Haemonetics Receives FDA Approval to Expand VASCADE MVP XL Labeling
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy HAE?
Haemonetics announced U.S. FDA approval to expand the labeling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation and left atrial appendage closure to treat atrial fibrillation.
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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: 56.360
Low
74.00
Averages
88.86
High
99.00
Current: 56.360
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.
GVS SpA Reports 2025 Earnings Highlights
- Sales Growth: GVS SpA achieved sales of EUR 425 million in 2025, reflecting a 2% increase compared to 2024 when excluding foreign exchange impacts, indicating stable market performance despite external challenges.
- Adjusted EBITDA Improvement: The adjusted EBITDA reached EUR 107 million, up 3% from 2024, with a margin increase from 24.3% to 25.2%, showcasing the company's ongoing improvements in cost control and operational efficiency.
- Strong Performance in Safety Division: The Safety division recorded nearly 12% growth, demonstrating robust demand in this segment, which is expected to support future revenue growth for the company.
- Negative Impact Factors: The Energy & Mobility division saw a 7.5% decline in sales, along with a EUR 10 million negative impact from the US Dialysis business, indicating challenges in certain areas that require strategic responses to market fluctuations.
See More
VASCADE MVP XL Receives FDA Approval for Larger Sheaths
- FDA Approval Expansion: The VASCADE MVP XL venous vascular closure system has received FDA approval to include procedures using 10-14F inner diameter and up to 17F outer diameter sheaths, marking a significant expansion in its application for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) technologies, which is expected to enhance its market competitiveness.
- Clinical Trial Support: The AMBULATE EXPAND trial demonstrated zero major or minor complications among 77 patients, with a median time to ambulation of 2.4 hours, validating the safety and effectiveness of the system with 17F sheaths and providing robust clinical evidence for market promotion.
- Technical Advantages: The VASCADE MVP XL system features a 25F diameter disc and 19 milligrams of resorbable thrombogenic collagen, eliminating the need for physicians to downsize sheaths for closure, thereby reducing procedural time and enhancing medical efficiency.
- Accelerated Commercial Strategy: According to Haemonetics' Vice President, the label expansion approval will accelerate the company's commercial strategy, enabling support for a greater number of procedures at hospitals and ambulatory surgical centers, further driving revenue growth and market share enhancement.
See More
VASCADE MVP XL Receives FDA Approval for Larger Sheaths
- FDA Approval Expansion: Haemonetics Corporation announced that its VASCADE MVP XL venous vascular closure system has received FDA approval to include procedures using 10-14F inner diameter and up to 17F outer diameter sheaths, marking an expansion in its application for treating atrial fibrillation and reinforcing its market leadership.
- Clinical Trial Support: The approval was supported by clinical evidence from the AMBULATE EXPAND trial, which enrolled 77 patients across eight U.S. centers, demonstrating 0% major and minor closure-related complications and a median time to ambulation of 2.4 hours, confirming the system's safety and effectiveness.
- Competitive Market Advantage: The VASCADE MVP XL system is the only clinically proven extravascular closure system for use with up to 17F outer diameter sheaths, allowing physicians to avoid downsizing procedural sheaths, thereby reducing procedural time and enhancing operational efficiency for hospitals and ambulatory surgical centers.
- Accelerated Commercial Strategy: With the FDA's label expansion approval, Haemonetics plans to accelerate its commercial strategy, leveraging this opportunity to support a broader range of procedures and increase its market share in the rapidly growing PFA and LAAC technology sectors.
See More
Haemonetics Stock Enters Oversold Territory
- Oversold Signal: Haemonetics Corp. (Ticker: HAE) hit an RSI of 29.2 during Wednesday's trading, indicating an oversold condition that suggests recent heavy selling may be exhausting, prompting investors to consider buying opportunities.
- Price Fluctuation: HAE shares reached a low of $55.115, with the current trading price at $55.93, showing a significant recovery from the 52-week low of $47.315, yet still far below the 52-week high of $87.32, reflecting market volatility.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 38.3, HAE's 29.2 RSI indicates relative weakness, potentially attracting investors looking for a rebound.
