13 unchanged sentences
“Blood Center” includes blood collection and processing devices and disposables for red cells, platelets and whole blood.
−Removed: “Hospital”, which is comprised of Hemostasis Management, Cell Salvage, Transfusion Management and Vascular Closure products, includes devices and methodologies for measuring coagulation characteristics of blood, surgical blood salvage systems, specialized blood cell processing systems and disposables, blood transfusion management software and vascular closure devices.
+Added: “Hospital”, which is comprised of Hemostasis Management, Vascular Closure, Transfusion Management and Cell Salvage products, includes devices and methodologies for measuring coagulation characteristics of blood, surgical blood salvage systems, specialized blood cell processing systems and disposables, blood transfusion management software and vascular closure devices.
Financial information concerning these segments is provided in Note 18 to our audited consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K.
17 unchanged sentences
These two methods are mainly used by blood centers to collect plasma for transfusions.
−Removed: The third method is a dedicated apheresis procedure that only collects plasma and returns the other blood components to the donor.
−Removed: This third method is mainly used for source plasma collection.
+Added: The third method is a dedicated apheresis procedure that only collects plasma and
+Added: returns the other blood components to the donor.
+Added: This third method is almost exclusively used for source plasma collection.
Our Plasma business unit focuses on the collection of source plasma by pharmaceutical manufacturers using apheresis devices that only collect plasma and software solutions that support the efficient operation of dedicated source plasma collection centers.
−Removed: Our Blood Center business supports the collection of plasma for blood collectors, such as the American Red Cross, using both whole blood and multi-component apheresis collection devices.
−Removed: Over the last 20 years, the collection of source plasma has increasingly been done by vertically integrated biopharmaceutical companies such as CSL Limited (together with its affiliates, “CSL”), Grifols S.A.
+Added: Our Blood Center business supports the collection of plasma for blood collectors, such as the American Red Cross, using both whole blood collections sets and multi-component apheresis collection devices.
+Added: 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.
(together with its affiliates, “Grifols”), Octapharma AG and Takeda's BioLife Plasma subsidiary.
5 unchanged sentences
has regulations that are significantly more favorable relative to other markets for plasma collectors.
−Removed: The frequency with which a donor may donate, the volume of plasma that may be donated each time and the ability to remunerate donors are all optimal in the U.S., leading to over 70% of worldwide source plasma collections occurring in the U.S.
+Added: The frequency with which a donor may donate, the volume of plasma that may be donated each time and the ability to remunerate donors are all optimal in the U.S., leading to approximately 70% of worldwide source plasma collections occurring in the U.S.
Plasma collectors have long sought changes to plasma collection regulations outside of the U.S.
−Removed: to allow for greater frequency, volume per donation, and remuneration but achievements have been limited and no changes are foreseen in the prevalence of U.S.
+Added: to allow for greater frequency, volume per donation, and remuneration but achievements have been limited and no significant short-term changes are foreseen in the prevalence of U.S.
Plasma Products — Built around our automated plasma collection devices, related disposables, and software, our portfolio of products and services is designed to support multiple facets of plasma collector operations.
4 unchanged sentences
We also offer a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain.
−Removed: Our software products, including our latest NexLynk DMS ® donor management system, automate the donor interview and qualification process, streamline the workflow process in the plasma center, provide the controls necessary to evaluate donor suitability, determine the ability to release units collected and manage unit distribution.
+Added: Our software products, including our latest NexLynk DMS ® donor management system and Donor360 ® app, automate the donor interview and qualification process, streamline the workflow process in the plasma center, provide the controls necessary to evaluate donor suitability, determine 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 quality and compliance business process support, react quickly to business changes and implement opportunities to reduce costs.
With our PCS brand, we have provided an automated platform dedicated to the collection of plasma for over 20 years.
−Removed: In fiscal 2018, we received U.S.
−Removed: Food and Drug Administration (“FDA”) 510(k) clearance for our next generation device, the NexSys PCS and CE mark clearance of the NexSys PCS device in the European Union, or EU, and Australia, subject to additional local requirements.
