Haemonetics Corporation (Haemonetics) operates as a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care.
The company's 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 b...
Haemonetics Corporation (Haemonetics) operates as a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care.
The company's 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.
The company views its operations and manages its business in three principal reporting segments: Plasma, Blood Center, and Hospital. For that purpose, 'Plasma' includes plasma collection devices and disposables, donor management software, and supporting software solutions sold to plasma customers. 'Blood Center' includes blood collection and processing devices and disposables for plasma, red cells, and platelets. 'Hospital' consists of Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies, and Esophageal Protection product lines, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage, and Transfusion Management product lines.
Market and Products
Product Lines and Franchises
Plasma
The company's Plasma business offers automated plasma collection systems, donor management software, and supporting software solutions that enable optimization of the yield, efficiency, quality, and overall donor experience at plasma collection centers. The company continues to invest in technology that lowers the overall cost to collect plasma while maintaining high standards of quality and safety.
Plasma Collection Market for Fractionation - Human plasma is collected for two purposes. First, it is used for transfusions in patients, such as trauma victims who need to compensate for extreme blood loss. Second, it is processed into pharmaceuticals that aid in the treatment of a broad range of immune system diseases and blood-related disorders.
Plasma for transfusion is almost exclusively collected by blood centers as part of their broader mission to supply blood components. Plasma that is fractionated and manufactured into pharmaceuticals - frequently referred to as 'source plasma' - is mainly collected by vertically integrated biopharmaceutical companies that operate their own collection centers and recruit donors specifically for source plasma donation. The markets for transfusion plasma and source plasma have different participants, product requirements, and growth profiles. The company serves the market for plasma that is processed into pharmaceuticals primarily through its Plasma business, and it serves the market for transfusion plasma through its Blood Center business.
The company's Plasma business focuses on the collection of source plasma for pharmaceutical manufacturers using apheresis devices that only collect plasma and software solutions that support the efficient operation of dedicated source plasma collection centers. The company's Blood Center business supports the collection of plasma for blood collectors, such as the American Red Cross, using apheresis collection devices.
Over the last 20 years, the collection of source plasma has increasingly been performed by vertically integrated biopharmaceutical companies, such as CSL Limited (together with its affiliates, 'CSL'), Grifols S.A., Octapharma AG, and Takeda's BioLife Plasma subsidiary. With their global operations and management expertise, these companies are focused on efficient plasma supply chain management and leveraging information technology to manage operations from the point of plasma donation through fractionation to the production of the final pharmaceutical product.
Plasma Products - The company's automated plasma collection devices, related disposables, software, and services are designed to support multiple facets of plasma collector operations. The company has a long-standing commitment to understanding its customers' collection and manufacturing processes. As a result, the company aims to design equipment that is durable, dependable, and easy to use, and to provide comprehensive training and support to help its customers optimize their plasma collections.
Nearly all source plasma collections worldwide are performed using automated collection technology at dedicated facilities. The company offers multiple products to support these dedicated source plasma operations, including the company's NexSys PCS plasmapheresis collection system and related disposables. The company also offers a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations, and supply chain. The company's software products, including its latest NexLynk DMS donor management system and Donor360 tools, automate the donor interview and qualification process, streamline the workflow process in the plasma center, provide the controls necessary to evaluate donor suitability, inform the ability to release units collected, and manage unit distribution. With the company's software solutions, plasma collectors can manage processes across the plasma supply chain, ensure high quality and compliance process support, react quickly to business changes, and implement opportunities to reduce costs.
The company has provided automated platforms dedicated to the collection of plasma for over 30 years. The company's NexSys PCS device is designed to enable higher plasma yield collections, improve productivity in its customers' centers, enhance the overall donor experience, and provide safe and reliable collections that will become life-changing medicines for patients. NexSys PCS includes bi-directional connectivity to the NexLynk DMS donor management system to improve operational efficiency within plasma centers, including through automated programming of donation procedures and automated data capture of procedure data.
The company's NexSys PCS with YES technology is a yield-enhancing solution that enables increases in plasma yield per collection by an additional 18-26 mL per donation, on average. In fiscal 2021, the company received the U.S. Food and Drug Administration (FDA) 510(k) clearance for the company's NexSys PCS with proprietary Persona technology. NexSys PCS with Persona technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor's body composition and enables a 9% to 12% average increase in plasma volume per donation, based on its baseline device, software configuration, and donor population. The company's Persona technology strengthens the NexSys PCS value proposition and reinforces its commitment to supporting its Plasma customers. In addition, during fiscal 2024, the company received FDA clearance for advancements to NexSys PCS, including a new plasma collection bowl and new Express Plus technology engineered to reduce procedure time. The company expects to pursue further regulatory clearances for additional enhancements to the overall product offering.
The company has entered into agreements with all the U.S. customers to adopt NexSys PCS somewhere in their global collection network, and the company's NexLynk DMS donor management software has been adopted by all the U.S. customers except those with internally developed systems. The company substantially completed conversion of its U.S. customers to Persona and Express Plus technologies as of the end of fiscal 2025.
