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Sharps Technology Inc. to Introduce New Specialized Prefillable Syringe Systems in 2023

Wednesday, January 11, 2023

Sharps Technology, Inc., an innovative medical device and drug delivery Company offering patented, best-in-class syringe products, announces the advancement of the Company's specialized prefillable syringe ("PFS") system product line, which will be manufactured in collaboration with Nephron Pharmaceuticals at the Inject EZ facility in West Columbia, South Carolina.

Braden Miller, Sharps Director of Product Management, commented, “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), which offers a high-quality solution compared to traditional glass syringe systems. These polymer syringes have many of the same characteristics as current pharmaceutical glass designs to support long term drug stability and increase shelf life for customers in the pharmaceutical segment. Polymer syringes can also be made into custom configurations, which can eliminate breakage, minimize dead space, reduce contamination, and support the development of custom devices including autoinjectors. The ability to produce these innovative products using advanced manufacturing techniques creates additional advantages in the areas of quality, performance and safety when compared to similar glass syringe products. We look forward to introducing this line of next generation products to the market."

Sharps' specialized product pipeline and market strategy will include a broad range of sizes, silicon free systems that address contamination issues for the broader healthcare market, dual chamber systems that improve drug shelf life while reducing unnecessary packaging, and customized solutions for systems that serve the growing autoinjector segment.

Sharps announced a manufacturing and research partnership with Nephron Pharmaceuticals in November 2022 that will support the manufacturing of the Company's new innovative prefillable syringe systems, which will begin in the third quarter of 2023 in South Carolina. Initial demand will be supported by manufacturing capacity of 20+ million units, with additional capacities that can be scaled by 2025 with an additional 100 million units annually. Products will be manufactured utilizing state-of-the-art Injection molding technologies with highly automated assembly lines. The products will be sterilized using an ecofriendly clean sterilization option easily adaptable for the pharmaceutical market. Sharps' PFS systems will utilize ISO Standard Nest and Tubs that will be compatible with existing fill-finish technologies to provide a drop-in solution for the industry.

Robert Hayes, Sharps Chief Executive Officer, commented: "Following years of research and development, Sharps is now in a position to commercialize and support the future of specialty syringe drug filling technology. The opportunity to advance our product and manufacturing strategy to include high value prefillable syringe products will significantly accelerate our revenue growth for 2023 and beyond. The launch of these products could not come at a better time to support a market that is in demand for products produced in the USA that provide specialized solutions for customers that need optionality for their drug filling operations. We look forward to providing updates as we commence manufacturing in South Carolina and introduce our new products to the market."

Growing Transition from the Use of Old Bulk Syringes to New Innovative Prefillable Syringes:
Over the last 20 years, the pharmaceutical syringe operational model has shifted from the use of bulk syringes to prefillable syringes, increasing prefillables from 15% to 85%. By purchasing the prewashed and sterile systems in specialty nest and tub packaging, pharmaceutical operations can decrease their manufacturing footprint by about 50%. With new technologies in fill-finish equipment, syringe filling has become more accurate and faster in this smaller footprint. This is the reason why prefillable syringe systems are considered a high growth segment of the drug packaging market.

There has been a rapid increase in demand for these systems and with legacy drugs and including the COVID 19 vaccine moving into the more economical packaging of PFS. Lead times for the procurement of PFS systems continue to rise with pharmaceutical companies expected average lead times increasing to 12-24 months from their current suppliers. The most common PFS systems are designed with pharmaceutical glass barrels which require the use of a complex series of production, washing and preparation processes prior to sterilization. A diminishing workforce of the highly skilled operators needed to manufacture glass syringes only adds speculation to the growing lead times for customers. Even with significant advancements in statistical modeling for production, the glass forming world is still struggling to implement these key manufacturing principles today.

Sharps Technology's solutions will support the future demand of specialty polymer-based syringe drug filling solutions, and its products should address the demand in the growing market for them.

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