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Item 1. Business

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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

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.

71 unchanged sentences

to join Avra’s engineering development team.

Effective October 11 th , 2021 Avra executed a Sponsored Student Project Agreement

which includes two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022.

Effective October 11th, 2021 Avra executed a Sponsored Student Project Agreement which

includes two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022.

Recent Developments

On August 5, 2022, AVRA entered into a non-binding letter of intent

On November 7, 2022, AVRA entered into a definitive

Merger Agreement (the “ Merger Agreement ”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware corporation

and wholly-owned subsidiary of AVRA (“ Merger Sub ”), CardioVentures, Inc., a Delaware corporation (“ SSI -

Sudhir Srivastava (“ Dr.

Srivastava ”), Cardio Ventures Pvt.

Ltd., a Bahamian private limited company of which

Srivastava is the sole stockholder(“ Cardio ”), Otto Pvt, Ltd., a Bahamian private limited company and direct subsidiary

of Cardio (“ Otto ”) and Sudhir Srivastava Innovations Pvt.

Ltd., an Indian private limited company and indirect subsidiary

of Cardio (“ SSI ,” and together with Cardio and Otto, the “ SSI Parties ”) with respect to a business

combination between AVRA and the SSI Parties (the “ Transaction ”).

SSI, based in Haryana, India is engaged in the development,

commercialization, manufacturing and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual

property held by Dr.

Srivastava ”), who, through his holding company, owns a controlling interest

SSI-DE, through a subsidiary, owns a controlling

interest in Sudhir Srivastava Innovations Pvt.

Ltd., an Indian private limited company (“ SSI - India ”).

Based in Haryana,

India, SSI-India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing

patents, trademarks and other intellectual property held by Dr.

Srivastava (the “SSI Intellectual Property”).

If and when the transaction is consummated, the

business of the SSI Parties, including the SSI Intellectual Property will be owned by AVRA.

The shareholders of the SSI Parties will own

95% of the common stock of post-transaction AVRA and the current shareholders of AVRA will own 5% of the common stock of post-transaction

In addition, there will be changes in composition of the board of directors, implementation of corporate governance policies and

changes in management, all with a view to listing the common stock of AVRA on the Nasdaq Stock Market, LLC or another National Securities

In addition, AVRA will change its name to “ SS Innovations, Inc.

Consummation of the Transaction is subject to,

among other matters, the negotiation and execution of definitive agreements and documentation, containing, in addition to the above terms,

terms and conditions customary for agreements of this type and nature, including, without limitation, representations, warranties, and

indemnities of the parties.

Consummation of the Transaction is also subject

to completion of a due diligence review by each party of the other, the results of which shall be satisfactory to the reviewing parties

in their sole discretion.

Given the foregoing, there can be no assurance

given that the Company will be able to successfully complete the Transaction.

In connection with executing the letter of intent,

we advanced the SSI Parties, the amount of $990,000 (the “ Interim Financing ”).

The Interim Financing is evidenced by

two notes, one for $100,000 and one for $1,000,000.

Both are one-year Automatically Convertible Notes made in favor of the Company by

Cardio, Otto and Dr.

Srivastava, jointly and severally (the “ Cardio Notes ”).

Interest on the Cardio Notes shall accrue

at the rate of 7% per annum, payable together with the principal amount at maturity.

The Cardio Notes have an original issue discount

If the Cardio Notes are not repaid in full on or at maturity, they will automatically convert into a percentage equity interest

in Cardio determined by dividing the principal amount of and accrued interest on the Cardio Notes divided by $100 million.

Notes contains customary default provisions and other typical terms and conditions.

We may make additional advances to the SSI Parties

of up to an aggregate principal amount of $5,000,000 of Interim Financing, evidenced by additional Cardio Notes.

These Cardio Notes will

be substantially similar in form and substance to the first Cardio Note, provided , however , that Cardio Notes issued in

excess of an aggregate principal amount of $2.000,000, will have an original issue discount of 6% as opposed to 10%, and the valuation

for determining conversion will be $250 million as opposed to $100 million.

In order to fund the Interim Financing, the Company offered and sold

to two accredited investors, $1,000,000 and $100,000 one-year convertible promissory notes (the “ Convertible Notes ”).

The Convertible Notes will have the same interest rate and payment terms as the Cardio Notes and otherwise be substantially similar to

the Cardio Notes, provided , however , that the Convertible Notes do not have an original issue discount.

Further, upon consummation

of the Transaction (if and when it is consummated) the Convertible Notes will automatically convert into a number of AVRA Shares determined

by dividing the principal amount of the Convertible Notes by $100 million and multiplying such number expressed as a percentage by the

number of AVRA Shares issued to Dr.

Srivastava and the other shareholders of the SSI Parties (if any) upon closing of the Transaction.

The Company may offer and sell up to an aggregate principal amount of $5,000,000 in Convertible Notes in order to fund the Interim Financing.

The Convertible Notes were issued in a private transaction

pursuant to the exemptions from registration under the Section 4(a)2 of the Securities Act of 1933, as amended (the “ Securities

Act ”) and the rules and regulations promulgated thereunder.

Advantages of Our Senior Leadership Team

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.

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.

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,

team is experienced in medical robotic engineering.

are working in conjunction with preeminent physicians, engineers and scientific institutions.

have substantially completed the design phase and are ready to complete a final, integrated prototype for the regulatory approval process

which has been initiated.

robotic arm was built under the required medical device standards of the FDA and has already received a CE Mark in Europe.