+Added: In fiscal 2018, we began transitioning customers from our PCS2 equipment to NexSys PCS.
NexSys PCS is designed to enable higher plasma yield collections, improve productivity in our customers’ centers, enhance the overall donor experience and provide safe and reliable collections that will become life-changing medicines for patients.
3 unchanged sentences
In fiscal 2021, we received FDA 510(k) clearance for our NexSys PCS with Persona ® technology.
−Removed: NexSys PCS with Persona technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor's body composition.
−Removed: The new, proprietary Persona technology strengthens the NexSys PCS value
−Removed: proposition and reinforces our commitment to supporting the plasma industry.
+Added: NexSys PCS with Persona technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor's body composition, including an additional 9-12% plasma yield.
+Added: The new, proprietary Persona technology strengthens the NexSys PCS value proposition and reinforces our commitment to supporting the plasma
We expect to pursue further regulatory clearances for additional enhancements to the overall product offering.
We have entered into long-term commercial contracts and are continuing the rollout and support of NexSys PCS devices and NexLynk DMS donor management software for these Plasma customers.
−Removed: Our Plasma business unit represented 38.2%, 46.4% and 44.1% of our total revenue in fiscal 2021, 2020 and 2019, respectively.
+Added: Our Plasma business unit represen ted 35.4%, 38.2% and 46.4% of our to tal revenue in fiscal 2022, 2021 and 2020, respectively.
• Blood Center
−Removed: Our Blood Center business offers a range of solutions that improve donor collection centers' ability to acquire blood, filter blood and separate blood components.
−Removed: We continue to look for solutions to improve donor safety and control costs through the existing product portfolio.
+Added: Our Blood Center business offers a range of solutions that improve donor collection centers' ability to collect and filter blood and separate blood components.
+Added: We continue to look for solutions to help our customers improve donor safety and control costs through the existing product portfolio.
Our products and technologies help donor collection centers optimize blood collection capabilities and donor processing management.
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• Our portfolio of disposable whole blood collection and component storage sets offer flexibility in collecting a unit of whole blood and the subsequent production and storage of blood components, including options for in-line or dockable filters for leukoreduction.
−Removed: Our Blood Center business unit represented 35.3%, 32.1% and 34.1% of our total revenue in fiscal 2021, 2020 and 2019, respectively.
+Added: Our Blood Center business unit represen ted 30.1%, 35.3% and 32.1% of ou r total revenue in fiscal 2022, 2021 and 2020, respectively.
Hospitals are called upon to provide the highest standard of patient care while at the same time reduce operating costs.
−Removed: Haemonetics' Hospital business has four product lines which include Hemostasis Management, Cell Salvage, Transfusion Management and Vascular Closure.
+Added: Haemonetics' Hospital business has four product lines:
+Added: Hemostasis Management, Vascular Closure, Transfusion Management and Cell Salvage.
Vascular Closure became a product line during fiscal 2021 as a result of the March 2021 acquisition of Cardiva Medical, Inc.
17 unchanged sentences
We continue to pursue a broader set of indications for TEG 6s in the U.S.
−Removed: During fiscal 2020, we received FDA clearance for the use of TEG 6s in adult trauma settings.
+Added: We received FDA clearance for the use of TEG 6s in adult trauma settings.
This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures, making it the first cartridge-based system available in the U.S.
to evaluate the hemostasis condition in adult trauma patients.
−Removed: The ClotPro system received CE mark clearance in March 2019 and is currently available in select European and Asia Pacific markets.
+Added: The ClotPro system received CE mark clearance and is currently available in select European and Asia Pacific markets.
The HAS-100 device is currently commercialized in China.
−Removed: Cell Salvage Market — The Cell Salvage market is mainly comprised of devices designed to transfuse back a patient’s own blood during or after surgery.
−Removed: Loss of blood is common in many surgical procedures, including open heart, trauma, transplant, vascular and orthopedic procedures, and the need for transfusion of oxygen-carrying red cells to make up for lost blood volume is routine.
−Removed: Patients commonly receive donor (or allogeneic) blood which carries various risks for transfusion reactions including chills, fevers or other side effects that can prolong a patient’s recovery.
