Full Press Release Details
Technology Positioned to Address Supply Chain Disruptions Resulting from Recent FDA Recalls, Warnings, and Tariffs on Chinese Manufactured
CEO issues letter to shareholders on FDA actions and tariffs affecting Chinese syringes.
FDA began raising quality concerns over Chinese-manufactured syringes in November 2023, resulting in multiple recalls and warnings for
these products during the first quarter of 2024, and has advised that healthcare facilities should use plastic syringes produced elsewhere.
tariff rate on Chinese-made syringes and needles was raised from 0% to 50% by the Biden Administration in May 2024.
YORK, MAY 28, 2024 - Sharps Technology, Inc., (NASDAQ: "STSS" and "STSSW"), an innovative medical
device and pharmaceutical packaging company offering patented, best-in-class syringe products, issues a shareholder update from Robert
Hayes, the Company's Chief Executive Officer.
Fellow Shareholders:
significant recent developments transforming the syringe market, I want to make it clear that Sharps Technology is extremely well-positioned
to help U.S. healthcare customers overcome supply chain disruptions caused by the Biden Administration's recent announcement to
increase tariffs on Chinese-made syringes and needles from 0% to 50% and the FDA's quality and import concerns related to Chinese
manufactured syringes.
response to these developments, Sharps Technology is experiencing heightened interest in our syringe products, and we are actively pursuing
these opportunities within the healthcare market.
innovative products, such as the SecureGard and SoloGard syringe lines, are designed to address the specific safety and performance
concerns highlighted by the FDA. Our in-demand syringes feature low waste and ultra-low waste technologies, active safety mechanisms,
and WHO-accredited re-use prevention measures, protecting both healthcare workers and patients from the risks associated with needle
stick injuries and syringe re-use.
manufacture our syringes at a state-of-the-art facility in Hungary, which is FDA and ISO registered, CE-Mark and WHO accredited, and
has a long-standing reputation for producing high-quality medical devices for the global market, and plan to bolster our manufacturing
capabilities with the addition of a US facility in the near term. Our commitment to quality and safety ensures that our products meet
the highest standards, providing reliable alternatives to the recalled and tariffed Chinese syringes.
to Innovation and Growth
addition to robust manufacturing capabilities, we have established a collaborative association with Roncadelle Operations to cooperatively
sell and distribute each other's products. This partnership will expand our market reach into Europe, the Middle East, Africa,
and the Asia-Pacific region.
in Italy, Roncadelle specializes in developing and manufacturing proprietary passive safety syringes and offers comprehensive Contract
Development and Manufacturing Organization (CDMO) services from design to finished products. Together, we aim to advance syringe market
opportunities through the continued development of technologies such as prefilled syringes, needle guard systems, auto-injectors, and
injector pen devices.
have also established North American sales and distribution support through a collaboration with Owens & Minor, a leading provider
of 3PL services to the pharmaceutical and medical device industries. This partnership, along with our expanding manufacturing capabilities
in the US and Europe, positions Sharps Technology for substantial revenue growth and enhanced market presence.
strategic initiatives and innovative product offerings underscore our commitment to providing safe, high-quality syringe solutions for
patients and healthcare providers worldwide. We remain dedicated to addressing supply chain challenges and ensuring that vital medical
supplies are readily available.
you for your continued support and confidence in Sharps Technology. We look forward to sharing more updates on our progress and growth
in the coming months.
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 signed
an agreement to acquire the InjectEZ syringe manufacturing facility in South Carolina. For additional information about the company,
please visit www.sharpstechnology.com.
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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
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Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events
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