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.

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.

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.

Medical Robotic and Skin Rejuvenation Markets

The United States is expected to see a shortage

of nearly 122,000 physicians by 2032 as demand for physicians continues to grow faster than supply, according to new data published by

the AAMC (Association of American Medical Colleges).

This trend is unfortunately being seen in the rest of the world as well.

Health Organization (“ WHO ”) estimates that there is a global shortage of 4.3 million physicians, nurses, and other

health professionals.

The shortage is often starkest in developing nations due to the limited numbers and capacity of medical schools

in these countries.

One solution that is expected to mitigate this

shortage will be the growing use of robotic systems for both their ability to be used remotely by the doctor (i.e.

a doctor could, from

a central location, cover anywhere in the world given proper connectivity), but also for their ability to increase the efficiency of existing

practitioners.

The ever-growing high cost of healthcare is also a driver for the growth in the use of robotic systems.

Advantages of using medical robotics include:

cost per treatment

treatment accuracy

treatment outcomes

patient throughput

multi-platform integration

shortfall of physicians/surgeons

The concept of using a robot in surgical procedures

became a practical reality in 2000, when the FDA approved the da Vinci® robotic system, introduced to the market by Intuitive Surgical,

For years, ISRG was essentially the sole company manufacturing and marketing robotic devices for use

in the rapidly emerging field of robotic assisted, minimally invasive surgery.

Today, the U.S.

is the leader in robot-assisted

However, other countries are fast followers, having already recognized both the need and the promise of such technologies.

development of surgical robotics is motivated by the desire to enhance the effectiveness of a procedure by coupling information to action

in the operating room or interventional suite and transcend human physical limitations in performing surgery and other interventional

procedures, while still affording human control over the procedure.

Two decades after the first reported robot assisted surgical procedure,

surgical robots are now being widely used in the operating room.

According to Kenneth Research, the worldwide medical robotics market

is projected to reach $11.36 billion by 2023, expanding at a compound annual growth rate (“ CAGR ”) of 12.6% during 2018–2023.

According to Kenneth Research, North America is

currently the world’s largest market for medical robotics, holding an over 40% market share as of 2019, with significant growth

expected in the coming years.

Growth in North America is driven by a few factors

including the high rate of adoption of these new technologies and the growing demand for more precise, less invasive, and safer surgical

The overall growth of this industry is driven by the rising demand for these technologies, the growing and aging population,

as well as increasing healthcare expenditures.

Due to the growth in robotics for medical applications

over the last several years, the medical robotics space has seen increasing mergers and acquisitions activity and we expect this to continue

for the foreseeable future.

Some recent examples include:

● Medtronic’s

acquisition of Mazor Robotics in September 2018 for $1.6 billion.

& Johnson’s acquisition of Auris Health in February 2019 for $5.75 billion (Johnson & Johnson is now a shareholder of Avra

through its ownership of Auris Health, which was one of the founding shareholders of Avra.

acquisition of Orthoscape in March 2019 for $220 million.

Surgical’s acquisition of Schölly Fiberoptic’s robotic endoscope business in July 2019 for an undisclosed sum.

Medical Solutions’ acquisition of Corindus Vascular Robotics in August 2019 for $1.1 billion.

Similar to growth in the use of medical robots

in various procedures, the demand for skin rejuvenation procedures is also rapidly growing, which is a primary reason why we chose the

skin rejuvenation market as our initial point of entry into the medical robotics field.

According to a research letter published by Jama

Network, in 2016, the total number of dermatology providers was 13,365 (10,845 dermatologists and 2,520 dermatology physician assistants).

The global medical aesthetic market is expected to reach $16.7 billion by 2022, with North America remaining the largest single market.

According to the National Laser Institute, between

2000 and 2018, the total number of non-surgical cosmetic treatments performed increased by 228% with 15.9 million non-surgical cosmetic

treatments performed in 2018.

The National Laser Institute also estimated that over $16.5 billion was spent in the U.S.

on cosmetic procedures

According to a research study by Persistence Market

Research, the global market for skin rejuvenation is projected to reach a CAGR of 8.7%.

By region, the North American and Asian Pacific

excluding Japan (“ APEJ ”) regions reflect high potential in the years to come.

The North American region is expected

to dominate the global market as it is estimated to be the largest and highly attractive for skin rejuvenation.

The North American skin

rejuvenation market is estimated to reach a CAGR of 9.4% at its peak.

Most products designed to improve the appearance

of the skin do not repair the skin itself;

rather, they cover and hide scarring and blemishes temporarily.

Wrinkles also are challenging

as the skin ages and are hard to cover over.

Some current treatments aim to slow or forestall the development of wrinkles, but with questionable

effectiveness.

Micro-needling and laser treatments are two common ablative procedures currently in use today for skin resurfacing, specifically

focused on tone, texture and skin tightening.

Other platforms include radiofrequency, ultrasound, cryolipolysis, and a multitude of laser

frequencies that are available to practitioners.

Micro-needling is used to treat and improve conditions

like acne scarring, fine lines and wrinkles, loose skin, skin texture, pore size, brown spots, stretch marks, and pigment issues.

also called skin needling, collagen induction therapy (“ CIT ”), and percutaneous collagen induction (“ PCI ”).

