What changed in this filing

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Item 1. Business

2026-05-20 compared with 2025-05-21 · 75 added, 85 removed, 415 unchanged (28% of the section changed)

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“Hospital” is comprised 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.

Financial information concerning these segments is provided in Note 18, Segment and Enterprise-Wide Information , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.

Financial information concerning these segments is provided in Note 18, Segment and Enterprise-Wide Information , within the consolidated financial statements in Item 8 of this Annual Report on Form 10-K.

We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value.

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These two methods are mainly used by blood centers to collect plasma for transfusions.

The third method is a dedicated apheresis procedure that only collects plasma and

returns the other blood components to the donor.

The third method is a dedicated apheresis procedure that only collects plasma and returns the other blood components to the donor.

This third method is almost exclusively used for source plasma collection.

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Our 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.

Over the last 20 years, the collection of source plasma has increasingly been performed by vertically integrated biopharmaceutical companies such as Grifols S.A., Octapharma AG, Takeda’s BioLife Plasma subsidiary and CSL Limited (together with its affiliates, “CSL”).

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.

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We also offer a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain.

Our software products, including our 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.

Our software products, including our 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 our 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.

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In fiscal 2021, we received U.S.

Food and Drug Administration or FDA, 510(k) clearance for our NexSys PCS with proprietary Persona ® technology.

Food and Drug Administration (“FDA”) 510(k) clearance for our 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 our baseline device, software configuration and donor population.

Our Persona technology strengthens the NexSys PCS value proposition and reinforces our commitment to supporting our Plasma customers.

In addition, during fiscal 2024, we received FDA clearance for advancements to NexSys PCS including a new plasma collection bowl and new Express Plus ® technology engineered to reduce procedure time.

In fiscal 2024, we received FDA clearance for advancements to NexSys PCS including a new plasma collection bowl and new Express ® Plus technology engineered to reduce procedure time.

Additionally, in the fourth quarter of fiscal 2026 we received FDA 510(k) clearance for our NexSys PCS Plasma Collection System with Persona ® PLUS technology.

Persona PLUS is the next generation of our proprietary and patented Persona technology that enables on average a mid-single digit percent increase of plasma per donation over Persona.

These recent innovations in Plasma strengthen the NexSys PCS value proposition and reinforce our commitment to supporting our Plasma customers.

We expect to pursue further regulatory clearances for additional enhancements to the overall product offering.

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customers except those with internally developed systems.

We substantially completed conversion of our U.S.

customers to Persona and Express Plus technologies as of the end of fiscal 2025.

We have completed conversion of our U.S.

customers to Express Plus and Persona technologies as of the end of fiscal 2026.

Our Plasma business unit represen ted 39.3% , 39.3% and 43.5% of our to tal revenue in fiscal 2026, 2025 and 2024, respectively.

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We also market to Blood Center customers our NexSys PCS device for plasma collections as well as our 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 our Blood Center business, allowing us to better align our resources to higher margin, higher growth opportunities.

In the fourth quarter of fiscal 2025, we completed the divestiture of the Whole Blood product line within our Blood Center business, allowing us to better align our resources to higher margin, higher growth opportunities.

Our Blood Center business represen ted 16.6% , 19.2% and 21.6% of ou r total revenue in fiscal 2026, 2025 and 2024, respectively.

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Haemonetics’ 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., d/b/a 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.

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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, we launched our 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.

During fiscal 2025, we launched our newest VASCADE product, the VASCADE MVP XL, which utilizes 58% more collagen and a larger disc than the VASCADE MVP system.

Additionally, in the fourth quarter of fiscal 2026 we received FDA approval to expand the indication for VASCADE MVP XL to include procedures using 10-14F ID and up to 17F OD sheaths.

Our PerQseal ® Elite large bore closure system is designed for percutaneous vessel closure following catheter-based procedures requiring large bore femoral access, including transcatheter aortic valve replacement (“TAVR”), endovascular aneurysm repair (“EVAR”) and mechanical circulatory support procedures.

