What changed in this filing

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Item 1A. Risk Factors

2024-03-29 compared with 2023-03-31 · 192 added, 143 removed, 219 unchanged (60% of the section changed)

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are an early-stage company with a history of losses.

incurred net losses of $ 4,639,662 and $4,664,412 for the year ended December 31, 2022 and

2021, respectively.

We have not generated any revenue to date, and we had accumulated deficit of $ 15,307,366

as of December 31, 2022.

We have developed our Sharps Provensa product line but there can be no assurance that it will be commercially

Our potential profitability is dependent upon a number of factors, many of which are beyond our control.

incurred net losses of $9,841,638 and $4,639,662 for the year ended December 31,2023 and 2022, respectively.

We have not generated any

revenue to date, and we had accumulated deficit of $25,149,004 as of December 31, 2023.

We have developed our Sharps product

line but there can be no assurance that it will be commercially successful.

Our potential profitability is dependent upon a number of

factors, many of which are beyond our control.

we are unable to achieve and sustain profitability, the value of our business and common stock may significantly decrease.

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have a limited operating history, and we may not succeed.

We have not yet commercialized our Sharps Provensa or other products.

consider, among other factors, our prospects for success in light of the risks and uncertainties encountered by companies that, like

us, are in their early stages.

For example, unanticipated expenses, problems, and technical difficulties may occur and they may result

in material challenges to our business.

We may not be able to successfully address these risks and uncertainties or successfully implement

our operating strategies.

If we fail to do so, such failure could have a material adverse effect on our business, financial conditions

and results of operation.

We may never generate significant revenues or achieve profitability.

may not succeed in commercializing Sharps syringe products or any future product.

may face difficulties or delays in the commercialization of Sharps Provensa or any future products, which could result in our inability

We have commercialized our Securgard syringe products in mid 2023 yet no revenues

have occurred and have not yet commercialized our Sharps Provensa products.

You should consider, among other factors, our prospects for

success in light of the risks and uncertainties encountered by companies that, like us, are in their early stages.

For example, unanticipated

expenses, problems, and technical difficulties may occur and they may result in material challenges to our business.

We may not be able

to successfully address these risks and uncertainties or successfully implement our operating strategies.

If we fail to do so, such failure

could have a material adverse effect on our business, financial conditions and results of operation.

We may never generate significant

revenues or achieve profitability.

may not succeed in commercializing Sharps products or any future product.

may face difficulties or delays in the commercialization of Sharps products, which could result in our inability

to timely offer products or services that satisfy the market.

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brand recognition and loyalty for our products.

addition, to increase our production capacity, we will need to build inventory, which will require that we purchase certain additional

equipment, including molding machines and molds.

We have not received any orders to date.

Even if we succeed in building inventory, and

increasing our production capacity, there is no assurance we will receive any orders for our Sharps Provensa or any future products.

addition, to increase our production capacity, we will need to build inventory, which will require that we purchase certain

additional equipment, including molding machines and molds.

We have not received any significant orders to date.

Even if we succeed

in building inventory, and increasing our production capacity, there is no assurance we will receive additional orders for our Sharps

= products or any future products.

may encounter significant competition and may not be able to successfully compete.

are many medical device companies offering safety syringes, and more competitors are likely to arrive.

Some of our competitors have

considerably more financial resources than us.

As a result, we may not be able to successfully compete in our market, which could

result in our failure to successfully commercialize Sharps disposable syringe products or otherwise fail to successfully compete.

anticipate that our major domestic competitors will include Retractable Technologies, Inc., Becton, Dickinson & Company,

Medtronic Minimally Invasive Therapies, Terumo Medical Corp., Smiths Medical, and B Braun.

There can be no assurances that we will

be able to compete successfully in this environment.

Some of our competitors have considerably

more financial resources than us.

As a result, we may not be able to successfully compete in our market, which could result in our failure

to successfully commercialize Sharps disposable syringe products or otherwise fail to successfully compete.

We anticipate that our major

domestic competitors will include Retractable Technologies, Inc., Becton, Dickinson & Company, Medtronic Minimally Invasive Therapies,

Terumo Medical Corp., Smiths Medical, and B Braun.

There can be no assurances that we will be able to compete successfully in this environment.

are vulnerable to new technologies.

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our products from being marketed abroad.

order to market and sell our syringe product line and any additional medical device products we may develop in the future in

the European Union and many other jurisdictions, we, and our collaborators, must obtain separate marketing approvals and comply with

numerous and varying regulatory requirements.

