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Haemonetics' (HAE) New TEG 6s Cartridge Gets FDA Approval
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Haemonetics Corporation (HAE - Free Report) announced receipt of the FDA 510(k) clearance for the TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. This new cartridge expands Haemonetics' TEG 6s viscoelastic testing capabilities to include fully heparinized patients undergoing adult cardiovascular surgeries/procedures and liver transplants in both laboratory and point-of-care settings.
The recent development will fortify Haemonetics’ portfolio of hemostasis diagnostic systems.
More on TEG 6s Cartridge
Clinical data from a multi-center trial with 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplants supported the 510(k) grant. Furthermore, an additional investigation was carried out with 164 healthy participants to determine the usual reference values for the test cartridge. More than 5,500 clinical data points were used to show the safety and efficacy of the Global Hemostasis - HN tests.
Compared to traditional coagulation testing, Haemonetics' cartridge-based TEG 6s technology gives clinicians a comprehensive view of a patient's coagulation profile with faster, more thorough information for actionable results. The TEG 6s analyzer is accompanied by TEG Manager software, which offers customizable alert messages and remote real-time result viewing throughout the hospital. It also provides Interpretation Guidance. In the upcoming months, Haemonetics intends to deliver the new Global Hemostasis-HN cartridge for the TEG 6s system.
Benefits of TEG 6s Cartridge
TEG testing gives vital information that can assist doctors with better control of their patients' hemostasis, particularly in life-threatening circumstances like open heart and liver transplant procedures and severe trauma. Patients receiving liver transplants or cardiopulmonary bypass, where heparin or endogenous heparinoids are present, can now benefit from the TEG 6s system thanks to the Global Hemostasis-HN assay cartridge.
Per management, with the support of its new cartridge, the company is likely to help more physicians enhance patient outcomes and care standards while also growing the influence of its Blood Management Technologies franchise through greater TEG 6 usage.
Industry Prospects
Per a report, the global hemostasis diagnostics market share is estimated to witness a CAGR of 8.1% through 2023-2029. Increasing demand for adequate treatment services and rising cases of blood loss from injuries sustained by accidents are driving the market.
Progress Within Hemostasis Portfolio
Haemonetics’ portfolio of hemostasis diagnostic systems enables clinicians to holistically assess a patient's coagulation status at the point-of-care or laboratory setting. The company markets four viscoelastic testing systems to hospitals and laboratories as an alternative to routine blood tests: the TEG 5000 hemostasis analyzer system, the TEG 6s hemostasis analyzer system, the ClotPro hemostasis analyzer system and the HAS-100 hemostasis analyzer system.
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In the third quarter of fiscal 2024, Hemostasis’ business revenues increased 18%, driven by strong utilization of TEG disposables in the United States and China.
The company is anticipating sustaining its growth momentum as it capitalizes on its significantly expanded R&D and clinical capabilities to develop new and existing products and commercial infrastructure to cover the majority of its strategic accounts in the $700 million underpenetrated total addressable market.
Price Performance
In the past year, HAE shares have gained 3.1% compared with the industry’s rise of 9.2%.
Zacks Rank and Key Picks
Haemonetics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2 (Buy) at present, reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2 at present, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, currently carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.
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Haemonetics' (HAE) New TEG 6s Cartridge Gets FDA Approval
Haemonetics Corporation (HAE - Free Report) announced receipt of the FDA 510(k) clearance for the TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. This new cartridge expands Haemonetics' TEG 6s viscoelastic testing capabilities to include fully heparinized patients undergoing adult cardiovascular surgeries/procedures and liver transplants in both laboratory and point-of-care settings.
The recent development will fortify Haemonetics’ portfolio of hemostasis diagnostic systems.
More on TEG 6s Cartridge
Clinical data from a multi-center trial with 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplants supported the 510(k) grant. Furthermore, an additional investigation was carried out with 164 healthy participants to determine the usual reference values for the test cartridge. More than 5,500 clinical data points were used to show the safety and efficacy of the Global Hemostasis - HN tests.
Compared to traditional coagulation testing, Haemonetics' cartridge-based TEG 6s technology gives clinicians a comprehensive view of a patient's coagulation profile with faster, more thorough information for actionable results. The TEG 6s analyzer is accompanied by TEG Manager software, which offers customizable alert messages and remote real-time result viewing throughout the hospital. It also provides Interpretation Guidance. In the upcoming months, Haemonetics intends to deliver the new Global Hemostasis-HN cartridge for the TEG 6s system.
Benefits of TEG 6s Cartridge
TEG testing gives vital information that can assist doctors with better control of their patients' hemostasis, particularly in life-threatening circumstances like open heart and liver transplant procedures and severe trauma. Patients receiving liver transplants or cardiopulmonary bypass, where heparin or endogenous heparinoids are present, can now benefit from the TEG 6s system thanks to the Global Hemostasis-HN assay cartridge.
Per management, with the support of its new cartridge, the company is likely to help more physicians enhance patient outcomes and care standards while also growing the influence of its Blood Management Technologies franchise through greater TEG 6 usage.
Industry Prospects
Per a report, the global hemostasis diagnostics market share is estimated to witness a CAGR of 8.1% through 2023-2029. Increasing demand for adequate treatment services and rising cases of blood loss from injuries sustained by accidents are driving the market.
Progress Within Hemostasis Portfolio
Haemonetics’ portfolio of hemostasis diagnostic systems enables clinicians to holistically assess a patient's coagulation status at the point-of-care or laboratory setting. The company markets four viscoelastic testing systems to hospitals and laboratories as an alternative to routine blood tests: the TEG 5000 hemostasis analyzer system, the TEG 6s hemostasis analyzer system, the ClotPro hemostasis analyzer system and the HAS-100 hemostasis analyzer system.
In the third quarter of fiscal 2024, Hemostasis’ business revenues increased 18%, driven by strong utilization of TEG disposables in the United States and China.
The company is anticipating sustaining its growth momentum as it capitalizes on its significantly expanded R&D and clinical capabilities to develop new and existing products and commercial infrastructure to cover the majority of its strategic accounts in the $700 million underpenetrated total addressable market.
Price Performance
In the past year, HAE shares have gained 3.1% compared with the industry’s rise of 9.2%.
Zacks Rank and Key Picks
Haemonetics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2 (Buy) at present, reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2 at present, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, currently carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.