Sharps CEO issues letter to shareholders regarding FDA actions and tariffs affecting Chinese-made syringes.

The FDA began voicing quality concerns about China-made syringes in November 2023, resulting in multiple recalls and warnings for these products in the first quarter of 2024 and advising medical facilities to use plastic syringes manufactured in other countries.

Tariffs on Chinese-made syringes and needles were increased by the Biden administration from 0% to 50% 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, today announced a shareholder update from Robert Hayes, the company's Chief Executive Officer.

Dear Shareholders:

With recent major developments that are game-changing the syringe market, we want to be clear that Sharps Technology is extremely well-positioned to help our U.S. healthcare customers navigate the supply chain disruptions caused by the Biden Administration's recent announcement to increase tariffs on Chinese-made syringes and needles from 0% to 50%, as well as the FDA's quality and import concerns regarding Chinese-made syringes.

As a result of these trends, Sharps Technology is experiencing increased interest in our syringe products and is actively pursuing these opportunities in the healthcare market.

Our innovative products, such as the SecureGard and SoloGard syringe lines, are designed to address specific safety and performance concerns highlighted by the FDA. Our highly sought-after syringes feature reduced waste and ultra-low waste technologies, active safety mechanisms and WHO-certified anti-reuse measures to protect both healthcare workers and patients from the risks associated with needlestick injuries and syringe reuse.

We manufacture our syringes in our state-of-the-art FDA and ISO registered, CE marked and WHO certified facility in Hungary, with a long-standing reputation for producing high-quality medical devices for the global market, and we plan to increase our manufacturing capabilities with an additional US facility in the near future. Our focus on quality and safety ensures our products meet the highest standards, offering a reliable alternative to recalled and tariffed Chinese made syringes.

Committed to innovation and growth

In addition to our strong manufacturing capabilities, we have also collaborated with Roncadelle Operations to jointly market and distribute each other's products. This partnership expands our market reach across Europe, the Middle East, Africa and Asia Pacific.

Based in Italy, Roncadelle specializes in the development and manufacture of unique passive safety syringes, offering comprehensive contract development and manufacturing organization (CDMO) services from design to finished product. We aim to expand the syringe market opportunity through the continuous development of technologies such as prefilled syringes, needle guard systems, auto-injectors and injection pen devices.

The company has also established sales and distribution support in North America through an alliance with Owens & Minor, a leading provider of 3PL services to the pharmaceutical and medical device industries. This alliance, along with the expansion of manufacturing capabilities in the United States and Europe, will position Sharps Technology for significant revenue growth and an enhanced market presence.

Our strategic initiatives and innovative product offerings underscore our commitment to providing safe, high-quality syringe solutions to patients and healthcare professionals around the world. We remain committed to addressing supply chain challenges and ensuring critical medical supplies remain available.

We thank you for your continued support and trust in Sharps Technology and look forward to sharing updates on our progress and growth in the coming months.

About Sharps Technology:
Sharps Technology is an innovative medical device and pharmaceutical packaging company providing patented, best-in-class smart safety syringe products to the healthcare industry. The company's product line is focused on providing waste minimization capabilities that incorporate syringe technology that uses both passive and active safety features. Sharps also offers products engineered with specialized copolymer technology to support the prefilled syringe market segment. The company has a manufacturing facility in Hungary and has signed an agreement to acquire the InjectEZ syringe manufacturing facility in South Carolina. For more 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 views with respect to future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” “positioned” 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 regarding our business strategy, future operating results and liquidity, and outlook for capital resources. Forward-looking statements are based on 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. Actual results may differ materially from those contemplated in the forward-looking statements. They are not statements of historical fact or guarantees of future performance. You are therefore cautioned not to place any reliance on these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, our ability to finance our continuing operations, our ability to protect our intellectual property rights, the impact of infringement lawsuits or other litigation brought against us, competition from other providers and products, our ability to develop and commercialize products and services, changes to government regulations, our ability to complete financing transactions, and other factors related to our industry, business, and operating results. Actual results may differ materially from what was anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause actual results to differ may arise from time to time, and it is impossible to predict all of them. We cannot guarantee future results, levels of activity, performance, or achievements. We undertake no obligation to update forward-looking statements to reflect events or circumstances that may occur after the date of this release.

Investor Relations:
Dave Gentry
Red Chip Companies Inc.
1-800-Red Tip (733-2447)
or 407-644-4256
inquiry



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