Blood Center
The company's Blood Center business offers a range of products and technologies to help blood centers optimize their blood collections, improve donor safety, enhance yields, and control costs.
Blood Center Products - The company offers automated blood component systems to blood centers to collect blood products efficiently and cost-effectively. The company's MCS brand apheresis equipment is designed to collect specific blood components from the donor, with collection options spanning from multi-dose collection of individual components to combinations of different blood components, increasing its customers' donor management capabilities and reducing the number of donors required to achieve collection targets. The company also markets to Blood Center customers its NexSys PCS device for plasma collections, as well as its ACP automated cell processor for the preparation and recovery of frozen blood cells. In the fourth quarter of fiscal 2025, the company completed the divestiture of its Whole Blood product line within the company's Blood Center business, allowing it to better align its resources to higher margin, higher growth opportunities.
Hospital
Hospitals are called upon to provide the highest standard of patient care while at the same time reducing operating costs. The company's Hospital business has two distinct franchises, Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies, and Esophageal Protection, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage, and Transfusion Management. The Esophageal Protection products were acquired as part of the Advanced Cooling Therapy, Inc., doing business as Attune Medical ('Attune Medical') transaction in April 2024. Both the Interventional Technologies and Blood Management Technologies franchises have a leading market position and a mission of helping hospitals and clinicians provide the highest standard of patient care while at the same time reducing operating and procedural costs and optimizing resources.
Interventional Technologies:
Vascular Closure
Vascular Closure Products - The company's VASCADE technology was developed to address the limitations of manual compression and existing vascular closure devices. The company's VASCADE family of Vascular Closure products consists of four devices, VASCADE 5F, VASCADE 6/7F, VASCADE MVP, and VASCADE MVP XL, which share a common, innovative technology that features a simple, catheter-based delivery system and leverages the natural clot-inducing properties of collagen. This novel design significantly reduces access site complications, increases patient satisfaction, and improves hospital workflow metrics that, in turn, drive economic benefits and overall cost savings. The company's Vascular Closure devices address the growing number of catheter-based coronary, structural heart, peripheral, and electrophysiology procedures that require vascular access site closure each year.
The company's VASCADE product is proven to have a statistically significant reduction in minor complications compared to manual compression based on a randomized clinical trial. The company's VASCADE MVP device is the first marketed vascular closure device clinically proven in a prospective, multi-center, randomized clinical trial to improve workflow relative to manual compression for electrophysiology procedures. Importantly, these improvements may drive meaningful cost savings for hospitals, ambulatory surgery centers, and other treatment facilities. VASCADE MVP was also the first vascular closure device to receive an FDA indication for same-day discharge following atrial fibrillation ablation. During fiscal 2025, the company launched its newest VASCADE product, the VASCADE MVP XL, which utilizes 58% more collagen and a larger disc than the VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths.
Sensor-Guided Technologies Products - The company's OptoWire pressure guidewire aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve ('FFR') and diastolic pressure ratio ('dPR') to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.
The company's SavvyWire is a sensor-guided 3-in-1 guidewire for transcatheter aortic valve replacement ('TAVR') procedures, advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients. SavvyWire serves as a guide-wire, delivers accurate hemodynamic measurement and display, and provides left ventricular ('LV') pacing without the need for adjunct devices or venous access.
The company's Sensor-Guided Technologies business also manufactures fiber optic sensor solutions used in medical devices and other industrial applications.
Esophageal Protection Products - The company's ensoETM system provides proactive cooling of the esophagus during RF ablation, reducing the likelihood of esophageal injury and enabling potential reductions in procedure times and patient readmissions, and increases in the rate of same-day discharge. The ensoETM can also be used to cool or warm a patient during other surgical and critical care procedures, particularly in procedures where external cooling or heating may not be available or effective, such as burn surgery.
Blood Management Technologies:
Hemostasis Management
Hemostasis Management Products - The company's portfolio of hemostasis diagnostic systems enables clinicians to assess holistically the coagulation status of a patient at the point-of-care or laboratory setting. The company has four viscoelastic testing systems that it markets to hospitals and laboratories as an alternative to routine blood tests: the TEG 5000 hemostasis analyzer system, the TEG 6s hemostasis analyzer system, the HAS-100 hemostasis analyzer system, and the HAS-300 hemostasis analyzer system. The TEG and HAS platforms utilize thromboelastography, providing a method of testing the efficiency of blood coagulation using whole blood samples.
Each hemostasis diagnostic system consists of an analyzer that is used with single-use reagents and disposables. In addition, TEG Manager software connects multiple TEG 5000 and TEG 6s analyzers throughout the hospital, providing clinicians with remote access to both active and historical test results that inform treatment decisions.
The TEG 5000 system is approved for a broad set of indications in all of the company's markets. The TEG 6s system is approved for the same set of indications as the TEG 5000 in Europe, Australia, and Japan. In the U.S., the TEG 6s system is indicated to assess hemorrhage or thrombosis conditions in cardiovascular surgery and cardiology procedures, as well as to evaluate the hemostasis condition in adult trauma patients. The TEG 6s PlateletMapping ADP & AA Cartridge can help understand a patient's platelet function and provide insight into the risk of bleeding and greater confidence in therapeutic decisions. In fiscal 2024, the company received FDA clearance for a new TEG 6s Global Hemostasis-HN assay cartridge. This new cartridge extends the company's TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings. The company continues to pursue a broader set of indications for TEG 6s in the U.S. The HAS-100 and HAS-300 devices are currently commercialized in China.