−Removed: An alternative to allogeneic blood is surgical cell salvage, also known as autotransfusion, which reduces or eliminates a patient’s need for blood donated from others and ensures that the patient receives the freshest and safest blood possible - his or her own.
−Removed: Surgical cell salvage involves the collection of a patient’s own blood during or after surgery for reinfusion of red cells to that patient.
−Removed: Blood is suctioned from the surgical site or collected from a wound or chest drain, processed and washed through a centrifuge-based system that yields concentrated red cells available for transfusion back to the patient.
−Removed: This process occurs in a sterile, closed-circuit, single-use consumable set that is fitted into an electromechanical device.
−Removed: We market our surgical blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, and to anesthesiologists and surgical suite service providers.
−Removed: 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.
−Removed: The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and transfuse a patient’s own high-quality blood.
−Removed: Transfusion Management
−Removed: Transfusion Management Market — Hospital transfusion services professionals and clinicians are facing cost restraints in addition to the pressure to enhance patient safety, compliance and operational efficiency.
−Removed: Managing the safety and traceability of the blood supply chain and comprehensive management of patients, orders, specimens, blood products, derivatives and accessories across the hospital network is challenging.
−Removed: In addition, providing clinicians with the vital access to blood when needed most while maintaining traceability is a key priority.
−Removed: Frequently when blood products leave the blood bank, the transfusion management staff loses control and visibility of the blood components.
−Removed: They often do not know if the blood was handled, stored or transfused properly, which may lead to negative effects on patient safety, product quality, inventory availability and staff efficiency as well as increased waste.
−Removed: 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.
−Removed: Our SafeTrace Tx ® transfusion management software is considered the system of record for all hospital blood bank and transfusion service information.
−Removed: 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.
−Removed: The software is designed to work with blood storage devices, including the BloodTrack HaemoBank ® .
Vascular Closure
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Importantly, these improvements drive meaningful cost savings for hospitals, ambulatory surgery centers, and other treatment facilities.
−Removed: Our Hospital business unit represented 24.2%, 19.6% and 19.9% of our total revenue in fiscal 2021, 2020 and 2019, respectively.
+Added: During fiscal 2022, the VASCADE MVP Venous Vascular Closure System became the first and only vascular closure device to receive FDA indication for same-day discharge following atrial fibrillation ablation.
+Added: Transfusion Management
+Added: Transfusion Management Market — Hospital transfusion services professionals and clinicians are facing cost restraints in addition to the pressure to enhance patient safety, compliance and operational efficiency.
+Added: Managing the safety and traceability of the blood supply chain and comprehensive management of patients, orders, specimens, blood products, derivatives and accessories across the hospital network is challenging.
+Added: In addition, providing clinicians with the vital access to blood when needed most while maintaining traceability is a key priority.
+Added: Frequently when blood products leave the blood bank, the transfusion management staff loses control and visibility of the blood components.
+Added: They often do not know if the blood was handled, stored or transfused properly, which may lead to negative effects on patient safety, product quality, inventory availability and staff efficiency as well as increased waste.
+Added: 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.
+Added: Our SafeTrace Tx ® transfusion management software is considered the system of record for all hospital blood bank and transfusion service information.
+Added: 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.
+Added: The software is designed to work with blood storage devices, including the BloodTrack HaemoBank ® .
+Added: Cell Salvage Market — The Cell Salvage market is mainly comprised of devices designed to transfuse back a patient’s own blood during or after surgery.
+Added: Loss of blood is common in many surgical procedures, including open heart, trauma, transplant, vascular and orthopedic procedures, and the need for transfusion of oxygen-carrying red cells to make up for lost blood volume is routine.
+Added: Patients commonly receive donor (or allogeneic) blood which carries various risks for transfusion reactions including chills, fevers or other side effects that can prolong a patient’s recovery.
+Added: An alternative to allogeneic blood is surgical cell salvage, also known as autotransfusion, which reduces or eliminates a patient’s need for blood donated from others and ensures that the patient receives the freshest and safest blood possible - his or her own.
