Haemonetics Corporation received 510(k) clearance from the U.S. Food and Drug Administration for its NexSys PCS plasma collection system equipped with Persona PLUS technology. The clearance, issued on February 23 2026, authorizes the system for commercial use in plasma collection facilities.
The clearance was based on a prospective, randomized, controlled, multicenter trial that enrolled more than 30,000 plasma donations from nearly 3,000 donors. Results showed a mid‑single‑digit percent increase in plasma volume per donation compared with the previous Persona system, confirming the platform’s ability to tailor collection to individual donor characteristics.
Haemonetics is a global leader in the plasma collections market, commanding more than 70 % of the collection device market. The new Persona PLUS platform builds on the company’s earlier 2020 clearance of the NexSys PCS system with Persona technology, which had already demonstrated an 8.2 % yield improvement over the older YES technology. The FDA approval removes a regulatory hurdle that had delayed the product’s launch and positions Haemonetics to capture additional market share in a high‑growth segment.
The clearance comes as Haemonetics reports strong financial performance. In Q4 FY2024 the company generated $343.3 million in revenue, up 12.8 % YoY, and an adjusted EPS of $0.90. Revenue fell 3.7 % in Q4 FY2025 to $330.6 million, but adjusted EPS rose to $1.24, reflecting margin expansion to 58.4 %. In Q3 FY2026 revenue reached $339 million, with plasma revenue up 3.5 % to $138.9 million, and adjusted EPS of $1.31, a 4.8 % beat. Operating margin expanded to 26.3 % from 26.0 % in the prior year, driven by higher mix and cost control.
Executive commentary underscores the strategic importance of the new platform. Chief Commercial Officer Roy Galvin said, "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." CEO Chris Simon added, "We delivered solid earnings growth in our fiscal 2025, with record margin expansion and strong cash flow as evidence of the health and vitality of our businesses. Our industry‑leading NexSys, TEG and Vascade technologies continue to propel our growth in attractive markets, and we are on track to deliver all of the goals of our four‑year long‑range plan in fiscal 2026."
The FDA clearance is expected to accelerate Haemonetics’ plasma business, which contributed 43.2 % of total revenue in FY2024. Management has guided for a 1‑3 % decline in FY2026 revenue and 0‑2 % organic growth, with adjusted EPS guidance of $4.90‑$5.00, reflecting confidence in maintaining profitability while investing in new technologies. The approval removes a regulatory barrier, enhances the company’s competitive positioning, and is likely to translate into incremental revenue and margin gains as the system is adopted by plasma collection centers.
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