- Investor Sentiment: While current market sentiment is cautious, the oversold condition may present potential buying opportunities for investors, especially if the market rebounds, suggesting HAE's stock price could recover.
See More
Invenomic Fully Exits Haemonetics Stake
- Share Sale Details: Invenomic sold 498,317 shares of Haemonetics in Q4, resulting in a $24.29 million decrease in position value, indicating a waning confidence in the company.
- Position Change Analysis: The stake previously accounted for 1.2% of fund AUM, and the complete exit suggests Invenomic opted to cash in on gains after Haemonetics shares surged nearly 70% last quarter.
- Company Performance Fluctuations: While Haemonetics continues to grow in blood and plasma management, its revenue declined about 3% last quarter to approximately $339 million, reflecting market pressures and uneven performance across business lines.
- Profitability Improvement: Despite the slowdown in revenue, Haemonetics achieved a gross margin nearing 60% and increased operating income, indicating progress in efficiency, which complicates Invenomic's exit decision.
See More
Invenomic Capital Exits Haemonetics Corporation Stake
- Position Change: According to a February 17, 2026 SEC filing, Invenomic Capital Management fully exited its position in Haemonetics Corporation by selling 498,317 shares valued at $24.29 million, reducing its stake from 1.2% to zero.
- Market Performance: Shares of Haemonetics are currently priced at $58.58, reflecting a 9% decline over the past year, significantly underperforming the S&P 500's approximately 16% gain, indicating relative weakness in the company's market standing.
- Financial Overview: Haemonetics reported a trailing twelve-month revenue of $1.32 billion and a net income of $175.44 million, with a 3% year-over-year revenue decline; however, gross margin improved to nearly 60%, demonstrating the company's efforts to enhance operational efficiency.
- Investor Strategy: Invenomic's exit appears to be a strategic move to lock in gains after Haemonetics' stock surged nearly 70% in the last quarter, despite facing challenges such as declining revenue and uneven performance across business lines, showcasing the fund's adaptability to market fluctuations.
See More
GVS SpA Reports 2025 Earnings Highlights
- Sales Growth: GVS SpA achieved sales of EUR 425 million in 2025, reflecting a 2% increase compared to 2024 when excluding foreign exchange impacts, indicating stable market performance despite external challenges.
- Adjusted EBITDA Improvement: The adjusted EBITDA reached EUR 107 million, up 3% from 2024, with a margin increase from 24.3% to 25.2%, showcasing the company's ongoing improvements in cost control and operational efficiency.
- Strong Performance in Safety Division: The Safety division recorded nearly 12% growth, demonstrating robust demand in this segment, which is expected to support future revenue growth for the company.
- Negative Impact Factors: The Energy & Mobility division saw a 7.5% decline in sales, along with a EUR 10 million negative impact from the US Dialysis business, indicating challenges in certain areas that require strategic responses to market fluctuations.
See More
VASCADE MVP XL Receives FDA Approval for Larger Sheaths
- FDA Approval Expansion: The VASCADE MVP XL venous vascular closure system has received FDA approval to include procedures using 10-14F inner diameter and up to 17F outer diameter sheaths, marking a significant expansion in its application for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) technologies, which is expected to enhance its market competitiveness.
- Clinical Trial Support: The AMBULATE EXPAND trial demonstrated zero major or minor complications among 77 patients, with a median time to ambulation of 2.4 hours, validating the safety and effectiveness of the system with 17F sheaths and providing robust clinical evidence for market promotion.
- Technical Advantages: The VASCADE MVP XL system features a 25F diameter disc and 19 milligrams of resorbable thrombogenic collagen, eliminating the need for physicians to downsize sheaths for closure, thereby reducing procedural time and enhancing medical efficiency.