Most anyone can have the procedure performed, as long as they do not have any active infections, lesions, or any known wound healing problems.

Micro-needling is typically performed in

a series of four to six sessions, spaced about a month apart.

During the procedure, a topical anesthetic is applied, and then stainless-steel

micro-needles are inserted into the skin to cause microinjuries or punctures.

The damage caused by the needles encourages the body to

send healing agents (elastin and collagen) to the punctures to repair them.

According to a 2008 study, skin treated with four micro-needling

sessions spaced one month apart produced up to a 400% increase in collagen and elastin six months after completing treatment.

Laser resurfacing also can shrink wrinkles,

even eliminating small wrinkles, by removing the outer layer of skin, allowing new skin to form.

While simple, this procedure can be painful.

Laser resurfacing works by burning off skin;

skin can reach 1500°F (800°C) in the process of being removed, and adjacent areas

of skin can approach 400°F.

Unsurprisingly, general anesthesia is often required.

Open wounds are created and healing may take up

to three weeks.

Skin redness may persist for three months, during which the skin is particularly sensitive to UV light.

Other risks of

laser resurfacing include scarring, changes in skin pigmentation and bacterial infection.

Most, if not all, of the more severe adverse

effects of laser resurfacing treatments are due to errors in the application of the treatment.

Applying the laser too close to the skin,

for too long on one area of the skin, and at the wrong settings, are just some examples of human errors for this procedure.

this procedure could reduce, if not eliminate, these human errors.

A recent study by Yongsoo Lee, M.D., co-CEO and

co-founder, Oh and Lee Medical Robot, Inc., in South Korea, presented at the American Society for Laser Medicine and Surgery meeting held

in April 2017, comparing the improvements in the evenness of laser irradiation using a robot versus manual irradiation found the robot-guided

treatment to be much more accurate than the human hand, achieving superior outcomes.

Results of the study showed that robotic irradiation

demonstrated consistency in distances between beams and distribution in fractions at both 30 and 10 Hz frequencies and was significantly

superior to manual irradiation in the ratio of area covered by beams to regions of interest, distances between beams, and distribution

in fractions at each frequency.

The investigators concluded the robot-guided treatment to be superior to the manually guided treatment.

“As an aesthetic dermatologist myself, I

can appreciate that virtually all doctors would welcome the robot-guided treatments, as valuable time can be saved in the busy practice.

That saved time can then be invested in other patients and procedures, allowing physicians to see more patients per day.

Moreover, due

to the heightened precision of robotic-guided treatments, cosmetic treatments are much safer with a significantly reduced chance of adverse

events occurring such as burns and spotty hypopigmentation,” Dr.

Technology Overview

Current robots used in surgery are under the direct

control of a surgeon — the so-called “ Master-slave system ”, often in a teleoperation scenario in which a human

operator manipulates a master input device and the patient-side robot follows the input.

There is no autonomy.

Traditional minimally invasive

surgical robots provide the surgeon with a higher degree of dexterity inside the body, eliminate operator tremor, scale down operator

motions to a fraction of normal distances, and provide a very intuitive connection between the operator and the instrument tips.

can cut, cauterize, suture and reconstruct tissue with accuracy equal to or better than that of invasive open surgery.

A surgical system

contains both robotic devices and real-time imaging devices to visualize the operative field during the course of surgery.

The use of robotics in medicine inherently involves

physical interaction between caregivers, patients, and robots — in all combinations.

Developing user-friendly physical interfaces between

humans and robots requires all the classic elements of a robotic system:

sensing, perception, and action.

A great variety of sensing and

perception tasks are required, including recording the motions and forces of a surgeon to infer their intent, determining the mechanical

parameters of human tissue, and estimating the forces between a robot and a moving patient.

The reciprocal nature of interaction means

that the robot will also need to provide useful feedback to the human operator, whether that person is a caregiver or a patient.

to consider systems that involve many human senses, the most common of which are vision, haptics (force and tactile), and sound.

reason why systems involving physical collaboration between humans and robots are so difficult to design well is that, from the perspective

of a robot, humans are extremely uncertain and dynamic.

Unlike in a passive, static environment, humans

dynamically change their motion, force, and immediate purpose throughout a procedure.

These changes can be caused by something as simple

as physiologic movement (e.g., a patient breathing during surgery), or as complex as the motions of a surgeon suturing during surgery.

During physical interaction with a robot, the human is an integral part of a closed-loop feedback system, simultaneously exchanging information

and energy with the robotic system, and thus cannot simply be thought of as an external system input002E

In addition, the loop is often closed with both

human force and visual feedback, each with its own errors and delays that can potentially cause challenges in a human-robot system.

these problems, how does one guarantee safe, collaborative and useful physical interaction between robots and humans?

To date, no existing

systems provide the user with an ideal experience of physically interacting with a robot.

Device design and control are essential to the

operation of all medical and health robots, since they interact physically with their environment.

Accordingly, one of the most important technical

challenges is in the area of mechanisms.

Miniaturization is challenging in large part because current electromechanical actuators (the

standard because of their desirable controllability and power to weight ratio) are relatively large.

Biological analogs (e.g., human muscles)

are far superior to engineered systems in terms of compactness, energy efficiency, low impedance, and high force output.

