What changed in this filing

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Item 1. Business

2024-03-29 compared with 2023-03-31 · 214 added, 190 removed, 80 unchanged (83% of the section changed)

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is a medical device company that has designed and patented various safety syringes and is seeking to commercialize them.

We were incorporated under the laws of the State of Nevada in the first quarter of 2022.

Sharps was incorporated to purchase, develop,

and commercialize a body of intellectual property resulting in a family of smart safety syringe products.

Sharps closed the acquisition

of this intellectual property in the fourth quarter of 2017.

The intellectual property we purchased consisted of issued patent and patent

files, new designs and iterations, samples, regulatory files, manufacturing files, product testing files, and market research files relating

to such safety syringe products.

We were initially incorporated under the laws of the State of Wyoming on December 16, 2017.

Prior to March 22, 2022, we were a Wyoming

corporation and on March 22, 2022, we reincorporated as a Nevada corporation pursuant to a merger into a newly formed Nevada corporation

which was approved by our board of directors and the holders of the majority of our outstanding shares of common stock Sharps was incorporated

to purchase, develop, and commercialize a body of intellectual property resulting in a family of smart safety syringe products and innovative

drug delivery devices.

Sharps closed the acquisition of this intellectual property in the fourth quarter of 2017.

The intellectual property

we purchased consisted of issued patent and patent files, new designs and iterations, samples, regulatory files, manufacturing files,

product testing files, and market research files relating to such safety syringe products.

June 2020, we entered into an asset/share purchase agreement with Safegard Medical Kft.

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Safegard Agreement, we received an option to purchase either the stock of Safegard or certain assets of Safegard, including the Securegard

product line of safety syringes and a manufacturing facility in Hungary, registered with the FDA and CE, for the manufacture of safety

syringes, for $2.5 million in cash plus additional consideration of 28,571 shares of common stock and 35,714 stock options with an exercise

price of $7.00 USD.

Under the Safegard Agreement, Sharps was granted the right to operate the facility in Hungary at our expense and

continued to do so through the closing date which occurred on July 6, 2022.

smart safety syringe products, which we refer to as Securgard™ and Sharps Provensa™, are ultra-low waste syringes that

incorporate both safety and reuse prevention features, which we believe will provide us a competitive advantage over other syringes.

The Sharps Securegard is a multi-feature safety syringe that had gained market acceptance prior to Sharps’ acquisition but not

been marketed or sold for several years due to a decision by the owners to wind down the business.

It is both FDA and WHO approved

and carries the European CE Mark.

The Sharps Provensa is a patented safety syringe that gained FDA clearance for subcutaneous and

and Sologard product line of safety syringes and a manufacturing facility in Hungary, registered with the FDA and CE, for the manufacture

of safety syringes, for $2.5 million in cash plus additional consideration of 28,571 shares of common stock and 35,714 stock options

with an exercise price of $7.00 USD.

Under the Safegard Agreement, Sharps was granted the right to operate the facility in Hungary at

our expense and continued to do so through the closing date which occurred on July 6, 2022.

smart safety syringe products, which we refer to as Securgard™, Sologard™, and Sharps Provensa™, are ultra-low waste

syringes that incorporate both passive and active safety and reuse prevention features, which we believe will provide us a competitive

advantage over other syringes.

The Sharps Securegard and Sologard lines, currently being marketed by the Company, are multi-feature safety

syringes that had gained market acceptance prior to Sharps’ acquisition but not been marketed or sold for several years due to

a decision by the owners to wind down the business.

Safegard and Sologard are both FDA and WHO approved and Safegard currently carries

the European CE Mark.

The Sharps Provensa syringe is a patented passive safety syringe that gained FDA clearance for subcutaneous and

intramuscular injections in June 2006.

Both of these product lines are focused on innovatively addressing the important needs of the

global healthcare market in the area of disposable syringes.

September 29, 2022, the Sharps Technology entered into an agreement (the “Nephron Agreement”) with InjectEZ, LLC (“InjectEZ”),

All three of these product lines are focused on innovatively addressing the most important needs

of the global healthcare market in the area of disposable syringes.