Cell Salvage
Cell Salvage Products - The company's Cell Saver Elite+ autologous blood recovery system is a surgical blood salvage system targeted to medium to high blood loss procedures, such as cardiovascular, orthopedic, trauma, transplant, vascular, obstetrical, and gynecological surgeries. The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and prepare a patient's own high-quality blood for reinfusion.
Transfusion Management
Transfusion Management Products - The company's Transfusion Management solutions are designed to help provide safety, traceability, and compliance from the hospital blood bank to the patient bedside and enable consistent care across the hospital network. The company's SafeTrace Tx transfusion management software is considered the system of record for all hospital blood bank and transfusion service information. BloodTrack blood management software is a modular suite of blood management and bedside transfusion solutions that combines software with hardware components and acts as an extension of the hospital's blood bank information system. The software is designed to work with blood storage devices, including the BloodTrack HaemoBank.
Marketing and Sales
The company markets and sells its products in approximately 95 countries through its own direct sales force (including full-time sales representatives and clinical specialists), as well as independent distributors in approximately 90 countries. The company's customers include biopharmaceutical companies, blood collection groups, independent blood centers, hospitals, hospital service providers, group purchasing organizations, and national health organizations. Sales representatives target the primary decision-makers within each of those organizations.
Competition
Terumo Blood and Cell Technologies ('Terumo BCT') and Fresenius SE & Co. KGaA, in particular, have significant financial and other resources and are strong competitors in a number of its businesses.
Plasma
In the automated plasma collection market, the company principally competes with Fresenius' Fenwal Aurora and Aurora Xi device product lines, and Terumo BCT's Rika device on the basis of procedure duration, donor experience, plasma yield per donation, product quality and reliability, ease of use, services, and technical features of the collection systems, supply chain reliability, and the long-term cost-effectiveness of equipment and disposables.
Blood Center
The company's main competitors include Fresenius, MacoPharma, and Terumo BCT.
Hospital
Interventional Technologies:
Vascular Closure
The company's main competitors in vascular access closure include Terumo BCT, Abbott Laboratories, and Cordis.
Blood Management Technologies:
Hemostasis Management
Competition includes routine coagulation tests, such as prothrombin time, partial thromboplastin time, and platelet count marketed by various manufacturers, such as Werfen, Diagnostica Stago SAS, and Sysmex. The TEG analyzer competes with these routine laboratory tests based on its ability to provide a more complete picture of a patient's hemostasis at a single point in time and to measure the clinically relevant platelet function for an individual patient.
In addition, TEG competes more directly with other viscoelastic testing systems, including ROTEM analyzers, the VerifyNow System, and HemoSonics Quantra.
Cell Salvage
For high-volume platforms, each manufacturer's technology is similar, and the company's Cell Saver technology competes principally with products offered by LivaNova PLC, Medtronic, and Fresenius.
SafeTrace Tx competition primarily consists of stand-alone BBIS, including WellSky, SSC Soft, and some electronic health record software that includes a built-in transfusion management solution, including Cerner and Clinsys. Global competition for BloodTrack varies by country, including MSoft, MAK Systems in Europe, and established blood practices in the U.S., such as using standard refrigerators and manual movement of blood products.
Customers
In fiscal 2025, the company's ten largest customers accounted for approximately 42% of its net revenues. One of the company's largest Plasma customers, CSL, informed the company in April 2021 of its intent not to renew its supply agreement for the use of PCS2 plasma collection system devices and the purchase of disposable plasmapheresis kits in the U.S. following the expiration of the then-current term of its contract, which was subsequently extended on a non-exclusive basis through December 2025.
Government Regulation
Due to the variety of products that the company manufactures, it and its products are subject to a wide range of regulations from numerous government agencies, including the FDA, and similar agencies outside the U.S. To varying degrees, each of these agencies requires the company to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of its products.
To obtain 510(k) clearance, the company must submit a premarket notification demonstrating that the proposed device is 'substantially equivalent' to a previously 510(k)-cleared device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of PMAs, or a device that has been the subject of a de novo classification.
The company's VASCADE portfolio of vascular closure systems are Class III products for which PMAs were previously obtained.
Additionally, the company and the manufacturing facilities of some of its suppliers are subject to unannounced inspections by the FDA to determine their compliance with the Quality System Regulation, or QSR.
The company's international sales are subject to regulatory requirements in the countries in which its products are sold. For example, the European Union ('EU') has adopted the EU Medical Device Regulation (the 'EU MDR') and the EU In Vitro Diagnostic Regulation (the 'EU IVDR'), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems, and postmarket surveillance, than the medical device directives they replace.
History
Haemonetics Corporation was founded in 1971. The company was incorporated in 1985.
