Sharps Technology Positioned to Address Supply Chain Disruptions Resulting from Recent FDA Recalls, Warnings, and Tariffs on Chinese Manufactured Syringes

Rhea-AI Summary

Sharps Technology (NASDAQ: STSS) CEO Robert Hayes addresses shareholders about the impact of recent FDA actions and tariffs. The FDA raised quality concerns over Chinese syringes in November 2023, leading to recalls and warnings in early 2024. The Biden Administration increased tariffs on Chinese syringes from 0% to 50% in May 2024. Sharps Technology, with its high-quality syringe products like SecureGard and SoloGard, is poised to fill the supply gap. The company manufactures in Hungary and plans to add a US facility. Sharps has also formed partnerships with Roncadelle Operations and Owens & Minor to expand market reach and distribution. These steps are expected to drive revenue growth and market presence.

Positive

• Increased demand for Sharps Technology's syringe products due to FDA recalls and tariffs on Chinese syringes.
• SecureGard and SoloGard syringe lines feature advanced safety and low-waste technologies.
• Manufacturing facility in Hungary is FDA and ISO registered, CE-Mark and WHO accredited.
• Plans to add a US manufacturing facility to bolster production.
• Partnership with Roncadelle Operations to expand market reach in Europe, the Middle East, Africa, and Asia-Pacific regions.
• Collaboration with Owens & Minor for North American sales and distribution support.
• Strategic initiatives expected to drive substantial revenue growth and enhanced market presence.

Negative

• FDA quality concerns over Chinese syringes could affect overall market trust in syringe products.
• High tariffs on Chinese syringes may lead to increased costs for healthcare facilities, potentially affecting demand.
• Dependence on manufacturing facilities outside the US could present supply chain risks until the US facility is operational.

Sharps CEO issues letter to shareholders on FDA actions and tariffs affecting Chinese syringes.

The 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.         

The tariff rate on Chinese-made syringes and needles was raised from 0% to 50% by the Biden Administration in May 2024.

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- 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.

Dear Fellow Shareholders:

With 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.

In 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.

Our 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.

We 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.

Commitment to Innovation and Growth

In 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.

Based 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.

We 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.

Our 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.

Thank 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.

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 signed an agreement to acquire the InjectEZ syringe manufacturing facility in South Carolina. For additional information about the company, please visit www.sharpstechnology.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 407-644-4256
STSS@redchip.com 

FAQ

Why is Sharps Technology experiencing increased demand for its syringes?

Due to FDA recalls and warnings on Chinese syringes and new tariffs, healthcare facilities are seeking alternative syringe suppliers, benefiting Sharps Technology.

What are the key features of Sharps Technology's syringe products?

Sharps Technology's syringes, including SecureGard and SoloGard, feature low waste, ultra-low waste technologies, active safety mechanisms, and WHO-accredited re-use prevention measures.

Where are Sharps Technology's syringes manufactured?

Sharps Technology manufactures its syringes at a state-of-the-art facility in Hungary, which is FDA and ISO registered, CE-Mark and WHO accredited.

What partnerships has Sharps Technology formed recently?

Sharps Technology has partnered with Roncadelle Operations to expand market reach and with Owens & Minor for North American sales and distribution support.

How will the new tariffs affect the syringe market?

The Biden Administration's increase of tariffs on Chinese syringes from 0% to 50% is expected to raise costs for Chinese syringe products, leading healthcare facilities to seek alternatives like Sharps Technology's syringes.

What are Sharps Technology's plans for expanding its manufacturing capabilities?

Sharps Technology plans to add a manufacturing facility in the US to bolster its production capabilities and meet increased demand.