The Company has not yet generated any revenues from the sale of the

Sharps products.

September 29, 2022, the Company entered into an agreement (the “NPC Agreement”) with Nephron Pharmaceuticals Corporation

(“NPC”) and various affiliates of NPC, including InjectEZ, LLC, t.

The NPC Agreement intended to support several areas of

the Company’s development and growth.

The Company and NPC intended to supplement the NPC Agreement by entering into a manufacturing

supply agreement, a sales and distribution agreement and a pharma services program to support growth, and a future agreement to support

manufacturing expansion.

As noted below, the sales and distribution agreement was terminated on March 8, 2024 and replaced.

manufacturing supply agreement, noted above, will be replaced as part of the Asset Purchase Agreement, entered into on September 22,

2023 (see below) and the Pharma Services agreement continues to be in place, but no activities have occurred to date.

The Company is

currently working to amend the terms of this NPC Agreement.

based on the below September 22, 2023 Asset Purchase Agreement.

Pharma Services Program (PSP) with Nephron is intended to create new business development growth opportunities for both companies.

opportunities will include the development and sale of next generation drug delivery systems that will be produced by the Company and can

be purchased by the healthcare industry, pharmaceutical markets, as well as by Nephron.

September 29, 2022, the Company also entered into an agreement (the “Nephron Agreement”) with InjectEZ, LLC (“InjectEZ”),

Nephron Pharmaceuticals Corporation (“NPC”), Nephron SC, Inc.

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LLC (“Sterile”) (NPC, NSC, and Sterile are sometimes collectively referred to as “Nephron”), pursuant to which

Sharps will provide technical advice and assistance to support manufacturing by InjectEZ, purchase certain quantities of syringes as

Sharps was to provide technical advice and assistance to support manufacturing by InjectEZ, purchase certain quantities of syringes as

they may order or require, and collaborate with Nephron on certain related business endeavors.

The Nephron Agreement is for a period

of four (4) years, expiring on September 28, 2026 and continues thereafter for successive one (1) year periods.

The Agreement includes

provisions for collaborations in the areas of Manufacturing and Supply, a Pharma Services Program, and Distribution, as detailed below.

NPC is a West Columbia, S.C.-based company that develops and produces safe, affordable generic inhalation solutions and suspension products.

NPC also operates an industry-leading 503B Outsourcing Facility division, which produces pre-filled sterile syringes, luer-lock vials,

IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs.

NPC launched a CLIA-certified diagnostics

lab in 2020 where it tests people for COVID-19 and administers vaccinations.

the Nephron Agreement, Sharps is entering into a manufacturing and supply agreement with InjectEZ regarding the development and manufacture

of high value pre-fillable syringe systems that can be used by the healthcare industry, pharmaceutical markets and including Nephron

on terms agreed upon by the parties.

The Nephron Agreement will allow for the supply of the pre-fillable systems of different sizes and

with specialized technology that will be compatible with industry standards and technology beginning in the third quarter, as recently

advised by Nephron.

The Agreement also allows for further expansion of manufacturing capabilities by Sharps Technology working with InjectEZ

to support future industry and customer demand of pre-fillable systems as detailed in the Agreement.

Additionally,

Sharps is entering into a Pharma Services Program (PSP) with Nephron that will create new business development growth opportunities for

both companies.

These opportunities will include the development and sale of next generation drug delivery systems that will be produced

by Sharps and can be purchased by the healthcare industry, pharmaceutical markets, as well as by Nephron.

December 8, 2022, Sharps entered into a distribution agreement (the “Distribution Agreement”) with Nephron Pharmaceuticals

pursuant to which the Sharps Technology appointed Nephron as its exclusive distributor for the sale and distribution of the products

subject to the Distribution Agreement in and throughout the United States.

Pursuant to the Distribution Agreement, the price of shipping

products will be based on the cost of delivery to Nephron’s warehouse and the Company will pay for the cost of delivery to Nephron.

