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What changed in ANGIODYNAMICS INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ANGIODYNAMICS INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+260 added−281 removedSource: 10-K (2025-07-18) vs 10-K (2024-07-25)

Top changes in ANGIODYNAMICS INC's 2025 10-K

260 paragraphs added · 281 removed · 200 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

59 edited+23 added−15 removed92 unchanged
Biggest changeThe Company also relies on third party manufacturers for the manufacturing of certain products. During the third quarter of fiscal year 2024, AngioDynamics announced the restructuring of its manufacturing footprint and a plan to shift to a fully outsourced model by the third quarter of fiscal year 2026.
Biggest changeOn January 5, 2024, the Company announced a restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan"). In the second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the manufacturing of select products, customer service, logistics, shipping, quality and regulatory operations.
The kit options include our AngioDynamics proprietary coaxial introducer with smooth transition at the tip, translucent 21G needle with bevel indicator and 0.018” access wire available in three different wire material configurations. • The Micro-Introducer Kits offer a variety of configurations that include aid in simplifying set up and gaining vascular access.
The kit options include our AngioDynamics proprietary coaxial introducer with smooth transition at the tip, translucent 21G needle with bevel indicator and 0.018” access wire available in three different wire material configurations. • The Micro-Introducer Kits offer a variety of configurations that aid in simplifying set up and gaining vascular access.
The 510(k) clearance procedure is available only if a manufacturer can establish that its device is “substantially equivalent” in intended use and in safety and effectiveness to a “predicate device,” which is (i) a device that has been cleared 9 through the 510(k) clearance process; (ii) a device that was legally marketed prior to May 28, 1976 (preamendment device); or (iii) a device that was originally on the U.S. market as a Class III device (Premarket approval) and later downclassified to Class II or I.
The 510(k) clearance procedure is available only if a manufacturer can establish that its device is “substantially equivalent” in intended use and in safety and effectiveness to a “predicate device,” which is (i) a device that has been cleared through the 510(k) clearance process; (ii) a device that was legally marketed prior to May 28, 1976 (preamendment device); or (iii) a device that was originally on the U.S. market as a Class III device (Premarket approval) and later downclassified to Class II or I.
Prior to his role at Covidien, Mr. Clemmer served as Group President at Kendall Healthcare (which was acquired by Tyco International in 1994), where he managed the U.S. business across five divisions and built the strategic plan for the medical supplies segment before Covidien was spun off 12 from Tyco. Mr. Clemmer began his career at Sage Products, Inc. Mr.
Prior to his role at Covidien, Mr. Clemmer served as Group President at Kendall Healthcare (which was acquired by Tyco International in 1994), where he managed the U.S. business across five divisions and built the strategic plan for the medical supplies segment before Covidien was spun off from Tyco. Mr. Clemmer began his career at Sage Products, Inc. Mr.
The funnel shaped tip enhances venous drainage flow when the distal tip 3 is exposed by retracting the sheath, helps prevent clogging of the cannula with commonly encountered undesirable intravascular material, and facilitates embolic removal of such extraneous material. AlphaVac The AlphaVac System is an emergent mechanical aspiration device that eliminates the need for perfusionist support.
The funnel shaped tip enhances venous drainage flow when the distal tip is exposed by retracting the sheath, helps prevent clogging of the cannula with commonly encountered undesirable intravascular material, and facilitates embolic removal of such extraneous material. AlphaVac The AlphaVac System is an emergent mechanical aspiration device that eliminates the need for perfusionist support.
These acquisitions added product lines including ablation and NanoKnife systems, vascular access products, angiographic products and accessories, dialysis products, 2 drainage products, thrombolytic products, embolization products and venous products. In May 2012, the Company acquired Navilyst Medical's Fluid Management business, which the Company sold in May 2019 to Medline Industries, Inc. pursuant to an asset purchase agreement.
These acquisitions added product lines including ablation and NanoKnife systems, vascular access products, angiographic products and accessories, dialysis products, drainage products, thrombolytic products, embolization products and venous products. In May 2012, the Company acquired Navilyst Medical's Fluid Management business, which the Company sold in May 2019 to Medline Industries, Inc. pursuant to an asset purchase agreement.
We cannot assure that any new medical devices we develop will be cleared, approved or certified in a timely or cost-effective manner or cleared, approved or certified at all. There can be no assurance that new laws or regulations regarding the release or sale of medical devices will not delay or prevent sale of our current or future products.
We cannot assure that any new medical devices we develop will be cleared, approved 11 or certified in a timely or cost-effective manner or cleared, approved or certified at all. There can be no assurance that new laws or regulations regarding the release or sale of medical devices will not delay or prevent sale of our current or future products.
The FDA may also require additional clinical trials, which can delay the PMA approval process by several years. After the PMA is approved, if significant changes are made to a device, its manufacturing or labeling, a PMA supplement containing additional information must be filed for prior FDA approval.
The FDA may also require additional clinical trials, which can delay the PMA approval process by several years. After the PMA is approved, if changes are made to a device, its manufacturing or labeling, a PMA supplement containing additional information must be filed for prior FDA approval.
International partners that are participating in the MDSAP include: • Therapeutic Goods Administration of Australia 8 • Brazil’s Agência Nacional de Vigilância Sanitária • Health Canada • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency • U.S.
International partners that are participating in the MDSAP include: • Therapeutic Goods Administration of Australia • Brazil’s Agência Nacional de Vigilância Sanitária • Health Canada • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency • U.S.
Historically, our products have been introduced into the market using the 510(k) procedure. FDA submissions require extensive validations and testing which requires a significant amount of time and financial resources.
Historically, our products have been introduced into the market using the 510(k) procedure. 10 FDA submissions require extensive validations and testing which requires a significant amount of time and financial resources.
We have custom-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing production machinery. We manufacture many of our products from two owned manufacturing properties, one in Queensbury, NY and one small facility in Glens Falls, NY, providing capabilities which include manufacturing, service, offices, engineering and research and we lease distribution warehouses.
We have custom-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing production machinery. We manufacture many of our products from two leased manufacturing properties, one in Queensbury, NY and one small facility in Glens Falls, NY, providing capabilities which include manufacturing, service, offices, engineering and research and we lease distribution warehouses.
Each kit features a coaxial design with a 4F or 5F sheath introducer and stiff or standard dilator, along with a 21G needle and various 0.018” access wire configurations. • Mini Stick MAX Coaxial Introducer kits contain a unique containment clip that keeps all the unique components of the kit together and organize.
Each kit features a coaxial design with a 4F or 5F sheath introducer and stiff or standard dilator, along with a 21G needle and various 0.018” access wire configurations. • Mini Stick MAX Coaxial Introducer kits contain a unique containment clip that keeps all the unique components of the kit together and organized.
Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our Corporate headquarters, Attention: Saleem Cheeks. Information on our website or connected to our website is not incorporated by reference into this Annual Report on Form 10-K. 13
Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our Corporate headquarters, Attention: Saleem Cheeks. Information on our website or connected to our website is not incorporated by reference into this Annual Report on Form 10-K. 14
The solid state Solero MW Generator with a 2.45 GHz operating frequency can power up to 140W for optimized power delivery and fast ablations. The Solero MW Applicator’s optimized ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue during the ablation.
The solid state Solero MW Generator with a 2.45 GHz operating frequency can power up to 140W for optimized power delivery and fast ablations. The Solero MW Applicator’s patented dipole array and ceramic tip tuning diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue during the ablation.
See Part I. Item 1A "Risk Factors" in this Annual Report on Form 10-K. INSURANCE Our product liability insurance coverage is limited to a maximum of $10 million per product liability claim and an annual aggregate policy limit of $10 million, subject to a self-insured retention of $500,000 per occurrence and $2 million in the aggregate.
Item 1A "Risk Factors" in this Annual Report on Form 10-K. INSURANCE Our product liability insurance coverage is limited to a maximum of $10 million per product liability claim and an annual aggregate policy limit of $10 million, subject to a self-insured retention of $500,000 per occurrence and $2 million in the aggregate.
Reimbursement 11 approval must be obtained individually in each country in which our products are marketed. Members of our healthcare economics team work directly with providers, our distributors and health systems to obtain reimbursement approval in the countries in which they will use or sell our products. There can be no assurance that reimbursement approvals will be received.
Reimbursement approval must be obtained individually in each country in which our products are marketed. Members of our healthcare economics team work directly with providers, our distributors and health systems to obtain reimbursement approval in the countries in which they will use or sell our products. There can be no assurance that reimbursement approvals will be received. See Part I.
Both lines offer options with a radiopaque marker band at the distal tip to aid in placement. • The Total Abscession Drainage Catheter line offers a soft, kink resistant shaft that features the lubricious Blue Silk Finish for easier insertion and pushability, while providing the optimal patient comfort.
The portfolio offers options with a radiopaque marker band at the distal tip to aid in placement. • The Total Abscession Drainage Catheter line offers a soft, kink resistant shaft that features the lubricious Blue Silk Finish for easier insertion and pushability, while providing the optimal patient comfort.
Laura Piccinini was appointed Senior Vice President and Global Manager for Endovascular Therapies and International in January 2024, after serving as Senior Vice President and General Manager for International since joining AngioDynamics in June 2021. Ms.
Laura Piccinini was appointed Senior Vice President and General Manager for Endovascular Therapies (now Cardiovascular) and International in January 2024, after serving as Senior Vice President and General Manager for International since joining AngioDynamics in June 2021. Ms.
All products discussed below have been cleared for sale in the United States by the Food and Drug Administration. International regulatory clearances vary by product and jurisdiction. Med Tech Auryon The Auryon Atherectomy System is one of our latest advancements in peripheral arterial disease.
PRODUCTS Our product offerings fall within two segments, Med Tech and Med Device. All products discussed below have been cleared for sale in the United States by the Food and Drug Administration. International regulatory clearances vary by product and jurisdiction. Med Tech Auryon The Auryon Atherectomy System is one of our latest advancements in peripheral arterial disease.
As of October 2021, Mr. Campbell assumed responsibility of the Oncology Global Business Unit in addition to his role of General Manager for Vascular Access. In his role, Mr. Campbell oversees global commercialization of the Global Business Unit’s portfolio. Mr.
Campbell assumed responsibility of the Oncology Global 13 Business Unit in addition to his role of General Manager for Vascular Access. In his role, Mr. Campbell oversees global commercialization of the Global Business Unit’s portfolio. Mr.
In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage. Solero is a single applicator system able to complete up to a 5 cm ablation in six (6) minutes at maximum power.
In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage. Solero is a single applicator system able to complete up to a 5 cm ablation in six (6) minutes at maximum power. It is designed for open, laparoscopic and percutaneous ablation of soft tissue masses.
Mariner Hydrophilic Catheters also feature a hydrophilic coating on the distal 20cm of the catheter that reduces friction during catheter advancement in the vasculature and allows for smooth navigation, as well as, optimum handling and control by the physician. • Accu-Vu Sizing Catheters are our line of flush catheters that also feature highly visible radiopaque marker bands, which are heat embedded, along the catheter shaft, providing a smooth transition across the catheter shaft to ensure the marker bands will not separate from the shaft.
Selective catheters are typically used to gain access to more specific vasculature within the body to deliver smaller amounts of contrast. • Mariner Hydrophilic Catheters also feature a hydrophilic coating on the distal 20cm of the catheter that reduces friction during catheter advancement in the vasculature and allows for smooth navigation, as well as, optimum handling and control by the physician. • Accu-Vu Sizing Catheters are our line of flush catheters that also feature highly visible radiopaque marker bands, which are heat embedded, along the catheter shaft, providing a smooth transition across the catheter shaft to ensure the marker bands will not separate from the shaft.
Angiographic Catheters & Guidewires Our extensive line of various angiographic catheter configurations are designed to allow physicians to navigate and reach targeted anatomical locations within a patient’s vasculature that are in need of angiographic diagnosis.
Product categories include an extensive line of angiographic catheters, guidewires, drainage catheters and micropuncture kits. Angiographic Catheters & Guidewires Our extensive line of various angiographic catheter configurations are designed to allow physicians to navigate and reach targeted anatomical locations within a patient’s vasculature that are in need of angiographic diagnosis.
Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe.
Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. Full paralytic anesthesiology is required for safe IRE delivery.
The NanoKnife System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue.
Unlike other ablation technologies, the NanoKnife System does not achieve tissue ablation using thermal energy. The NanoKnife System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue.
Although we believe that we have complied with environmental, health and safety laws and regulations in all material respects and, to date, have not been required to take any action to correct any noncompliance, there can be no assurance that we will not be required to incur significant costs to comply with environmental regulations in the future.
Although we believe that we have complied with environmental, health and safety laws and regulations in all material respects and, to date, have not been required to take any action to correct any noncompliance, there can be no assurance that we will not be required to incur significant costs to comply with environmental regulations in the future. 12 EMPLOYEES As of May 31, 2025, we had approximately 675 full time employees.
Flush catheters are used in procedures where a large volume of contrast is required to deliver a concentrated bolus of contrast quickly for visualization or larger anatomical locations, such as the aorta or for run-offs into lower extremities. Selective catheters are typically used to gain access to more specific vasculature within the body to deliver smaller amounts of contrast.
Flush catheters are used in procedures where a large volume of contrast is required to deliver a concentrated bolus of contrast quickly for visualization or larger anatomical locations, such as the aorta or for run-offs into lower extremities.
On October 2, 2019, the Company acquired Eximo Medical, Ltd., a pre-commercial stage medical device company and its proprietary 355nm laser atherectomy technology (now called Auryon), which treats Peripheral Artery Disease.
On October 2, 2019, the Company acquired Eximo Medical, Ltd., a pre-commercial stage medical device company and its proprietary 355nm laser atherectomy technology (now called Auryon), which treats Peripheral Artery Disease. On December 17, 2019, the Company acquired the C3 Wave tip location asset from Medical Components Inc.
Our primary device competitors include: Boston Scientific Corporation; Cook Medical; Medical Components, Inc. (MedComp); TeleFlex Medical; Becton Dickinson; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and Johnson; Philips Healthcare; Inari Medical; Varian Medical Systems and Total Vein Systems. We believe our products compete primarily based on their quality, clinical outcomes, ease of use, reliability, physician familiarity and cost-effectiveness.
(MedComp); TeleFlex Medical; Becton Dickinson; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and Johnson; Philips Healthcare; Stryker Corporation; Penumbra, Inc.; Varian Medical Systems; Abbott Laboratories and Total Vein Systems. 8 We believe our products compete primarily based on their quality, clinical outcomes, ease of use, reliability, physician familiarity and cost-effectiveness.
