Haemonetics Receives FDA 510(k) Clearance for NexSys PCS Plasma Collection System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 23 2026
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Should l Buy HAE?
Haemonetics announced U.S. 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.
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Analyst Views on HAE
Wall Street analysts forecast HAE stock price to rise
8 Analyst Rating
4 Buy
4 Hold
0 Sell
Moderate Buy
Current: 64.230
Low
74.00
Averages
88.86
High
99.00
Current: 64.230
Low
74.00
Averages
88.86
High
99.00
About HAE
Haemonetics Corporation is a medical technology company. Its solutions address critical medical needs, which includes 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. Its Plasma segment includes plasma collection devices and disposables, donor management software and supporting software solutions. Its Blood Center segment manufactures and provides customers with its full line of apheresis solutions for automated blood collection. Its Hospital segment consists of Interventional Technologies, which includes Vascular Closure, Sensor Guided Technologies and Esophageal Protection products, and Blood Management Technologies (Hemostasis Management, Cell Salvage and Transfusion Management products). It also offers solutions for structural heart and endovascular procedures.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Haemonetics Receives FDA Clearance for NexSys PCS Plasma Collection System
- FDA Approval: Haemonetics Corporation announced that its NexSys PCS® Plasma Collection System with Persona®PLUS technology has received FDA 510(k) clearance, marking a significant advancement in blood plasma collection technology.
- Clinical Trial Support: This clearance was supported by clinical data from a pivotal trial involving over 30,000 plasma donations from nearly 3,000 donors, demonstrating that Persona PLUS technology increases plasma volume per donation by a mid-single digit percentage, confirming its safety and effectiveness.
- Growing Market Demand: With the rising demand for plasma-derived therapies, Haemonetics' Persona PLUS technology not only enhances yield per liter but also reduces costs, further solidifying its leadership position in the global plasma collection market.
- Significant System Advantages: The NexSys PCS is regarded as the industry's most advanced integrated system, significantly optimizing operations for plasma centers by improving yield, productivity, and donor satisfaction, thereby addressing the urgent need for innovation in the market.
See More
Haemonetics Reports Strong Q3 Earnings, Raises Guidance
- Earnings Beat: Haemonetics reported Q3 earnings of $1.31 per share, surpassing the analyst consensus of $1.25, indicating strong operational performance that boosts investor confidence.
- Sales Growth: The company achieved quarterly sales of $338.967 million, exceeding the analyst estimate of $331.616 million, reflecting robust demand for its products and driving overall revenue growth.
- Guidance Upgrade: Haemonetics raised its FY2026 adjusted EPS guidance from $4.80-$5.00 to $4.90-$5.00, showcasing the company's optimistic outlook for future performance, which may attract more investor interest.
- Analyst Rating Changes: Despite the strong earnings, shares fell 6% to $61.13, with Barrington Research raising its price target from $93 to $94, while Mizuho lowered its target from $90 to $80, indicating market uncertainty about future prospects.
See More
Haemonetics Raises Full-Year Guidance After Strong Q3 Performance
- Strong Performance: Haemonetics reported third-quarter revenue of $339 million, bringing year-to-date revenue to $988 million; despite a $153 million impact from nonrecurring items, organic growth of 8% indicates resilience in core products and sustained market demand.
- Profitability Improvement: Adjusted earnings per share increased by 10% to $1.31 in the third quarter and 11% year-to-date to $3.67, underscoring enhanced earnings quality and durability, which further solidifies investor confidence.
- Cash Flow Performance: The company generated $74 million in free cash flow in the third quarter, totaling $165 million year-to-date, driven by strong operating cash flow of $222 million, reflecting improved cash flow management and operational efficiency.
- Optimistic Outlook: Haemonetics raised its full-year revenue guidance to a decline of 1% to 3% and expects hospital business to achieve approximately 4% organic growth, demonstrating management's confidence in future growth, particularly in plasma and blood management technologies.
