What changed in this filing

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Item 1. Business

2025-03-27 compared with 2024-03-29 · 191 added, 204 removed, 90 unchanged (81% of the section changed)

Technology, Inc.

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

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.

and certain other parties, and in August 2020,

October 2020, and July 2021, we entered into amendments to this agreement (as amended, the “Safegard Agreement”).

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

is an innovative medical device and pharmaceutical packaging company offering patented, best-in-class smart-safety syringe

products to the healthcare industry.

The Company’s product lines focus on providing ultra-low waste capabilities, that incorporate

syringe technologies that use both passive and active safety features.

Sharps also offers products that are designed with specialized

copolymer technology to support the prefillable syringe market segment.

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.

In June 2020, we entered into an

asset/share purchase agreement with Safegard Medical Kft.

(“Safegard”) and certain other parties, and in August 2020, October

2020, and July 2021, we entered into amendments to this agreement (as amended, the “Safegard Agreement”).

Under the Safegard

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

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.

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.

(“NSC”), and Nephron Sterile Compounding Center

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

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 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

of safety syringes.

Through this transaction, the Company now owns and operates a 41,000 square foot manufacturing facility in Hungary,

which was previously used for the development and testing of our products.

It is now primarily utilized for the manufacture of our safety

syringe products.

The Securegard and Sologard product

lines continue to be manufactured in Hungary and are actively marketed through the existing agreements detailed below.

We believe these

products, which feature ultra-low waste syringes incorporating both passive and active safety mechanisms, along with reuse prevention

features, will provide a competitive advantage over other syringes in the market.

The Sharps Securegard and Sologard lines are multi-feature

safety syringes that had previously gained market acceptance prior to Sharps’ acquisition of Safegard.

Both Safegard and Sologard are

FDA and WHO approved, and Safegard currently holds the European CE Mark.

These products remain in the qualification phases with leading

EU and US companies, which could potentially generate initial revenue for the Company in 2025.

Recent agreements for both Sologard and

Securegard have been announced, which are expected to contribute to future revenue growth potential in 2025.

In January of

2025, we completed a $20 million offering that we believe positions Sharps with the working capital needed to expand operations in

Europe by adding advanced machinery, expanding our workforce, and enhancing production capabilities and returns Sharps to being debt

Sharps is committed to advancing innovation in the syringe space and we continue to collaborate with both government and

private investment sources in Hungary to increase our manufacturing footprint and meet the escalating demand for Sharps’

Securegard and Sologard syringes.

We believe that the demand for our innovative injection solutions is growing rapidly, with injectables continuing

to be the preferred delivery method for therapies in areas like vaccines, biologics, weight loss (GLP-1), ophthalmic and cosmetic

applications, gene therapies, and diabetes and inflammatory disease management.

In September 2022 and amended in September 22, 2023, Sharps entered into an

agreement to acquire InjectEZ, LLC, a specialty prefillable syringe manufacturing facility based in South Carolina.

This agreement was

initiated to support several key areas of the Company’s development and growth initiatives through the manufacturing and distribution

of Sharps’ advanced prefillable syringes.

The agreement was terminated on March 8, 2024, and replaced with a revised agreement for

the manufacturing and distribution of Sharps’ products.

The leadership team at Sharps continues to engage with the Seller to finalize

manufacturing arrangements in South Carolina, while the Company actively seeks funding partners to expand its U.S.

manufacturing capacity.

The Company will continue working to amend the terms of this NPC Agreement and Nephron Agreement, based on the Amended Asset Purchase

Agreement below dated May 20, 2024.

May 20, 2024, the Company entered into an Amendment to the Asset Purchase

Agreement dated September 22, 2023, with Nephron and Nephron’s InjectEZ, LLC, (collectively, the “Seller”).

The September

22, 2023 agreement superseded the manufacturing and supply agreement entered into in connection with the NPC Agreement on September 29,

2022, and the Nephron Agreement entered into on September 29, 2022.

The Amended Asset Purchase Agreement includes the purchase of certain

In connection with the Asset Purchase agreement, the Company paid a non-refundable deposit of $1M to be held in escrow as a deposit

on the purchase price.

The Asset Purchase agreement stipulated that the $1M deposit would be maintained until July 19, 2024, at which

date, if the contemplated transaction was not consummated, through no fault of the Seller, the escrow would be released to the Seller

by the escrow agent.

The escrow deposit of $1M was released to the Seller and recorded in Other Expense as a forfeited agreement

cost in the three months ended June 30, 2024.

As stated above, The Company and Seller continue to work towards a further amendment of

the Asset Purchase Agreement.

The closing of the Asset Purchase Agreement is contingent on obtaining further amendments and the necessary

There can be no assurance that the closing of the asset sale will occur.

On July 24, 2024, the Company

entered into a Supply Agreement (the “Agreement”) with Stericare Solutions, LLC, a Texas limited liability company (“Stericare”),

pursuant to which Stericare agreed to purchase 520 million units of 10ml polypropylene (“PP”) Sologard syringes from the Company.

The specific purchase price is confidential, but revenues are expected to exceed $50 million.