The Auryon system is designed to deliver an optimized wavelength, pulse width, and amplitude to remove lesions while preserving vessel wall endothelium. Additionally, the Auryon system includes aspiration which enhances the safety of the procedure. Regardless of lesion type, the Auryon system provides safety and efficacy.
The Auryon system is designed to deliver an optimized wavelength and short pulse width to remove lesions while preserving the vessel wall endothelium. Additionally, the Auryon system features integrated aspiration which enhances the safety of the procedure.
In the highly competitive medical technology industry, we consider attracting, developing, engaging and retaining high performing talent in positions critical to our long-term growth strategy including but not limited to technical, operational, marketing, sales, research and development, and management.
None of our employees are represented by a labor union and we have never experienced a work stoppage. In the highly competitive medical technology industry, we consider attracting, developing, engaging and retaining high performing talent in positions critical to our long-term growth strategy including but not limited to technical, operational, marketing, sales, research and development, and management.
The NiT-Vu wires are designed to reduce friction during wire advancement and also provides torque control, flexibility and kink resistance. Drainage Products To aid physicians in percutaneous drainage procedures, AngioDynamics offers two different Drainage Catheter lines: Total Abscession Drainage Catheters and Exodus Drainage Catheters.
The NiT-Vu wires are designed to reduce friction during wire advancement and also provides torque control, flexibility and kink resistance. Drainage Products To aid physicians in percutaneous drainage procedures, AngioDynamics offers the Total Abscession Drainage Catheters. The Total Abscession Drainage Catheter is available in Multipurpose/General and Biliary configurations, and also offers a Nephrostomy option.
Sales of medical devices are subject to regulatory requirements in many countries. The regulatory review process may vary greatly from country to country. In order to distribute and sell products into the European Union as well as a number of other countries including many Central European Free Trade Agreement participants, Scandinavian, and Middle Eastern countries, a CE Mark is required.
In order to distribute and sell products into the European Union as well as a number of other countries including many Central European Free Trade Agreement participants, Scandinavian, and Middle Eastern countries, a CE Mark is required.
Our research and development (R&D) teams work closely with our marketing teams, sales force and regulatory and compliance teams to incorporate customer feedback into our development and design process.
This happens through internal product development, technology licensing, strategic alliances and acquisitions. Our research and development (R&D) teams work closely with our marketing teams, sales force and regulatory and compliance teams to incorporate customer feedback into our development and design process.
AngioDynamics offers a line of diagnostic and interventional guidewires which are designed to aid in delivering diagnostic and/or therapeutic devices to the desired location. • The ADx Peripheral Vascular Guidewire line is AngioDynamics diagnostic line of guidewires that is available in a multitude of fixed core wire configurations, including J-Tip and Bentson, in various lengths and ODs.
The tight tolerances and consistent placement across the entire sizing pattern, within +/-1mm of accuracy, provide a highly accurate measurement to the physician. 5 AngioDynamics offers a line of diagnostic and interventional guidewires which are designed to aid in delivering diagnostic and/or therapeutic devices to the desired location. • The ADx Peripheral Vascular Guidewire line is AngioDynamics diagnostic line of guidewires that is available in a multitude of fixed core wire configurations, including J-Tip and Bentson, in various lengths and outer diameters (OD).
These radiopaque marker bands come in different patterns along the shaft and allow physicians, under fluoroscopy, to take measurements in different anatomical locations for the placement of stents, IVC filters or other devices. The tight tolerances and consistent placement across the entire sizing pattern, within +/-1mm of accuracy, provide a highly accurate measurement to the physician.
These radiopaque marker bands come in different patterns along the shaft and allow physicians, under fluoroscopy, to take measurements in different anatomical locations for the placement of stents, IVC filters or other devices.
Advanced features of the BioFlo Port include multiple profile and catheter options, a large septum area for ease of access, PASV and non-PASV valve technology and the ability to administer contrast through a CT injection for purposes of imaging. • Xcela Plus : The Xcela Plus Port product family is Power-Injectable and part of a complete portfolio of vascular access products, and is fully compatible with the LifeGuard Safety Infusion product family.
Advanced features of the BioFlo Port include multiple profile and catheter options, a large septum area for ease of access, PASV and non-PASV valve technology and the ability to administer contrast through a CT injection for purposes of imaging.
Campbell 53 Senior Vice President and General Manager, Global Oncology and Vascular Access Laura Piccinini 54 Senior Vice President and General Manager, Endovascular Therapies and International Warren G. Nighan 55 Senior Vice President, Global Supply Chain, Quality and Regulatory Affairs James C. Clemmer became our President and Chief Executive Officer (CEO) in April 2016. Prior to joining AngioDynamics, Mr.
Nighan 56 Senior Vice President, Global Supply Chain, Quality and Regulatory Affairs James C. Clemmer became our President and Chief Executive Officer (CEO) in April 2016. Prior to joining AngioDynamics, Mr.
It is present throughout the catheter, including the extraluminal, intraluminal and cut catheter surface of the tip. Endexo Technology remains present for the life of the catheter.
Endexo Technology is a permanent and non-eluting polymer that is “blended” into the polyurethane from which the catheter is made. It is present throughout the catheter, including the extraluminal, intraluminal and cut catheter surface of the tip. Endexo Technology remains present for the life of the catheter.
The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, the assets of Diomed in June 2008, Vortex Medical, Inc. in October 2012, the assets of Microsulis Medical Limited in January 2013, and Clinical Devices in August 2013.
Initially dedicated to the research and development of products used in interventional radiology, the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems. 2 The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, the assets of Diomed in June 2008, Vortex Medical, Inc. in October 2012, the assets of Microsulis Medical Limited in January 2013, and Clinical Devices in August 2013.
During that time period, significant design modifications cannot be made. Similar regulations are in place for Canada, Japan, China, Brazil and most other countries. In some cases, we rely on our international distributors to obtain regulatory approvals, complete product registrations, comply with clinical trial requirements and complete those steps that are customarily taken in the applicable jurisdictions.
In some cases, we rely on our international distributors to obtain regulatory approvals, complete product registrations, comply with clinical trial requirements and complete those steps that are customarily taken in the applicable jurisdictions.
There can be no assurance that we will not be required to incur significant costs to comply with such laws and regulations now or in the future, or that such laws or regulations will not have a material adverse effect upon our ability to do business. 10 International Regulation Internationally, all of our current products are considered medical devices under applicable regulatory regimes, and we anticipate that this will be true for all of our future products.
Many states have similar laws. There can be no assurance that we will not be required to incur significant costs to comply with such laws and regulations now or in the future, or that such laws or regulations will not have a material adverse effect upon our ability to do business.
During the fourth quarter of fiscal year 2022, AngioDynamics entered into a supply agreement with Precision Concepts, Costa Rica S.A., a Costa Rica corporation, with its principal place of business in Alajuela, Costa Rica. Precision Concepts is manufacturing, storing, and handling certain products for the Company and is registered with the FDA and certified to the ISO 13485 standard.
AngioDynamics entered into a supply agreement with Biomerics (previously Precision Concepts) in Alajuela, Costa Rica. Biomerics is manufacturing, storing, and handling certain products for the Company and is registered with the FDA and certified to the ISO 13485 standard. The Company also relies on other third party manufacturers for the manufacturing of certain products.
These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife System does not achieve tissue ablation using thermal energy.
The system utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death.
Lastly, the IsoLoc device repositions and lifts the bowel in patients that have a low-lying bowel. 7 Alatus Vaginal Balloon Packing System The Alatus device was developed with the patient's comfort in mind and to assist the physician to move healthy tissue away from the radiation treatment field.
Alatus Vaginal Balloon Packing System The Alatus device was developed with the patient's comfort in mind and to assist the physician to move healthy tissue away from the radiation treatment field. Prior to the Alatus device, the clinician would push gauze into the vagina to move the bladder and bowel away from the radiation treatment field.
Secondly, the structure of the ERB aids in defining the anatomy for difficult planning scenarios with post-radical patients.
Secondly, the structure of the ERB aids in defining the anatomy for difficult planning scenarios with post-radical patients. Lastly, the IsoLoc device repositions and lifts the bowel in patients that have a low-lying bowel.
AngioVac Our AngioVac venous drainage system includes a Venous Drainage Cannula and Extracorporeal Circuit. The cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass. The AngioVac circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
AngioDynamics offers a range of options when treating thrombus and removing fresh, soft thrombi or emboli. 3 AngioVac Our AngioVac venous drainage system includes a Venous Drainage Cannula and Extracorporeal Circuit. The cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass.
It has easily identifiable critical information radiopaque “CT” lettering which helps to confirm if port is power-injectable or flipped. The Xcela Plus port family is available in single lumen standard size in either a non-valved or valved configuration.
It has easily identifiable critical information radiopaque “CT” lettering which helps to confirm if port is power-injectable or flipped.
Thrombectomy Our Thrombus Management portfolio includes the AlphaVac Mechanical Thrombectomy System, AngioVac venous drainage cannula and circuit, as well as catheter directed thrombolytic devices, including the Uni-Fuse system, the Uni-Fuse+ system, the Pulse Spray system and SpeedLyser infusion catheters. AngioDynamics offers a range of options when treating thrombus and removing fresh, soft thrombi or emboli.
Thrombectomy Our Thrombus Management portfolio includes the AlphaVac Mechanical Thrombectomy System, AngioVac venous drainage cannula and circuit, as well as catheter directed thrombolytic devices, including the Uni-Fuse system and the Uni-Fuse+ system.
We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents designed to shorten treatment time, and the SpeedLyser infusion system built for dialysis grafts and fistulas.
We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents designed to shorten treatment time, and the SpeedLyser infusion system built for dialysis grafts and fistulas. 4 NanoKnife The NanoKnife IRE Ablation System is an alternative to traditional thermal ablation that received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue.
We are an equal opportunity/affirmative action employer committed to making employment decisions without regard to race, religion, ethnicity or national origin, gender, sexual orientation, gender identity or expression, age, disability, protected veteran status or any other characteristics protected by law.
We are committed to making employment decisions without regard to race, religion, ethnicity or national origin, gender, sexual orientation, gender identity or expression, age, disability, protected veteran status or any other characteristics protected by law. The engagement of our workforce is crucial to delivering on our competitive strategy, and we place high importance on informed and engaged employees.
Trowbridge received a Bachelor of Science in Science and Technology Studies from Rensselaer Polytechnic Institute, a Juris Doctor from the University of Pennsylvania Law School, and a Master of Business Administration from Duke University’s Fuqua School of Business. Chad T. Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for Vascular Access.
Trowbridge received a Bachelor of Science in Science and Technology Studies from Rensselaer Polytechnic Institute, a Juris Doctor from the University of Pennsylvania Law School, and a Master of Business Administration from Duke University’s Fuqua School of Business. Lawrence T. Weiss was appointed Senior Vice President, Chief Legal Officer and Corporate Secretary in December 2024. Prior to joining AngioDynamics, Mr.
Executive Officers of the Company The following table sets forth certain information with respect to our executive officers. Name Age Position James C. Clemmer 60 President and Chief Executive Officer Stephen A. Trowbridge 50 Executive Vice President and Chief Financial Officer Chad T.
We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, town hall meetings and our company intranet. Executive Officers of the Company The following table sets forth certain information with respect to our executive officers. Name Age Position James C. Clemmer 60 President and Chief Executive Officer Stephen A.
Port Technologies • BioFlo: AngioDynamics offers the BioFlo catheter, the only catheter on the market with Endexo Technology, a material more resistant to thrombus accumulation, in vitro (based on platelet count). Endexo Technology is a permanent and non-eluting polymer that is “blended” into the polyurethane from which the catheter is made.
The Xcela Plus port family is available in single lumen standard size in either a non-valved or valved configuration. 6 Port Technologies • BioFlo Endexo: AngioDynamics offers the BioFlo catheter, the only catheter on the market with Endexo Technology, a material more resistant to thrombus accumulation, in vitro (based on platelet count).
AngioVac devices are for use with other manufacturers’ off-the-shelf pump, filter and reinfusion cannula, to facilitate venous drainage as part of an extracorporeal bypass procedure. The AngioVac venous drainage cannula is a 22 French flat coil-reinforced cannula designed with a proprietary self-expanding nitinol reinforced funnel shaped distal tip.
The AngioVac circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. AngioVac devices are for use with other manufacturers’ off-the-shelf pump, filter and reinfusion cannula, to facilitate venous drainage as part of an extracorporeal bypass procedure.
The unique Sure-Twist hub provides audible and tactile feedback when locked, without the need for a separate tool. 5 Micropuncture Kits AngioDynamics offers physicians two micropuncture kit lines that are designed to start each procedure with ease and efficiency: Mini Stick MAX Coaxial Microintroducer Kits and Micro-Introducer Kits.
The unique Vault Locking Mechanism securely fixes the pigtail and prevents tampering or accidental removal. Micropuncture Kits AngioDynamics offers physicians two micropuncture kit lines that are designed to start each procedure with ease and efficiency: Mini Stick MAX Coaxial Microintroducer Kits and Micro-Introducer Kits.
This product line consists of titanium, plastic and dual-lumen offerings. • PASV Valve Technology: The PASV Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications. 6 Venous Insufficiency VenaCure EVLT laser system Our VenaCure EVLT system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins).
With its rounded chamber, the Vortex port is designed to have no sludge-harboring corners or dead spaces. This product line consists of titanium, plastic and dual-lumen offerings. • PASV Valve Technology: The PASV Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.
RESEARCH & DEVELOPMENT Our growth depends in large part on the continuous introduction of new and innovative products, together with ongoing enhancements to our existing products. This happens through internal product development, technology licensing, strategic alliances and acquisitions.
Inserting gauze into the vagina can be uncomfortable before treatment and unpleasant at the end of treatment as it tends to dry out before removing. RESEARCH & DEVELOPMENT Our growth depends in large part on the continuous introduction of new and innovative products, together with ongoing enhancements to our existing products.
BACKLOG We have historically kept sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand.
The restructuring activities associated with the modified Plan are still expected to be completed in the third quarter of fiscal year 2026. BACKLOG We seek to maintain sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand, and accordingly our backlog is not significant.
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Item 1. Business. OVERVIEW AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. HISTORY AngioDynamics was founded in Queensbury, N.Y., U.S., in 1988 and began manufacturing and shipping product in the early 1990s.
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Item 1. Business. OVERVIEW AngioDynamics is a dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes and quality of life by designing, manufacturing and selling products and technologies which aid clinicians in the treatment of patients with cardiovascular disease and cancer diagnoses.
