Haemonetics FDA Win Boosts Plasma Supply with Personalized Tech

BOSTON, MA – February 24, 2026 – Haemonetics Corporation, a global leader in medical technology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® Plasma Collection System featuring the new Persona® PLUS technology. The clearance marks a significant step forward in the effort to meet the soaring global demand for plasma by personalizing the donation process to safely increase the amount of plasma collected from each donor.

The announcement comes at a critical time for the healthcare industry. Plasma, the liquid component of blood, is the essential raw material for a host of life-saving therapies used to treat rare and chronic conditions, including immune deficiencies, hemophilia, and autoimmune disorders. The new technology promises to deliver a mid-single-digit percentage increase in plasma volume per donation compared to its predecessor, an efficiency gain that could have a substantial impact on the world's supply chain.

Addressing a Critical Global Demand

The market for plasma-derived therapies is experiencing explosive growth. Recent market analyses project the global plasma protein products market, valued at over $32 billion in 2024, to surge towards $55 billion by 2034, driven by an aging population and an increasing prevalence of chronic diseases. Immunoglobulins (IG), which are crucial for treating immune disorders, represent the largest and fastest-growing segment of this market.

This escalating demand has placed immense pressure on the global plasma supply chain. The United States is the epicenter of plasma collection, supplying over 70% of the plasma used by fractionators worldwide. Consequently, any innovation that enhances collection efficiency within the U.S. has a direct and profound effect on the availability of these critical medicines for patients globally. Supply has historically struggled to keep pace with demand, creating vulnerabilities and driving up costs.

Haemonetics' Persona PLUS technology is engineered to address this very challenge. By optimizing the yield from each individual donation, the system allows collection centers to increase their overall output without a proportional increase in donors, infrastructure, or operational hours. This boost in productivity is vital for creating a more resilient and responsive supply chain capable of meeting the needs of a growing patient population.

The Science of Personalized Collection

The core innovation of Persona PLUS lies in its sophisticated, data-driven approach to plasmapheresis. Moving beyond a one-size-fits-all model, the technology leverages advanced algorithms to tailor the collection process to each donor's unique physiological characteristics, such as their body composition. This next-generation system builds upon the company's patented Persona technology, refining its ability to customize collection parameters to maximize yield while upholding the highest standards of donor safety and comfort.

The FDA's clearance was not granted lightly; it was supported by robust clinical data from a large-scale pivotal trial. The prospective, randomized, and controlled study involved nearly 3,000 donors and encompassed over 30,000 plasma donations, providing strong evidence of the system's safety and effectiveness. This rigorous validation underscores the technology's readiness for widespread implementation in collection centers across the country.

"With the growing demand for plasma-derived therapies, plasma collectors' need for innovation to scale operations efficiently and cost-effectively has never been greater," said Roy Galvin, Executive Vice President and Chief Commercial Officer at Haemonetics, in a statement accompanying the announcement. "Persona PLUS extends Haemonetics' leadership in delivering solutions which lower cost-per-liter and enhance yields safely."

A High-Stakes Race for Efficiency

The introduction of Persona PLUS heats up an already competitive landscape where medical technology firms are racing to innovate in the plasma collection space. Haemonetics, the established market leader, faces formidable competition from other industry giants who have recently launched their own efficiency-boosting technologies.

Fresenius Kabi, a key competitor, received FDA clearance in early 2025 for its Adaptive Nomogram, a feature of its Aurora Xi Plasmapheresis System. This technology also uses donor data to personalize collections, with the company reporting an average 11.5% increase in plasma volume per donation. Major plasma collection networks like BioLife have already begun integrating this system across their U.S. centers.

Meanwhile, CSL Plasma, one of the world's largest collection networks, has been deploying the Rika Plasma Donation System, developed by Terumo Blood and Cell Technologies. The Rika system focuses on a different aspect of efficiency: speed. It aims to reduce the average donation time by about one-third, to 35 minutes or less, while also enhancing donor comfort by reducing the amount of blood outside the body at any given time. Haemonetics' focus on maximizing yield with Persona PLUS represents a distinct but equally critical strategy in this high-stakes contest to define the future of plasma collection.

The Economic Ripple Effect for Collection Centers

For the thousands of plasma collection centers operating across the nation, the economic implications of this new technology are significant. The primary metric of success for these centers is the "cost-per-liter"—the total operational cost required to collect one liter of plasma. By increasing the volume of plasma from each donation, Persona PLUS allows centers to spread their fixed costs, such as staffing, rent, and utilities, across a larger volume of product, thereby driving down the cost-per-liter.

This efficiency gain translates directly to improved profitability and a stronger financial footing for operators. Increased yield per donor chair means higher potential revenue and a better return on investment for the sophisticated equipment required for plasmapheresis. Furthermore, the integrated NexSys PCS platform is designed to streamline the entire collection workflow, enhancing productivity, ensuring compliance, and improving the overall donor experience.

A positive and comfortable donation experience is crucial for donor retention, which is the cornerstone of a stable plasma supply. By personalizing the procedure, technologies like Persona PLUS can lead to higher donor satisfaction, encouraging the repeat visits that are essential for the long-term viability of collection centers and the patients who depend on their products.