We have not yet received approval or clearance to sell our products in any jurisdiction

outside the United States.

order to market and sell our Provensa product line and any additional medical device products we may develop in the future in the European

Union and many other jurisdictions, we, and our collaborators, must obtain separate marketing approvals and comply with numerous and

varying regulatory requirements.

We have not yet received approval or clearance to sell our products in any jurisdiction outside the

United States.

The approval procedure varies among countries and may involve additional testing.

We may conduct clinical

trials for, and seek regulatory approval to market, our product candidates in countries other than the United States.

We may conduct clinical trials for,

and seek regulatory approval to market, our product candidates in countries other than the United States.

If we or our collaborators

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regulation of our products may limit how we market our products, which could materially impair our ability to generate revenue.

or clearance of a medical device product may carry conditions that limit the market for the product or put the product at a

competitive disadvantage relative to alternative products.

For instance, a regulatory approval or clearance may limit the indicated

uses for which we can market a product or the patient population that may utilize the product.

These restrictions could make it more

difficult to market any product effectively.

Accordingly, we expect to continue to expend time, money and effort in all areas of

regulatory compliance.

or clearance of a medical device product may carry conditions that limit the market for the product or put the product at a competitive

disadvantage relative to alternative products.

For instance, a regulatory approval or clearance may limit the indicated uses for which

we can market a product or the patient population that may utilize the product.

These restrictions could make it more difficult to market

any product effectively.

Accordingly, we expect to continue to expend time, money and effort in all areas of regulatory compliance.

are dependent on our management;

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care crises could have an adverse effect on our business.

during 2020, several states and local jurisdictions imposed, and others in the future may impose, “shelter-in-place”

orders, quarantines, executive orders and similar government orders and restrictions for their residents to control the spread of

Although the manufacturing facility we operate has continued to operate during the 2020-2021 COVID-19 pandemic due to its

status as an essential business, we continue to monitor the evolving situation and cannot guarantee that the situation would be the

same for any future pandemic.

In the future, we may elect or be required to close temporarily which would result in a disruption in

our activities and operations.

Our supply chain, including transportation channels, may be impacted by any such restrictions as

Any such disruption could impact our sales and operating results.

during 2020, several states and local jurisdictions imposed, and others in the future may impose, “shelter-in-place” orders,

quarantines, executive orders and similar government orders and restrictions for their residents to control the spread of COVID-19.

the manufacturing facility we operate continued to operate during the 2020-2021 COVID-19 pandemic due to its status as an essential

business, we cannot guarantee that the situation would be the same for any future pandemic.

In the future, we may elect or be required to close temporarily which would result in a disruption in our activities and operations.

Our supply chain, including transportation channels, may be impacted by any such restrictions as well.

Any such disruption could impact

our sales and operating results.

health crises also negatively affect economies which could affect demand for our products.

While we plan to market our Sharps smart

safety syringe products for use for injecting medicines as well as Covid-19 and other vaccines, in the event of a resurgence of

COVID-19 or in the case of any future pandemic, there is no guarantee that revenues from syringes needed for vaccines would offset

the effects to our business in a global economic decline.

systems and other healthcare providers in our markets that provide procedures that may use our products have suffered financially

and operationally and may not be able to return to pre-pandemic levels of operations.

Travel and import restrictions may also

disrupt our ability to manufacture or distribute our devices.

Any import or export or other cargo restrictions related to our

products, or the raw materials used to manufacture our products could restrict our ability to manufacture and ship products and harm

our business, financial condition, and results of operations.

key personnel and other employees could still be affected by COVID-19 or any future pandemic, which could affect our ability to operate

While we plan to market our Sharps smart safety

syringe products for use for injecting medicines as well as Covid-19 and other vaccines, in the event of a resurgence of COVID-19 or

in the case of any future pandemic, there is no guarantee that revenues from syringes needed for vaccines would offset the effects to

our business in a global economic decline.

systems and other healthcare providers in our markets that provide procedures that may use our products have suffered financially and

operationally and may not be able to return to pre-pandemic levels of operations.

Travel and import restrictions may also disrupt our

ability to manufacture or distribute our devices.

Any import or export or other cargo restrictions related to our products, or the raw

materials used to manufacture our products could restrict our ability to manufacture and ship products and harm our business, financial

condition, and results of operations.

key personnel and other employees could still be affected by any future pandemic, which could affect our ability to operate

business may be adversely affected by uncertainties in obtaining and enforcing intellectual property rights.