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The Company is headquartered in Latham, N.Y., with manufacturing primarily out of the Queensbury facility. Initially dedicated to the research and development of products used in interventional radiology, the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems.
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Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales performance. HISTORY AngioDynamics was founded in Queensbury, N.Y., U.S., in 1988 and began manufacturing and shipping product in the early 1990s. The Company is headquartered in Latham, N.Y., with manufacturing primarily out of the Queensbury facility.
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On December 17, 2019, the Company acquired the C3 Wave tip location asset from Medical Components Inc., which the Company sold in February 2024 to Spectrum Vascular pursuant to an asset purchase agreement.
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On July 27, 2021, AngioDynamics acquired the Camaro Support Catheter asset from QX Medical, LLC. On June 8, 2023, the Company completed the sale of the dialysis and BioSentry businesses to Merit Medical Systems, Inc.
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On July 27, 2021, AngioDynamics acquired the Camaro Support Catheter asset from QX Medical, LLC and subsequently discontinued this product in the third quarter of fiscal year 2024. AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO. PRODUCTS Our product offerings fall within two segments, Med Tech and Med Device.
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On February 15, 2024, the Company completed the sale of its PICC and Midline businesses, which included the C3 Wave tip location asset, to Spectrum Vascular. As of February 29, 2024, the Company discontinued the RadioFrequency Ablation and Syntrax product lines. AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.
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NanoKnife The NanoKnife IRE Ablation System is an alternative to traditional thermal ablation that received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The system utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes.
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Regardless of lesion type or location - whether above or below the knee - the Auryon system provides safety, efficacy and versatility, supporting femoral, pedal or radial access.
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The energy delivery is hyperechoic and can be monitored under real-time ultrasound. 4 Med Device Peripheral Products (Interventional Devices) We offer a comprehensive portfolio of products for use during minimally invasive procedures. Product categories include an extensive line of angiographic catheters, guidewires, drainage catheters and micropuncture kits.
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The AngioVac venous drainage cannula is a 22 French flat coil-reinforced cannula designed with a proprietary self-expanding nitinol reinforced funnel shaped distal tip.
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Each line is available in a Multipurpose/General and Biliary configuration, while Total Abscession also offers a Nephrostomy option.
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In December 2024, the NanoKnife System received expanded FDA 510(k) clearance for the ablation of prostate tissue which broadens treatment options for men and reinforces the system’s strong safety and efficacy profile. Med Device Peripheral Products (Interventional Devices) We offer a comprehensive portfolio of products for use during minimally invasive procedures.
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The unique Vault Locking Mechanism securely fixes the pigtail and prevents tampering or accidental removal. • The Exodus Drainage line features an integrated polymer blend extruded shaft with external catheter markings, and GLYCE Hydrophilic Coating on the distal 20cm of the catheter shaft.
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The BioFlo port family is available in single or dual lumen configurations. • Xcela Plus : The Xcela Plus Port product family is Power-Injectable and part of a complete portfolio of vascular access products, and is fully compatible with the LifeGuard Safety Infusion product family.
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With its rounded chamber, the Vortex port is designed to have no sludge-harboring corners or dead spaces.
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Venous Insufficiency VenaCure EVLT laser system Our VenaCure EVLT system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins).
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Procedure kits are available in a variety of lengths and configurations to accommodate varied patient anatomies. The VenaCure EVLT system comes with a comprehensive physician training program and extensive marketing support. Microwave Ablation Solero Microwave Tissue Ablation (MTA) System The Solero MTA System features the Solero Microwave (MW) Generator and the specially designed Solero MW Applicators.
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Procedure kits are available in a variety of lengths and configurations to accommodate varied patient anatomies. NeverTouch and NeverTouch Direct gold-tip laser fibers, is an integral part of AngioDynamics’ advanced varicose vein treatment and establishes a new standard for patient comfort, visibility and ease of use. The innovation behind the NeverTouch tip is a glass weld at the distal tip.
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Prior to the Alatus device, the clinician would push gauze into the vagina to move the bladder and bowel away from the radiation treatment field. Inserting gauze into the vagina can be uncomfortable before treatment and unpleasant at the end of treatment as it tends to dry out before removing.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

71 edited+17 added−25 removed166 unchanged
Biggest changeForeign Corrupt Practices Act (“FCPA”) and similar anti-bribery laws in international jurisdictions, including the UK Anti-Bribery Act, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), General Data Protection Regulation (“GDPR”), domestic and foreign data protection, data security and privacy laws, laws related to the collection, storage, use and disclosure of personal data and laws and regulations relating to sanctions and money laundering. 24 The failure to comply with these laws and regulatory standards, allegations of such non-compliance or the discovery of previously unknown problems with a product or manufacturer: (i) could result in FDA Form-483 notices and/or warning letters or the foreign equivalent, fines, delays or suspensions of regulatory clearances, investigations, detainment, seizures or recalls of products (with the attendant expenses), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and/or civil or criminal prosecution, and/or penalties, as well as decreased sales as a result of negative publicity and product liability claims; (ii) could expose us to breach of contract claims, fines and penalties, costs for remediation and harm to our reputation; (iii) could result in criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid and health programs outside the United States; and (iv) could otherwise disrupt our business and could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
Biggest changeThe failure to comply with these laws and regulatory standards, allegations of such non-compliance or the discovery of previously unknown problems with a product or manufacturer: (i) could result in FDA Form-483 notices and/or warning letters or the foreign equivalent, fines, delays or suspensions of regulatory clearances, investigations, detainment, seizures or recalls of products (with the attendant expenses), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and/or civil or criminal prosecution, and/or penalties, as well as decreased sales as a result of negative publicity and product liability claims; (ii) could expose us to breach of contract claims, fines and penalties, costs for remediation and harm to our reputation; (iii) could result in criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid and health programs outside the United States; and (iv) could otherwise disrupt our business and could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
Our sales and profitability from our international operations are subject to risks and uncertainties that could have a material adverse effect on our business, financial condition and/or results of operations, many of which we cannot predict, including: • fluctuations in currency exchange rates which may, in some instances affect spending behavior and reduce cash flows and revenue outside the U.S.; • healthcare reform legislation; • multiple non-U.S. regulatory requirements that are subject to change and could restrict our ability to manufacture and sell our products; • local product preferences and product requirements; • longer-term receivables than are typical in the U.S. and/or the ability to obtain payment; • trade protection measures and import or export licensing requirements; • less intellectual property protection in some countries outside the U.S. than exists in the U.S.; • different labor regulations and workforce instability; • the potential payment of U.S. income taxes on earnings of certain foreign subsidiaries subject to U.S. taxation upon repatriation; • the expiration and non-renewal of foreign tax rulings; • potential negative consequences from changes in or interpretation of tax laws, including changes in our effective tax rate or the applicable tax rate in one or more jurisdictions; and • economic instability and inflation, recession or interest rate fluctuations.
Our sales and profitability from our international operations are subject to risks and uncertainties that could have a material adverse effect on our business, financial condition and/or results of operations, many of which we cannot predict, including: • fluctuations in currency exchange rates which may, in some instances affect spending behavior and reduce cash flows and revenue outside the U.S.; • healthcare reform legislation; • multiple non-U.S. regulatory requirements that are subject to change and could restrict our ability to manufacture and sell our products; • local product preferences and product requirements; • longer-term receivables than are typical in the U.S. and/or the ability to obtain payment; • trade protection measures, tariffs and import or export licensing requirements; • less intellectual property protection in some countries outside the U.S. than exists in the U.S.; • different labor regulations and workforce instability; • the potential payment of U.S. income taxes on earnings of certain foreign subsidiaries subject to U.S. taxation upon repatriation; • the expiration and non-renewal of foreign tax rulings; • potential negative consequences from changes in or interpretation of tax laws, including changes in our effective tax rate or the applicable tax rate in one or more jurisdictions; and • economic instability and inflation, tariffs, recession or interest rate fluctuations.
Comparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly based on many factors, including: • the level of sales of our products and services in our markets; • our ability to introduce new products or services and enhancements in a timely manner; • the demand for and acceptance of our products and services; • the success of our competition and the introduction of alternative products or services; • our ability to command favorable pricing for our products and services; • the growth of the market for our devices and services; • the expansion and rate of success of our direct sales force in the United States and internationally and our independent distributors internationally; • actions relating to ongoing FDA compliance; • our ability to integrate acquired assets or companies; • the effect of intellectual property disputes; • the size and timing of orders from independent distributors or customers; • the attraction and retention of key personnel, particularly in sales and marketing, regulatory, manufacturing and research and development; • unanticipated delays or an inability to control costs; • general economic conditions, including inflationary pressure, as well as those specific to our customers and markets; and • seasonal fluctuations in revenue due to the elective nature of some procedures.
Comparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly based on many factors, including: • the level of sales of our products and services in our markets; • our ability to introduce new products or services and enhancements in a timely manner; • the demand for and acceptance of our products and services; • the success of our competition and the introduction of alternative products or services; • our ability to command favorable pricing for our products and services; • the growth of the market for our devices and services; • the expansion and rate of success of our direct sales force in the United States and internationally and our independent distributors internationally; • actions relating to ongoing FDA compliance; • our ability to integrate acquired assets or companies; • the effect of intellectual property disputes; 28 • the size and timing of orders from independent distributors or customers; • the attraction and retention of key personnel, particularly in sales and marketing, regulatory, manufacturing and research and development; • unanticipated delays or an inability to control costs; • general economic conditions, including inflationary pressure, as well as those specific to our customers and markets; and • seasonal fluctuations in revenue due to the elective nature of some procedures.
Patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assess safety and effectiveness, if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts or if they participate in contemporaneous clinical trials of competing products.
Patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assess safety and effectiveness, if they 16 determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts or if they participate in contemporaneous clinical trials of competing products.
While we have implemented cost containment measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.
While we have implemented cost containment 20 measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.
If we are unable to maintain our relationships or establish direct sales capabilities on acceptable terms or at all, we may lose significant revenue or be unable to achieve our growth aspirations. In certain circumstances, distributors may also sell competing products, or products for competing diagnostic modalities, and may have incentives to shift sales 17 towards those competing products.
If we are unable to maintain our relationships or establish direct sales capabilities on acceptable terms or at all, we may lose significant revenue or be unable to achieve our growth aspirations. In certain circumstances, distributors may also sell competing products, or products for competing diagnostic modalities, and may have incentives to shift sales towards those competing products.
Factors that may be considered a change in circumstances indicating that the carrying value of our intangible assets and/or goodwill may not be recoverable include a decline in stock price and market capitalization, slower growth rates in our industry or our own operations and/or other materially adverse events that have implications on the profitability of our business.
Factors that may be considered a change in circumstances indicating that the carrying value of our intangible assets may not be recoverable include a decline in stock price and market capitalization, slower growth rates in our industry or our own operations and/or other materially adverse events that have implications on the profitability of our business.
If any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
If 15 any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
In addition, our sales force is highly talented and we face intense competition in our industry for sales personnel which could have an adverse effect on our business and revenue if there is significant turnover. If we are unable to manage our growth profitably, our business, financial results and stock price could suffer.
In addition, our sales force is highly talented and we face intense competition in our industry for sales personnel which could have an adverse effect on our business and revenue if there is significant turnover. 21 If we are unable to manage our growth profitably, our business, financial results and stock price could suffer.
Third-party infringement claims, regardless of their outcome, would not only consume our financial resources but also divert our management’s time and effort. 27 Such claims could also cause our customers or potential customers to purchase competitors’ products or defer or limit their purchase or use of our affected products until resolution of the claim.
Third-party infringement claims, regardless of their outcome, would not only consume our financial resources but also divert our management’s time and effort. Such claims could also cause our customers or potential customers to purchase competitors’ products or defer or limit their purchase or use of our affected products until resolution of the claim.
Clinical trials must be conducted in accordance with the applicable laws and regulations in the jurisdictions in which the clinical trials are conducted, including FDA’s current Good Clinical Practices. The clinical trials are subject to oversight by the FDA, regulatory agencies in other jurisdictions, ethics committees and institutional review boards at the medical institutions where the clinical trials are conducted.
Clinical trials must be conducted in accordance with the applicable laws and regulations in the jurisdictions in which the clinical trials are conducted, including current Good Clinical Practices. The clinical trials are subject to oversight by the FDA, regulatory agencies in other jurisdictions, ethics committees and institutional review boards at the medical institutions where the clinical trials are conducted.
Our future financial results will depend in part on our ability to profitably manage our growth. Management will need to maintain existing customers and attract new customers, recruit, retain and effectively manage employees, as well as expand 20 operations and integrate customer support and financial control systems.
Our future financial results will depend in part on our ability to profitably manage our growth. Management will need to maintain existing customers and attract new customers, recruit, retain and effectively manage employees, as well as expand operations and integrate customer support and financial control systems.
These economic conditions make it more difficult for us to accurately forecast and plan our future business activities. 19 Volatility in the cost of raw materials, components, freight and energy increases the costs of producing and distributing our products.
These economic conditions make it more difficult for us to accurately forecast and plan our future business activities. Volatility in the cost of raw materials, components, freight and energy increases the costs of producing and distributing our products.
Most of our intangible and fixed assets have finite useful lives and are amortized or depreciated over their useful lives on either a straight-line basis or over the expected period of benefit or as revenues are earned from the sales of the related products.
Our intangible and fixed assets have finite useful lives and are amortized or depreciated over their useful lives on either a straight-line basis or over the expected period of benefit or as revenues are earned from the sales of the related products.
However, no assurances can be made that any pending or future patent applications will result in the issuance of patents, that any current or future patents issued to, or licensed by us, will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.
However, no assurances can be made that any pending or future patent applications will result in the issuance of 27 patents, that any current or future patents issued to, or licensed by us, will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.
Patient enrollment is a function of many factors, including the size of the patient population for the target indication, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the 15 availability of alternative or new treatments.
Patient enrollment is a function of many factors, including the size of the patient population for the target indication, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of alternative or new treatments.
We are committed to providing a safe and secure environment for all of our personnel, our business partners and our customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”).
We are committed to providing a safe and secure environment for all of our personnel, our business partners and our 23 customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”).
We rely on third-party manufacturers to manufacture some of our products today, and we have announced a plan to move to a fully outsourced model for manufacturing in various parts of the world, which exposes us to additional risks, including reduced control over manufacturing, delivery timing, product quality issues, potential price fluctuations, regulatory, environmental, labor or other operational disruptions, which would result in a loss of revenue or reduced profitability.