+Added: Surgical cell salvage involves the collection of a patient’s own blood during or after surgery for reinfusion of red cells to that patient.
+Added: Blood is suctioned from the surgical site or collected from a wound or chest drain, processed and washed through a centrifuge-based system that yields concentrated red cells available for transfusion back to the patient.
+Added: This process occurs in a sterile, closed-circuit, single-use consumable set that is fitted into an electromechanical device.
+Added: We market our surgical blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, and to anesthesiologists and surgical suite service providers.
+Added: 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.
+Added: The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and transfuse a patient’s own high-quality blood.
+Added: Our Hospital business unit repr esented 32.5%, 24.2% and 19.6% of our t otal revenue in fiscal 2022, 2021 and 2020, respectively.
Marketing/Sales/Distribution
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This software version features significant improvements to the user experience and workflow efficiency.
−Removed: Additionally, we have continued to make investments related to our next generation plasma collection and software systems, the European Medical Device Regulation, our Hemostasis Management produce line, and our recent product acquisitions in Hospital.
+Added: Additionally, we have continued to make investments related to our next generation plasma collection and software systems, the European Medical Device Regulation and In Vitro Diagnostic Regulation, our Hemostasis Management product line, and our recent product acquisitions in Hospital.
Manufacturing
5 unchanged sentences
Our primary consumable manufacturing operations are located in North America and Malaysia.
−Removed: Contract manufacturers also supply component sets and liquid solutions according to our specifications and manufacture in Mexico, Japan, Singapore, Thailand and the Philippines.
+Added: Contract manufacturers also supply component sets and liquid solutions according to our specifications and manufacture in Japan, Singapore, Thailand and the Philippines.
Our capital equipment is principally manufactured in Malaysia, Australia and the U.S.
−Removed: Plastics and other petroleum-based products are the principal component of our disposable products and can be affected by oil and gas prices.
+Added: Plastics and other petroleum-based products are the principal components of our disposable products and can be affected by oil and gas prices.
Contracts with our suppliers help to mitigate some of the short term effects of price volatility in this market.
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Certain patents may also be defensive in that they are directed to technologies not currently embodied in our current products.
−Removed: We also license patent rights from third parties that cover technologies that we use or plan to use in our business.
+Added: We also may license patent rights from third parties that cover technologies that we use or plan to use in our business.
We own various trademarks that have been registered in the United States and certain other countries.
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The following provides an overview of the key competitors in each of our three global product enterprises.
−Removed: In the automated plasma collection market, we principally compete with Fresenius' Fenwal Aurora and Aurora Xi product lines on the basis of speed, plasma yield per donation, quality, reliability, ease of use, services and technical features of the collection systems and on the long-term cost-effectiveness of equipment and disposables.
+Added: In the automated plasma collection market, we principally compete with Fresenius' Fenwal Aurora and Aurora Xi product lines a nd Terumo BCT's Rika device on the basis of speed, plasma yield per donation, quality, reliability, ease of use, services and technical features of the collection systems and on the long-term cost-effectiveness of equipment and disposables.
In China, the market is populated by local producers of a product that is intended to be similar to ours.
1 unchanged sentence
In the field of plasma related software, MAK Systems is the primary competitor along with applications developed internally by our customers.
−Removed: In April 2021, Terumo BCT and CSL announced a collaboration to deliver a new plasma collection platform for CSL's U.S.
−Removed: collection centers.
−Removed: This potential new entrant to the market is undergoing a clinical trial and will require FDA device clearance prior to use in the U.S.
• Blood Center
−Removed: Most donations worldwide are traditional manual whole blood collections and approximately 30% of the Blood Center portfolio competes in this space.
+Added: Most donations worldwide are traditional manual whole blood collections and approximate ly 30% of th e Blood Center portfolio competes in this space.
We face intense competition in our whole blood business on the basis of quality and price.
Our main competitors are Fresenius, MacoPharma and Terumo BCT.
−Removed: Our MCS automated component blood collections, which represents approximately 60% of the Blood Center portfolio, not only compete against the traditional manual whole blood collection market (particularly in red cells) but also compete with products from Terumo BCT and Fresenius.
