Haemonetics Granted FDA Approval for Upgraded Features of NexSys PCS® Plasma Collection System

Friday, June 23, 2023

Haemonetics Corporation (NYSE: HAE), a renowned global medical technology company dedicated to improving patient outcomes, announced today that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for significant advancements made to its NexSys PCS® plasma collection system. The enhancements include a newly designed plasma collection bowl, incorporating a patented design that optimizes performance, as well as the incorporation of Express® Plus Technology, engineered to reduce procedure time.

With its dominant position in the plasma collections market, Haemonetics brings over 50 years of industry experience and a remarkable track record of more than 50 million real-world collections using the highly advanced NexSys PCS system. This fully integrated system is specifically designed to streamline plasma collections, enhancing yield, productivity, safety, quality, compliance, and donor satisfaction. With the latest upgrades, Haemonetics anticipates an average procedure time of 33 to 38 minutes, as per the standard FDA nomogram, enabling customers to achieve higher levels of plasma center efficiency and reduce collection costs.

The bi-directionally connected NexSys PCS, combined with the NexLynk DMS® donor management software, already boasts an average reduction of 16 minutes in donor door-to-door time, with a significant portion of this improvement occurring before and after the collection procedure. Furthermore, the NexSys PCS with Persona® Technology ensures safe and personalized collection tailored to individual donor characteristics, resulting in an average additional plasma yield of 9% to 12%. Haemonetics plans to initiate the market release of NexSys PCS with the new bowl and Express Plus Technology in the upcoming months.

"Haemonetics sets the standard in global plasma collection solutions that meet collectors' most critical needs. With our redesigned bowl and new Express Plus Technology for faster procedure times and enhanced plasma center efficiency, we continue to advance our innovation to lead the industry in reducing cost per liter for collectors and ensuring the best experience for their donors," said Roy Galvin, President, Global Plasma and Blood Center at Haemonetics.



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