We rely on third-party manufacturers to manufacture some of our products today, and we have announced a plan to move to a partially outsourced model for manufacturing in various parts of the world, which exposes us to additional risks, including reduced control over manufacturing, delivery timing, product quality issues, potential price fluctuations, regulatory, environmental, labor or other operational disruptions, which would result in a loss of revenue or reduced profitability.
Any significant uninsured loss, prolonged or repeated disruption, or inability to 23 operate experienced by us or any of our principal suppliers could cause significant harm to our business, financial condition, results of operations and/or liquidity.
Any significant uninsured loss, prolonged or repeated disruption, or inability to operate experienced by us or any of our principal suppliers could cause significant harm to our business, financial condition, results of operations and/or liquidity.
The imposition of tariffs or export restrictions on products imported by us from China could require us to (i) increase prices to our members or (ii) locate suitable alternative manufacturing capacity or relocate our operations from China to other countries.
The imposition of tariffs or export restrictions on products imported by us from China could require us to (i) increase prices to our customers or (ii) locate suitable alternative manufacturing capacity or relocate our operations from China to other countries.
In the past, securities class action litigation has often been brought against a company after a period of volatility in the market price of its common stock. 28 Item 1B. Unresolved Staff Comments. None.
In the past, securities class action litigation has often been brought against a company after a period of volatility in the market price of its common stock. 29 Item 1B. Unresolved Staff Comments. None.
Any of these results could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. Laws and regulations governing the export of our products could adversely impact our business. If the U.S. government imposes strict sanctions on Iran, our revenue could be impacted. The U.S.
Any of these results could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. Laws and regulations governing the export of our products could adversely impact our business. If the U.S. government imposes strict sanctions on certain countries, our revenue could be impacted. The U.S.
Sales outside the U.S. accounted for approximately 17% of our net sales during our fiscal year ended May 31, 2024. We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we intend to continue our expansion into emerging and/or faster-growing markets outside the U.S.
Sales outside the U.S. accounted for approximately 14% of our net sales during our fiscal year ended May 31, 2025. We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we intend to continue our expansion into emerging and/or faster-growing markets outside the U.S.
As such, our revenue, if any, depends on the terms of such arrangements and the distributors’ efforts. These efforts may turn out not to be sufficient and our third-party distributors may not effectively sell our products. International distributors accounted for approximately 77% of international revenues for the fiscal year ended May 31, 2024.
As such, our revenue, if any, depends on the terms of such arrangements and the distributors’ efforts. These efforts may turn out not to be sufficient and our third-party distributors may not effectively sell our products. International distributors accounted for approximately 74% of international revenues for the fiscal year ended May 31, 2025.
If we cannot successfully complete such renegotiation, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers in a timely manner, if at all; and • manufacturing could be curtailed or partially or completely shut down as the result of a number of circumstances, most of which are outside of our control, such as unscheduled maintenance, an earthquake, hurricane, flood, tsunami or other natural disaster, significant labor strikes or work stoppages, government implementation of export limitations or freezes, political unrest or pandemics.
If we cannot successfully complete such renegotiation, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers in a timely manner, if at all; and • manufacturing could be curtailed or partially or completely shut down as the result of a number of circumstances, most of which are outside of our control, such as unscheduled maintenance, an earthquake, hurricane, flood, tsunami or other natural disaster, significant labor strikes or work stoppages, government implementation of export limitations or freezes, political unrest or pandemics. 17 In addition, our business practices in international markets are subject to the requirements of the U.S.
International sales decreased 6% in fiscal year 2024 partially due to the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation product line.
International sales decreased 21% in fiscal year 2025 partially due to the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation product line.
For example, impacts from the COVID-19 pandemic and measures taken in response thereto, such as constraints in the capacities of hospitals and other healthcare providers to perform non-COVID related procedures, changes to our on-site operations, delays in product development efforts and related clinical trials and regulatory clearances and approvals, and disruptions to global supply chains and labor markets, resulting in cost inflation and raw material supply constraints, adversely affected our business and there can be no assurance that similar events will not occur in the future.
For example, impacts from the COVID-19 pandemic and measures taken in response thereto, such as constraints in the capacities of hospitals and other healthcare providers to perform non-COVID related procedures, changes to our on-site operations, delays in product development efforts and related clinical trials and regulatory clearances and approvals, and disruptions to global supply chains and labor markets, resulting in cost inflation and raw material supply constraints, adversely affected our business and there can be no assurance that similar events will not occur in the future. 24 We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters .
Complying with and obtaining regulatory approval in foreign countries, including our efforts to comply with the requirements of the MDR, have and will likely continue to lead to additional uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a material adverse effect on our business, financial condition and/or results of operations.
Complying with and obtaining regulatory approval in foreign countries, including our efforts to comply with the requirements of the MDR, have and will likely continue to lead to additional uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a material adverse effect on our business, financial condition and/or results of operations. 26 Our products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources.
A portion of the manufacturing activities is conducted in China. As a result, our business, financial condition, results of operations could be affected significantly by economic, political and legal developments in China as well as trade disputes between China and the United States and the potential imposition of bilateral tariffs.
A portion of our component sourcing, supply chain and manufacturing activities are conducted in or partially sourced from China. As a result, our business, financial condition, results of operations could be affected significantly by economic, political and legal developments in China as well as trade disputes between China and the United States and the potential imposition of bilateral tariffs.
We rely on information technology systems to process, transmit, and store electronic information in our day-to-day operations. Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to cyber-attacks, malicious intrusions, breakdowns, destruction, losses of data privacy, or other significant disruptions. Our distributors and supply chain partners face similar risks.
Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to cyber-attacks, malicious intrusions, breakdowns, destruction, losses of data privacy, or other significant disruptions. Our distributors and supply chain partners face similar risks.
The additional time and resources required to obtain MDR certification has been a significant factor in, and will likely continue to influence, our decisions whether to discontinue sales and distribution of certain products in the EU.
The additional time and resources required to obtain MDR certification was a significant factor in, and the diligence required to maintain the CE mark under MDR will likely continue to influence, our decisions whether to discontinue sales and distribution of certain products in the EU.
We face competition globally from a wide range of companies, many of whom have substantially greater financial, marketing and other resources than us. We may not be able to compete effectively, and we may lose market share to our competitors. Our primary device competitors include: Boston Scientific Corporation; Cook Medical; Medical Components, Inc.
We face competition globally from a wide range of companies, many of whom have substantially greater financial, marketing and other resources than us. We may not be able to compete effectively, and we may lose market share to our competitors.
Our state net operating loss carryforwards as of May 31, 2024 after considering remaining IRC Section 382 limitations are $14.4 million which expire in various years from 2029 to 2043.
Our state net operating loss carryforwards as of May 31, 2025 after considering remaining IRC Section 382 limitations are $23.9 million which expire in various years from 2030 to 2043.
Actual or potential changes in international, national, regional and local economic, business and financial conditions, including recession, high inflation and trade protection measures, creditworthiness of our customers, may negatively affect consumer preferences, perceptions, spending patterns or demographic trends, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.
Actual or potential changes in international, national, regional and local economic, business and financial conditions, including recession, high inflation and trade protection measures, creditworthiness of our customers, fluctuations in currency values, U.S. export controls, U.S. and non-U.S. tax laws, shipping delays and economic and political instability, may negatively affect consumer preferences, perceptions, spending patterns or demographic trends, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.
If a product liability claim is brought against us or our product liability insurance coverage is inadequate, our business could be harmed. The design, manufacture and marketing of the types of medical devices we sell entail an inherent risk of product liability. Our products are used by physicians to treat seriously ill patients.
Pending or future product liability claims brought against us, especially if our product liability insurance coverage is inadequate, could adversely impact our business, operations and financial results. The design, manufacture and marketing of the types of medical devices we sell entail an inherent risk of product liability. Our products are used by physicians to treat seriously ill patients.
We do not have written employment agreements with our executive officers, other than the CEO. Our ability to maintain and expand our business may be impaired if we are unable to retain our current key personnel or hire or retain other qualified personnel in the future, including personnel for our manufacturing facilities and field based sales employees.
Our ability to maintain and expand our business may be impaired if we are unable to retain our current key personnel or hire or retain other qualified personnel in the future, including personnel for our manufacturing facilities and field based sales employees.
The PMA process is much more costly, lengthy and uncertain. It generally takes from one to three years from the date the application is submitted to, and filed with the FDA, and may take even longer.
It generally takes from one to three years from the date the application is submitted to, and filed with the FDA, and may take even longer.
Our Federal net operating loss carryforwards as of May 31, 2024 after considering IRC Section 382 limitations are $111.0 million. The expiration of the Federal net operating loss carryforwards is as follows: $37.1 million between 2029 and 2032 and $73.9 million indefinitely.
Our Federal net operating loss carryforwards as of May 31, 2025 after considering IRC Section 382 limitations are $135.6 million. The expiration of the Federal net operating loss carryforwards is as follows: $37.1 million between 2030 and 2032 and $98.5 million indefinitely.
If we are unable to effectively execute on this Plan within the announced timeline it could have a material adverse effect on our business, financial condition and/or results of operations.
The restructuring activities associated with this plan are expected to be completed in the third quarter of fiscal year 2026. If we are unable to effectively execute on this plan within the announced timeline it could have a material adverse effect on our business, financial condition and/or results of operations.
Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including, but not limited to, our NanoKnife DIRECT clinical study, our NanoKnife PRESERVE clinical study and clinical studies for AngioVac.
Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including, but not limited to, our Ambition BTK clinical study.
We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters . Governments, investors, customers, employees and other stakeholders are increasingly focusing on corporate ESG practices and disclosures, including risks associated with climate change and expectations in this area are rapidly evolving.
Governments, investors, customers, employees and other stakeholders are increasingly focusing on corporate ESG practices and disclosures, including risks associated with climate change and expectations in this area are rapidly evolving.
This has created an increasing level of price sensitivity among customers for our products and could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions.
This has created an increasing level of price sensitivity among customers for our products and could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
The magnitude of the potential losses relating to these lawsuits may remain unknown for substantial periods of time. 18 We carry a product liability policy with a limit of $10.0 million per product liability claim and an aggregate policy limit of $10.0 million, subject to a self-insured retention of $0.5 million per occurrence and $2.0 million in the aggregate.
We carry a product liability policy with a limit of $10.0 million per product liability claim and an aggregate policy limit of $10.0 million, subject to a self-insured retention of $0.5 million per occurrence and $2.0 million in the aggregate.
Our products are used in medical procedures and purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthcare services provided to their patients.
If we are unable to convince customers that our products can improve the cost structure of their business, or to secure adequate reimbursement for our products our revenue growth and profitability may be materially and adversely impacted. 18 Our products are used in medical procedures and purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthcare services provided to their patients.
A significant portion of our assets consist of goodwill, intangible assets and fixed assets, the carrying value of which may be reduced if we determine that those assets are impaired, including intangible assets from recent acquisitions.
Our intangible assets and fixed assets are subject to potential impairment; we have historically recorded significant impairment charges and may be required to record additional charges to future earnings if our assets become impaired. 22 A significant portion of our assets consist of intangible assets and fixed assets, the carrying value of which may be reduced if we determine that those assets are impaired, including intangible assets from recent acquisitions.
If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable post-market requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions.
The occurrence of an adverse monetary or equitable judgment or a large expenditure in connection with a settlement of any of these matters could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. 25 If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable post-market requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions.
In addition, if rates continue to increase, we may incur significant additional expense and adversely impact our ability to achieve our other strategic goals and business plans.
For example, a rapid increase in inflation levels may negatively impact demand for our products and increase our costs and may lead to a rapid increase in market interest rates. In addition, if rates increase, we may incur significant additional expense and adversely impact our ability to achieve our other strategic goals and business plans.
If we are not able to hire and retain personnel in our manufacturing facilities, we may not meet our production demand. We experienced labor shortages in fiscal year 2023 that significantly contributed to the backlog in fiscal year 2023.
If we are not able to hire and retain personnel in our manufacturing facilities, we may not meet our production demand.
Our business could be harmed if we cannot hire or retain qualified personnel. Our business depends upon our ability to attract and retain highly qualified personnel, including managerial, sales, and technical personnel. We compete for key personnel with other companies, healthcare institutions, academic institutions, government entities and other organizations.
Our business depends upon our ability to attract and retain highly qualified personnel, including managerial, sales, and technical personnel. We compete for key personnel with other companies, healthcare institutions, academic institutions, government entities and other organizations. We do not have written employment agreements with our executive officers, other than the CEO.
A significant deterioration in economic conditions, including economic slowdowns or recessions, increased unemployment levels, inflationary pressures or disruptions to credit and capital markets, could lead to decreased consumer confidence and spending and availability of credit. For example, in 2022 and continuing into 2024, the United States and other certain foreign countries have experienced a rapid increase in inflation levels.
A significant deterioration in economic conditions, including economic slowdowns or recessions, increased unemployment levels, inflationary pressures or disruptions to credit and capital markets, could lead to decreased consumer confidence and spending and availability of credit.
If we are incorrect in our belief that our promotional materials and training methods regarding the use of our products are conducted in compliance with regulations of the FDA and other applicable regulations, and the FDA determines that our promotional materials or training constitutes promotion of an unapproved use, the FDA could request that we modify our training or promotional materials or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties.
If the FDA determines that our promotional materials, sales techniques, pricing programs or training constitutes promotion of an off-label use or encourages over-utilization of our products or use of our products in combinations that are not indicated or appropriate, the FDA could request that we modify materials, techniques, programs or training or subject us to enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties.
Even after a device receives regulatory approval it remains subject to significant regulatory and quality requirements, such as manufacturing, recordkeeping, renewal, recertification or reporting and other post market approval requirements, which may include clinical, laboratory or other studies. 25 Product approvals by the FDA and other foreign regulators can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval or may be re-classified to a higher regulatory classification, such as requiring a PMA for a previously cleared 510(k) device.
Product approvals by the FDA and other foreign regulators can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval or may be re-classified to a higher regulatory classification, such as requiring a PMA for a previously cleared 510(k) device. The PMA process is much more costly, lengthy and uncertain.
It is also possible that other federal, state or foreign enforcement authorities might take action if they consider promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.
It is also possible that other federal, state or foreign enforcement authorities, including the U.S. Department of Justice ("DOJ"), might take similar actions, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.
These activities may result in substantial investment of our time and financial resources and competition for targets may be significant. We may not be able to identify appropriate acquisition candidates, consummate transactions, obtain agreements with favorable terms or obtain any necessary financing or regulatory approvals.