The Distribution Agreement has a term of two years and will continue in effect unless either party notifies the other party of its desire

to terminate.

At any time and for any reason, either party can terminate the Distribution Agreement after thirty (30) days’ notice

and in the event of a breach of any of the Distribution Agreement’s terms and provisions, either party can terminate the Distribution

Agreement by providing 90 days written notice.

The Company has the right to terminate the Distribution Agreement with 60 days written

notice in the event that certain conditions are met as set forth in the Distribution.

we currently have production capacity for our products and thus ability to receive and fulfill orders, we expect that the proceeds from

the February 2023 Private Placement will allow us to further increase our production capacity.

This will help us to generate and fulfill

orders for our current product line and advance our new, innovative products in connection with recent collaboration arrangements with

Nephron Pharmaceuticals.

We are currently building inventory though our Distribution Agreement with Nephron and anticipate that we will

commence receiving orders for and continue producing commercial quantities of our products in the second quarter of 2022.

continue to be in discussions with healthcare companies and distributors for sales of our disposable syringe products.

We intend to market

these products to the US and foreign governments.

In certain situations, we will also look to sell our disposable syringe products to

hospitals and clinician offices as opportunities present themselves.

expect that the Sharps Securegard product line will represent our initial disposable syringe platform to be commercially available to

The Securegard platform has an advanced set of features and benefits to support the needs of the market along with a high

level of readiness for manufacturing and the ability to provide large commercial quantities for customers.

have been delays in the commercialization of the Sharps Provensa product line.

The Provensa product’s combination of specialized

technology has created the need for further optimization related to the final assembly steps for the product.

This was identified as

we moved towards commercialization for the product line and the need to generate production quantities to support customer orders.

type of delay is typical with the development of new technology for the healthcare market to ensure the products are safe and effective

for use every time.

We are endeavoring to address all obstacles to advance the commercialization of the Provensa product line as soon

safety disposable syringes with Ultra-low waste space technology are the preferred syringe platform for the administration of many vaccines

and injectable medications.

Their design inherently reduces the amount of thrown way, wasted therapies and thus improves the supply of

crucial and in-demand medicines.

Both syringe lines carry less than 20 microliters of dead space, as compared to the 70 microliters “Low

Dead Space” designation and the up 140 microliters dead space found in competitors’ syringes.

In addition, both passive and

active safety features are those most requested by clinicians in the field, in order to avoid infectious needlestick injuries, and reuse

prevention features are a requirement by the World Health Organization.

Sharps Securegard and Provensa safety syringe product lines have been designed to address the three primary administration concerns with

syringe delivery systems:

The Company is currently working

to amend the terms of the Nephron Agreement based on the below September 22, 2023 Asset Purchase Agreements.

September 22, 2023, the Company entered into a series of agreements with Nephron and Nephron’s wholly owned subsidiary

InjectEZ, LLC.

The Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) to purchase certain

equipment and leasehold improvements at Nephron’s facility (the “Facility”) in West Columbia, South Carolina.

Company continues to work with Nephron towards the purchase of the Nephron facility pursuant to the Asset Purchase Agreement dated

September 22, 2023.

This Asset Purchase Agreement, when closed, will supercede the manufacturing and supply agreement entered into

in connection with the NPC Agreement on September 29, 2022, as noted in the subsequent paragraph.

The closing of the Asset Purchase

Agreement is contingent on obtaining the necessary financing and there can be no assurance that the closing of the asset sale will

March 4, 2024 (the “Effective Date”) the Company entered into a cooperative sales and distribution agreement (the “Agreement)

with Roncadelle Operations s.r.l (Roncadelle”).

In conjunction with the execution of the Agreement, Roncadelle appointed

the Company as its exclusive distributor of Roncadelle products in the United States, Canada, Central and South America and their territories.

The Company appointed Roncadelle as its exclusive distributor of Sharps products in Europe, Middle East, APAC, South Africa and Australia and

their territories.