See More
Haemonetics Q3 Earnings Report Analysis
- Earnings Performance: Haemonetics reported a Q3 GAAP EPS of $0.95, missing expectations by $0.01, indicating slight profitability concerns that could affect investor confidence.
- Revenue Figures: The company generated $338.9 million in revenue for Q3, a 2.9% year-over-year decline, yet it exceeded market expectations by $6.18 million, suggesting some resilience in market demand despite challenges.
- Market Reaction: Although revenue surpassed expectations, the EPS miss may lead to short-term stock volatility, prompting investors to monitor subsequent market dynamics and potential strategic adjustments by the company.
- Acquisition Activity: Haemonetics recently acquired Vivasure Medical, further expanding its product line and market share, demonstrating the company's ongoing investment and growth potential in the medical device sector.
See More
Haemonetics Corporation Revises Fiscal 2026 Outlook
- Earnings Guidance Upgrade: Haemonetics Corporation has raised its fiscal 2026 adjusted earnings per share outlook to between $4.90 and $5, improving from the previous range of $4.80 to $5, indicating increased confidence in future profitability.
- Revenue Forecast Improvement: The company now expects annual revenue to decline by 1% to 3% for fiscal 2026, a narrower range compared to the earlier forecast of a 1% to 4% decline, reflecting relative stability in market demand.
- Historical Performance Comparison: In fiscal 2025, Haemonetics reported adjusted earnings of $4.57 per share and revenue of $1.361 billion, demonstrating solid financial performance over the past year.
- Market Reaction Potential: This outlook revision may enhance investor confidence in Haemonetics, potentially leading to a positive impact on its stock price, especially against the backdrop of ongoing growth in the healthcare sector.
See More
Haemonetics Releases Q3 Fiscal 2026 Financial Results
- Earnings Announcement: Haemonetics Corporation announced its financial results for the third quarter of fiscal year 2026, ending December 27, 2025, on February 5, 2026, emphasizing the company's commitment to transparency and investor communication.
- Investor Conference Call: The company will host a conference call and webcast at 8:00 a.m. ET on February 5, 2026, to discuss the financial results with investors and analysts, highlighting its focus on engaging with stakeholders.
- Financial Materials Prepared: Prior to the call, Haemonetics has made available its third-quarter earnings release and supplemental presentation on its Investor Relations website, ensuring participants are well-informed for in-depth discussions.
- Company Overview: Haemonetics is a global medical technology company dedicated to improving healthcare quality and efficiency, with innovative solutions spanning hospital technologies, plasma collection, and blood component collection, showcasing its significant impact in the medical technology sector.
See More
Haemonetics Receives FDA Clearance for NexSys PCS Plasma Collection System
- FDA Approval: Haemonetics Corporation announced that its NexSys PCS® Plasma Collection System with Persona®PLUS technology has received FDA 510(k) clearance, marking a significant advancement in blood plasma collection technology.
- Clinical Trial Support: This clearance was supported by clinical data from a pivotal trial involving over 30,000 plasma donations from nearly 3,000 donors, demonstrating that Persona PLUS technology increases plasma volume per donation by a mid-single digit percentage, confirming its safety and effectiveness.
- Growing Market Demand: With the rising demand for plasma-derived therapies, Haemonetics' Persona PLUS technology not only enhances yield per liter but also reduces costs, further solidifying its leadership position in the global plasma collection market.
- Significant System Advantages: The NexSys PCS is regarded as the industry's most advanced integrated system, significantly optimizing operations for plasma centers by improving yield, productivity, and donor satisfaction, thereby addressing the urgent need for innovation in the market.
See More
Haemonetics Reports Strong Q3 Earnings, Raises Guidance
- Earnings Beat: Haemonetics reported Q3 earnings of $1.31 per share, surpassing the analyst consensus of $1.25, indicating strong operational performance that boosts investor confidence.
- Sales Growth: The company achieved quarterly sales of $338.967 million, exceeding the analyst estimate of $331.616 million, reflecting robust demand for its products and driving overall revenue growth.