Under the terms of the Agreement, Stericare

has committed to purchasing 520 million units of 10ml PP Sologard syringes in the following increments:

40 million units in the first

year, and 120 million units each year for the remainder of the Agreement’s term.

The Agreement has an initial five (5)-year term,

targeted to commence in November 2024 (the “Initial Term”).

Upon expiration of the Initial Term, the Agreement will automatically

renew for successive one (1)-year periods (each, a “Renewal Term”), unless either party provides written notice of termination

at least ninety (90) days prior to the end of the Initial Term or any Renewal Term.

To date, Sharps has used pilot tooling for initial

material qualifications and concept product approvals.

As part of the proceeds from the recent $20 million financing, the Company has

placed orders for advanced production technology for Sologard and will soon begin installation and operational qualification for the next

phase of the project with Stericare.

In December 2024, Sharps signed

a sales agreement with a prominent European medical supply company serving Poland, Slovakia, and the Czech Republic.

The Company began

deliveries for the qualification purposes of Sharps’ Securegard safety syringes, manufactured at the Company’s facility in

Early qualification processes are underway with healthcare groups, and the Company is currently shipping Securegard to across

Europe for qualification approval.

The proceeds from the 2023 and

2024 fundraising efforts were utilized to further increase production capacity, build inventory, and support working capital requirements.

A portion of the proceeds from the January 2025 offering will be allocated to expanding production capacity in Hungary, including the

purchase of advanced machinery and other facility upgrades.

This expansion will facilitate the fulfillment of Securegard and Sologard

orders in connection with recently announced agreements with Stericare and the European distributor.

Sharps is committed to driving

revenue growth from both the Securegard and Sologard projects in 2025, as well as securing manufacturing capacity for the Company’s

next generation polymer-based prefillable syringes.

With the recent financing secured,

the Company believes that it is positioned to advance its growth strategy by utilizing new working capital to support essential operating

Production is currently on track, with the Company preparing for a potential transition to revenue in the second half of 2025,

subject to the successful execution of its plans.

The Company has delayed the commercialization of the Sharps Provensa

product line.

The product’s specialized technology requires further design and assembly optimization, which requires further capital

investment and not currently budgeted.

At this time Sharps is not able to determine a timeline for further development and commercialization

of the Provensa product.

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, safety syringe product lines incorporate both active and passive safety features and have been designed

to address the primary administration concerns with syringe delivery systems

Accidental needlestick injuries:

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billion injections are delivered worldwide each year (pre-Covid era).

A recent analysis showed that 55.1% of healthcare workers had sustained

An analysis showed that 55.1% of healthcare workers had sustained

a needlestick injury, or NSI, at some point in their career.

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

medicine/dead space:

Wasted medicine/dead space:

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

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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 lifesaving doses which could be available to the public.

When doses are extremely small, waste space can

exceed the required dose.

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.

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 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

Invasive Therapies (“Medtronic,” formerly known as Covidien), Terumo Medical Corp., Smiths Medical, and B Braun.

Our competitors

may have greater financial resources, larger and more established sales, marketing, and distribution organizations;

and greater market

influence, including long-term and/or exclusive contracts.

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 a family of innovative drug delivery systems incorporating active

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

Sharps has developed an alternative high-quality solution to glass syringes

through the use of inert polymers such as Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC), offering a superior alternative

to traditional glass syringe systems.

These polymer syringes share many of the same characteristics as current pharmaceutical glass designs,

supporting long-term drug stability and extending shelf life for customers in the pharmaceutical sector.

Polymer syringes can also be

customized, reducing the risk of breakage, minimizing dead space, limiting contamination, and supporting the development of custom devices,

including autoinjectors.

The product pipeline includes 1mL short, 2.25mL, 5mL, 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.

The ability to produce these innovative products using advanced manufacturing techniques provides additional

advantages in quality, performance, and safety when compared to similar glass syringe products.

Sharps looks forward to the potential

of introducing this next-generation product line to the market and is currently working to establish US based manufacturing.

We anticipate that our major domestic competitors will include Retractable

Technologies, Inc., Becton Dickinson & Company, Medtronic Minimally Invasive Therapies (“Medtronic,” formerly known as

Covidien), Terumo Medical Corp., Smiths Medical, and B.

Our competitors may have greater financial resources, larger and more established

sales, marketing, and distribution organizations, and greater market influence, including long-term and/or exclusive contracts.

to compete primarily on the basis of healthcare worker and patient safety, product performance, and quality.

We believe our competitive

advantages will include a family of innovative drug delivery systems incorporating both active and passive safety features, as well as

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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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.

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, 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.

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

We own four utility patents used in the Sharps Provensa

product that is not currently being commercialized and would require further R&D efforts.

Such patents expire between 2035 and

Our issued patents include a design patent (US 743,025) 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, 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.

have two additional pending patent applications in the United States and four PCT (Patent Cooperation Treaty) patent applications.

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

have fifty-five 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.

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

We expect to add additional

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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.

We file annual, quarterly,

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

Securities Exchange Commission (the “SEC”).

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

6 unchanged sentences

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