Interestingly,

these biological systems often combine “mechanisms” and “actuation” into an integrated, inseparable system.

for systems that achieve high dexterity at any scale will naturally differ greatly depending on the medical application (e.g.

rehabilitation, and prosthetics).

We are focusing on truly innovative technology

that is in line with current applications, but delivers an innovative approach.

We are integrating image-guidance with navigation, AI,

and organ-targeting to bring a system that is truly diverse and multi-dimensional.

Having identified limitations in the predominantly

non-autonomous robotic systems, we propose a disruptive model, which considers design and development through a seamless collaboration

of the surgeon, the engineer and the scientist.

The core of the design and engineering of our

medical robotic system is the AI-driven robotic arm navigation and guidance software which permits the system to autonomously guide a

medical, surgical grade robotic arm and end-effector for safer and more effective treatment of patients.

Our initial medical robotic system

is designed to perform minimally invasive, surgical facial corrections using a micro-needling device for skin resurfacing.

quickly follow this up with a laser end-effector, a tool useable for various skin resurfacing procedures.

This modular approach should

allow us to quickly adopt future technologies and instruments with only minor adaptations to the end-effectors and surgical tools approved

The key technology in our system is the Avra Intelligent

Instrument Guidance Software (“ AIIGS ”), an image-guided robotic guidance system that receives real-time 3D images,

live sensor inputs from various subsystems to calculate precise orientation of the arm and end-effector over the patient in real-time

during a procedure, ultimately allowing precision delivery of treatment to any area of the human body that is beyond the capabilities

of a human being, and which should allow for more optimal and consistent treatments.

The various image capture and sensor subsystems are

outlined below and include, 2D image capture, 3D image capture and tracking, distance sensors, and touch sensors.

We expect the AIIGS

capability should then be relatively easily employed to support other surgical procedures beyond skin resurfacing, such as skin and wound

care, drug delivery, tattoo removal, cellulite reduction, biopsies and Mohs surgery, to name a few.

In the case of facial micro-needling, through

our proprietary intuitive graphic user interface, the doctor will be able to acquire a high-resolution depth map of the patient’s

face and superimpose a trajectory map over Aesthetic Regions-of-Interest (“ AROIs ”).

The doctor would then accept the

suggested treatment protocol or assign specific micro-needling parameters to each AROI.

AIIGS will autonomously control the arm and end-effector

to follow a predetermined path based on the doctor’s specified parameters for each AROI, and continuously calculate the current

and desired position over the sequential AROIs to ensure the precise treatment parameters are met.

It will also reorient the end-effector

so it is perpendicular to each AROI to ensure optimal application of micro-needling injection, and with the precise pressure needed, accounting

for patient movement in real-time.

Our medical robotic subsystems modules are outlined

Areas of continuous development work include AI, DL, and medical robotic safety guidelines.

While we plan to continue to develop our own custom

robotic arm we are using an existing robotic arm that has been specifically developed under medical device standards and that meets all

of our requirements for a robotic arm.

The robot is classified as a lightweight robot and is a jointed-arm robot with seven axes.

drive units and current-carrying cables are routed inside the robot.

Every axis contains multiple sensors that provide signals for robot

control (e.g.

position control and impedance control) and that are also used as a protective function for the robot.

Every axis is monitored

axis range sensors ensure that the permissible axis range is adhered to, torque sensors ensure that the permissible axis loads

are not exceeded, and temperature sensors monitor the thermal limit values of the electronics.

Our medical robotic system requires high levels

of accuracy and repeatability.

Repeatability is a measure of the ability of the robot to consistently reach a specified point in 3D space

Accuracy is a measure of the distance error between the commanded point and the achieved point.

Accuracy can be improved with

external sensing, for example proximity, vision system or infra-red.

For skin resurfacing, technological improvements

in motors, materials and in high resolution imaging allow for the use of robotic devices to assist the surgeon to autonomously treat damaged

Presently, we are not aware of any commercially available robotic devices designed for this application.

Application of Artificial Intelligence and

Deep Learning

Artificial intelligence, or AI, refers to software

technologies that make a robot or computer act and think like a human.

Some software engineers state that it is only artificial intelligence

if it performs as well or better than a human.

In this context, when we talk about performance, we mean human computational accuracy,

speed, and capacity.

Artificial intelligence includes the development

of computer systems that can perform tasks that normally require human intelligence.

Speech recognition, decision-making, visual perception,

for example, are features of human intelligence that artificial intelligence may possess.

Translation between languages is another feature.

Humans can “ learn as we go along .”

In other words, learn from experience.

Machines with AI can also do this, which we call machine learning.

A neural network is an example

of machine learning.

A broad definition of a Deep Learning (“ DL ”)

solution is the implementation of algorithms and techniques that endow machines with the ability to autonomously acquire the skills for

executing complex tasks effectively letting robots acquire their own skills over time.

The term “ learning ” can be

equated to an optimization process.

Optimizing an objective that reflects the actual fitness of the behavior at accomplishing a specific

task, such as a robot learning optimal trajectory, where the objective is to traverse a predetermined trajectory in a timely, safe and

efficient manner.

Telling our AIIGS system to find the optimal trajectory is a very high-level objective.

This cannot be implemented with

simple, static equations that control the robotic arm and end-effector, but with a reinforcement-learning algorithm we can discover the

behavioral skills that optimize the goal.

We will need to choose a “ representation ” for a behavioral skill.