PerQseal Elite features a fully bioabsorbable, sutureless sealing patch intended to address the clinical need for large bore closure through a simple over-the-wire deployment approach that maintains 0.035” guidewire access.

The system is compatible with arteriotomies and venotomies up to 26F (14F – 22F sheaths).

PerQseal Elite has received CE Mark in Europe for arterial and venous indications, and we have submitted a premarket approval (“PMA”) application to the FDA for an arterial indication in the United States.

We believe PerQseal Elite complements and expands our Vascular Closure portfolio into the large bore market.

Sensor-Guided Technologies

Sensor-Guided Technologies Market — Coronary guidewires facilitate the delivery and positioning of interventional devices through the catheters and can also assist in the diagnosis of certain heart conditions.

These guidewires are thin and flexible, allowing surgeons to navigate coronary arteries.

Sensor-Guided Technologies Products — Our 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.

Our 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.

Sensor-Guided Technologies Products — Our OptoWire ® pressure guidewire aims to improve clinical outcomes by accurately and consistently measuring fractional flow reserve and diastolic pressure ratio to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.

Our SavvyWire ® is a sensor-guided 3-in-1 guidewire for 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.

Our Sensor-Guided Technologies business also manufactures fiber optic sensor solutions used in medical devices and other industrial applications.

Esophageal Protection

Esophageal Protection Market — Cardiac ablation, which is the primary treatment for atrial fibrillation, is a procedure that uses thermal energy or electrical pulses to cause lesions in certain areas of the heart, with the aim of preventing abnormal electrical signals from triggering irregular heartbeats.

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Esophageal protection devices cool or move the esophagus during RF ablation procedures to minimize the risk of thermal injury.

Esophageal Protection Products — Our 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.

Esophageal Protection Products — Our ensoETM ® system consists of a multi-lumen silicone tube placed in the esophagus, akin to a standard orogastric tube.

By circulating temperature-controlled water, the ensoETM system provides proactive cooling during RF cardiac ablation, reducing the likelihood of esophageal injury.

The ensoETM system can also be used to cool or warm a patient in other surgical and critical care settings, particularly in procedures where external cooling or heating may not be available or effective, such as burn surgery.

Blood Management Technologies:

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Hemostasis Management Products — Our portfolio of hemostasis diagnostic systems enables clinicians to assess holistically the coagulation status of a patient at the point-of-care or laboratory setting.

We have four viscoelastic testing systems that we market 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 our markets.

The TEG 6s system is approved for the same set of indications as the TEG 5000 in Europe, Australia and Japan.

The TEG ® 6s system quickly delivers a comprehensive assessment of a patient’s hemostasis, giving clinicians the invaluable insight needed to deliver more targeted treatment.

It delivers high quality test results with an easy-to-operate analyzer.

The automated cartridge-based system runs up to four assays simultaneously without any manual reagent mixing.

The TEG 6s analyzer is our smallest cartridge-based viscoelastic analyzer available and can be utilized in a variety of settings.

TEG Manager ® software centralizes data from connected TEG analyzers throughout the hospital, providing clinicians secure remote access to both active and historical test results that inform treatment decisions.

Clinical alert messages can be configured according to institution guidelines, providing standardized practice and efficient test interpretation.

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.

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We continue 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.

The TEG 6s system is approved for a broader set of indications outside of the U.S., including Europe, Australia and Japan.

Cell Salvage Market — The Cell Salvage market is mainly comprised of devices designed to collect, wash and prepare a patient’s own blood for reinfusion during or after surgery.

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This process occurs in a sterile, closed-circuit, single-use consumable set that is fitted into an electromechanical device.

We market our surgical

blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, OB-GYN and to anesthesiologists and surgical suite service providers.

We market our surgical blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, OB-GYN and to anesthesiologists and surgical suite service providers.

Cell Salvage Products — Our 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.

