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
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
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.
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.
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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.
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
We previously retained the services of
Since 2016, we had a research partnership with the
To further the depth of our research and development we also began a partnership
in 2021 with
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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
? 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
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
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.
See "Note10. Subsequent Events" to our unaudited Condensed Financial Statements
included in Item 1 of this report with respect the definitive Merger Agreement
entered into on
SSI-DE, through a subsidiary, owns a controlling interest in
Pursuant to the Merger Agreement, Avra (which will change its name to
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
Balance Sheet Data As of As of March 31, December 31, 2022 2021 Cash$ 346,869 $ 405,774 Total Assets$ 367,396 $ 428,607 Total Liabilities$ 278,250 $ 287,281 Total Stockholders' Deficit$ 89,145 $ 141,326 20
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.
Three months ended
Revenues. We had no revenues during either the three months ended
Research and Development Expenses. Research and development expenses were
Compensation Expense. We had compensation expense of
General and Administrative Expenses. We incurred
Other Income/Expenses. We had
Net Loss. We incurred a net loss of
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 (
In
In addition to the foregoing, from
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In
In
In
In the fourth quarter of 2021 the Company raised a total of
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
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.
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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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