Haemonetics Receives FDA Clearance For NexSys PCS® With Persona™ Technology

Haemonetics Corporation today announced it 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.

Chris Simon, Haemonetics' President and CEO Said: The NexSys PCS system has transformed and improved the way our customers can collect plasma, 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.

Dr. Jan Hartmann, Haemonetics' Vice President, Medical Affairs, Clinical Development and Medical Safety Said: 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, Persona now sets a new paradigm by leveraging improved technology and taking a personalized approach to optimize plasma collection for each individual donor.

Judy Smith, Executive Vice President and Chief Operating Officer at Octapharma Plasma Said: Octapharma strives to improve the health and lives of people worldwide and our participation in this randomized clinical trial reinforces our commitment to advancing science in plasma collection, We are excited about the prospect of using this new technology to help meet the rising demand for plasma-derived therapies.

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.

The results of the IMPACT study will be presented at the AABB 2020 Virtual Annual Meeting in the Plenary Oral Abstract Session on October 4.

About NexSys PCS® with Persona™ Technology

The NexSys PCS® plasma collection system with Persona™ technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS system include source plasma and plasma for transfusion. The Persona technology builds on NexSys PCS® with YES® technology, which received FDA 510(k) clearance in 2018 and has been used to perform approximately 11 million collections to date. The NexSys PCS system with Persona technology includes disposables and the ability to integrate with NexLynk DMS® donor management system.

SOURCE Haemonetics Corporation

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