We may not be able to identify appropriate acquisition candidates, consummate transactions, obtain agreements with favorable terms or obtain any necessary financing or regulatory approvals.
Department of Commerce (BIS), administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons, in conducting activities, transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S. economic sanctions. 26 Due to our international operations, we are subject to such laws and regulations, which are complex, restrict our business dealings with certain countries and individuals, and are constantly changing.
Department of the Treasury’s Office of Foreign Assets Control (OFAC), and the Bureau of Industry and Security at the U.S. Department of Commerce (BIS), administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons, in conducting activities, transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S. economic sanctions.
Additionally, there can be no assurance that the size of the markets in which we compete will increase above existing levels or not decline, that we will be able to maintain, gain or regain market share or that we can compete effectively on the basis of price or that the number of procedures in which our products are used will increase above existing levels or not decline. 14 In particular, the future prospects of many of our high growth products, such as the NanoKnife system, the AngioVac system, the AlphaVac system and the Auryon system, rely on continued market development and continued generation of clinical data pursuant to clinical trials conducted by us, our competitors or other third parties.
Additionally, there can be no assurance that the size of the markets in which we compete will increase above existing levels or not decline, that we will be able to maintain, gain or regain market share or that we can compete effectively on the basis of price or that the number of procedures in which our products are used will increase above existing levels or not decline.
If our distributors fail to comply with applicable laws or fail to effectively market and sell our products, our financial condition and results of operations could be materially and adversely impacted. Failure to secure adequate reimbursement for our products could materially impair our ability to grow revenue and drive profitability.
If our distributors fail to comply with applicable laws or fail to effectively market and sell our products, our financial condition and results of operations could be materially and adversely impacted. We face currency and other risks associated with international sales.
We expect all of our contracted manufacturing facilities, to comply with all applicable laws, including labor, safety and environmental laws, and to otherwise meet our standards of conduct. Our ability to find manufacturing facilities that uphold these standards is a challenge, especially with respect to facilities located outside the United States.
Our ability to find manufacturing facilities that uphold these standards is a challenge, especially with respect to facilities located outside the United States.
When testing for impairment of definite-lived intangible assets held for use, the Company groups assets at the lowest level for which cash flows are separately identifiable. The Company operates as a single asset group.
When testing for impairment of definite-lived intangible assets held for use, the Company groups assets at the lowest level for which cash flows are separately identifiable. The Company operates as two reporting units and two asset groups. If a triggering event is deemed to exist, the Company performs an undiscounted operating cash flow analysis to determine if an impairment exists.
See Note 10, "Income Taxes" set forth in our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended May 31, 2024 for a further discussion of our tax loss carryovers. 22 A cyber-attack or other breach of our, our distributors, or our supply chain partners' information technology systems could have a material adverse effect on our business, financial condition and/or results of operations.
See Note 9, "Income Taxes" set forth in our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended May 31, 2025 for a further discussion of our tax loss carryovers.
Our failure to generate sufficient operating cash flow to pay our potential debts or to successfully undertake any of these actions could have a material adverse effect on us. On June 8, 2023, the Company completed the sale of the dialysis and BioSentry businesses to Merit Medical Systems, Inc.
Our failure to generate sufficient operating cash flow to pay our potential debts or to successfully undertake any of these actions could have a material adverse effect on us. Inflationary pressure and unfavorable economic conditions could negatively affect our operations and business.
If actual results differ from the assumptions and estimates used in the intangible asset calculations, we could incur future impairment or amortization charges, which could negatively impact our financial condition and results of operations. During the third quarter of fiscal year 2024, the Company made the decision to abandon the Syntrax product line.
If actual results differ from the assumptions and estimates used in the intangible asset calculations, we could incur future impairment or amortization charges, which could negatively impact our financial condition and results of operations. We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability.
Further restrictions may be enacted, amended, enforced or interpreted in a manner that materially impacts our operations. In fiscal year 2024 we generated $1.4 million of revenue for sales to distributors doing business in Iran. We continuously review our ability to sell products to distributors that conduct business in Iran in accordance with all applicable U.S. laws.
In fiscal year 2025 we generated $0.6 million of revenue for sales to distributors doing business in Iran. We continuously review our ability to sell products to distributors that conduct business in Iran in accordance with all applicable U.S. laws. We have limited business dealings in certain other countries that are or may become subject to comprehensive sanctions.
In general, we intend to obtain Medical Device Regulation ("MDR") approvals for our principal products sold in the European Union ("EU") ahead of expiration dates; however for multiple reasons, including but not limited to changing business strategies, labor shortages and contract resources, administrative delays, increased costs of obtaining MDR certification, availability of necessary data and notified body capacity, certain products may not be fully compliant at the time of CE mark expiration.
For multiple reasons, including but not limited to changing business strategies, labor shortages and contract resources, administrative delays, increased costs of obtaining MDR certification and availability of necessary data, certain products will not continue to be CE marked under MDR.
This Plan is intended to transfer all product manufacturing processes to third-party 16 manufacturers located in various parts of the world, including, but not limited to the United States, Costa Rica, Latvia, Italy, Israel and China. The restructuring activities associated with the Plan are expected to be completed in the third quarter of fiscal year 2026.
We currently rely on third-party manufacturers for a portion of our products. We also announced a plan to transfer certain product manufacturing processes from Queensbury, NY to third-party manufacturers located in various parts of the world, including, but not limited to the United States, Costa Rica, Latvia, Italy, Israel and China.
Termination of our clinical trials or significant delays in completing our clinical trials could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. If we are unable to convince customers that our products can improve the cost structure of their business, our revenue growth and profitability may be materially and adversely impacted.
Termination of our clinical trials or significant delays in completing our clinical trials could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions.
The Company and Merit entered into various agreements to facilitate the transition to Merit, including a Transactions Services Agreement and Contract Manufacturing Agreement. These divestitures along with potential future divestitures of certain product lines will allow us to transform ourselves into a high growth, highly profitable, medical technology company.
The Company's recent divestitures of its PICCs and Midline businesses to Spectrum Vascular and dialysis product portfolio and BioSentry tract sealant system biopsy business to Merit Medical Systems, Inc., along with potential future divestitures of certain product lines will allow us to transform ourselves into a high growth, highly profitable, medical technology company.
In addition, individuals or groups seeking to represent a class may file suit against us. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages.
Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages. The magnitude of the potential losses relating to these lawsuits may remain unknown for substantial periods of time.
We may choose to, or may be required to, suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.” As part of our business strategy, we expect to continue to engage in business development activities which includes selectively evaluating and pursuing the acquisition of complementary businesses, technologies and products.
As part of our business strategy, we expect to continue to engage in business development activities which includes selectively evaluating and pursuing the acquisition of complementary businesses, technologies and products. These activities may result in substantial investment of our time and financial resources and competition for targets may be significant.
In addition, our business practices in international markets are subject to the requirements of the U.S. Foreign Corrupt Practices Act of 1977, as amended, any violation of which could subject us to significant fines, criminal sanctions and other penalties.
Foreign Corrupt Practices Act of 1977, as amended, any violation of which could subject us to significant fines, criminal sanctions and other penalties. We expect all of our contracted manufacturing facilities, to comply with all applicable laws, including labor, safety and environmental laws, and to otherwise meet our standards of conduct.
Although these transitions are thoroughly planned, it is not unlikely in a transaction of this complexity that disruptions could occur. If disruptions to our financial controls, IT, administrative support, manufacturing or regulatory processes occur, and if such disruptions prove to be more severe than our planning anticipated, this could have a material adverse effect on our business.
The sale of product lines could require us to restructure significant personnel, systems and infrastructure which may cause disruptions to our financial controls, IT, administrative support, manufacturing or regulatory processes and could have a material adverse effect on our business.
Removed
(MedComp); TeleFlex Medical; Becton Dickinson; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and Johnson; Philips Healthcare; Inari Medical; Varian Medical Systems and Total Vein Systems.
Added
In particular, the future prospects of many of our high growth products, such as the NanoKnife system, the AngioVac system, the AlphaVac system and the Auryon system, rely on continued market development and continued generation of clinical data pursuant to clinical trials conducted by us, our competitors or other third parties.
Removed
See Risk Factor titled “Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including, but not limited to, our NanoKnife DIRECT clinical study, our NanoKnife PRESERVE clinical study and clinical studies for AngioVac.
Added
Recent changes in trade policy, treaties, government regulations and tariffs have created significant uncertainty about the future relationship between the U.S. and various other countries where we have employees, customers, suppliers and operations. Changes in policy regarding international trade, including import and export regulation and international trade agreements, could negatively impact our business.
Removed
Simultaneously, hospitals are redefining their role in health care delivery as many assume much more risk and control of the total cost of patient care. To successfully make this transformation, health systems are consolidating, purchasing or partnering with physicians and post-acute care providers, while also narrowing networks thus allowing greater control over outcomes.
Added
The implementation of new tariffs on imports from Canada, Mexico, China or other countries for an extended period and without specific exemptions for our products, and any reciprocal tariffs or other reactions by other countries thereto, could have a material adverse impact on our financial condition, results of operations and cash flows.
Removed
We currently rely on third-party manufacturers for a portion of our products and due to the resource and cost limitations of manufacturing in upstate New York, on January 5, 2024, we announced a restructuring of our manufacturing footprint and a shift to an outsourced model (the “Plan”).
Added
We generate revenue from international sales which could expose us to risks including fluctuations in currency values, trade restrictions, tariff and trade regulations, U.S. export controls, U.S. and non‑U.S. tax laws, shipping delays and economic and political instability, which could have a material adverse effect on our business, results of operations, financial conditions and cash flows.
Removed
On February 15, 2024, the Company entered into an asset purchase agreement (the "Asset Purchase Agreement") with Spectrum Vascular pursuant to which Spectrum acquired the Company's PICC and Midline businesses for $34.5 million in cash and resulted in a pre-tax book income of $6.7 million.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed9 unchanged
Biggest changeOur SVP of IT reports to the Chief Executive Officer (CEO), who works closely with the Executive Committee to guide strategic direction and IT decisions to drive business outcomes.
Biggest changeOur SVP of IT reports to the Chief Executive Officer (CEO), who works closely with the Executive Committee to guide strategic direction and IT decisions to drive business outcomes. Our SVP of IT also leads the Security & Risk Governance committee which provides general oversight and assists in the Cybersecurity program when appropriate.

Item 2. Properties

Properties — owned and leased real estate

3 edited+0 added−0 removed0 unchanged
Biggest changeProperty Type Latham, NY Corporate headquarters 39,000 Leased Glens Falls, NY Manufacturing 21,000 Owned Queensbury, NY Manufacturing 135,000 Owned Queensbury, NY Distribution 58,000 Leased Marlborough, MA Research and development 8,400 Leased Amsterdam, NL Selling, marketing and administrative 8,100 Leased Rehovot, IL Research and development 4,300 Leased In addition, we lease sales offices in various other jurisdictions. Item 3. Legal Proceedings.
Biggest changeProperty Type Latham, NY Corporate headquarters 39,000 Leased Glens Falls, NY Manufacturing 21,000 Leased Queensbury, NY Manufacturing 135,000 Leased Queensbury, NY Distribution 58,000 Leased Marlborough, MA Research and development 8,400 Leased Rehovot, IL Research and development 4,300 Leased In addition, we lease sales offices in various other jurisdictions. Item 3. Legal Proceedings.
Information regarding legal proceedings is included in Note 17 to our consolidated financial statements in this Annual Report on Form 10-K. Item 4. Mine Safety Disclosures. Not applicable. 30 Part II
Information regarding legal proceedings is included in Note 17 to our consolidated financial statements in this Annual Report on Form 10-K. Item 4. Mine Safety Disclosures. Not applicable. 31 Part II
Item 2. Properties. During the year ended May 31, 2024, we operated in the following locations: 29 Location Purpose Approx. Sq. Ft.
Item 2. Properties. During the year ended May 31, 2025, we operated in the following locations: 30 Location Purpose Approx. Sq. Ft.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed4 unchanged
Biggest changeSale Price High Low Year ended May 31, 2024 Fourth Quarter $ 7.03 $ 5.27 Third Quarter $ 8.04 $ 5.49 Second Quarter $ 7.73 $ 6.17 First Quarter $ 11.16 $ 8.00 Sale Price High Low Year ended May 31, 2023 Fourth Quarter $ 12.65 $ 8.29 Third Quarter $ 15.48 $ 12.06 Second Quarter $ 22.81 $ 12.51 First Quarter $ 24.30 $ 17.83 As of July 24, 2024, there were 166 holders of record of our common stock.
Biggest changeSale Price High Low Year ended May 31, 2025 Fourth Quarter $ 10.86 $ 8.37 Third Quarter $ 12.94 $ 7.00 Second Quarter $ 7.78 $ 5.88 First Quarter $ 7.84 $ 5.51 Sale Price High Low Year ended May 31, 2024 Fourth Quarter $ 7.03 $ 5.27 Third Quarter $ 8.04 $ 5.49 Second Quarter $ 7.73 $ 6.17 First Quarter $ 11.16 $ 8.00 As of July 15, 2025, there were 163 holders of record of our common stock.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from May 31, 2019 to May 31, 2024. The stock price performance included in this graph is not necessarily indicative of future stock price performance. 31 Item 6. [Reserved] 32
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from May 31, 2020 to May 31, 2025. The stock price performance included in this graph is not necessarily indicative of future stock price performance. 32 Item 6. [Reserved] 33

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

58 edited+18 added−41 removed29 unchanged
Biggest changeCash (used in) provided by financing activities: Years ended May 31, 2024 and 2023: • $50.0 million prepayment of the Credit Agreement in connection with the completion of the dialysis and BioSentry divestiture in fiscal year 2024; • $70.0 million in proceeds on long-term debt less the repayment of $45.0 million associated with the new Credit Agreement in the first quarter of fiscal year 2023; • $0.8 million of deferred financing costs associated with the then new Credit Agreement in the first quarter of fiscal year 2023; • $15.0 million of contingent consideration payments made in fiscal year 2024; and • $0.8 million and $1.2 million, respectively, of proceeds from stock option and ESPP activity. 42 On June 8, 2023 and in connection with the completion of the sale of the dialysis and BioSentry divestiture, the Company repaid all amounts outstanding under its existing Credit Agreement, and as a result, the Credit Agreement was extinguished.