+Added: Our MCS automated component blood collections, which represents approx imately 60% of the Blood Center portfolio, not only compete against the traditional manual whole blood collection market (particularly in red cells) but also compete with products from Terumo BCT and Fresenius.
Technology is the key differentiator in automated component blood collections, as measured by the time to collect more than one unit of a specific targeted blood component.
10 unchanged sentences
In the advanced viscoelastic testing segment, Haemonetics is the global market leader.
−Removed: In the intraoperative autotransfusion market, competition is based on reliability, ease of use, service, support and price.
−Removed: For high-volume platforms, each manufacturer's technology is similar and our Cell Saver technology competes principally with products offered by LivaNova PLC, Medtronic and Fresenius.
+Added: Vascular Closure
+Added: 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.
+Added: Our VASCADE family of products serves as an alternative to existing methods of femoral vascular access site closure in interventional procedures, including manual compression and other femoral access closure devices.
+Added: Our main competitors in femoral access closure for coronary and peripheral procedures include Terumo BCT, Abbott Laboratories and Cardinal Health.
+Added: There are not currently any competing vascular access site closure devices that are labeled for electrophysiology procedures that require multiple access sites.
+Added: We compete primarily on the basis that our products are optimized for the requirements of coronary, peripheral and electrophysiology procedures, including procedures that require multiple access sites.
+Added: 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.
Transfusion Management
7 unchanged sentences
BloodTrack integrates with the hospital’s existing lab or blood bank system allowing for greater market acceptance.
−Removed: Vascular Closure
−Removed: 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.
−Removed: Our VASCADE family of products serves as an alternative to existing methods of femoral vascular access site closure in interventional procedures, including manual compression and other femoral access closure devices.
−Removed: Our main competitors in femoral access closure for coronary and peripheral procedures include Terumo BCT, Abbott Laboratories and Cardinal Health.
−Removed: There are not currently any competing vascular access site closure devices that are labeled for electrophysiology procedures that require multiple access sites.
−Removed: We compete primarily on the basis that our products are optimized for the requirements of coronary, peripheral and electrophysiology procedures, including procedures that require multiple access sites.
−Removed: 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.
+Added: In the intraoperative autotransfusion market, competition is based on reliability, ease of use, service, support and price.
+Added: For high-volume platforms, each manufacturer's technology is similar and our Cell Saver technology competes principally with products offered by LivaNova PLC, Medtronic and Fresenius.
Significant Customers
In fiscal 2022, 2021 and 2020, our ten largest customers accounted for approximately 45%, 49% and 54% of our net revenues, respectively.
−Removed: Two of our Plasma customers, CSL and Grifols, each were greater than 10% of total net revenues and in total accounted for approximately 23%, 27% and 27% of our net revenues in fiscal 2021, 2020 and 2019, respectively.
−Removed: In addition, a third customer accounted for greater than 10% of the Plasma segment's net revenues, but did not exceed 10% of total net revenues in fiscal 2021, 2020 and 2019.
−Removed: One customer accounted for greater than 10% of our Blood Center segment’s net revenues, but did not exceed 10% of total net revenues in fiscal 2021, 2020 and 2019.
+Added: In fiscal 2022, one Plasma customer, CSL, was greater than 10% of total net revenue and in total accounted for approximately 12% of net revenues.
+Added: In addition to CSL, two customers also accounted for greater than 10% of the Plasma segment's net revenues and one customer accounted for greater than 10% of the Blood Center segment's net revenue, but did not exceed 10% of total net revenues, in fiscal 2022.
Government Regulation
−Removed: Due to the variety of products that we manufacture, we and our products are subject to a wide variety of regulations from numerous government agencies, including the FDA, and similar agencies outside the U.S.
+Added: Due to the variety of products that we manufacture, we and our 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 us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our products.
21 unchanged sentences
Prior to the acquisition of Cardiva in March 2021, we had not been required to obtain a PMA for any of our products and did not have any Class III products in our product pipeline.