A representation could be a trajectory, a sequence

of points, a motion.

The robot could traverse to a specific point, but will do so from its current pose.

What if you ask it to go to the

same point from a different starting pose?

The same sequence will not work.

It needs to be more flexible to control a more complex movement.

This could be in the form of a feedback controller where it looks at the state, applies a function and outputs the action.

The more flexible

the representation, the greater number of skills can be learned as it relates to a real-world environment.

One choice for a general, flexible representation

is a Large Neural Network (“ LNN ”) that can represent any function;

therefore, they can represent any motor skill.

needs more prior knowledge in order to learn.

This is where sensor feedback is used and integrated.

These can be cameras, tactile sensors,

joint encoders that feed into the LNN, reducing the need to engineer specific perceptions and actions for any input modality.

For non-embodied systems such as image processing

and speech processing, machine learning has been used and is very successful.

This is primarily due to having good supervision.

is very successful when you know what the output should be for a given input.

Deep Learning is a typical machine learning method

which we intend to use extensively for the perception and intelligent control of our medical robotic system.

We intend to apply a DL approach

to detect and recognize facial features and use this information to optimally map, code and plan a trajectory over the individual AROIs

virtually superimposed over a patient’s face.

This is accomplished through “ feature ” learning.

In machine learning

and pattern recognition, a feature is an individual measurable property or characteristic of a phenomenon being observed.

Choosing informative,

discriminating and independent features is a crucial step for effective algorithms in pattern recognition, classification and regression.

DL is typically classified into three categories:

supervised learning, unsupervised learning, and reinforcement learning.

learning, the most common form of machine learning, where the error is measured between the actual and desired output and assigned a

cost function with the goal being to minimize the cost.

Supervised learning can be directly applied to the trajectory the arm and end-effector

follows to arrive at a specific AROI.

Accumulated data will be analyzed and used in future path trajectories.

● Unsupervised

learning does not assign a cost function, but instead aims to find the hidden patterns, structures or features embedded in the collected

Unsupervised learning can be applied to the specific sequence of movements the arm and end-effector traverses to arrive at a specific

AROI at the proper orientation and at the proper pressure.

This varies with each patient’s skin type as well as the curvature and

location on the face.

For example, prior to firing the needles the micro-needling instrument must approach at a perpendicular angle to

the specific AROI and make even and consistent contact with the patient’s skin.

Our AIIGS will accumulate this information and

apply it to future procedures.

reinforcement learning, a software agent is defined to explore and exploit the space of possible strategies.

Feedback in the form of

reward or cost from the dynamic environment is referred as the outcome of the chosen action.

With our medical robotic system, some examples

of functionality where DL will be employed are:

trajectory of the arm and end-effector based on the size and shape of the patient’s head and face;

arm manipulation as it traverses the trajectory;

and safe arm movements;

approach attitude of the micro-needling instrument as it approaches various topographical sections of the patient’s face;

treatment protocols such as depth, energy, time for micro-needling for specific skin types and for each AROI.

Product Description

There are five key elements to our medical robotic

system, all of which can potentially generate revenues:

Standardized robotic arms, precision guidance system, and software controls designed to the needs of doctors and physicians.

This includes elements of AI, DL and related algorithms which may have applications to other fields of work beyond medical and may be

licensed out in the future.

Standardized tools that can be modified to cover a wide range of medical procedures.

Avra plans to sell its robotic systems

while obtaining recurring revenues and high gross margins from its tools, which will need to be replaced, just as they are in the handheld

versions, for each individual procedure.

● Maintenance:

Service contracts supporting ongoing operation and simplified so that much of the support can be performed remotely.

and Training:

Remote and on-site training programs for surgeons, aestheticians, hospitals and medical support staff.

Updates to both the software and algorithms.

Regulatory Strategy

Our products and operations will be subject to

extensive regulation in the U.S.

by the FDA and by similar agencies in other countries or regions in which we may market our medical robotic

In order to smooth our market entry a comprehensive regulatory strategy has been devised where we create robust preclinical and

clinical data supporting our product’s claims and proving the Avra Medical Robotic Arm is safe and will perform as intended.

plan to employ four tiers of tightly interrelated activities.

The specific undertaking in each of the tiers will be coordinated in advance

with each regulatory jurisdiction where we intend to offer the product line for sale (the U.S., Canada, the European Union, Brazil, Japan

and Australia).

The four tiers are:

Preclinical testing of the system

(the controller, the computer, the arm and the end-effector.) Preclinical testing encompasses testing without using the device on human

Key facets of preclinical testing are electrical safety, EMC and EMI testing;

integration testing of the system elements and

the development of a clinical training program.

Software involves all elements of

the arm’s operations.

The documentation required to demonstrate safety and effectiveness is comprehensive.

Each task within a process

is mapped and controlled.

A risk matrix is established to guide the software development and also to play the pivotal role in verification,

validation and testing.

Proof of concept testing follows

preclinical and software.

In proof of concept we demonstrate the arm and its end-effector operation and that even someone with little

robotic experience can successfully use the arm within the indications for use and for the purposes intended.

A three-stage demonstration

will be undertaken first on animals of various sizes and weights;

then on human cadavers of various sizes and weights and finally on a

small cohort of human subjects.

Each stage must be successfully completed before the next stage is undertaken.