Biggest changeCash provided by (used in) financing activities: Years ended May 31, 2025 and 2024: • $6.3 million of proceeds from financing arrangements offset with $0.1 million of principal payments on the financing arrangements in fiscal year 2025; • $1.7 million of cash was used for the repurchase of common shares in fiscal year 2025; • $5.0 million and $15.0 million, respectively, of contingent consideration payments; • $50.0 million repayment of the Credit Agreement in connection with the completion of the dialysis and BioSentry divestiture in fiscal year 2024; and 42 • $0.9 million and $0.8 million, respectively, of proceeds from stock option and ESPP activity.
Product revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer, net of any variable consideration described below. If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Product revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer, net of any variable consideration as described below. If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Revenue is recognized when control of the product is transferred to the customer (i.e., when the Company’s performance obligation is satisfied), which occurs at a point in time, and may be upon shipment from the Company’s manufacturing site or delivery to the customer’s named location, based on the contractual shipping terms of a contract.
Revenue is recognized when control of the product is transferred to the customer (i.e., when the Company’s performance obligation is satisfied), which occurs at a point in time, and may be upon shipment from the Company’s manufacturing site or delivery to the customer’s named location, based on the shipping terms of a contract.
We recognize the importance of, and intend to continue to make investments in research and development activities and selective business development opportunities to provide growth opportunities. We sell our products in the United States primarily through a direct sales force, and outside the U.S. through a combination of direct sales and distributor relationships.
We recognize the importance of, and intend to continue to make investments in research and development activities and selective business development opportunities to provide growth opportunities. We sell our products in the United States primarily through a direct sales force, and outside the U.S. mainly through distributor relationships.
Goodwill impairment - Represents the impairment charge taken on goodwill. • The Company recorded a non-cash goodwill impairment charge of $159.5 million for the year ended May 31, 2024 as the fair value of the Med Tech reporting unit was less than its carrying value compared to a $14.5 million goodwill impairment charge for the year ended May 31, 2023 as the fair value of the Med Device reporting unit was less than its carrying value. 40 Change in fair value of contingent consideration - Represents changes in contingent consideration driven by changes to estimated future payments on earn-out liabilities created through acquisitions and amortization of present value discounts on long-term contingent consideration. • The change in the fair value for the year ended May 31, 2024 is related to the Eximo contingent consideration and the increased probability of achieving the revenue milestones.
Goodwill impairment - Represents the impairment charge taken on goodwill. • The Company recorded a non-cash goodwill impairment charge of $159.5 million for the year ended May 31, 2024 as the fair value of the Med Tech reporting unit was less than its carrying value. 40 Change in fair value of contingent consideration - Represents changes in contingent consideration driven by changes to estimated future payments on earn-out liabilities created through acquisitions and amortization of present value discounts on long-term contingent consideration. • The change in the fair value for the year ended May 31, 2025 is related to the Eximo contingent consideration and the increased probability of achieving the revenue milestones.
In some cases, if control of the product has not yet transferred to the customer or the timing of the payments made by the customer precedes the Company’s fulfillment of the performance obligation, the Company recognizes a contract liability that is included in deferred revenue in the accompanying Consolidated Balance Sheets.
In some cases, if control of the product has not yet transferred to the customer or the timing of the payments made by the customer precedes the Company’s fulfillment of the performance obligation, the Company recognizes a contract liability that is included as deferred revenue in "Accrued liabilities" in the accompanying Consolidated Balance Sheets.
As a result of the full impairment of Goodwill and the reversal of the naked credit deferred tax liability sourced income, the Company has recorded a full valuation allowance on its U.S. net deferred tax assets as of May 31, 2024. The Company will continue to assess the level of the valuation allowance required.
As a result of the full impairment of Goodwill and the reversal of the naked credit deferred tax liability sourced income, the Company has recorded a full valuation allowance on its U.S. net deferred tax assets as of May 31, 2025. The Company will continue to assess the level 41 of the valuation allowance required.
The change from the prior year was primarily driven by: • Legal expense, related to litigation that is outside of the normal course of business, which increased $25.0 million and was driven by the $19.3 million settlement between the Company and BD; • Plant closure expense, related to the restructuring of our manufacturing footprint which was announced on January 5, 2024, which increased $9.5 million; • An impairment of $3.4 million on the Syntrax product technology intangible and fixed assets and an inventory write-off of $2.9 million was taken in the third quarter of fiscal year 2024 related to the abandonment of the Syntrax and RF product lines; • Transaction services agreements that were entered into as a result of the sale of the PICCs, Midline, dialysis and BioSentry businesses.
The change from the prior year was primarily driven by: • Legal expense, related to litigation that is outside of the normal course of business, which decreased $34.2 million and was driven by the $19.3 million settlement between the Company and BD in the prior year; • Mergers and acquisitions expense, which increased $0.3 million; • Plant closure expense, related to the restructuring of our manufacturing footprint which was announced on January 5, 2024, which increased $4.3 million; • An impairment of $3.4 million on the Syntrax product technology intangible and fixed assets and an inventory write-off of $2.9 million was taken in the third quarter of fiscal year 2024 related to the abandonment of the Syntrax and RF product lines; • Transaction services agreements that were entered into as a result of the divestiture of the PICCs, Midline, dialysis and BioSentry businesses.
In these arrangements, revenue recognized for the sale of the disposables is not allocated 35 between the disposal revenue and lease revenue due to the insignificant value of the units in relation to the total agreement value. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
In these arrangements, revenue recognized for the sale of the disposables is not allocated between the disposable revenue and lease revenue due to the insignificant value of the units in relation to the total agreement value. 36 Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
Acquisition, restructuring and other items, net - Acquisition, restructuring and other items, net represents costs associated with mergers and acquisitions, restructuring expenses, legal costs that are related to litigation that is not in the ordinary course of business, legal settlements and other one-time items. Acquisition, restructuring and other items, net increased by $37.5 million compared to the prior year.
Acquisition, restructuring and other items, net - Acquisition, restructuring and other items, net represents costs associated with mergers and acquisitions, restructuring expenses, legal costs that are related to litigation that is not in the ordinary course of business, legal settlements and other one-time items. Acquisition, restructuring and other items, net decreased by $37.6 million compared to the prior year.
General and administrative expense - General and administrative (“G&A”) expense includes executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities. G&A expense increased by $1.2 million compared to the prior year.
General and administrative expense - General and administrative (“G&A”) expense includes executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities. G&A expense increased by $0.9 million compared to the prior year.
Actual results may differ from those estimates. Revenue Recognition Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
Actual results may differ from those estimates. Revenue Recognition Under ASC 606, Revenue from Contracts with Customers , revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services.
Cash provided by (used in) investing activities: Years ended May 31, 2024 and 2023: • $2.5 million and $3.8 million, respectively, of cash was used for fixed asset additions; • $5.0 million and $5.4 million, respectively, of cash was used for Auryon placement and evaluation unit additions; • $134.5 million of cash was received for the divestiture of the PICCs, Midline, dialysis and BioSentry businesses; and • $3.3 million and $0.5 million, respectively, of cash was used for the acquisition of exclusive licenses.
Cash (used in) provided by investing activities: Years ended May 31, 2025 and 2024: • $4.5 million and $2.5 million, respectively, of cash was used for fixed asset additions; • $5.7 million and $5.0 million, respectively, of cash was used for Auryon placement and evaluation unit additions; • $134.5 million of cash was received for the divestiture of the PICCs, Midline, dialysis and BioSentry businesses in fiscal year 2024; and • $3.3 million of cash was used for the acquisition of exclusive licenses in fiscal year 2024.
The change in sales from the prior year was primarily driven by: • Decreased sales of PICCs and Midline products of $13.8 million which was due to the divestiture of these businesses on February 15, 2024; • Decreased sales of dialysis and BioSentry products of $31.8 million which was due to the divestiture of these businesses on June 8, 2023; • Decreased sales of RadioFrequency Ablation of $2.8 million due to the discontinuation of this product line as of February 29, 2024; and • Increased sales of Ports, Core and Venous of $2.5 million, $2.0 million and $0.9 million, respectively.
The change in sales from the prior year was primarily driven by: • Decreased sales of PICCs and Midline products of $30.1 million which was due to the divestiture of these businesses on February 15, 2024; • Decreased sales of dialysis and BioSentry products of $0.7 million which was due to the divestiture of these businesses on June 8, 2023; • Decreased sales of RadioFrequency Ablation of $2.2 million due to the discontinuation of this product line as of February 29, 2024; and • Increased sales of Core and Venous of $1.9 million and $0.9 million, respectively.
Results of Operations for the years ended May 31, 2023 and 2022 For management discussion and analysis of our 2023 financial results and liquidity compared with 2022, see Part II, Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended May 31, 2023 filed on August 3, 2023.
Results of Operations for the years ended May 31, 2024 and 2023 For management discussion and analysis of our 2024 financial results and liquidity compared with 2023, see Part II, Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended May 31, 2024 filed on July 25, 2024.
Income Tax Benefit Year ended May 31, (in thousands) 2024 2023 Income tax benefit $ (7,289) $ (1,995) Effective tax rate 3.8 % 3.7 % Our effective tax rate was a benefit of 3.8% for fiscal year 2024 compared with an effective tax rate benefit of 3.7% for the prior year.
Income Tax Benefit Year ended May 31, (in thousands) 2025 2024 Income tax benefit $ (39) $ (7,289) Effective tax rate 0.1 % 3.8 % Our effective tax rate was a benefit of 0.1% for fiscal year 2025 compared with an effective tax rate benefit of 3.8% for the prior year.
The Med Device business net sales decreased $44.6 million for the year ended May 31, 2024 compared to the prior year. The backlog, which primarily impacted sales of Core and Vascular Access products, was $1.3 million at May 31, 2024 compared to $2.7 million at May 31, 2023.
The Med Device business net sales decreased $31.7 million for the year ended May 31, 2025 compared to the prior year. The backlog, which primarily impacted sales of Core and Vascular Access products, was $0.3 million at May 31, 2025 compared to $1.3 million at May 31, 2024.
Sales and marketing expense - Sales and marketing (“S&M”) expense consists primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities. S&M expense decreased by $1.4 million compared to the prior year.
Sales and marketing expense - Sales and marketing (“S&M”) expense consists primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities. S&M expense increased by $0.3 million compared to the prior year.
R&D expense increased $1.6 million compared to the prior year. The change from the prior year was primarily driven by: • The timing of certain projects and clinical spend associated with the ongoing clinical trials, which decreased R&D expense by $0.4 million; and • Compensation and benefits expenses, which increased $2.0 million.
R&D expense decreased $5.3 million compared to the prior year. The change from the prior year was primarily driven by: • The timing of certain projects, clinical spend and other costs associated with the ongoing clinical trials, which decreased R&D expense by $5.1 million; and • Compensation and benefits expenses, which decreased $0.2 million.
The Company establishes reserves for such amounts, which is included in accrued expenses in the accompanying Consolidated Balance Sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes. The Company is also required to pay administrative fees to group purchasing organizations. The Company generally offers customers a limited right of return.
The Company establishes reserves for such amounts, which is included in "Accrued liabilities" in the accompanying Consolidated Balance Sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes. The Company is also required to pay administrative fees to group purchasing organizations.
To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
To determine revenue recognition for arrangements, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established for discounts, returns, rebates and allowances that are offered within contracts between the Company and its customers.
Reserves: Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established for discounts, product returns, rebates and allowances that are offered within contracts between the Company and its customers. The Company generally offers customers a limited right of return.
Payment terms on invoiced amounts are based on contractual terms with each customer and generally coincide with revenue recognition. Accordingly, the Company does not have any contract assets associated with the future right to invoice its customers.
A receivable is generally recognized in the period the Company ships the product. Payment terms on invoiced amounts are based on contractual terms with each customer and generally coincide with revenue recognition. Accordingly, the Company does not have any contract assets associated with the future right to invoice its customers.
At May 31, 2024, the Company had a backlog of $1.3 million compared to $2.7 million at the end of May 31, 2023. The Med Tech business net sales increased $9.7 million for the year ended May 31, 2024 compared to the prior year.
At May 31, 2025, the Company had a backlog of $0.3 million compared to $1.3 million at the end of May 31, 2024. The Med Tech business net sales increased $20.3 million for the year ended May 31, 2025 compared to the prior year.
Our Med Device business decreased 18.4% in fiscal year 2024 driven mainly by the sale of the PICCs, Midlines, dialysis and BioSentry businesses along with the discontinuation of the RadioFrequency Ablation product lines.
Our Med Device business decreased 16.0% in fiscal year 2025 driven mainly by the divestiture of the PICCs, Midlines, dialysis and BioSentry businesses along with the discontinuation of the RadioFrequency Ablation product lines.
The Med Device segment gross profit decreased by $24.8 million compared to the prior year.
The Med Device segment gross margin decreased by $8.3 million compared to the prior year.
The table below summarizes our cash flows for the years ended May 31, 2024 and 2023: Year ended May 31, (in thousands) 2024 2023 Cash provided by (used in): Operating activities $ (28,158) $ 78 Investing activities 123,717 (9,746) Financing activities (64,248) 25,420 Effect of exchange rate changes on cash and cash equivalents 125 43 Net change in cash and cash equivalents $ 31,436 $ 15,795 During the years ended May 31, 2024 and 2023, cash flows consisted of the following: Cash (used in) provided by operating activities: Years ended May 31, 2024 and 2023: • Net loss of $184.3 million and $52.4 million, respectively, plus the non-cash items, primarily driven by depreciation and amortization, gain on the divestiture and related expenses, goodwill impairment and stock-based compensation, along with the changes in working capital below, contributed to cash used in operations of $28.2 million for the year ended May 31, 2024 and cash provided by operations of $0.1 million for the year ended May 31, 2023; • For the year ended May 31, 2024, working capital was unfavorably impacted by increased prepaid expenses and inventory on hand of $11.6 million and $9.4 million, respectively.
The table below summarizes our cash flows for the years ended May 31, 2025 and 2024: Year ended May 31, (in thousands) 2025 2024 Cash (used in) provided by: Operating activities $ (10,128) $ (28,158) Investing activities (10,178) 123,717 Financing activities (255) (64,248) Effect of exchange rate changes on cash and cash equivalents 398 125 Net change in cash and cash equivalents $ (20,163) $ 31,436 During the years ended May 31, 2025 and 2024, cash flows consisted of the following: Cash used in operating activities: Years ended May 31, 2025 and 2024: • Net loss of $34.0 million and $184.3 million, respectively, plus the non-cash items, primarily driven by depreciation and amortization, gain on the divestiture and related expenses, goodwill impairment and stock-based compensation, along with the changes in working capital below, contributed to cash used in operations of $10.1 million and $28.2 million for the years ended May 31, 2025 and 2024, respectively; • For the year ended May 31, 2025, working capital was unfavorably impacted by decreased accounts payable and accrued liabilities and inventory on hand of $15.9 million and $1.3 million, respectively.