The Company and Roncadelle agreed to bear their own separate costs and expenses, including fees and other expenses, relating

to external advisors and the preparation negotiation, execution and performance of this Agreement and any related documents.

The Agreement

is effective as of the Effective Date for the initial period of one (1) year (the “Initial Term”).

Upon expiration of the

Initial Term, the term of the Agreement shall automatically renew for additional successive one-year terms, unless either party provides

written notice of non-renewal at least ninety (90) days prior to the end of the then-current term, unless any renewal term is terminated

earlier pursuant to the terms of the Agreement or applicable law.

(See “Recent Developments”)

March 8, 2024, the Company and Nephron Pharmaceuticals Corporation terminated their distribution agreement dated December 8, 2022.

The Nephron distribution agreement has been partially replaced by the aforementioned Agreement with Roncadelle, as stated above, and

plans to use other parties to distribute for the US domestic market.

The Company entered into a new logistics services agreement on

the warehousing side with Owens and Minor (“O&M”) to replace Nephron’s distribution services.

The Company had

no revenues from the Nephron Distribution Agreement and does not believe that the cancellation is material.

The Company is currently

negotiating its contract with O&M to provide 3PL services for both the Company and Roncadelle products, in North and South

America, beginning in the third quarter of 2024.

The Company and Nephron continue to maintain the Pharma Services Program (PSP) that

focuses on the creation of new business development and growth opportunities for both companies.

These opportunities will include

the development and sale of next generation drug delivery systems that will be produced by the Company and can be purchased by the

healthcare industry, pharmaceutical markets, and Pharma companies such as Nephron and others.

we currently have production capacity for our products and thus the ability to receive and fulfill orders, we used the proceeds from

the February 2023 and September 2023 fund raising to allow us to further increase our production capacity, build inventory and

support working capital requirements This will help us to generate and fulfill orders for our current product line and advance our

new innovative products in connection with recent collaboration arrangements.

We are currently continuing to produce commercial

quantities of our products and building inventory to support the Sales and distribution Agreement with Roncadelle, in anticipation

of receiving additional orders in 2024.

continue to be in discussions with healthcare companies and distributors for sales of our disposable syringe and prefillable syringe

We intend to market these products to the U.S.

and foreign governments and have already received a Purchase Order for our first

Securegard sales to South America.

We will also look to sell our disposable syringe products to hospitals and clinician offices as opportunities

present themselves.

Sharps Securegard product line continues to represent our initial disposable syringe platform to be commercially available to the market.

The addition of the Sologard products and SafeR products from Roncadelle are recent expansions to the Company’s product portfolio.

These platforms have advanced features and benefits to support the needs of the market along with a high level of readiness for manufacturing

and the ability to provide large commercial quantities for customers.

continues to be delays in the commercialization of the Sharps Provensa product line.

The product’s specialized technology

requires further design and assembly optimization as identified in our previous commercialization efforts.

This on-going product

refinement process is typical with the development of new technology for the healthcare market to ensure the products are safe and

effective for use every time.

At this time Sharps is not able to determine a timeline for final commercialization of the Provensa

safety disposable syringes with ultra-low waste technology are the preferred syringe platform for the administration of many

vaccines and injectable medications.

Their design inherently reduces the amount of drug product that is thrown away, minimizing

wasted therapies and thus improving the supply of crucial and in-demand medicines.

Sharp’s disposable syringe lines carry less

than 20 microliters of dead space, as compared to the 70 microliters “Low Dead Space” designation and the up to 140

microliters dead space found in competitors’ syringes.

In addition, both passive and active safety features are those most

requested by clinicians in the field, in order to avoid infectious needlestick injuries, and reuse prevention features are a

requirement by the World Health Organization.

Sharps Securegard and Sologard, and Roncadelle SafeR safety syringe product lines incorporate both active and passive safety features

and have been designed to address the three primary administration concerns with syringe delivery systems

Accidental needlestick injuries:

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of injuries continue to occur with non-safety devices or before full activation of a safety-protection feature.