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Transfusion Management Products — Our 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.

Our SafeTrace Tx ® transfusion management software is considered the system of record for all hospital blood bank and transfusion service information.

Our SafeTrace Tx ® transfusion management software is designed to be used as 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 ® .

The software is designed to work with blood storage devices, including the BloodTrack HaemoBank ® device.

Our Hospital business represented 44.1% , 41.5% and 34.9% of our total revenue in fiscal 2026, 2025 and 2024, respectively.

Marketing and Sales

We market and sell our products in approximately 95 countries through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors in approximately 90 countries.

We market and sell our products in approximately 90 countries through a combination of our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors in approximately 87 countries.

Our customers include biopharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations.

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In fiscal 2026, our ten largest customers accounted for approximately 44% of our net reve nues.

We did not have any customers that represented more than 10% of our consolidated revenues in fiscal 2025.

In fiscal 2026, one Plasma customer accounted for approximately 13% of total net revenues.

Research and Development

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Research and development resources were allocated primarily to support innovation across our Plasma and Hospital product portfolios in fiscal 2026.

During fiscal 2025 we announced FDA clearance and our launch of a new TEG 6s Global Hemostasis-HN assay cartridge, which extends the system’s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings, as well as FDA approval and our launch of the VASCADE MVP XL mid-bore venous closure device, which utilizes 58% more collagen and a larger disc than the current VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths such as cryoablation and left atrial appendage closure for atrial fibrillation patients.

Also during fiscal 2025, we announced CE mark certification for the SavvyWire pre-shaped pressure guidewire.

During fiscal 2026 we announced FDA clearance for the NexSys PCS Plasma Collection System with Persona PLUS technology, which represents the next generation of our proprietary and patented Persona technology that tailors plasma collections to each donor for improved average plasma volume per donation.

Additionally, during fiscal 2026 we received FDA approval to expand the labeling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) 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 (“PFA”) and left atrial appendage closure (“LAAC”) to treat atrial fibrillation.

Manufacturing

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In general, we design our equipment and consumables and use contract manufacturers to build the devices, while the majority of consumables are manufactured by us.

Our production activities occur in controlled settings or “clean room” environments and have built-in quality checks throughout the manufacturing processes.

Our production activities occur in controlled settings or “clean room” environments and have built-in quality checks throughout the manufacturing process.

Our manufacturing teams are focused on continuously improving our productivity, product cost and product quality through change control procedures, validations and strong supplier management programs.

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Our primary consumable manufacturing operations are located in North America and Malaysia.

Contract manufacturers also supply component sets and liquid solutions according to our specifications, with component sets manufactured in Japan, Singapore, Thailand, Indonesia and the Philippines and liquid solutions manufactured in Europe.

Contract manufacturers also supply component sets according to our specifications, with component sets manufactured in Japan, Singapore, Thailand, Indonesia and the Philippines.

Our capital equipment is principally manufactured in Malaysia, Australia and the U.S.

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We believe that unpatented know-how and trade secrets relied upon in connection with our business and products are generally as important as patent protection in establishing and maintaining a competitive advantage.

We are engaged in intellectual property litigation as described in Note 15, Commitments & Contingencies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.

We are engaged in intellectual property litigation as described in Note 15, Commitments & Contingencies , within the consolidated financial statements in Item 8 of this Annual Report on Form 10-K.

We have instituted, and may in the future institute, intellectual property litigation to enforce our patent rights, to protect our trade secrets or know-how and to determine the scope and validity of the proprietary rights of others.

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In addition, we face competition from several large global companies with product offerings similar to ours.

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 our businesses.

Terumo Blood and Cell Technologies (“Terumo BCT”), Fresenius SE & Co.

KGaA, and Abbott Laboratories, in particular, have significant financial and other resources and are strong competitors in a number of our businesses.

The following provides an overview of the key competitors in each of our three global business units.

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• Blood Center

Most donations worldwide are manual whole blood collections.

