What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-05-15 compared with 2022-11-30 · 23 added, 174 removed, 119 unchanged (62% of the section changed)

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of Financial Condition and Results of Operations.

When used in this report, unless otherwise indicated,

the terms “ Avra ,” “ the Company ,” “ we ,” “ us ” and “ our ”

refer to Avra Medical Robotics, Inc.

Note Regarding Forward Looking Statements

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healthcare, robotic 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.

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:

cost per treatment.

treatment accuracy.

treatment outcomes.

patient throughput and revenue generation for the physician.

multi-platform integration.

shortfall of physicians/surgeons.

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 U.S.

Food and Drug Administration (the “ FDA ”).

is to integrate the robotic arm with FDA approved devices, which is expected to allow for a more expedited approval of the integrated

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 The Horizon

Phoenix Group (“ HPG ”), a consulting firm experienced in securing U.S.

and foreign regulatory approvals 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 August 2019 held an initial pre-collaboration meeting with 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.

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 U.S., Canadian, European, Australian, Japanese, and Brazilian 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 University of Central Florida (“ 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 April 30, 2021.

To further the depth of our research and development

we also began a partnership in 2021 with Florida Polytechnic University and are actively working with them on developing our system.

recently brought in two Associate Professors and a graduate to join Avra’s engineering development team.

Effective October 11 th ,

2021 Avra executed a Sponsored Student Project Agreement which included two payments of $8,030 each covering Fall semester in 2021 and

Spring semester in 2022.

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.

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 November 7, 2022 (the “ Merger Agreement ”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware

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

Sudhir Srivastava (“ Dr.

Srivastava ”), who, through his holding company, owns a controlling interest in SSI-DE.

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 ”).

Pursuant to the Merger Agreement, Avra (which

will change its name to SS Innovations International, Inc.), will acquire an indirect controlling interest in SSI India and ownership

of the SSI Intellectual Property and Dr.

Srivastava will become the Company’s controlling shareholder.

On April 14, 2023, a wholly-owned subsidiary of

the Company merged with CardioVentures, Inc., a Delaware corporation, which is the indirect parent of Sudhir Srivastava Innovations Pvt.

Ltd., (“ SSI India ”) an Indian private limited company engaged in the business of developing innovative surgical robotic

technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population.

SSII’s product range includes its proprietary “SSI Mantra” surgical robotic system and a wide range of surgical instruments

capable of supporting a variety of cardiac and other surgical procedures.

The Company now intends to focus on the business of SSI-India

and has plans to globally expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions.

As a result of the transaction, a “ change

in control ” of the Company took place.

In addition, among other matters, the Company changed its name to “ SS Innovations

International, Inc.

” and implemented a one for ten reverse stock split.

The financial statements and financial information contained

in this report only reflect the operations of the Company prior to the acquisition and do not give pro forma effect to the reverse stock

See Note 6 to the Notes to Financial Statements

included in Part I, Item 1 of this report for additional details regarding the acquisition.

Results of Operations

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Total Liabilities

Total Stockholders’ Deficit

Total Stockholders’ Equity

To date, the Company has relied on debt and equity

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a shortfall in operating capital, we could be faced with having to limit our research and development activities.

Three months ended March 31, 2022, as compared

to three months ended March 31, 2021

Three months ended March 31, 2023, as compared to

three months ended March 31, 2022

We had no revenues during either

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We had compensation

expense of $28,240 and $219,600 during the three months ended no revenues during either the three months ended March 31, 2022 and March

expenses of $1,592,309 and $28,240 during the three months ended no revenues during either the three months ended March 31, 2023 and March

31, 2022, respectively.

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Other Income/Expenses .

We had $35 in interest

in the first three quarters of 2022 as compared to $22 of other expenses during the three months ended March 31, 2021 consisting of interest

We had $52,747 in

the first three quarters of 2023 as compared to $35 of other expenses during the three months ended March 31, 2022 consisting of interest

expense related to loans.

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development activities.

During the period from inception (February 4,

2015) through March 21, 2020, the Company raised (a) $1,900 from an initial private offering of its common stock in February 2017;

$480,000 from the private offering of the convertible notes completed in June 2017;

of common stock at a price of $1.00 per share completed in February 2017;

(d) $542,260 from a private offering of 433,808 shares of stock

in a private offering at a price of $1.25 per share completed in September 2017;

and (e) $20,000 from the private sale of 16,000 shares

of our common stock at a price of $1.25 per share in August 2018.

In March 2019, the Company sold 7.5 Units in a

private offering of ten (10) units (“ Units ”), each Unit consisting of a $10,000 principal amount six-month 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 $1.25 per share.

In addition to the foregoing, from December 2018

thru March 2020, the Company obtained fourteen loans from Barry F.

Cohen, our Chief Executive Officer totaling $468,500.

The loans were

due 12 months from funding date and did not bear interest.

With the exception of two loans totaling $145,000, all of these loans were

subsequently repaid in full via conversions into restricted company shares or Units including one loan for $100,000 which was used to

exercise a stock option for 1,000,000 shares held by Mr.

In October 2020 the Company raised $301,027 through

the sale of 301,027 Units.

Each Unit gave the investor four restricted common shares, five warrants with an exercise price of $0.40 per

share, and one put option for one of the Company’s restricted common shares.

In December 2020 the Company raised $227,700 through

the sale of 227,700 Units.

Each Unit gave the investor four restricted common shares and five warrants with an exercise price of $0.40

The Company’s CEO participated in this investment by agreeing to use 202,700 of Notes due to him from the Company to

purchase 202,700 Units.

In January 2021 the Company raised $235,000 through

the sale of 235,000 Units.

Each Unit gave the investor four restricted common shares and five warrants with an exercise price of $0.40

In the fourth quarter of 2021 the Company raised

a total of $315,200 from six accredited investors by selling 2,229,231 shares of the Company’s restricted common stock at prices

ranging from $0.13 per share to $0.52 per share.

While we have been successful in raising

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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-Q

Item 2. Management’s Discussion and Analysis