Wasted medicine/dead space:

all needle and syringes have space which permits the accumulation of injectable medications which

medicine/dead space:

all needle and syringes have dead space which permits the accumulation of injectable medications which

cannot be accessed and are thrown away with each injection.

Both Sharps Securegard and Provensa have less than 20 microliters of waste

Sharps disposable safety syringes have less than 20 microliters of waste

space – others have as much as 140 microliters of waste space.

Without knowing what syringe is going to be used, pharmaceutical companies

must overfill their vials to account for this loss.

For difficult to manufacture injectable medications, this reduces the number of life

saving doses which could be available to the public.

When doses are extremely small, waste space can exceed the required dose.

more medications are being thrown away than injected into the patient.

When healthcare providers use ultra-low waste syringes with multi-dose

vials it allows for the availability of up to 20% to 40% more medication for patients that need the treatment.

Without knowing what syringe is going to be used,

pharmaceutical companies must overfill their vials to account for this loss.

For difficult to manufacture injectable medications,

this reduces the number of lifesaving doses which could be available to the public.

When doses are extremely small, waste space can

exceed the required dose.

That means more medications are being thrown away than injected into the patient.

When healthcare

providers use ultra-low waste syringes with multi-dose vials it allows for the availability of up to 20% to 40% more medication for

patients that need the treatment.

Reuse prevention :

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Securegard product line has been approved by the organization.

Technology is poised to expand its commercialized product portfolio through its collaboration with Nephron Pharmaceuticals.

The Sharps-Nephron

manufacturing and supply agreement is focused on the development and manufacture of high value pre-fillable syringe systems that are

highly sought after by the healthcare industry and pharmaceutical markets, with projected product supply beginning the 4 th

quarter of 2023.

Plans are already being developed by Sharps for further expansion of its current manufacturing capabilities to support

the anticipated future industry and customer demand for pre-fillable syringe systems capable of incorporating passive safety, low waste,

and reuse prevention features as applicable.

The prefillable syringe lines will utilize highly automated equipment and controlled environments

established in collaboration with Nephron.

These premium offerings will be made from what the Company believes to be the highest quality

raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well

as the EP and JP international standards.

The products provide an alternative high-quality solution to glass syringes by utilizing inert

polymers such as Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC).

These polymer syringes have many of the same characteristics

as current pharmaceutical glass to support long term drug stability.

The product pipeline includes 1mL short, 2.25mL, 5 mL, 10ml and

50ml volumetric sizes, silicone free systems and ophthalmic drug delivery for the ever-growing cosmetics market, dual chamber systems

for lyophilized products, and custom container solutions for autoinjectors.

Technology is poised to expand its commercialized product portfolio through the anticipated Asset Purchase Agreement with Nephron Pharmaceuticals

and the collaborative agreement with Roncadelle Operations.

The Asset Purchase Agreement is focused on the development and manufacture

of high value prefillable syringe systems that are highly sought after by the healthcare industry and pharmaceutical markets, with projected

product supply beginning early in 2025.

Sharps is currently working with a leading U.S.

based global healthcare company to develop and

manufacture polymer prefillable syringes and components for their drug products, and plans are already being developed by Sharps for

further expansion of its current manufacturing capabilities to support the anticipated future industry and customer demand for prefillable

syringe systems capable of incorporating passive safety, low waste, and reuse prevention features as applicable.

The prefillable syringe

lines will utilize highly automated equipment and controlled environments established in collaboration with manufacturing and healthcare

industry leaders.

These premium offerings will be made from what the Company believes to be the highest quality raw materials, on the

most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international

The products provide an alternative high-quality solution to glass syringes by utilizing inert polymers such as Cyclic Olefin

Polymer (COP) and Cyclic Olefin Copolymer (COC).

These polymer syringes have many of the same characteristics as current pharmaceutical

glass to support long term drug stability.

The product pipeline includes 1mL short, 2.25mL, 5 mL, 10ml and 50ml volumetric sizes, silicone

free systems and ophthalmic drug delivery for the ever-growing cosmetics market, dual chamber systems for lyophilized products, and custom

container solutions for autoinjectors.