The final stage (human

proof of concept testing) will be under the supervision of an Institutional Review Board (“ IRB ”) or similar ethics

The strength of our testing to date

has two aims — address all aspects of risk and second to minimize the size and expense of a human clinical trial.

It is our belief

that any remaining element of risk or uncertainty will only require a small sample size (50 or less).

Regardless of the sample size the

human clinical trial shall have a performance endpoint and a safety endpoint that will serve as milestones to measure the outcome.

To support our ongoing compliance the company

plans to become registered to the requirements of EN ISO 13485, the U.S.FDA QSR, ANVISA from Brazil, TGA from Australia, Health Canada,

Japanese MHLW and CE Marking under new Medical Device Regulations.

To achieve this with minimal expense, we plan to use a Medical Device

Single Audit Program (“ MDSAP ”) Auditing Organization that is also a European Notified Body.

Unless an exemption applies, each medical device

that we intend to market in the U.S.

must first receive either “ 510(k) clearance ” or “ Premarket (PMA) approval ”

from the FDA pursuant to the Federal Food, Drug, and Cosmetic Act.

The FDA’s 510(k) clearance process usually takes from four to

12 months, but it can last longer.

The process of obtaining PMA approval can be more costly, lengthy and uncertain.

It generally takes

from one to three years or even longer.

The FDA decides whether a device must undergo

either the 510(k) clearance or PMA approval process based upon statutory criteria.

These criteria include the level of risk that the agency

perceives is associated with the device and a determination whether the product is similar to devices that are already legally marketed.

Devices deemed to pose relatively less risk are placed in either class I or II, which requires the manufacturer to request 510(k) clearance,

unless an exemption applies.

The manufacturer must demonstrate that the proposed device is “ substantially equivalent ”

in intended use, safety and effectiveness to a legally marketed “ predicate device ” that is either in class I, class

II, or is a “ pre-amendment ” class III device, one that was in commercial distribution before May 28, 1976, for which

the FDA has not yet called for submission of a PMA application.

After a device receives 510(k) clearance, any modification to the device

that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new

510(k) clearance or could require a PMA approval.

Devices deemed by the FDA to pose the greatest

risk, such as life-sustaining, life-supporting, or devices deemed not substantially equivalent to a legally marketed predicate device,

are placed in class III.

Such devices are required to undergo the PMA approval process in which the manufacturer must prove the safety

and effectiveness of the device to the FDA’s satisfaction.

PMA application must provide preclinical and clinical

trial data as well as information about the device and its components regarding, among other things, device design, manufacturing and

As part of the PMA review, the FDA will inspect the manufacturer’s facilities for compliance with cGMP and QSR requirements,

which include elaborate testing, control, documentation and other quality assurance procedures.

During the FDA’s review, an FDA

advisory committee, typically a panel of clinicians, likely will be convened to review the application and recommend to the FDA whether,

or upon what conditions, the device should be approved.

Although the FDA is not bound by the advisory panel decision, the panel’s

recommendation is important to the FDA’s overall decision-making process.

If the FDA’s evaluation of the PMA application is

favorable, the FDA typically issues an “approvable letter” requiring the applicant’s agreement to comply with specific

conditions or to supply specific additional data or information in order to secure final PMA approval.

Once the approvable letter conditions are satisfied,

the FDA will issue a PMA order for the approved indications, which can be more limited than those originally sought by the manufacturer.

The PMA order can include post-approval conditions that the FDA believes necessary to ensure the safety and effectiveness of the device

including, among other things, restrictions on labeling, promotion, sale and distribution.

Failure to comply with the conditions of approval

can result in an enforcement action, including withdrawal of the approval.

After approval of a PMA, a new PMA or PMA supplement may be

required in the event of modifications to the device, its labeling or its manufacturing process.

A clinical trial may be required to support a

510(k) submission and generally is required for a PMA application.

Such trials generally require an Investigational Device Exemption,

or IDE, application be approved in advance by the FDA for a specified number of patients and study sites, unless the product is deemed

an insignificant risk device eligible for more abbreviated IDE requirements.

The IDE must be supported by appropriate data, such as animal

and laboratory testing results.

Clinical trials may begin if the FDA and the appropriate institutional review boards at the clinical trial

sites approve the IDE.

Trials must be conducted in conformance with FDA regulations and institutional review board requirements.

In order for us to market our products in other

countries, we must obtain regulatory approvals and comply with safety and quality regulations in those countries.

These regulations, including

the requirements for approval or clearance and the time required for regulatory review, vary from country to country.

To expedite securing approvals to market, we initially

retained the services of HPG, a consulting firm experienced in securing U.S.

and foreign approvals to market medical devices.

and filed an application with the FDA for our initial medical robotic system and participated in the initial pre-collaboration meeting

with the FDA in August 2019.

This is the first of a series of meetings where the Avra system and its regulatory requirements will be discussed

in ever-increasing specificity.

We believe that this should allow us to closely focus on only the meaningful activities saving both resources

The robotic arm we will utilize for our system has already been approved in the EU and received a CE mark.

The Company has 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 our medical robotic system.

The Medical Device Single Audit Program, which we are employing, is a single inspection

that, when completed, is expected to support market access to these six most important medical device marketplaces.

Our regulatory strategy has been designed so that

once the first treatment is approved then following treatments, such as those using lasers, should enjoy a much quicker time to approval.