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commercially exploiting products similar to ours.

have three issued patents, three pending patent applications in the United States, and one PCT (Patent Cooperation Treaty) patent application.

have four issued patents, two pending patent applications in the United States, and four PCT (Patent Cooperation Treaty) patent application.

We cannot be certain that we are the first inventor of the subject matter to which we have filed a particular patent application, or

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common stock could be subject to extreme volatility.

trading price of our common stock may be affected by a number of factors, including events described in the risk factors set forth

in this annual report, as well as our operating results, financial condition and other events or factors.

In addition to the

uncertainties relating to future operating performance and the profitability of operations, factors such as variations in interim

financial results or various, as yet unpredictable, factors, many of which are beyond our control, may have a negative effect on the

market price of our common stock.

In recent years, broad stock market indices, in general, and smaller capitalization companies, in

particular, have experienced substantial price fluctuations.

In a volatile market, we may experience wide fluctuations in the market

price of our common stock and wide bid-ask spreads.

These fluctuations may have a negative effect on the market price of our common

In addition, the securities market has, from time to time, experienced significant price and volume fluctuations that are not

related to the operating performance of particular companies.

These market fluctuations may also materially and adversely affect the

market price of our common stock.

trading price of our common stock may be affected by a number of factors, including events described in the risk factors set forth in

this annual report, as well as our operating results, financial condition and other events or factors.

In addition to the uncertainties

relating to future operating performance and the profitability of operations, factors such as variations in interim financial results

or various, as yet unpredictable, factors, many of which are beyond our control, may have a negative effect on the market price of our

common stock.

In recent years, broad stock market indices, in general, and smaller capitalization companies, in particular, have experienced

substantial price fluctuations.

In a volatile market, we may experience wide fluctuations in the market price of our common stock and

wide bid-ask spreads.

These fluctuations may have a negative effect on the market price of our common stock.

In addition, the securities

market has, from time to time, experienced significant price and volume fluctuations that are not related to the operating performance

of particular companies.

These market fluctuations may also materially and adversely affect the market price of our common stock.

have never paid common stock dividends and have no plans to pay dividends in the future, as a result our common stock may be less valuable

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of shares of our common stock are entitled to receive such dividends as may be declared by our Board of Directors.

To date, we have

paid no cash dividends on our shares of common stock, and we do not expect to pay cash dividends on our common stock in the

foreseeable future.

To date, we have paid

no cash dividends on our shares of common stock, and we do not expect to pay cash dividends on our common stock in the foreseeable future.

We intend to retain future earnings, if any, to provide funds for operations of our business.

Therefore, any

return investors in our common stock will be in the form of appreciation, if any, in the market value of our shares of common stock.

There can be no assurance that shares of our common stock will appreciate in value or even maintain the price at which our

stockholders have purchased their shares.

Therefore, any return investors in our

common stock will be in the form of appreciation, if any, in the market value of our shares of common stock.

There can be no assurance

that shares of our common stock will appreciate in value or even maintain the price at which our stockholders have purchased their shares.

shares will be subject to potential delisting if we do not maintain the listing requirements of the Nasdaq Capital Market.

has rules for continued listing, including, without limitation, minimum market capitalization and other requirements.

Failure to maintain

our listing, or de-listing from Nasdaq, would make it more difficult for shareholders to dispose of our common stock and more difficult

to obtain accurate price quotations on our common stock.

shares of our common stock are listed on the Nasdaq Capital Market, or Nasdaq.

Nasdaq has rules for continued listing, including, without

limitation, minimum market capitalization and other requirements.

Failure to maintain our listing, or de-listing from Nasdaq, would make

it more difficult for shareholders to dispose of our common stock and more difficult to obtain accurate price quotations on our common

This could have an adverse effect on the price of our common stock.

to issue additional securities for financing or other purposes, or otherwise to arrange for any financing we may need in the future,

may also be materially and adversely affected if our common stock is not traded on a national securities exchange.

Our ability to issue additional securities for financing or

other purposes, or otherwise to arrange for any financing we may need in the future, may also be materially and adversely affected if

our common stock is not traded on a national securities exchange.

we fail to comply with the continued listing requirements of NASDAQ, we may face possible delisting, which would result in a limited

public market for our shares and make obtaining future debt or equity financing more difficult for us.