Our recently divested Whole Blood product line, which historically represented approximate ly 25% of th e Blood Center portfolio, competed in this space and faced intense competition from our main competitors, including Fresenius, MacoPharma and Terumo BCT, based on quality and price.

In the fourth quarter of fiscal 2025, we completed the divestiture of our Whole Blood product line, including our complete portfolio of proprietary manual whole blood collection, processing and filtration solutions, along with our manufacturing facility in Covina, California where certain of these products were produced, and related equipment and assets located at our manufacturing facility in Tijuana, Mexico.

We believe exiting this product line will help to align our resources to higher margin, higher growth opportunities.

Our MCS brand apheresis equipment competes not only against manual whole blood collections but also with products from Terumo BCT and Fresenius.

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The vascular closure industry is highly competitive and has been evolving rapidly with the introduction of new products, technologies, regulations and activities of industry participants.

Our VASCADE family of products serves as an alternative to existing methods of vascular access site closure in interventional procedures, generally including manual compression, figure-of-eight sutures and other advanced closure devices.

Our main competitors in vascular access closure include Terumo BCT, Abbott Laboratories and Cordis, where we compete primarily based on clinical and economic value, ease of use, workflow improvements and patient satisfaction.

Our products are optimized for the

requirements of coronary, structural heart, peripheral and electrophysiology procedures, including procedures that require multiple access sites.

Our VASCADE and PerQseal products serve as alternatives to existing methods of vascular access site closure in interventional procedures, generally including manual compression, figure-of-eight sutures and other advanced closure devices.

Our main competitors in vascular access closure include Terumo BCT, Abbott Laboratories, Cordis, and Teleflex, where we compete primarily based on clinical and economic value, ease of use, workflow improvements and patient satisfaction.

Our products are optimized for the requirements of coronary, structural heart, peripheral and electrophysiology procedures, including procedures that require multiple access sites.

In addition, our value proposition is supported by robust clinical trial evidence and study data, which demonstrate reduced access site complication rates as well as workflow improvements compared to manual compression that lead to cost savings.

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Competitors such as Abbott Laboratories, Boston Scientific, and Philips pose challenges and opportunities in the coronary physiology segment, each offering their own technologies and solutions.

There are not currently competing, commercially available TAVR guidewires that are indicated to deliver both hemodynamic measurement and LV pacing for TAVR procedures.

There are not currently competing, commercially available guidewires that are indicated to deliver both hemodynamic measurement and LV pacing for TAVR procedures;

however, at least one competitor (SoloPace(R)) has entered the market with a guidewire indicated for on-label LV pacing during TAVR, which may increase competitive pressure in this segment over time.

Esophageal Protection

The ensoETM system competes primarily with temperature monitoring as the current standard of care for esophageal protection during RF ablations, as well as with a small number of other esophageal protection devices that deviate the esophagus.

Additionally, RF ablation technologies are experiencing significant competition from companies advancing pulse field ablation (“PFA”) technologies on the basis of, among other factors, workflow efficiencies and safety profile.

Additionally, RF ablation technologies are experiencing significant competition from companies advancing PFA technologies on the basis of, among other factors, workflow efficiencies and safety profile.

In this context, ensoETM supports the continued use of RF ablation technologies by reducing the likelihood of ablation-related esophageal injury.

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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.

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.

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To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our products.

In the United States, medical devices, drugs and biological products are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and other federal and state statutes and regulations.

In the United States, medical devices, drugs and biological products are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and other federal and state statutes and regulations.

The failure to comply with applicable U.S.

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The PMA process is more detailed, lengthier and more expensive than the 510(k) and de novo processes.

Our VASCADE portfolio of vascular closure systems are Class III products for which PMAs were previously obtained.

Our VASCADE portfolio of vascular closure systems are Class III products for which PMAs were previously obtained and we have submitted a PMA application to the FDA for an arterial indication for the PerQseal Elite product.

