Zephyrus Innovations, a privately owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), has received its first product 510(k) approval from the US Food and Drug Administration (FDA) for its Aeroject 3ml safety syringe.
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Rubber stamping that says 'FDA Approved'.
The Aeroject 3ml safety syringe is the first device in a generation of safety syringes being developed by Zephyrus. In a global market expected to reach c.$8.5 billion by 2024, with the US accounting for 40% of sales, demand for safety syringes is growing.
The needle system contains an internal mechanism that retracts the needle inside the syringe after activation. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Upon retraction, the needle is fully contained inside the syringe plunger, preventing reuse of the needle and syringe, as well as providing protection from accidental needlestick injuries during normal handling and disposal.
Safety syringes are critical to healthcare workers. Less than 33% of safety syringes sold are automatic retracting needles, with the majority requiring cumbersome, manual intervention. Poor safety outcomes can be costly and deadly due to potential transmission of bloodborne pathogens, and with increasing regulation, there is a growing threat of class action lawsuits. There has never been a greater demand for syringes that improve the safety of clinicians.
Guy Reynolds, chief executive officer of Zephyrus, said: “FDA approval of Aeroject is a significant milestone for Zephyrus, and for healthcare professionals. Our innovative, next generation retractable device, helps with stopping exposure to potentially harmful needlestick injuries, lowering the risk of exposure to potential transmission of bloodborne pathogens, truly bringing real benefits to patients, clinicians, and healthcare providers alike, in a currently underserved high-risk environment.
“We are passionate about meeting the high safety standards that the industry expects and with significant market growth anticipated in the coming years, we are well positioned to support healthcare professionals across the board.
“The development of this device and its approval has been a remarkable team effort, drawing on the extensive experience that we have across the business. I would like to thank them, along with our shareholders, for their commitment and support to date.”
Zephyrus’ syringes are for general medical use in healthcare facilities by medical professionals for paediatric and adult population patients for aspiration and injection of fluids.
