
Net Loss. We incurred a net loss of
2021
2020
large part due to increase in stock-based compensation expense.
Six months ended
Revenues. We had no revenues during either the six months ended
the six months ended
Research and Development Expenses. Research and development expenses during the
six months ended
months ended
development work on the Company’s prototype robotic system at its facilities at
UCF’s incubator in
General and Administrative Expenses. We incurred
general and administrative expenses during the six months ended
and
legal and other professional expenses related to the Company’s filings as a
public company with the
Compensation Expense. We had compensation expense of
during the six months ended
includes compensation for the management staff and stock-based compensation
expenses related to the Company’s 2016 Stock Incentive Plan.
Other Income/Expenses. We have
as compare to
2020
Net Loss. We incurred a net loss of
2021
2020
large part due to decreases in stock-based compensation expense.
23
Liquidity and Capital Resources
The Company expects to require substantial funds for research and development,
to continue to develop, secure marketing approval for and ultimately manufacture
and market its initial medical robotic system. Until the Company is able to
generate revenues from the sale of its initial medical robotic system, it
expects to meet its operating cash flow requirements from the net proceeds of
this Offering and if necessary, from future public or private sales of its
securities and, if possible, on favorable terms, by entering into development
partnerships to assist the Company with its technology development activities.
During the period from inception (
Company raised (a)
in
notes completed in
shares of common stock at a price of
(d)
offering at a price of
In
units (“Units”), each Unit consisting of a
promissory note bearing interest at the rate of 5% per annum and a three-year
warrant to purchase 5,000 shares of common stock at an exercise price of
per share.
In addition to the foregoing, from
obtained fourteen loans from
totaling
bear interest. With the exception of two loans totaling
loans were subsequently repaid in full via conversions into restricted company
shares or Units including one loan for
stock option for 1,000,000 shares held by
While we have been successful in raising funds to fund our operations since
inception and we believe that we will be successful in obtaining the necessary
financing to fund our operations going forward, we do not have any committed
sources of funding and there are no assurances that we will be able to secure
additional funding. The accompanying financial statements have been prepared
assuming that the Company will continue as a going concern; however, if the
efforts noted above are not successful, it would raise substantial doubt about
the Company’s ability to continue as a going concern. If we cannot obtain
financing, then we may be forced to further curtail our operations or consider
other strategic alternatives. Even if we are successful in raising the
additional financing, there is no assurance regarding the terms of any
additional investment and any such investment or other strategic alternative
would likely substantially dilute our current shareholders.
Critical Accounting Policies Use of Estimates
The preparation of financial statements in conformity with accounting principles
generally accepted in
and assumptions that affect the reported amounts of assets and liabilities and
disclosures of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates. Significant
estimates included deferred revenue, costs incurred related to deferred revenue,
the useful lives of property and equipment and the useful lives of intangible
assets.
24
Income Taxes
The Company accounts for income taxes in accordance with ASC 740, Accounting for
Income Taxes, as clarified by ASC 740-10, Accounting for Uncertainty in Income
Taxes. Under this method, deferred income taxes are determined based on the
estimated future tax effects of differences between the financial statement and
tax basis of assets and liabilities given the provisions of enacted tax
laws. Deferred income tax provisions and benefits are based on changes to the
assets or liabilities from year to year. In providing for deferred taxes, the
Company considers tax regulations of the jurisdictions in which the Company
operates, estimates of future taxable income, and available tax planning
strategies. If tax regulations, operating results or the ability to implement
tax-planning strategies vary, adjustments to the carrying value of deferred tax
assets and liabilities may be required. Valuation allowances are recorded
related to deferred tax assets based on the “more likely than not” criteria of
ASC 740.
ASC 740-10 requires that the Company recognize the financial statement benefit
of a tax position only after determining that the relevant tax authority would
more likely than not sustain the position following an audit. For tax positions
meeting the “more-likely-than-not” threshold, the amount recognized in the
financial statements is the largest benefit that has a greater than 50 percent
likelihood of being realized upon ultimate settlement with the relevant tax
authority.
Off-Balance Sheet Arrangements
There are no off-balance sheet arrangements that have or are reasonably likely
to have a current or future effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures or capital resources that is material to investors.
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