Our expected timeline may change depending on available resources and FDA response times.

We plan to be registered via the MDSAP in accordance

with the requirements of the U.S.

FDA, Health Canada, Australian TGA, MHLW Japan, ANVISA of Brazil and the EU Medical Device Regulation,

and plan to have completed integration testing for the system (controller, computer, arm, cabling, end-effector and the software) for

at least two medical systems within two years of receipt of required funding.

Depending upon the terms of our agreement with

the FDA on the need for and depth of proof of concept and clinical trial testing we believe that we should have completed the proof of

concept and human clinical trial portion within one year of our agreement with them.

We would then hold market clearances for our robotic

system from the U.S.

FDA, Health Canada, and CE Marking under the European Medical Directive.

At around the same time, we believe that

we will have made substantial progress toward market clearances in Australia, Japan and Brazil.

Manufacturing and Sources of Supply

We plan to initially assemble our systems in our

own facilities and will only begin using contract manufacturers when the volume of systems being sold becomes sufficiently large to justify

Most of the components used in our initial medical robotic system consist of existing hardware technologies relatively easily

available from multiple sources.

We will then make any required modifications to allow them to be assembled on site.

Recent advances in

such manufacturing techniques as 3D printing should allow us to do so relatively quickly.

The software integration into our initial medical

robotic system, calibration and testing is expected to be done on site as well.

We have already identified potential manufacturers for

the modified end-effectors, such as the microneedling tool, and other components we will integrate into the system.

Intellectual Property

Our proprietary software and algorithms are expected

to be one of the greatest value drivers for the Company.

The software and AI links all our robotic system’s various sensors, systems

and tools and allows them to work seamlessly together to complete procedures autonomously given the treatment parameters provided by the

To date, we have submitted six provisional patents

which, upon further review internally with our IP counsel, were subsequently combined into one (1) international utility patent application.

This consolidation brought together the various parts of our AIIGS.

In addition, it included broad device claims involving the combination

of a navigation system, sensors, a variety of end-effectors, and the robotic arm.

The national stages of the international patent application

were then submitted in the U.S.

in July 2018 and in Brazil in December 2018.

In April 2018, we also submitted a U.S.

design patent application,

specifically applied to the robotic arm segment housing.

This design patent application was subsequently filed in Canada in October 2019.

We intend to continue filing, as necessary, patent

applications in the U.S., as well as in other jurisdictions where we intend to market our products and where the dates of our initial

patent applications will give us a right of priority.

We also expect to accumulate a tremendous amount

of data as needed for its AI and DL systems.

This should result in continuous improvements in patient outcomes.

This proprietary data

should not only be of value to Avra, but may also be of value to third parties in the aesthetics world.

Research Partnership with UCF

Effective as of May 2016, we entered into a Research

Agreement with UCF (the “ Research Agreement ”) establishing a research partnership for the development of a prototype

surgical robotic device supporting minimal invasive surgical facial corrections.

Pursuant to the Research Agreement, UCF provided personnel

for the development of prototype navigation and control software for the robotic medical device and the integration of all the necessary

subcomponents.

UCF engineering doctoral students under the direction of Professor of Electrical Engineering Zhihua Qu assisted Avra with

its research and development efforts in autonomous medical robotics pursuant to the Research Agreement, which was extended several times

and finally expired in April 2021.

We provided funding of $163,307 for the project, which was supplemented by a $68,952 matching funds

grant from the Florida High Tech Corridor Council.

In addition, Avra paid UCF $43,548 for outright ownership of work developed by UCF

in the collaboration.

The development and commercialization of medical

devices is highly competitive.

We will compete with a variety of multinational companies and specialized medical device companies, as

well as technology being developed at universities and other research institutions.

As our technology would replace current handheld

solutions, our natural competition would be existing manufacturers of those handheld devices such as Hologic’s Cynosure, Syneron

Medical, and Lumenis.

The current aesthetics device market is fragmented with no single company dominating the sector, particularly in

the laser and micro-needling segments.

Based on our research and communications with the FDA, we are not currently aware of any companies

developing an autonomous robotic approach to aesthetics procedures.

As our strategy includes building a robotic platform

system that would work with any handheld device, we are not tied to any particular treatment or device and could potentially partner with

manufacturers of any particular end-effector technology versus competing with them.

This strategy also ensures that our aesthetics solutions

never become outdated as we would only need to adapt emerging end-effector instrumentation and technology to our robotic system.

As of the date of this report the Company has

four full-time and six part-time employees, including certain executive officers.

We also rely on independent third-party consultants

to perform additional services as needed.

As we implement our business plan and subject to the availability of capital, additional employees

will be hired to meet the needs of our growth.

We currently have agreements with several individuals, particularly in the software, artificial

intelligence and engineering disciplines, who are currently working on a part-time basis, but will become full-time Avra employees upon

Pursuant to the Merger Agreement, Merger Sub

will merge with and into SSI – DE (the “ Merger ”).

In the Merger, holders of the outstanding shares of common

stock of SSI – DE at closing (including certain parties providing Interim Financing as described below), will receive in exchange

for their SSI – DE shares, such number of shares of AVRA common stock as will result in such holders owning 95% of the outstanding

post-Merger shares of AVRA common stock, with the current shareholders of AVRA owning 5% of the outstanding post-Merger shares of AVRA

common stock.