Specifically, as disclosed in

a Current Report filed on Form 8-K on July 16, 2023, the Company had received a notice (the “Notice”) from the staff of the

Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company

that it was not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Rule”) because it failed to maintain a minimum bid

price of $1.00 over the previous 30 consecutive business days dated May 26, 2023 to July 11, 2023.

The Rules provide the Company a compliance

period of 180 calendar days in which to regain compliance.

If at any time during this 180 day period the closing bid price of the Company’s

security is at least $1 for a minimum of ten (10) consecutive business days, the Staff will provide written confirmation of compliance

and this matter will be closed.

January 16, 2024, the Staff determined that the Company is eligible for an additional 180 calendar day period, or until July 8, 2024,

to regain compliance.

The Staff’s determination is based on the Company meeting the continued listing requirement for market value

of publicly held shares and all other applicable requirements for initial listing on the Capital Market with the exception of the bid

price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period

by effecting a reverse stock split, if necessary.

However, if it appears to the Staff that the Company will not be able to cure the deficiency,

the Staff will provide notice that its securities will be subject to delisting.

The Company will continue to monitor the closing bid

price of its Common Stock and will consider its available options to resolve the deficiency and regain compliance with the Minimum Bid

Price Requirement within the allotted compliance period.

There can be no assurance that the Company will regain compliance with the Minimum

Bid Price Requirement.

will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time

to compliance with our public company responsibilities and corporate governance practices.

a public company, we will incur significant legal, accounting and other expenses, which we

expect to further increase after we are no longer an “emerging growth company.” The Sarbanes-Oxley Act, the Dodd-Frank Wall

Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Capital Market, and other applicable securities rules

and regulations impose various requirements on public companies.

Our management and other personnel will devote a substantial amount

of time to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance

costs and will make some activities more time-consuming and costly.

We cannot predict or estimate the amount of additional costs we will

incur as a public company or the specific timing of such costs.

a result of being a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting,

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result, the value of our common stock.

will be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the

effectiveness of our internal control over financial reporting as of the end of the fiscal year that coincides with the filing of

our second annual report on Form 10-K.

This assessment will need to include disclosure of any material weaknesses identified by our

management in our internal control over financial reporting.

In addition, our independent registered public accounting firm may be

required to attest to the effectiveness of our internal control over financial reporting in our first annual report required to be

filed with the SEC following the date we are no longer an “emerging growth company.” We have not yet commenced the

costly and time-consuming process of compiling the system and processing documentation necessary to perform the evaluation needed to

comply with Section 404, and we may not be able to complete our evaluation, testing and any required remediation in a timely fashion

once initiated.

Our compliance with Section 404 will require that we incur substantial expenses and expend significant management

We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with

appropriate public company experience and technical accounting knowledge and compile the system and process documentation necessary

to perform the evaluation needed to comply with Section 404.

are required for 2023, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness

of our internal control over financial reporting as of the end of the fiscal year that coincides with the filing of our second annual

report on Form 10-K.

This assessment will need to include disclosure of any material weaknesses identified by our management in our internal

control over financial reporting.

In addition, our independent registered public accounting firm may be required to attest to the effectiveness

of our internal control over financial reporting in our first annual report required to be filed with the SEC following the date we are

no longer an “emerging growth company.” We have commenced the costly and time-consuming process of compiling the

system and processing documentation necessary to perform the evaluation needed to comply with Section 404, and we expect to be able to

complete our evaluation, testing and any required remediation in a timely fashion.

Our compliance with Section 404 will

require that we incur substantial expenses and expend significant management efforts.

We currently do not have an internal audit group,

and we in the future we may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting

knowledge and compile the system and process documentation necessary to perform the evaluation needed to comply with Section 404.

current controls and any new controls that we develop may become inadequate because of changes in conditions in our business.

addition, changes in accounting principles or interpretations could also challenge our internal controls and require that we

establish new business processes, systems and controls to accommodate such changes.

Additionally, if these new systems, controls or

standards and the associated process changes do not give rise to the benefits that we expect or do not operate as intended, it could

adversely affect our financial reporting systems and processes, our ability to produce timely and accurate financial reports or the

effectiveness of internal control over financial reporting.

Moreover, our business may be harmed if we experience problems with any

new systems and controls that result in delays in their implementation or increased costs to correct any post-implementation issues

that may arise.

changes in accounting principles or interpretations could also challenge our internal controls and require that we establish new business

processes, systems and controls to accommodate such changes.

