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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): March 7, 2024
Sharps
Technology, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
(State
or Other Jurisdiction of Incorporation)
001-41355 |
|
82-3751728 |
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
105
Maxess Road, Melville, New York 11747
(Address
of Principal Executive Offices)
(631)
574 -4436
(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value |
|
STSS |
|
NASDAQ
Capital Market |
Common
Stock Purchase Warrants |
|
STSSW |
|
NASDAQ
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
7.01 Regulation FD Disclosure
On
March 7, 2024, Sharps Technology, Inc. (the “Company”) issued a press release. A copy of the press release is furnished
hereto as Exhibit 99.1 and incorporated herein by reference.
Exhibits
9.01 Financial Statements and Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
Date:
March 7, 2024
SHARPS
TECHNOLOGY, INC. |
|
|
|
/s/
Robert Hayes |
|
Robert
Hayes |
|
Chief
Executive Officer |
|
Exhibit 99.1
Sharps
Technology and Roncadelle Operations Sign Worldwide Sales and Distribution Agreement for their Innovative Portfolio of Safe Technology
Drug Delivery Systems
Sharps
and Roncadelle are Joining Forces to Sell and Distribute their Securegard, SAFER, and Sologard Lines of Disposable Smart Safety Syringes
and Expand their Market Reach Around the Globe
Sharps
Technology, Inc., (NASDAQ: “STSS” and “STSSW”), an innovative medical device and pharmaceutical packaging
company offering patented, best-in-class syringe products, and Roncadelle Operations, a driving force in the development of novel
medical drug delivery devices, have signed a sales and distribution agreement to cooperatively sell and distribute each other’s
products to their respective areas of influence. The agreement expands Sharps’ American-based product market into Europe, the Middle
East, Africa, and the Asia-Pacific region, and opens Roncadelle’s reach into the dynamic North American and Latin American markets.
The agreement, signed on March 4, 2024, lays the groundwork for further collaboration between Sharps and Roncadelle to develop and manufacture
next-generation drug delivery products.
“We
believe that this is just the beginning of Sharps’ collaboration with Roncadelle. It expands our footprint as a premier manufacturer
and a distributor of smart safety syringes as well as a collaborative leader in the development of drug delivery systems for the world
market,” commented Sharps Technology CEO Robert Hayes. “Sharing our product portfolio gives healthcare customers one-stop
access to a broad range of delivery solutions and price points to match their needs and strictest requirements.”
Italian-based
Roncadelle Operations is a driving force in the development of novel medical drug delivery devices with its seasoned team boasting over
two decades of healthcare expertise. The company specializes in developing and manufacturing proprietary passive safety syringes, and
as a Contract Development and Manufacturing Organization (CDMO), they also provide end-to-end services from design to finished products
of innovative, safer medical drug delivery solutions. Roncadelle’s premiere product line of SafeR Retractable Safety Syringes and
needles offers a completely passive safety system with auto-disable reuse prevention features that provide world class technology at
a competitive price point.
“We
have embarked on a transformative journey in healthcare delivery through our partnership with Sharps Technology. I firmly believe this
collaboration signifies our joint dedication to advancing the industry. Together, we are expanding our market presence and pioneering
safer, more advanced solutions for medical administration,” states Erik Ryckalts, CEO of Roncadelle. “This alliance underscores
our unwavering commitment to innovation and excellence, reshaping standards within the global healthcare landscape.”
Sharps
Technology specializes in the development and manufacturing of innovative drug delivery systems. The Company’s Securegard
and Sologard product lines, manufactured at Sharps’ Hungary facility, focus on low waste and ultra-low waste syringe technologies
that incorporate active safety features as well as World Health Organization accredited re-use prevention measures. These features protect
front line healthcare workers from life-threatening needle stick injuries and protect the public from the dangers of needle re-use. Sharps’
active safety Securegard and Sologard product lines complement Roncadelle’s passive engagement SafeR Retractable Safety Syringes
to provide the global healthcare market with a broad range of options and choices to fulfill the specific requirements for drug therapy
delivery.
As
part of the cooperative agreement, Sharps and Roncadelle intend to collaborate on the development of new drug delivery products. The
need for innovative injection solutions is expected to grow over the next several years as injectables are the first choice for therapies
as diverse as vaccines, biologics, weight loss and maintenance, ophthalmics, gene therapies, and diabetes management. The collaboration
between Sharps and Roncadelle creates a very important player in advancing these market opportunities through the development of technologies
such as prefilled syringes, needle guard systems, auto-injectors, and injector pen devices. In light of the recent FDA safety communication
concerning the use of syringes manufactured in China, the Company believes that the market for safer syringes produced in the U.S.
and Europe will grow at an accelerated rate.
About
Sharps Technology:
Sharps
Technology 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. The Company has a manufacturing facility in Hungary and is pursuing
plans to expand its manufacturing capacity in the U.S. For additional information, please visit www.sharpstechnology.com.
About
Roncadelle Operations:
Roncadelle
Operations, located in proximity to Milan, specializes in Injection Devices. Operating as OEM and a Contract Development and Manufacturing
Organization (CDMO), Roncadelle combines technical and engineering expertise with high-quality industry standards. The Company is guided
by a “just do it faster” philosophy and a “value-for-money” focus, and delivers swift, economical solutions.
The core aspiration is to safeguard people from infection, creating safer injection solutions based on sound engineering performance.
Roncadelle Operations forge strategic partnerships with customers, investing in incremental resources when they are needed. Roncadelle’s
strategically located facility with state-of-the-art clean room manufacturing embodies its strong commitment to innovation, efficiency
and safety in healthcare. For additional information, please visit www.roncadelle-operations.com.
FORWARD-LOOKING
STATEMENTS:
This
press release contains “forward-looking statements”. Forward-looking statements reflect our current view about future events.
When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,”
“future,” “intend,” “plan,” “poised” or the negative of these terms and similar expressions,
as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements
contained in this press release relating to our business strategy, our future operating results and liquidity, and capital resources
outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy, and other
future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks,
and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking
statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore
against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from
those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our
ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition
from other providers and products; our ability to develop and commercialize products and services; changes in government regulation;
our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations.
Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events
that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We
cannot guarantee future results, levels of activity, performance, or achievements. The Company assumes no obligation to update any forward-looking
statements in order to reflect any event or circumstance that may arise after the date of this release.
Investor
Relations:
Dave
Gentry
RedChip
Companies, Inc.
1-800-RED-CHIP
(733-2447)
Or
407-491-4498
STSS@redchip.com
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