−Removed: With the acquisition of Cardiva, we have acquired VASCADE and VASCADE
−Removed: MVP, which are both Class III products for which PMAs were previously obtained.
+Added: With the acquisition of Cardiva, we have acquired VASCADE and VASCADE MVP, which are both Class III products for which PMAs were previously obtained.
The 510(k) clearance, de novo classification, and PMA processes can be resource intensive, expensive, lengthy and require payment of significant user fees.
28 unchanged sentences
Our international sales are subject to regulatory requirements in the countries in which our products are sold.
−Removed: For example, the 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 current medical device directives they replace.
−Removed: The EU MDR is fully applicable as of May 26, 2021, and the EU IVDR as of May 26, 2022.
+Added: For example, the 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.
+Added: The EU MDR became fully applicable as of May 26, 2021, and the EU IVDR is fully applicable as of May 26, 2022.
There is a transition period for devices with a notified body certificate with an expiry date after the date of full application.
1 unchanged sentence
There are nevertheless a number of provisions that need to be complied with from the date of application, including updating the postmarket surveillance process, appointing an importer for the EU, appointing a person responsible for regulatory compliance, and updating economic operator agreements.
−Removed: Complying with the requirements of these regulations may require us to incur significant expenditures.
+Added: Complying with the requirements of these regulations has and will continue to require us to incur significant expenditures.
Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.
+Added: Regulatory requirements in other jurisdictions also continue to become more stringent, increasing regulatory requirements to register and maintain products in these markets.
Drug Regulation
2 unchanged sentences
NDAs require extensive studies and submission of a large amount of data by the applicant.
−Removed: 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.
+Added: 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
+Added: “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.
12 unchanged sentences
The requirements and process governing product licensing vary from country to country.
−Removed: 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
−Removed: 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.
+Added: 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
10 unchanged sentences
The federal healthcare program Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federally financed healthcare programs.
−Removed: This statute has been interpreted to apply to arrangements between manufacturers of federally reimbursed products on one hand and prescribers, purchasers and others in a position to recommend, refer, or order federally reimbursed products on the other.
+Added: This statute has been interpreted to apply
+Added: to arrangements between manufacturers of federally reimbursed products on one hand and prescribers, purchasers and others in a position to recommend, refer, or order federally reimbursed products on the other.
Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration to those who prescribe, purchase, or recommend medical devices or pharmaceutical and biological products, including certain discounts, or engaging consultants as speakers or consultants, may be subject to scrutiny if they do not fit squarely within the exemption or safe harbor.
8 unchanged sentences
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.
−Removed: 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
−Removed: 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) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
−Removed: Beginning calendar year 2021, manufacturers must 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 in 2022.
+Added: 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) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
+Added: 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.
The reported data is made available in searchable form on a public website on an annual basis.
10 unchanged sentences
We continue to monitor changes in U.S.
−Removed: and international environmental regulations that may present a significant risk to the business, including laws or regulations relating to the manufacture or sale of products using plastics.
+Added: and international environmental regulations and emerging industry expectations that may present a significant risk to the business, including laws or regulations relating to the manufacture or sale of products using plastics and evolving customer expectations with respect to environmental stewardship.
Human Capital
1 unchanged sentence
As of April 2, 2022, we employed the full-time equivalent of 2,821 persons.
−Removed: Approximately 79% of our employees are located in the U.S.
−Removed: and the remaining 21% are located across 19 other countries.
+Added: Approximately 78% of our employees are located in North America and the remaining 22% are located across 19 other countries.
In our industry, there is substantial competition for key personnel in the regions in which we operate.
9 unchanged sentences
◦ Manager development sessions focused on leadership skills, such as performance management training, coaching and feedback;
−Removed: ◦ Continuous improvement training for colleagues in functions that can best leverage and utilize process improvement practices;
−Removed: ◦ Best-in-class learning management system and dynamic content libraries aimed to meet the individual needs of colleagues’ current and future goals and aspirations;
+Added: ◦ Continuous improvement training for employees in functions that can best leverage and utilize process improvement practices;
+Added: ◦ Best-in-class learning management system and dynamic content libraries aimed to meet the individual needs of employees’ current roles as well as future goals and aspirations;
◦ Tuition reimbursement to support degree programs and certifications.