Additionally, if these new systems, controls or standards and the associated

process changes do not give rise to the benefits that we expect or do not operate as intended, it could adversely affect our financial

reporting systems and processes, our ability to produce timely and accurate financial reports or the effectiveness of internal control

over financial reporting.

Moreover, our business may be harmed if we experience problems with any new systems and controls that result

in delays in their implementation or increased costs to correct any post-implementation issues that may arise.

failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition

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our stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock could fall.

These sales also may make it more difficult for us to sell equity or equity-related securities in the future at a time and price

that we deem reasonable or appropriate.

Stockholders who have held their shares for at least six months are able to sell their

shares pursuant to Rule 144 under the Securities Act.

We have registered under separate registration statements in aggregate up to

4,497,042 shares of our common stock for sale into the public market (2,248,521 of which are issuable upon the exercise of warrants)

by certain selling stockholders named therein.

These shares represent a large number of shares of our common stock, and if sold in

the market all at once or at about the same time, could depress the market price of our common stock during the period the

registration statement remains effective and could also affect our ability to raise equity capital.

These sales also may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that

we deem reasonable or appropriate.

Stockholders who have held their shares for at least six months are able to sell their shares pursuant

to Rule 144 under the Securities Act.

Almost all of our outstanding shares are available to be sold in the open market under Rule 144

or because they have been registered under the Securities Act We have also registered shares of our common stock for sale into the public

market ,which are issuable upon the exercise of warrants, by certain selling stockholders named therein.

These shares represent a large

number of shares of our common stock, and if sold in the market all at once or at about the same time, could depress the market price

of our common stock during the period the registration statement remains effective and could also affect our ability to raise equity

stock price may be volatile, and the value of our common stock may decline.

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of our common stock or result in dilution to our existing stockholders.

holder of our Series A Preferred Stock has 29.5 % of the voting power of our stockholders for the election of directors

and will have certain senior rights upon sale of our Company under certain conditions.

holder of our Series A Preferred Stock will have 29.5 % of the voting power of our stockholders for the election of directors and will

have certain senior rights upon sale of our Company under certain conditions.

is 1 share of Series A Preferred Stock issued and outstanding, which is held by our co-chairman and chief operating officer, Alan Blackman.

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Blackman is able to exert substantial influence over the election of directors to the

the Series A Preferred Stock, provides that in the event the Company is sold during the two year period commencing on April 19, 2023,

at a price per share of more than 500% of $4.25, the Series A Preferred Stock will entitle the holder to 10% of the total purchase price.

This may reduce the value of our common stock, as other holders, in the event of such an acquisition, will be entitled to a lower price

per share than they would otherwise receive.

However, as discussed above, Mr.

Blackman resigned

from the Board of the Company effective July 27, 2023.

Additionally, in connection with Mr.

Blackman’s resignation, once his severance

payments are satisfied, Mr.

Blackman shall return the Series A Preferred Stock to the Company for cancellation.

In the meantime, Mr.

Blackman has granted the right to vote the Preferred Stock outstanding.

the Series A Preferred Stock, provides that in the event the Company is sold during the two year period following completion of the offering

at a price per share of more than 500% of $ t he

inital offering price per Common Stock unit in this offering, the Series A Preferred Stock will entitle the holder to 10% of the total

purchase price.

This may reduce the value of our common stock, as other holders, in the event of such an acquisition, will be entitled

to a lower price per share than they would otherwise receive.

executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly

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executive officers, directors and principal stockholders in the aggregate, beneficially own approximately 14.5% of our common stock.

Such persons acting together, will have the ability to control or significantly influence all matters submitted to our stockholders for

approval, as well as our management and business affairs.

This concentration of ownership may have the effect of delaying, deferring

or preventing a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging

a potential acquiror from making a tender offer or otherwise attempting to obtain control of our business, even if such a transaction

would benefit other stockholders.

persons acting together, will have the ability to control or significantly influence all matters submitted to our stockholders for approval,

as well as our management and business affairs.

This concentration of ownership may have the effect of delaying, deferring or preventing

a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging a potential

acquiror from making a tender offer or otherwise attempting to obtain control of our business, even if such a transaction would benefit

other stockholders.

stock offerings in the future may dilute then-existing shareholders’ percentage ownership of the Company.

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as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

Unresolved Staff Comments

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 1A. Risk Factors