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

Rhea-AI Summary

Haemonetics (NYSE: HAE) received FDA 510(k) clearance on Feb 23, 2026 for the NexSys PCS Plasma Collection System with Persona PLUS technology. Persona PLUS is the next generation of Persona and was supported by a prospective, randomized, controlled, multicenter pivotal trial of over 30,000 donations from nearly 3,000 donors.

Trial data showed Persona PLUS delivered a mid-single-digit percent increase in average plasma volume per donation versus Persona, supporting safety and effectiveness for U.S. use.

Positive

• FDA 510(k) clearance for NexSys PCS with Persona PLUS
• Large pivotal trial: over 30,000 donations from nearly 3,000 donors demonstrating safety and effectiveness
• Yield improvement: Persona PLUS delivered a mid-single-digit percent increase in plasma per donation versus Persona

Negative

• Modest uplift: increase described as mid-single-digit percent, limiting near-term per-donation volume impact

News Market Reaction – HAE

+0.64%

+0.64% Session close to close

In the Feb 24 session, HAE gained 0.64%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights FDA 510(k) clearance for NexSys PCS with Persona PLUS, supported by a p...

Analysis

This announcement highlights FDA 510(k) clearance for NexSys PCS with Persona PLUS, supported by a pivotal trial of over 30,000 donations from nearly 3,000 donors. It adds to Haemonetics’ track record of device clearances while the company manages softer top‑line trends but stronger profitability and cash generation. Investors may watch adoption of the new system, future regulatory milestones, and how leverage of about $1.22 billion evolves alongside further portfolio moves.

Key Figures

Plasma donations in trial: over 30,000 donations Donors in trial: nearly 3,000 donors Quarterly net revenues: $338.97 million +5 more

8 metrics

Plasma donations in trial over 30,000 donations Prospective randomized controlled multicenter pivotal trial for NexSys PCS with Persona PLUS

Donors in trial nearly 3,000 donors Pivotal trial supporting 510(k) clearance

Quarterly net revenues $338.97 million Three months ended December 27, 2025 (down from $348.54M year earlier)

Quarterly net income $44.74 million Three months ended December 27, 2025 (up from $37.49M)

Quarterly diluted EPS $0.95 Three months ended December 27, 2025 (up from $0.74)

Nine‑month revenue $987.68 million Nine months ended December 27, 2025 (vs. $1.03 billion prior year)

Operating cash flow $222.28 million Nine months ended December 27, 2025

Total debt $1.22 billion Includes convertible senior notes due 2026 and 2029

Previous Clinical trial,fda approval Reports

1 past event · Latest: Apr 04 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 04	FDA clearance update	Positive	+1.2%	FDA clearance for new TEG 6s Global Hemostasis - HN cartridge.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Prior FDA/clinical trial clearances for HAE led to a modest positive move of about 1.16%, consistent with today’s mild uptick on regulatory news.

Recent Company History

Recent news shows Haemonetics combining portfolio reshaping with regulatory progress. A prior Apr 4, 2024 FDA clearance for a TEG 6s cartridge (same clinical trial,fda approval tag) saw a +1.16% move. Since then, the company has reported solid earnings with softer sales, executed multiple acquisitions, and maintained active investor communication through conferences and filings. Today’s NexSys PCS Persona PLUS clearance fits this pattern of incremental product and regulatory advances within a broader strategic transformation.

Key Terms

510(k) clearance, pivotal trial, plasma-derived therapies, CE mark, +4 more

8 terms

510(k) clearance regulatory

"today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the NexSys PCS"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

pivotal trial medical

"clinical data from a prospective, randomized, controlled, multicenter, pivotal trial involving"

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

plasma-derived therapies medical

"With the growing demand for plasma-derived therapies, plasma collectors' need for innovation"

Plasma-derived therapies are medical products made from proteins extracted from donated blood plasma, used to treat immune deficiencies, bleeding disorders and other chronic conditions. Think of them like concentrated ingredients pulled from a large pot of soup to make a targeted remedy; their manufacture depends on steady donations, complex processing and strict regulation. For investors, that means revenue can be recurring and resilient but also sensitive to supply bottlenecks, regulatory changes and pricing pressures.

CE mark regulatory

"Vivasure previously received an expanded CE mark for PerQseal Elite covering"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

PMA application regulatory

"has submitted a PMA application to the FDA for PerQseal Elite for arterial procedures"

A PMA application is a formal submission to a medical device regulator seeking Premarket Approval to sell a high‑risk device, supported by clinical data and detailed manufacturing and safety information. For investors it signals a make‑or‑break regulatory hurdle: approval opens large markets and revenue potential, while rejection or delay can sharply increase risk and push back commercialization—think of it like seeking a rigorous safety permit before a product can legally be sold.

convertible senior notes financial

"including convertible senior notes due 2026 and 2029"

Convertible senior notes are a type of loan that a company issues to investors, which can be turned into company shares later on. They are called "senior" because they are paid back before other debts if the company runs into trouble. This allows investors to earn interest like a loan but also have the chance to own part of the company if its value rises.

ASR financial

"executed a new ASR in August 2025, repurchasing $75.0 million of stock"

An ASR (Accelerated Share Repurchase) is a deal where a company buys back a large block of its own shares quickly by contracting with a bank: the company pays up front and the bank delivers shares immediately, later settling the exact amount over time. Investors care because it reduces the number of shares on the market—like reducing the number of slices in a pie—which can boost per-share earnings and often supports the stock price, while shifting some execution risk to the bank.

restricted stock units financial

"includes unvested restricted stock units that were previously reported"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

Investor Contacts:        Olga Guyette, Vice President-Investor Relations & Treasury              (781) 356-9763    olga.guyette@haemonetics.com   Media Contact:     Josh Gitelson, Sr. Director-Global Communications        (781) 356-9776 josh.gitelson@haemonetics.com

David Trenk, Manager-Investor Relations (203) 733-4987 david.trenk@haemonetics.com

 

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SOURCE Haemonetics Corporation

FAQ

What did Haemonetics (HAE) announce on February 23, 2026 about NexSys PCS?

Haemonetics announced FDA 510(k) clearance for NexSys PCS with Persona PLUS technology. According to the company, the clearance was supported by a pivotal trial with over 30,000 plasma donations from nearly 3,000 donors showing safety and effectiveness.

How much additional plasma does Persona PLUS deliver per donation for HAE's NexSys PCS?

Persona PLUS delivered a mid-single-digit percent increase in average plasma volume per donation versus Persona. According to the company, that result came from a randomized, controlled, multicenter pivotal trial covering over 30,000 donations.

Why is the FDA 510(k) clearance important for Haemonetics (HAE) plasma business?

FDA 510(k) clearance permits U.S. marketing of the NexSys PCS with Persona PLUS technology. According to the company, clearance validates safety and effectiveness from a large pivotal trial, enabling commercial deployment in the U.S. plasma market.

How large was the clinical trial supporting HAE's Persona PLUS clearance?

The pivotal trial included over 30,000 plasma donations from nearly 3,000 donors across multiple centers. According to the company, the prospective, randomized, controlled design supported the safety and effectiveness findings for Persona PLUS.

What operational impact might NexSys PCS with Persona PLUS have for plasma collectors (HAE)?

Persona PLUS may increase average plasma yield per donation by a mid-single-digit percentage versus Persona. According to the company, that uplift is intended to improve yield and support lower cost-per-liter for plasma collection operations.