- Accelerated Commercial Strategy: According to Haemonetics' Vice President, the label expansion approval will accelerate the company's commercial strategy, enabling support for a greater number of procedures at hospitals and ambulatory surgical centers, further driving revenue growth and market share enhancement.
See More
VASCADE MVP XL Receives FDA Approval for Larger Sheaths
- FDA Approval Expansion: Haemonetics Corporation announced that its VASCADE MVP XL venous vascular closure system has received FDA approval to include procedures using 10-14F inner diameter and up to 17F outer diameter sheaths, marking an expansion in its application for treating atrial fibrillation and reinforcing its market leadership.
- Clinical Trial Support: The approval was supported by clinical evidence from the AMBULATE EXPAND trial, which enrolled 77 patients across eight U.S. centers, demonstrating 0% major and minor closure-related complications and a median time to ambulation of 2.4 hours, confirming the system's safety and effectiveness.
- Competitive Market Advantage: The VASCADE MVP XL system is the only clinically proven extravascular closure system for use with up to 17F outer diameter sheaths, allowing physicians to avoid downsizing procedural sheaths, thereby reducing procedural time and enhancing operational efficiency for hospitals and ambulatory surgical centers.
- Accelerated Commercial Strategy: With the FDA's label expansion approval, Haemonetics plans to accelerate its commercial strategy, leveraging this opportunity to support a broader range of procedures and increase its market share in the rapidly growing PFA and LAAC technology sectors.
See More
Haemonetics Stock Enters Oversold Territory
- Oversold Signal: Haemonetics Corp. (Ticker: HAE) hit an RSI of 29.2 during Wednesday's trading, indicating an oversold condition that suggests recent heavy selling may be exhausting, prompting investors to consider buying opportunities.
- Price Fluctuation: HAE shares reached a low of $55.115, with the current trading price at $55.93, showing a significant recovery from the 52-week low of $47.315, yet still far below the 52-week high of $87.32, reflecting market volatility.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 38.3, HAE's 29.2 RSI indicates relative weakness, potentially attracting investors looking for a rebound.
- Investor Sentiment: While current market sentiment is cautious, the oversold condition may present potential buying opportunities for investors, especially if the market rebounds, suggesting HAE's stock price could recover.
See More
Invenomic Fully Exits Haemonetics Stake
- Share Sale Details: Invenomic sold 498,317 shares of Haemonetics in Q4, resulting in a $24.29 million decrease in position value, indicating a waning confidence in the company.
- Position Change Analysis: The stake previously accounted for 1.2% of fund AUM, and the complete exit suggests Invenomic opted to cash in on gains after Haemonetics shares surged nearly 70% last quarter.
- Company Performance Fluctuations: While Haemonetics continues to grow in blood and plasma management, its revenue declined about 3% last quarter to approximately $339 million, reflecting market pressures and uneven performance across business lines.
- Profitability Improvement: Despite the slowdown in revenue, Haemonetics achieved a gross margin nearing 60% and increased operating income, indicating progress in efficiency, which complicates Invenomic's exit decision.
See More
Invenomic Capital Exits Haemonetics Corporation Stake
- Position Change: According to a February 17, 2026 SEC filing, Invenomic Capital Management fully exited its position in Haemonetics Corporation by selling 498,317 shares valued at $24.29 million, reducing its stake from 1.2% to zero.
- Market Performance: Shares of Haemonetics are currently priced at $58.58, reflecting a 9% decline over the past year, significantly underperforming the S&P 500's approximately 16% gain, indicating relative weakness in the company's market standing.
- Financial Overview: Haemonetics reported a trailing twelve-month revenue of $1.32 billion and a net income of $175.44 million, with a 3% year-over-year revenue decline; however, gross margin improved to nearly 60%, demonstrating the company's efforts to enhance operational efficiency.
- Investor Strategy: Invenomic's exit appears to be a strategic move to lock in gains after Haemonetics' stock surged nearly 70% in the last quarter, despite facing challenges such as declining revenue and uneven performance across business lines, showcasing the fund's adaptability to market fluctuations.
See More