The 510(k) clearance, de novo classification, and PMA processes can be resource intensive, expensive, lengthy and require payment of significant user fees.

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Generally, establishments that design and/or manufacture devices are required to register with the FDA.

They also must provide

the FDA with a list of the devices that they design and/or manufacture at their facilities.

They also must provide the FDA with a list of the devices that they design and/or manufacture at their facilities.

Other postmarket requirements include compliance with:

• The Quality System Regulation, or QSR (which will be replaced by the Quality Management System Regulation, or QMSR, beginning in February 2026), which sets forth current good manufacturing practice, or cGMP, requirements for medical devices.

The QSR applies to manufacturers, including contract manufacturers, of finished medical devices, and governs methods, facilities, and controls used in designing, manufacturing, packaging, labeling, storing, installing and servicing such devices.

• The Quality Management System Regulation (“QMSR”), which in February 2026 replaced the Quality System Regulation (“QSR”).

It sets forth current good manufacturing practice (“cGMP”) requirements for medical devices, incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

The QMSR applies to manufacturers, including contract manufacturers, of finished medical devices, and governs methods, facilities, and controls used in designing, manufacturing, packaging, labeling, storing, installing and servicing such devices.

Manufacturers of medical devices must establish a quality system appropriate for the devices they manufacture.

For example, devices containing certain types of software must implement comprehensive cybersecurity risk management programs and documentation consistent with the QSR;

For example, devices containing certain types of software must implement comprehensive cybersecurity risk management programs and documentation consistent with the QMSR.

The Haemonetics quality management system is certified to ISO 13485:2016;

• Labeling regulations, including unique device identification;

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• Medical device correction and removal (recall) regulations with their associated reporting obligations.

Additionally, we and the manufacturing facilities of some of our suppliers are subject to unannounced inspections by the FDA to determine our compliance with the QSR and other applicable regulations described above.

Additionally, we and the manufacturing facilities of some of our suppliers are subject to unannounced inspections by the FDA to determine our compliance with the QMSR and other applicable regulations described above.

If a company fails to comply with regulatory requirements, the FDA can issue Form 483 Notices of Observation, warning letters or untitled letters, recommend or require product recalls, issue safety communications, seek a court order detaining or seizing certain devices, seek an injunction, suspend or withdraw regulatory clearance or approvals, ban certain medical devices, order repair, replacement or refund of medical devices or require notification of health professionals and others with regard to medical devices that present risks of substantial harm to the public health.

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In addition, manufacturers are subject to periodic inspections by the FDA.

Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with QSRs.

Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with QMSRs.

Advertising, marketing and promotional activities for devices are also subject to FDA oversight.

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The failure to comply with prohibitions on “off-label” promotion can result in significant monetary penalties, suspension of sales of certain products, product recalls, civil or criminal sanctions, exclusion from participating in federal healthcare programs, or other administrative and enforcement actions.

In the United States, allegations of such wrongful conduct could also result in a corporate integrity agreement with the U.S.

In the U.S., allegations of such wrongful conduct could also result in a corporate integrity agreement with the U.S.

government that imposes significant administrative obligations and costs.

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The EU MDR became fully applicable as of May 26, 2021 and the EU IVDR became fully applicable as of May 26, 2022.

We achieved initial EU MDR and IVDR certifications in October 2023.

EU MDR certification is ongoing for legacy devices.

There is a conditional transition period after the date of full application, the duration of which is dependent on the classification of the device and conditioned upon manufacturers having submitted EU MDR applications by May 26, 2024.

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Regulatory requirements in other jurisdictions also continue to become more stringent, increasing regulatory requirements to register and maintain products in these markets.

Drug Regulation

Development and Approval

Under the FDCA, FDA approval of a new drug application, or NDA, is generally required before any new drug can be marketed in the U.S.

NDAs require extensive studies and submission of a large amount of data by the applicant.

A generic version of an approved drug is approved by means of an abbreviated new drug application, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the “reference listed drug,” or RLD.