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

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anticipate that we will compete primarily on the basis of healthcare worker and patient safety, product performance, and quality.

believe our competitive advantages will include the combination of passive safety and ultra low waste features.

believe our competitive advantages will include the combination of a family of innovative drug delivery systems incorporating active

and passive safety features, and ultra-low waste features.

the United States, the Federal Food, Drug and Cosmetic Act, or FDCA, FDA regulations and other federal and state statutes and regulations

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injunctions, fines, civil penalties and criminal prosecution.

an exemption applies, each medical device we wish to distribute commercially in the United States will require marketing

authorization from the FDA prior to distribution.

The two primary types of FDA marketing authorization applicable to a device are

premarket notification, also called 510k clearance, and premarket approval, also called PMA approval.

The type of marketing

authorization is generally linked to the classification of the device.

The FDA classifies medical devices into one of three classes

(Class I, II or III) based on the degree of risk the FDA determines to be associated with a device and the level of regulatory

control deemed necessary to ensure the device’s safety and effectiveness.

Devices requiring fewer controls because they are

deemed to pose lower risk are placed in Class I or II.

Class I devices are deemed to pose the least risk and are subject only to

general controls applicable to all devices, such as requirements for device labeling, premarket notification and adherence to the

FDA’s current Good Manufacturing Practices, or cGMP, known as the Quality System Regulations, or QSR.

Class II devices are

intermediate risk devices that are subject to general controls and may also be subject to special controls such as performance

standards, product-specific guidance documents, special labeling requirements, patient registries or post-market surveillance.

III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special

controls and include life sustaining, life-supporting or implantable devices, devices of substantial importance in preventing

impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Our Sharps Provensa has been

cleared by the FDA under the 510k premarket notification process (Class II).

an exemption applies, each medical device we wish to distribute commercially in the United States will require marketing authorization

from the FDA prior to distribution.

The two primary types of FDA marketing authorization applicable to a device are premarket notification,

also called 510k clearance, and premarket approval, also called PMA approval.

The type of marketing authorization is generally linked

to the classification of the device.

The FDA classifies medical devices into one of three classes (Class I, II or III) based on the degree

of risk the FDA determines to be associated with a device and the level of regulatory control deemed necessary to ensure the device’s

safety and effectiveness.

Devices requiring fewer controls because they are deemed to pose lower risk are placed in Class I or II.

I devices are deemed to pose the least risk and are subject only to general controls applicable to all devices, such as requirements

for device labeling, premarket notification and adherence to the FDA’s current Good Manufacturing Practices, or cGMP, known as

the Quality System Regulations, or QSR.

Class II devices are intermediate risk devices that are subject to general controls and may also

be subject to special controls such as performance standards, product-specific guidance documents, special labeling requirements, patient

registries or post-market surveillance.

Class III devices are those for which insufficient information exists to assure safety and effectiveness

solely through general or special controls and include life sustaining, life-supporting or implantable devices, devices of substantial

importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Provensa has been cleared by the FDA under the 510k premarket notification process (Class II).

of the United States, our ability to market our products will be contingent also upon our receiving marketing authorizations from the

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anti-self-referral, and false claims laws in the United States.

property rights, particularly patent rights, are material to our business.

We own three patents used in the Sharps Provensa, which expire

between 2035 and 2040.

Our issued patents include a design patent (USD743,025) for the ornamental design for a safety syringe, a patent

Intellectual property rights, particularly patent rights, are material

to our business.

We own four patents used in the Sharps Provensa, which expire between 2035 and 2040.

Our issued patents include a design

patent (USD743,025) for the ornamental design for a safety syringe which will reach full term and expire on November 10, 2029, a patent

(US 10,980,950) for an ultra low-waste needle and syringe system that automatically and passively renders a needle safe during the injection

process, and a patent (US 11,154,663) for a pre-filled safety needle and syringe system.

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

patent applications, which we own, have an anticipated expiration date of June 22, 2040.