- Guidance Upgrade: Haemonetics raised its FY2026 adjusted EPS guidance from $4.80-$5.00 to $4.90-$5.00, showcasing the company's optimistic outlook for future performance, which may attract more investor interest.
- Analyst Rating Changes: Despite the strong earnings, shares fell 6% to $61.13, with Barrington Research raising its price target from $93 to $94, while Mizuho lowered its target from $90 to $80, indicating market uncertainty about future prospects.
See More
Haemonetics Raises Full-Year Guidance After Strong Q3 Performance
- Strong Performance: Haemonetics reported third-quarter revenue of $339 million, bringing year-to-date revenue to $988 million; despite a $153 million impact from nonrecurring items, organic growth of 8% indicates resilience in core products and sustained market demand.
- Profitability Improvement: Adjusted earnings per share increased by 10% to $1.31 in the third quarter and 11% year-to-date to $3.67, underscoring enhanced earnings quality and durability, which further solidifies investor confidence.
- Cash Flow Performance: The company generated $74 million in free cash flow in the third quarter, totaling $165 million year-to-date, driven by strong operating cash flow of $222 million, reflecting improved cash flow management and operational efficiency.
- Optimistic Outlook: Haemonetics raised its full-year revenue guidance to a decline of 1% to 3% and expects hospital business to achieve approximately 4% organic growth, demonstrating management's confidence in future growth, particularly in plasma and blood management technologies.
See More
Haemonetics Q3 Earnings Report Analysis
- Earnings Performance: Haemonetics reported a Q3 GAAP EPS of $0.95, missing expectations by $0.01, indicating slight profitability concerns that could affect investor confidence.
- Revenue Figures: The company generated $338.9 million in revenue for Q3, a 2.9% year-over-year decline, yet it exceeded market expectations by $6.18 million, suggesting some resilience in market demand despite challenges.
- Market Reaction: Although revenue surpassed expectations, the EPS miss may lead to short-term stock volatility, prompting investors to monitor subsequent market dynamics and potential strategic adjustments by the company.
- Acquisition Activity: Haemonetics recently acquired Vivasure Medical, further expanding its product line and market share, demonstrating the company's ongoing investment and growth potential in the medical device sector.
See More
Haemonetics Corporation Revises Fiscal 2026 Outlook
- Earnings Guidance Upgrade: Haemonetics Corporation has raised its fiscal 2026 adjusted earnings per share outlook to between $4.90 and $5, improving from the previous range of $4.80 to $5, indicating increased confidence in future profitability.
- Revenue Forecast Improvement: The company now expects annual revenue to decline by 1% to 3% for fiscal 2026, a narrower range compared to the earlier forecast of a 1% to 4% decline, reflecting relative stability in market demand.
- Historical Performance Comparison: In fiscal 2025, Haemonetics reported adjusted earnings of $4.57 per share and revenue of $1.361 billion, demonstrating solid financial performance over the past year.
- Market Reaction Potential: This outlook revision may enhance investor confidence in Haemonetics, potentially leading to a positive impact on its stock price, especially against the backdrop of ongoing growth in the healthcare sector.
See More
Haemonetics Releases Q3 Fiscal 2026 Financial Results
- Earnings Announcement: Haemonetics Corporation announced its financial results for the third quarter of fiscal year 2026, ending December 27, 2025, on February 5, 2026, emphasizing the company's commitment to transparency and investor communication.
- Investor Conference Call: The company will host a conference call and webcast at 8:00 a.m. ET on February 5, 2026, to discuss the financial results with investors and analysts, highlighting its focus on engaging with stakeholders.
- Financial Materials Prepared: Prior to the call, Haemonetics has made available its third-quarter earnings release and supplemental presentation on its Investor Relations website, ensuring participants are well-informed for in-depth discussions.
- Company Overview: Haemonetics is a global medical technology company dedicated to improving healthcare quality and efficiency, with innovative solutions spanning hospital technologies, plasma collection, and blood component collection, showcasing its significant impact in the medical technology sector.
See More