Generally, an ANDA must contain data and information showing that the proposed generic product and RLD have the same active ingredient, in the same strength and dosage form, to be delivered via the same route of administration, are intended for the same uses and are bioequivalent.

This more limited data set is in lieu of independently demonstrating the proposed product’s safety and effectiveness, which are inferred from the fact that the product is the same as the RLD, which the FDA previously found to be safe and effective.

We hold NDAs and ANDAs for liquid solutions (including anticoagulants, intravenous saline and a red blood cell storage solution) that we are in the process of transferring in connection with the divestiture of our Whole Blood product line in the fourth quarter of fiscal 2025.

Post-Approval Regulations

After the FDA permits a drug to enter commercial distribution, numerous regulatory requirements continue to apply.

These include the FDA's current cGMPs, which include a series of requirements relating to organization and training of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, quality control and quality assurance, packaging and labeling controls, holding and distribution, and laboratory controls and records and reports.

The FDA has also established labeling regulations, advertising and promotion requirements and restrictions, regulations regarding conducting recalls of product and requirements relating to the reporting of adverse events.

Failure to comply with applicable FDA requirements and restrictions in this area may subject a company to adverse publicity, such as warning letters, and enforcement action by the FDA, the Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities.

This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and entering into agreements with the government that materially restrict the manner in which a company promotes or distributes drug or biological products.

Requirements Outside the U.S.

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The requirements and process governing product licensing vary from country to country.

supplements to applications filed by us, suspension or the imposition of restrictions on operations, product recalls, the refusal to permit the import or export of our products or the seizure or detention of products.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, warning letters or untitled letters, injunctions, civil, administrative, or criminal penalties, monetary fines or imprisonment, suspension or withdrawal of regulatory approvals, suspension of ongoing clinical studies, refusal to approve pending applications or supplements to applications filed by us, suspension or the imposition of restrictions on operations, product recalls, the refusal to permit the import or export of our products or the seizure or detention of products.

Conflict Minerals

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The federal civil False Claims Act prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false, fraudulent or materially incomplete claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.

In recent years, companies in the healthcare industry have faced enforcement actions under the federal False Claims Act for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product or causing false claims to be submitted because of the company’s marketing the product for unapproved and thus non-reimbursable, uses.

In recent years, companies in the healthcare industry have faced enforcement actions under the federal False Claims Act for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product or causing false claims to be submitted because of the company’s marketing of the product for unapproved and thus non-reimbursable, uses.

False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of tens of thousands of dollars per false claim or statement.

Healthcare companies also are subject to other federal false claims laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third party payers and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

to the federal government on certain payments or transfers of value that they make to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse midwives and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payers and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

In addition, the Physician Payment Sunshine Act, implemented as the Open Payments program, requires manufacturers of certain products reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to track and report information to the federal government on certain payments or transfers of value that they make to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse midwives and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Manufacturers are also required to collect information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse-midwives for reporting.

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impacts of acquisitions or dispositions;

impacts of share repurchases;

and market position and expenditures.

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• Security breaches of our products or information technology systems, or those of our customers, suppliers or other business partners, which could impair our ability or our customers’ ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers’ patients;

• The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of OpSens Inc.

and Attune Medical, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected;

• The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of Vivasure Medical Limited (“Vivasure”), OpSens Inc.

and Advanced Cooling Therapy, Inc., d/b/a Attune Medical (“Attune Medical”), divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected;

• Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants;

• Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events;

• Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our market and regional alignment and portfolio rationalization initiatives;

• Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our ongoing market and regional alignment and portfolio rationalization initiatives;

• The impact of enhanced requirements to obtain regulatory approval in the U.S.

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• The potential impact of our convertible senior notes and related capped call transactions;

• Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, the Middle East and other foreign jurisdictions where we do business;

• Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, Iran and other parts of the Middle East, and other foreign jurisdictions where we do business;

• Our ability to execute and realize anticipated benefits from our investments in emerging economies;

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business