Haemonetics Receives FDA Clearance for NexSys PCS with Persona Technology

Haemonetics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology. The new, proprietary Persona technology is the latest innovation on the NexSys PCS system and it customizes plasma collection based on an individual donor's body composition.

"The NexSys PCS system has transformed and improved the way our customers can collect plasma," said Chris Simon, Haemonetics' President and CEO. "Persona builds on that legacy by delivering meaningful innovation and reinforces our commitment to supporting the plasma industry."

The 510(k) clearance was supported by clinical data from the IMPACT (IMproving PlasmA CollecTion) study, a multicenter, prospective, double-blinded, randomized controlled clinical trial involving 3,443 donors who underwent 23,137 plasma donations. The study was one of the largest clinical trials on the topic of plasmapheresis and it demonstrated that the NexSys PCS system with Persona technology was safe and effective. Using NexSys PCS with Persona technology, which incorporates a novel, personalized percent plasma nomogram, study results showed an average 8.2% increase in volume of plasma collected per donation across the study population when compared with NexSys PCS® with YES® technology. Additionally, the average number of repeat donations was not impacted and increasing plasma collection volume up to a maximum of 1,000 mL was well tolerated in eligible donors.

The amount of plasma a donor can donate is currently based on a variable calculation, also called a nomogram, which is solely correlated to an individual's weight. The IMPACT study showed that, compared to the current industry standard nomogram, the Persona technology and nomogram customizes collection to an individual donor's body mass index (BMI) and hematocrit to optimize each collection and yield a greater average volume of plasma collected per donation.

"Plasma is an essential component used to make life-saving and life-improving medicines for many conditions, and the current nomogram has been a safe and effective method for collecting plasma for decades," said Dr. Jan Hartmann, Haemonetics' Vice President, Medical Affairs, Clinical Development and Medical Safety. "Persona now sets a new paradigm by leveraging improved technology and taking a personalized approach to optimize plasma collection for each individual donor."

According to the Plasma Protein Therapeutics Association (PPTA), approximately 750,000 people across Europe and North America rely on plasma for life-saving therapies. Plasma-derived medicines are used to treat hundreds of conditions, like primary immunodeficiency, hemophilia and others, and it can take hundreds of plasma donations to treat a single patient.