In addition to the foregoing, upon completion

of the Merger, the holders of SSI – DE common stock will receive, pro rata, shares of newly designated Series A Non-Convertible

Preferred Stock (the “ Series A Preferred Shares ”).

The Series A Preferred Shares will vote together

with Shares of our common stock as a single class on all matters presented to a vote of stockholders, except as required by law and entitle

the holders of the Series A Preferred Shares to exercise 51.0% of the total voting power of the Company.

The Series A Preferred Shares

are not convertible into common stock, do not have any dividend rights and have a nominal liquidation preference.

The Series A Preferred

Shares also have certain protective provisions, such as requiring the vote of a majority of Series A Preferred Shares to change or amend

their rights, powers, privileges, limitations and restrictions.

The Series A Preferred Shares are automatically redeemable by the Company

for nominal consideration at such time as the holder owns less than 50% of the shares of AVRA common stock received in the Merger.

Concurrent with consummation of the Merger, Dr.

Srivastava will assign the SSI Intellectual Property being utilized by SSI – India in the development, manufacture and sale of its

robotic surgical system to a subsidiary of AVRA.

In exchange for such assignment, Dr.

Srivastava will receive a royalty of three percent

(3%) of net revenues (gross revenues less cost of goods sold) generated from the sale or license of products using the SSI Intellectual

In addition, at closing, the current directors

and executive officers will resign, other than Barry Cohen, who will continue as a director and in a new executive capacity, and the designees

of the SSI – DE stockholders will be appointed to AVRA’s board of directors and management.

Post – Merger, AVRA intends

to focus a significant part of its efforts on expanding and further developing the business of SSI-India, which will be an indirect majority-owned

subsidiary of AVRA.

In addition to customary closing conditions, consummation

of the Merger is subject to the following conditions to be satisfied or waived by SSI – DE and Dr.

Srivastava at or prior to consummation

of the Merger:

● AVRA shall have changed its corporate name to “SS Innovations,

● AVRA shall have implemented a one for ten reverse stock split;

● AVRA shall have increased its authorized common stock to

250,000,000 shares.

The Merger Agreement, the Merger and the above

corporate actions have been approved by AVRA’s board of directors and majority stockholders.

They are subject to the final processing

of an Issuer Company – Related Action Notification Form, which we have filed with the Financial Industry Regulatory Authority and

the filing of appropriate amendments to our Articles of Incorporation with the Florida Secretary of State.

Interim Financing

As contemplated by the Merger Agreement, pending

consummation of the Merger, we have provided SSI – DE and its affiliates, a total of $5,000,000 in interim financing as of the date

of this Report (the “ Interim Financing ”).

The Interim Financing is evidenced by one-year promissory Notes made in favor

of the Company by SSI-DE and its affiliates, including Dr.

Srivastava, jointly and severally (the “ SSI Notes ”).

on the SSI Notes accrues at the rate of 7% per annum, payable together with the principal amount at maturity.

The SSI Notes have an original

issue discount of 10% for the first $2,000,000 and 6% for the balance.

If the SSI Notes are not repaid in full on or at maturity, they

will automatically convert into a percentage equity interest in SSI-DE determined by dividing the principal amount of accrued interest

on the SSI Notes divided by $100 million.

The SSI Notes contain customary default provisions and other typical terms and conditions.

Prior to consummation of the Merger, we may make

additional advances to SSI – DE and its affiliates, evidenced by additional SSI Notes.

These SSI Notes will be substantially similar

in form and substance to the initial SSI Notes, provided, however, that SSI Notes issued in excess of an aggregate principal amount of

$2,000,000, will have an original issue discount of 6% as opposed to 10%, and the valuation for determining conversion may be $250 million

as opposed to $100 million.

In order to fund the Interim Financing, the Company

offered and sold to two accredited investors, a total of $3,000,000 and $2,000,000 in principal amount of one-year convertible promissory

notes (the “ Convertible Notes ”), respectively.

The Convertible Notes will have the same interest rate and payment terms

as the SSI Notes and otherwise be substantially similar to the SSI Notes, provided, however, that the Convertible Notes do not have an

original issue discount.

Further, upon consummation of the Merger (if and when it is consummated) the Convertible Notes will automatically

convert into a number of shares of AVRA common stock determined by dividing the principal amount of the Convertible Notes by $100 million

and multiplying such number expressed as a percentage by the number of AVRA shares of common stock issued to the stockholders of SSI-DE

upon consummation of the Merger.

The Convertible Notes were issued in private transactions

pursuant to the exemptions from registration under Section 4(a)2 of the Securities Act of 1933, as amended and the rules and regulations

promulgated thereunder.

Pending the Merger, each of AVRA and SSI–DE

and its affiliates may seek to secure additional equity or debt financing, including, without limitation, further Interim Financing.

As of the date of this report the Company has two full-time and three

part-time employees, including certain executive officers.

We also rely on independent third-party consultants to perform additional services

Risk Factors.

4 unchanged sentences

Not applicable.

The Company currently does not own any properties

but leases an office from UCF at 3259 Progress Drive, Suite 114, Orlando, FL 32826 under a lease expiring July 31, 2023, at a rental of

$2,082.64 per month.

The Company currently does not own any properties but leases an office

from UCF at 3259 Progress Drive, Orlando, FL 32826 under a lease expiring July 31, 2023, at a rental of $404.68 per month.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business