Haemonetics Receives FDA Clearance for NexSys® PCS Plasma Collection System with Persona® PLUS Technology

BOSTON, Feb. 23, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE:HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the NexSys PCS^® Plasma Collection System with Persona^® PLUS technology. Persona PLUS represents the next generation of Haemonetics' proprietary and patented Persona technology that tailors plasma collections to each donor for improved average plasma volume per donation.

The 510(k) clearance was supported by clinical data from a prospective, randomized, controlled, multicenter, pivotal trial involving over 30,000 plasma donations from nearly 3,000 donors, demonstrating the safety and effectiveness of the NexSys PCS Plasma Collection System with Persona PLUS technology. Trial results showed Persona PLUS delivered on average a mid-single digit percent increase of plasma per donation over Persona.

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

Haemonetics is the global leader in the plasma collections market. NexSys PCS is the industry's most advanced, completely integrated system designed to streamline plasma collections and lower cost-per-liter through improved yield, productivity, safety, quality, compliance and donor satisfaction.

About Haemonetics

Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.

Cautionary Statement Regarding Forward-Looking Information

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the NexSys PCS Plasma Collection System with Persona PLUS technology and Haemonetics' plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

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SOURCE Haemonetics Corporation