Our end users include interventional radiologists, interventional cardiologists, vascular surgeons, urologists, interventional and surgical oncologists and critical care nurses. We expect our businesses to grow in both sales and profitability by expanding geographically, penetrating new markets, introducing new products and increasing our presence internationally.
Our end users include interventional radiologists, interventional cardiologists, vascular surgeons, urologists, interventional and surgical oncologists and critical care nurses. We expect our businesses to grow in both sales and profitability by expanding geographically, penetrating new markets, introducing new products and increasing our presence internationally. The current macroeconomic environment continues to impact our business and may continue to pose future risks.
Results of Operations for the years ended May 31, 2024 and 2023 For the fiscal year ended May 31, 2024, the Company reported a net loss of $184.3 million, or a loss of $4.59 per diluted share, on net sales of $303.9 million compared to a net loss of $52.4 million, or a loss of $1.33 per diluted share, on net sales of $338.8 million in fiscal year 2023.
Results of Operations for the years ended May 31, 2025 and 2024 For the fiscal year ended May 31, 2025, the Company reported a net loss of $34.0 million, or a loss of $0.83 per diluted share, on net sales of $292.5 million compared to a net loss of $184.3 million, or a loss of $4.59 per diluted share, on net sales of $303.9 million in fiscal year 2024.
The change from the prior year was primarily driven by: • The sale of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross profit by $23.9 million; • Sales volume and price mix, which positively impacted gross profit by $3.3 million; • Production volume and other incentives which positively impacted gross profit by $0.6 million; • Sales mix, which negatively impacted gross profit by $3.6 million; • Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $1.0 million; and • Incremental depreciation on placement units of $0.2 million. 39 Operating Expenses and Other Income (expense) Year ended May 31, (in thousands) 2024 2023 $ Change Research and development $ 31,512 $ 29,883 $ 1,629 % of sales 10.4 % 8.8 % Selling and marketing $ 102,818 $ 104,249 $ (1,431) % of sales 33.8 % 30.8 % General and administrative $ 41,164 $ 40,003 $ 1,161 % of sales 13.5 % 11.8 % Research and development expense - Research and development (“R&D”) expense includes internal and external costs to develop new products, enhance existing products, validate new and enhanced products, manage clinical, regulatory and medical affairs.
The change from the prior year was primarily driven by: • The divestiture of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross margin by $9.0 million; • Price and product mix, which positively impacted gross margin by $3.6 million; • Other incentives and a prior year supplier recall, which positively impacted gross profit by $2.7 million; • Sales volume and production volume which negatively impacted gross margin by $1.4 million; • Tariffs, along with inflationary costs on raw materials, labor shortages and freight and other costs, which negatively impacted gross margin by $0.5 million and $3.7 million, respectively; and • Incremental depreciation on placement units of $0.1 million. 39 Operating Expenses and Other Income (expense) Year ended May 31, (in thousands) 2025 2024 $ Change Research and development $ 26,222 $ 31,512 $ (5,290) % of sales 9.0 % 10.4 % Selling and marketing $ 103,135 $ 102,818 $ 317 % of sales 35.3 % 33.8 % General and administrative $ 42,092 $ 41,164 $ 928 % of sales 14.4 % 13.5 % Research and development expense - Research and development (“R&D”) expense includes internal and external costs to develop new products, enhance existing products, validate new and enhanced products, manage clinical, regulatory and medical affairs.
The change from the prior year was primarily driven by: • Sales volume and price mix, which positively impacted gross profit by $5.5 million; • Production volume and other incentives which positively impacted gross profit by $1.6 million; • Sales mix, which negatively impacted gross profit by $0.9 million; • Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $0.2 million; and • Incremental depreciation on placement units of $0.8 million.
The change from the prior year was primarily driven by: • Sales volume, price and product mix, which positively impacted gross margin by $17.2 million; • Production volume and other incentives which negatively impacted gross margin by $1.5 million; • Tariffs, along with inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross margin by $1.1 million and $0.4 million, respectively; • The abandonment of the Syntrax product line, which negatively impacted gross margin by $0.2 million; and • Incremental depreciation on placement units of $2.7 million.
Those initiatives included: • Product development process. The Company continued its disciplined product development process which is intended to improve the Company’s ability to bring new products to market.
Those initiatives included: • Innovative R&D and Clinical and Regulatory Pathway Expansion. The Company continued its disciplined product development process which is intended to improve the Company’s ability to bring new products to market and achieve clinical and regulatory pathway expansion.
The change from the prior year was primarily driven by: • The sale of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross profit by $23.9 million; • Sales volume and price mix, which positively impacted gross profit by $8.4 million; • Production volume and other incentives which positively impacted gross profit by $2.2 million; • Sales mix, inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $5.0 million; and • Incremental depreciation on placement units of $1.2 million.
The change from the prior year was primarily driven by: • The divestiture of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross margin by $9.2 million; • Sales volume, price and product mix, which positively impacted gross margin by $19.9 million; • Other incentives and a prior year supplier recall, which positively impacted gross profit by $1.7 million; • Production volume and other costs which negatively impacted gross margin by $1.5 million; • Tariffs, along with inflationary costs on raw materials, labor shortages, freight and other costs, which negatively impacted gross margin by $1.6 million and $3.6 million, respectively; and • Incremental depreciation on placement units of $2.6 million.
The change from the prior year was primarily driven by: • Compensation and benefits expense, which increased by $1.1 million; and • Travel, meeting, tradeshow and other selling expenses, which decreased $2.5 million.
The change from the prior year was primarily driven by: • Trade shows, subscriptions and other marketing expenses, which increased $1.5 million; • Consulting and other selling expenses, which increased $0.7 million; and • Compensation and benefits expense, which decreased by $2.0 million.
A summary of these key financial metrics for the year ended May 31, 2024 compared to the year ended May 31, 2023 follows: Year ended May 31, 2024: • Revenue decreased by 10.3% to $303.9 million • Med Tech growth of 10.0% and Med Device decrease of 18.4% • Gross profit decreased by 50 bps to 50.9% • Net loss increased by $131.9 million to $184.3 million • Loss per share increased by $3.26 to a loss of $4.59 • Cash flow from operations decreased by $28.2 million resulting in cash used in operations of $28.2 million For the year ended May 31, 2024, the decrease in revenue is partially due to the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation and Syntrax product lines, the total of which impacted sales by $48.4 million compared to the year ended May 31, 2023.
A summary of these key financial metrics for the year ended May 31, 2025 compared to the year ended May 31, 2024 follows: Year ended May 31, 2025: • Revenue decreased by 3.8% to $292.5 million • Med Tech growth of 19.0% and Med Device declined by 16.0% • Gross margin increased by 300 bps to 53.9% • Net loss decreased by $150.4 million to $34.0 million • Loss per share decreased by $3.76 to a loss of $0.83 • Cash flow from operations increased by $18.0 million resulting in cash used in operations of $10.1 million For the year ended May 31, 2025, the decrease in revenue is due to the divestiture of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation and Syntrax product lines, the total of which impacted sales by $33.4 million compared to the year ended May 31, 2024.
Year ended May 31, (in thousands) 2024 2023 $ Change Amortization of intangibles $ 13,048 $ 18,790 $ (5,742) Goodwill impairment $ 159,476 $ 14,549 $ 144,927 Change in fair value of contingent consideration $ 432 $ 2,320 $ (1,888) Acquisition, restructuring and other items, net $ 53,182 $ 15,633 $ 37,549 Other income (expense) $ 797 $ (3,256) $ 4,053 Amortization of intangibles - Represents the amount of amortization expense that was taken on intangible assets held by the Company. • Amortization expense decreased $5.7 million compared to the prior year.
Year ended May 31, (in thousands) 2025 2024 $ Change Amortization of intangibles $ 10,318 $ 13,048 $ (2,730) Goodwill impairment $ — $ 159,476 $ (159,476) Change in fair value of contingent consideration $ 272 $ 432 $ (160) Acquisition, restructuring and other items, net $ 15,620 $ 53,182 $ (37,562) Other income $ 5,922 $ 797 $ 5,125 Amortization of intangibles - Represents the amount of amortization expense that was taken on intangible assets held by the Company. • Amortization expense decreased $2.7 million compared to the prior year.
This increase was partially offset by decreased sales of Oncology and Microwave products of $1.2 million and $0.4 million, respectively. 38 Gross Profit Year ended May 31, (in thousands) 2024 2023 $ Change Med Tech $ 67,198 $ 61,966 $ 5,232 Gross profit % of sales 63.2 % 64.1 % Med Device $ 87,500 $ 112,280 $ (24,780) Gross profit % of sales 44.3 % 46.4 % Total $ 154,698 $ 174,246 $ (19,548) Gross profit % of sales 50.9 % 51.4 % Gross profit - Gross profit consists of net sales less the cost of goods sold, which includes the costs of materials, products purchased from third parties and sold by us, manufacturing personnel, royalties, freight, business insurance, depreciation of property and equipment and other manufacturing overhead, exclusive of intangible amortization.
This increase was partially offset by decreased sales of Ports, Microwave and other Oncology products of $0.3 million, $0.8 million and $0.5 million, respectively. 38 Gross Margin Year ended May 31, (in thousands) 2025 2024 $ Change Med Tech $ 78,515 $ 67,198 $ 11,317 Gross margin % of sales 62.0 % 63.2 % Med Device $ 79,190 $ 87,500 $ (8,310) Gross margin % of sales 47.7 % 44.3 % Total $ 157,705 $ 154,698 $ 3,007 Gross margin % of sales 53.9 % 50.9 % Gross margin - Gross margin consists of net sales less the cost of goods sold, which includes the costs of materials, products purchased from third parties and sold by us, manufacturing personnel, royalties, freight, business insurance, depreciation of property and equipment and other manufacturing overhead, exclusive of intangible amortization.
The Med Tech segment gross profit increased by $5.2 million compared to the prior year.
The Med Tech segment gross margin increased by $11.3 million compared to the prior year.
As such, we believe the growth in the near to mid-term will continue to be driven by our high technology products including Auryon, Mechanical Thrombectomy (which includes AngioVac and AlphaVac) and NanoKnife. Throughout the year, we introduced strategic moves designed to streamline our business, improve our overall business operations and position ourselves for growth.
Our investments in our high technology products including Auryon, Mechanical Thrombectomy (which includes AngioVac and AlphaVac) and NanoKnife, will provide us access to larger and faster growing markets. Throughout the year, we introduced strategic moves designed to streamline our business, improve our overall business operations and position ourselves for growth.
The change from the prior year was primarily driven by: • Compensation and benefits expense, which increased $0.9 million; and • Other outside consultant spend for legal and IT which increased $0.4 million.
The change from the prior year was primarily driven by: • Compensation and benefits expense, which increased $2.1 million; • Other outside consultant spend, which increased $0.8 million; and • Depreciation and other corporate expenses, which decreased $2.0 million.
Our Med Tech business, comprised of Auryon, the thrombus management platform and NanoKnife grew 10.0% in fiscal year 2024. The growth in Auryon and NanoKnife was partially offset by continued softness in the thrombus management platform.
Our Med Tech business, comprised of Auryon, the thrombus management platform and NanoKnife grew 19.0% in fiscal year 2025 was driven by growth in growth in Auryon and the thrombus management platform, while Nanoknife sales remained consistent year over year.
This was partially offset by decreased accounts receivable and increased accounts payable and accrued liabilities of $7.9 million and $27.5 million, respectively; and • For the year ended May 31, 2023, working capital was unfavorably impacted by increased accounts receivable, inventory on hand and prepaids of $1.3 million and $8.2 million, respectively.
This was partially offset by decreased prepaid expenses of $3.1 million; and • For the year ended May 31, 2024, working capital was unfavorably impacted by increased prepaid expenses and inventory on hand of $11.6 million and $9.4 million, respectively.
This was partially offset by decreased prepaids and increased accounts payable and accrued liabilities of $0.3 million and $2.1 million, respectively.
This was partially offset by decreased accounts receivable and increased accounts payable and accrued liabilities of $7.9 million and $27.5 million, respectively.
If an intangible asset is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset. Goodwill is not amortized, but rather, are tested for impairment annually or more frequently if impairment indicators arise.
If an intangible asset is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset.
Total Company gross profit decreased by $19.5 million compared to the prior year.
Total Company gross margin increased by $3.0 million compared to the prior year.
Other income (expense) - Other expense includes interest income and expense, foreign currency impacts and bank fees. • The change in other income and expe nse of $4.1 million compared to the prior year, is primarily due to decreased interest ex pense of $2.5 million and increased interest income of $1.6 million.
Other income (expense) - Other expense includes interest income and expense, foreign currency impacts and bank fees. Other income, net increased by $5.1 million compared to the prior year.
Net Sales Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts, rebates and returns. 37 Year ended May 31, (in thousands) 2024 2023 $ Change Net Sales Med Tech $ 106,403 $ 96,687 $ 9,716 Med Device 197,511 242,065 $ (44,554) Total $ 303,914 $ 338,752 $ (34,838) Net Sales by Geography United States $ 251,486 $ 282,713 $ (31,227) International 52,428 56,039 $ (3,611) Total $ 303,914 $ 338,752 $ (34,838) For the year ended May 31, 2024, net sales decreased $34.8 million to $303.9 million compared to the year ended May 31, 2023.
Net Sales Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts, rebates and returns. 37 Year ended May 31, (in thousands) 2025 2024 $ Change Net Sales Med Tech $ 126,653 $ 106,403 $ 20,250 Med Device 165,845 197,511 $ (31,666) Total $ 292,498 $ 303,914 $ (11,416) Net Sales by Geography United States $ 250,983 $ 251,486 $ (503) International 41,515 52,428 $ (10,913) Total $ 292,498 $ 303,914 $ (11,416) For the year ended May 31, 2025, net sales decreased $11.4 million to $292.5 million compared to the year ended May 31, 2024.
If sufficient positive evidence exists in future periods to support a release of some or all of the valuation allowance, such a release would likely have a material impact on the Company’s results of operations. 41 Liquidity and Capital Resources We regularly review our liquidity and anticipated capital requirements and we believe that our current cash on hand provides sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months.
If sufficient positive evidence exists in future periods to support a release of some or all of the valuation allowance, such a release would likely have a material impact on the Company’s results of operations.