9 unchanged sentences
Our response to the COVID-19 pandemic has focused on business continuity and the safety of our employees.
−Removed: This includes prioritizing employee safety with remote work and travel restrictions, and limiting exposure for our manufacturing and customer facing employees, including field service and sales teams, to ensure supplies and support for our customers.
+Added: This includes prioritizing employee safety with remote work for employees in our administrative functions, implementing extensive cleaning and sanitation processes for all Haemonetics facilities, and instituting various safety protocols to limit exposur e for our manufacturing and customer facing employees, including field service and sales teams, to ensure supplies and support for our customers.
+Added: We have also instituted protocols to ensure compliance with vaccine mandates applicable to our employees.
+Added: Beginning in March 2022, we executed plans to return employees to offices in jurisdictions where safe and feasible and introduced a new hybrid work model for administrative functions in the U.S.
+Added: and certain other jurisdictions.
• Diversity, Equity and Inclusion .
The diversity of our teams and their ideas helps build our collaborative, performance driven culture.
−Removed: We understand the value that each individual brings to our workplace, and we are committed to providing an inclusive environment where every individual has the opportunity to thrive.
+Added: We understand the value that each individual brings to our workplace, and we are committed to providing an inclusive e nvironment where every individual has the opportunity to thrive.
Additionally, we encourage colleagues with shared interests and affinities to connect and learn from one another.
+Added: For example, in 2020 we formed the Women’s Initiative Network under the sponsorship of executive leaders that meets regularly, provides development opportunities and participates in external networking events.
Availability of Reports and Other Information
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Risk Factors in this report.
−Removed: • The effect of the ongoing COVID-19 pandemic, or outbreaks of communicable diseases, on our business, financial conditions and results of operations, including the time it will take for vaccines to be broadly distributed and accepted in the U.S.
−Removed: and the rest of the world, and the effectiveness of such vaccines in slowing or stopping the spread of COVID-19 and mitigating the economic effects of the pandemic;
+Added: • The effect o f the ongoing COVID-19 pandemic, or outbreaks of communicable diseases, on our business, financial conditions and results of operations, including the time it will take for vaccines to be broadly distributed and a dministered worldwide, and the effectiveness of such vaccines in slowing or stopping the spread of COVID-19 and its variants and mitigating the economic effects of the pandemic, including inflationary pressures and higher freight costs in our global supply chain;
• Failure to achieve our long-term strategic and financial-improvement goals;
• Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer;
+Added: • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete;
• Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S.
regulatory agencies), reputational damage, declining sales or litigation;
+Added: • Our ability to retain and attract key personnel;
• Security breaches of our information technology systems or our products, which could impair our ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers' patients;
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• 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 and distribution;
−Removed: • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete;
• Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including the Operational Excellence Program;
−Removed: • The potential that the expected strategic benefits and opportunities from our acquisition of Cardiva and any other planned or completed acquisition or divestiture by the Company may not be realized or may take longer to realize than expected;
+Added: • The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected;
• The impact of enhanced requirements to obtain regulatory approval in the U.S.
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• Our ability to comply with established and developing U.S.
−Removed: and foreign legal and regulatory requirements, including FCPA, MDR and similar laws in other jurisdictions, as well as U.S.
+Added: and foreign legal and regulatory requirements, including FCPA, EU MDR/EU IVDR and similar laws in other jurisdictions, as well as U.S.
and foreign export and import restrictions and tariffs;
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• The potential impact of our convertible senior notes and related capped call transactions;
+Added: • Geopolitical and economic conditions in China, Russia 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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• Our ability to protect intellectual property and the outcome of patent litigation;
−Removed: • Costs and risks associated with product liability and other litigation claims;
−Removed: • Our ability to retain and attract key personnel;
+Added: • Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future;
• Market conditions impacting our stock price and/or share repurchase programs we may enter into from time to time, and the possibility that such share repurchase programs may be delayed, suspended or discontinued.
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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.