The pending patent applications are for (i)

an ultra-low waste disposable syringe with self-adjusting integrating safety features, (ii) an ultra-low waste disposable safety syringe

for low dose injections, and (iii) a needle and syringe system with automatic safety shield that renders a needle safe.

Our pending patent

applications are for utility patents.

With respect to the last of these patent applications, we have, in addition to our United States

patent application, also filed a PCT patent application.

A PCT application is a single utility patent filing that provides international

patent-pending status.

By itself, a PCT application will not lead to foreign patents.

To obtain foreign patents for this PCT patent application,

we will need to file individual patent applications at a later time.

process, a patent (US 11,154,663) for a pre-filled safety needle and syringe system, and a patent (US 11,497,860) for a Ultra-Low Waste

Disposable Safety Syringe for Low Dose Injections.

We have two additional pending patent applications in the United States

and four PCT (Patent Cooperation Treaty) patent applications.

The patent applications, which we own, have an anticipated expiration date

of 2039/2040.

The pending patent applications are for (i) an ultra-low waste disposable syringe with self-adjusting integrating safety

features, and (ii) a needle and syringe system with automatic safety shield that renders a needle safe.

Our pending patent applications

are for utility patents.

With respect to the last of these patent applications, we have, in addition to our United States patent application,

also filed PCT patent applications.

The PCT applications have entered National Phase.

Some of the issued US patents have issued in other

countries, some are still pending.

have certain trademarks for Sharps Provensa, Sharps Provensa Ultra-Low Waste and filed applications to register other trademarks for

use in our Sharps Provensa product line.

have fifty-eight full-time employees, one of which is our Chief Executive Officer, and retain the services of additional personnel

on an independent contractor basis to support R&D, Finance, Marketing and Regulatory areas.

We do not have any part-time employees.

Of the fifty-eight employees, fifty-two work at our facilities in Hungary.

We expect to add additional employees in order to increase

production capacity.

March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic.

This contagious disease outbreak has adversely

affected workforces, economies, and financial markets globally leading to an economic downturn in certain industries and countries.

is not possible for the Company to predict the duration or magnitude of the adverse results of the outbreak and its effects on the Company’s

business or ability to raise funds.

Management continues to monitor the situation but has not experienced a significant disruption to

its product development efforts.

Reincorporation

and Reverse Split

to March 22, 2022, we were a Wyoming corporation and on March 22, 2022, we reincorporated as a Nevada corporation pursuant to a merger

into a newly formed Nevada corporation which was approved by our board of directors and the holders of the majority of our outstanding

shares of common stock.

have fifty-seven full-time employees, two of which are our Chief Executive Officer and Chief Financial Officer, and retain the services

of additional personnel, as needed, on an independent contractor basis to support R&D, Finance, Marketing and Regulatory areas.

do not have any part-time employees.

Of the fifty-seven employees, fifty work at our facilities in Hungary.

We expect to add additional

employees as we increase production capacity.

Company was incorporated in the State of Wyoming on December 16, 2017.

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The information that can be accessed through our website is not part

of this prospectus, and investors should not rely on any such information in deciding whether to purchase our securities.

of this Form 10K, and investors should not rely on any such information in deciding whether to purchase our securities.

address of our principal executive office is 105 Maxess Road, Melville, New York 11747.

common stock is quoted on the Nasdaq under the symbol “STSS”.

We file annual, quarterly, and current reports, proxy statements

and other information with the U.S.

Securities Exchange Commission (the “SEC”).

These filings are available to the public

on the Internet at the SEC’s website at http://www.sec.gov.

common stock and warrants are quoted on the Nasdaq under the symbol “STSS” and “STSSW”.

We file annual,

quarterly, and current reports, proxy statements and other information with the U.S.

Securities Exchange Commission (the

These filings are available to the public on the Internet at the SEC’s website at

http://www.sec.gov.

corporate website is located at www.sharpstechnology.com (this website address is not intended to function as a hyperlink and the

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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-K

Item 1. Business