Cash payments due by period as of May 31, 2024 (in thousands) Total Less than One Year 1-3 Years 3-5 Years After 5 Years Contractual Obligations: Operating leases (1) $ 6,406 $ 2,202 $ 2,960 $ 1,244 $ — Purchase obligations (2) 2,946 2,946 — — — Acquisition-related future obligations (3) 5,000 5,000 — — — Royalties 36,005 3,625 7,240 7,240 17,900 $ 50,357 $ 13,773 $ 10,200 $ 8,484 $ 17,900 (1) Operating leases include short-term leases that are not recorded on our Consolidated Balance Sheets under ASU No. 2016-02 .
Cash payments due by period as of May 31, 2025 (in thousands) Total Less than One Year 1-3 Years 3-5 Years After 5 Years Contractual Obligations: Operating leases (1) $ 4,580 $ 2,277 $ 1,788 $ 515 $ — Finance leases 4,714 800 1,549 2,365 — Royalties 32,380 3,620 7,240 7,240 14,280 $ 41,674 $ 6,697 $ 10,577 $ 10,120 $ 14,280 (1) Operating leases include short-term leases that are not recorded on our Consolidated Balance Sheets under ASU No. 2016-02 .
Our cash and cash equivalents totaled $76.1 million as of May 31, 2024, compared with $44.6 million as of May 31, 2023.
Our cash and cash equivalents totaled $55.9 million as of May 31, 2025, compared with $76.1 million as of May 31, 2024. As of May 31, 2025 and 2024 the Company did not have any outstanding debt.
The Company continued its discipline on deploying resources. This included: ◦ The announcement on January 5, 2024 to restructure the manufacturing footprint and a shift to an outsourced model which will transfer all product manufacturing processes to third-party manufacturers to allow the Company to more effectively compete in chosen markets and fundamentally change its corporate gross margin profile.
This included: ◦ The announcement to restructure the manufacturing footprint, which includes maintaining a presence in Queensbury, NY for select products, customer service, logistics, shipping, quality and regulatory operations, and shifting all other products to an outsourced model utilizing third-party manufacturers to allow the Company to more effectively compete in chosen markets and fundamentally change its corporate gross margin profile.
These reserves are based on the amounts earned or to be claimed on the related sales and are classified as a contra asset. The Company provides certain customers with rebates and allowances that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.
During the years ended May 31, 2025, 2024 and 2023, such product returns were not material. The Company provides certain customers with rebates and allowances that are explicitly stated in the Company's contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.
Goodwill and Intangible Assets Intangible assets other than goodwill and in process research and development ("IP R&D") are amortized over their estimated useful lives, which range between two to eighteen years, on a straight-line basis over the expected period of benefit.
An increase to inventory reserves results in a corresponding increase in cost of revenue. Inventories are written off against the reserve when they are physically disposed. Intangible Assets Intangible assets are amortized over their estimated useful lives, which range between two to eighteen years, on a straight-line basis over the expected period of benefit.
Pursuant to the terms of the Credit Agreement, AngioDynamics had the option to repay this facility prior to the maturity date without penalty. Our contractual obligations as of May 31, 2024 are set forth in the table below (in thousands). We have no variable interest entities or other off-balance sheet obligations.
If we seek to make acquisitions of other businesses or technologies in the future for cash, we may require external financing. Our contractual obligations as of May 31, 2025 are set forth in the table below (in thousands). We have no variable interest entities or other off-balance sheet obligations.
The change in sales from the prior year was primarily driven by: • Increased Auryon sales of $6.4 million; • Increased NanoKnife sales of $5.7 million, which was driven by both NanoKnife disposable and capital sales, which increased $2.5 million and $3.2 million, respectively, due to increased case volume in both the U.S and international markets; and • Decrease in the thrombectomy platform of $2.4 million, which was driven by softness in the mechanical thrombectomy platform in AngioVac, AlphaVac and Thrombolytic sales of $1.4 million, $0.4 million and $0.6 million, respectively.
The change in sales from the prior year was primarily driven by: • Increased Auryon sales of $9.8 million; • Decreased sales of Syntrax of $0.4 million due to the discontinuation of this product line as of February 29, 2024; • Increased sales of the thrombus management platform of $10.9 million, which was driven by increases in AngioVac, AlphaVac and thrombolytic sales of $5.8 million, $4.0 million and $1.1 million, respectively; and • NanoKnife sales remained consistent year over year, and was comprised of increased NanoKnife disposable sales of $1.7 million offset by decreased capital sales of $1.7 million.
The Company invoiced Merit Medical Systems, Inc. $0.5 million for the year ended May 31, 2024; • Manufacturing relocation expense related to the move of certain manufacturing lines from Queensbury, New York to a third party, which decreased $0.5 million; • Other expenses, mainly severance associated with organizational changes, which increased $2.0 million; and • The payment to the Israeli Innovation Authority of $3.5 million related to grant funds that were provided to Eximo to develop the Auryon laser prior to the acquisition in the second quarter of fiscal year 2020.
The increase in the fees invoiced was $0.7 million; • Manufacturing relocation expense related to the move of certain manufacturing lines from Queensbury, New York to a third party, which decreased $0.6 million; and • Other expenses, mainly severance associated with organizational changes, which decreased $0.4 million.
The Company currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. During the year ended May 31, 2024, such product returns were not material. A receivable is generally recognized in the period the Company ships the product.
The Company currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. Discounts and product returns are based on amounts earned or to be claimed on the related sales and are classified as a contra asset.
The second revenue milestone was achieved in April 2024 and was paid in the fourth quarter of fiscal year 2024.
The final milestone associated with the contingent consideration was reached during the third quarter of fiscal year 2025 and was paid during the fourth quarter of fiscal year 2025.
Removed
Company and Market AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients.
Added
Company and Market AngioDynamics is a dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes and quality of life by focusing on cardiovascular disease and cancer. Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales performance.
Removed
On June 8, 2023, the Company completed the sale of the dialysis and BioSentry businesses to Merit Medical Systems, Inc. The Company also entered into various agreements to facilitate the transition to Merit, including a Transition Services Agreement and Contract Manufacturing Agreement.
Added
The Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog, inflation (including the cost and availability of raw materials, direct labor and shipping) and tariffs have impacted our business, trends that may continue.
Removed
Total consideration received by the Company for the Divestiture was $100.0 million in cash and resulted in a pre-tax book gain of $47.8 million. On June 8, 2023 and in connection with the completion of the Divestiture, the Company repaid all amounts outstanding under its existing Credit Agreement, and as a result, the Credit Agreement was extinguished.
Added
Accordingly, management continues to evaluate the Company’s liquidity position, communicate with and monitor the actions of our customers and suppliers, and review our near-term financial performance. On January 5, 2024, the Company announced a restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan").
Removed
On January 5, 2024, the Company announced a restructuring of its manufacturing footprint and a shift to an outsourced model (the "Plan"). This Plan is intended to transfer all product manufacturing processes to third-party manufacturers.
Added
In the second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the manufacturing of select products, customer service, logistics, shipping, quality and regulatory operations. The restructuring activities associated with the modified Plan are still expected to be completed in the third quarter of fiscal year 2026.
Removed
The restructuring activities associated with the Plan are expected to be completed in the third quarter of fiscal year 2026 and will allow the Company to more effectively compete in chosen markets and fundamentally change its corporate gross margin profile. On February 15, 2024, the Company completed the sale of its PICC and Midline businesses to Spectrum Vascular.
Added
The modified Plan is still expected to generate $15.0 million in annual cost savings starting in fiscal year 2027. On July 16, 2024, the Board of Directors approved a share repurchase program (the "Repurchase Program") under which they authorized the Company the option to repurchase up to $15.0 million of its outstanding common stock.
Removed
The Company also entered into various agreements to facilitate the transition to Spectrum, including a Transition Services Agreement and Contract Manufacturing Agreement. Total consideration received by the Company for the Divestiture was $34.5 million in cash and resulted in a pre-tax book gain of $6.7 million.
Added
The timing and amount of any share repurchases under the authorization will be determined by management within certain parameters and based on market conditions and other considerations. During the year ended May 31, 2025, the Company repurchased 243,847 shares of common stock in the open market at an aggregate cost of $1.7 million under the Repurchase Program.
Removed
Included in the agreement is a $5.5 million earn-out related to the sales of divested products over a two year period and a milestone payment of $5.0 million paid upon final transfer of the manufacturing to a third-party. 33 In the third quarter of fiscal year 2024, the Company concluded that the sustained decline in our stock price was a triggering event for the Med Tech reporting unit.
Added
As of May 31, 2025, $13.3 million remained available for repurchase under the Repurchase Program. On December 24, 2024, the Company entered into an agreement to sell the manufacturing facilities in Queensbury, NY and Glens Falls, NY for a purchase price of $5.5 million and $1.2 million, respectively, and net proceeds of $5.2 million and 34 $1.1 million, respectively.
Removed
The Company utilized the income approach to determine the fair value of the remaining Med Tech reporting unit. Based on the results of this evaluation, the Company recorded a goodwill impairment charge of $159.5 million for the quarter ended February 29, 2024 to write down the carrying value of the Med Tech reporting unit to fair value.
Added
The Company simultaneously entered into lease agreements with future lease payments of $4.6 million over seven years for the Queensbury, NY facility and $0.4 million over three years for the Glens Falls, NY facility. On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A.
Removed
On March 31, 2024, the Company and BD entered into a Settlement Agreement as described in Note 17 "Commitments and Contingencies" set forth in the Notes to our consolidated financial statements in this Annual Report on Form 10-K.
Added
The Credit Agreement has a two-year maturity and provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a borrowing base comprised of certain working capital assets of the Company. As of May 31, 2025, there is no outstanding balance on the Revolving Facility.
Removed
The Company will make a one-time lump sum payment to BD in the amount of $7.0 million, $3.0 million of which was paid within 5 business days of execution of the Settlement Agreement, and the remainder of which will be payable in installments over the 12 month period ending March 31, 2025.
Added
Strategic Initiatives to Drive Growth The Company is focused on its Med Tech segment which is committed to expanding treatment options and improving patient outcomes and quality of life by focusing on cardiovascular disease and cancer. Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales performance.
Removed
The Company will also make six minimum annual payments to BD of $2.5 million through February 2029, and potential additional payments if six percent (6%) of annual net sales of AngioDynamics’ port products exceed the minimum payment. The parties will participate in the pending appeal before the Federal Circuit of the case titled C.R.
Added
The Company: ◦ Received CE mark approval in Europe for Auryon; ◦ Received CPT Category I Codes for Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, for the treatment of lesions in the prostate and liver, effective January 2026; ◦ Received FDA 510(k) clearance for NanoKnife Prostate Tissue Ablation; ◦ Received CPT Category I Codes for Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, for the treatment of the pancreas, effective January 2027; ◦ Published APEX-AV trial results in the Journal of the Society for Cardiovascular Angiography & Interventions demonstrating the safety and efficacy of the AlphaVac F1885 System; ◦ Initiated RECOVER-AV Clinical Trial in Europe for AlphaVac; and ◦ Initiated the AMBITION BTK RCT and Registry to generate definitive clinical evidence supporting the use of the Auryon Atherectomy System in treating below the knee lesions in patients with critical limb ischemia. • Customer Centric Sales Performance.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeCONCENTRATION OF CREDIT RISK Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and trade accounts receivable. The Company maintains cash and cash equivalents at various institutions and performs periodic evaluations of the relative credit standings of these financial institutions to ensure their credit worthiness.
Biggest changeThe Company maintains cash and cash equivalents at various institutions and performs periodic evaluations of the relative credit standings of these financial institutions to ensure their credit worthiness. Concentration of credit risk with respect to trade accounts receivable is limited due to the large number of customers that purchase products from the Company.
Dollar strengthens, our sales and gross profit will be negatively impacted. In addition, we have assets and liabilities denominated in non-functional currencies which are remeasured at each reporting period, with the offset to changes presented as a component of Other (Expense) Income. Significant non-functional balances include accounts receivable due from some of our international customers.
Dollar strengthens, our sales and gross margin will be negatively impacted. In addition, we have assets and liabilities denominated in non-functional currencies which are remeasured at each reporting period, with the offset to changes presented as a component of Other (Expense) Income. Significant non-functional balances include accounts receivable due from some of our international customers.
INTEREST RATE RISK The risk associated with fluctuating interest rates is primarily limited to indebtedness. As of May 31, 2024, the Company does not have any outstanding debt (see Note 12, "Long-Term Debt" set forth in the Notes in the consolidated financial statements included in this Annual Report on Form 10-K).
INTEREST RATE RISK The risk associated with fluctuating interest rates is primarily limited to indebtedness. As of May 31, 2025, the Company does not have any outstanding debt (see Note 11, "Long-Term Debt" set forth in the Notes in the consolidated financial statements included in this Annual Report on Form 10-K).
Dollar, particularly the Euro, British pound and Canadian dollar. Approximately 3.6% of our sales in fiscal year 2024 were denominated in foreign currencies. We do not have expenses denominated in foreign currencies at the level of our sales and as a result, our profitability is exposed to currency fluctuations. When the U.S.
Dollar, particularly the Euro, British pound and Canadian dollar. Approximately 3.4% of our sales in fiscal year 2025 were denominated in foreign currencies. We do not have expenses denominated in foreign currencies at the level of our sales and as a result, our profitability is exposed to currency fluctuations. When the U.S.
As the Company’s standard payment terms are 30 to 90 days from invoicing, the Company does not provide any significant financing to its customers. Although the Company does not currently foresee a significant credit risk associated with the outstanding accounts receivable, repayment is dependent upon the financial stability of our customers.
Although the Company does not currently foresee a significant credit risk associated with the outstanding accounts receivable, repayment is dependent upon the financial stability of our customers.
Concentration of credit risk with respect to trade accounts receivable is limited due to the large number of customers that purchase products from the Company. No single customer represents more than 10% of total sales. The Company monitors the creditworthiness of its customers.
No single customer represents more than 10% of total sales. The Company monitors the creditworthiness of its customers. As the Company’s standard payment terms are 30 to 90 days from invoicing, the Company does not provide any significant financing to its customers.
Added
Interest on the Revolving Facility will be based, at the Company's option, on a rate equal to (i) the Secured Overnight Financing Rate ("SOFR") plus 0.1% (subject to a floor of 0%) ("Adjusted Term SOFR"), or (ii) the alternate base rate (subject to a floor of 0%) ("ABR"), and in each case with a margin for Adjusted Term SOFR loans of 2.0% and for ABR loans of 1.0%.
Added
The Revolving Facility will also carry a commitment fee of 0.2% per annum on the unused portion. The Revolving Facility contains customary benchmark replacement and rate fallback provisions. CONCENTRATION OF CREDIT RISK Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and trade accounts receivable.

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