What changed in this filing

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Item 1. Business

2025-07-18 compared with 2024-07-25 · 74 added, 50 removed, 347 unchanged (26% of the section changed)

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.

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.

Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales performance.

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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in October 2012, the assets of Microsulis Medical Limited in January 2013, and Clinical Devices in August 2013.

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.

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.

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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., which the Company sold in February 2024 to Spectrum Vascular pursuant to an asset purchase agreement.

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.

On December 17, 2019, the Company acquired the C3 Wave tip location asset from Medical Components Inc.

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.

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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The Auryon Atherectomy System is one of our latest advancements in peripheral arterial disease.

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.

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.

The Auryon system is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infrainguinal arteries.

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.

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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.

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.

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.

The AlphaVac System is an emergent mechanical aspiration device that eliminates the need for perfusionist support.

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The generator then delivers a series of short electric pulses between each electrode probe.

The energy delivery is hyperechoic and can be monitored under real-time ultrasound.

Full paralytic anesthesiology is required for safe IRE delivery.

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.

Peripheral Products (Interventional Devices)

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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.

By utilizing a proprietary pre-coat process for the Polytetrafluoroethylene (PTFE) and upholding tight specifications, our ADx Guidewires offer high quality and performance for physicians.

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Drainage Products

To aid physicians in percutaneous drainage procedures, AngioDynamics offers two different Drainage Catheter lines:

Total Abscession Drainage Catheters and Exodus Drainage Catheters.

Each line is available in a Multipurpose/General and Biliary configuration, while Total Abscession also offers a Nephrostomy option.

Both lines offer options with a radiopaque marker band at the distal tip to aid in placement.

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.

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.

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.

The unique Sure-Twist hub provides audible and tactile feedback when locked, without the need for a separate tool.

Micropuncture Kits

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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.

• Mini Stick MAX Coaxial Introducer kits contain a unique containment clip that keeps all the unique components of the kit together and organized.

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 Micro-Introducer Kits offer a variety of configurations that aid in simplifying set up and gaining vascular access.

Ports are implantable devices utilized for the central venous administration of a variety of medical therapies and for blood sampling and diagnostic purposes.

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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.

The BioFlo port family is available in single or dual lumen configurations.

• Xcela Plus :

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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).

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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.

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.

This glass weld tip technology has less focal charring of the vein wall versus a bar-tip fiber.

The NeverTouch procedure kit is available in 25cm, 45cm, 65cm, and 90cm lengths.

It is also available with an .018” access system, which eliminates the need for a 5F micro-access sheath and the need to exchange wires and size up, resulting in few procedure steps, and may result in faster procedure time.

The 400 Micron Perforator & Accessory Vein Ablation kit (PVAK) is an AngioDynamics VenaCure EVLT endovenous laser vein treatment offering that provides patients a minimally-invasive choice for treating the source of their varicose veins.

The PVAK kit may also provide patients a potentially quicker recovery and return to normal daily routines, as compared to surgical stripping.

The PVAK kit allows for simple access and accurate positioning.

The smaller fiber aids in access and positioning for deep and saphenous veins.

The 21G venous access needle ensures easy, atraumatic access and the .018” guidewire navigates small, tortuous veins with a floppy tip and has a firm anchor to guide the sheath and hold it in place.

Microwave Ablation

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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 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.

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.

The Solero MTA System and Accessories are indicated for the ablation of soft tissue during open procedures.

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We face competitors, ranging from large manufacturers with multiple business lines, to small manufacturers that offer a limited selection of products.

Our primary device competitors include:

Our primary competitors include:

Boston Scientific Corporation;

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Philips Healthcare;

Inari Medical;

Varian Medical Systems and Total Vein Systems.

Stryker Corporation;

Penumbra, Inc.;

Varian Medical Systems;

Abbott Laboratories 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.

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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 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.

The manufacturing facilities are registered with the FDA and have been certified to ISO 13485 standards.

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See Part I, Item 2 "Properties" in this Annual Report on Form 10-K for details on each manufacturing location.

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.

The 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.

We have historically kept sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand.

In fiscal year 2024, the Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog and inflation (including the cost and availability of raw materials, direct labor and shipping) have impacted our business and resulted in a backlog of $1.3 million at the end of the fourth quarter down $1.4 million from the fourth quarter of fiscal year 2023.

We continue to focus on meeting the demand for our product and working towards standard inventory and backlog levels in fiscal year 2025.

See Part I, Item 1A "Risk Factors" in this Annual Report on Form 10-K.

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.

On 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 restructuring activities associated with the modified Plan are still expected to be completed in the third quarter of fiscal year 2026.

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.

As we shift additional manufacturing to Costa Rica and/or other manufacturing partners, we have built sufficient safety stock to reduce the risk of backlog during the transition.

INTELLECTUAL PROPERTY

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Before a new medical device can be introduced into the market, a manufacturer generally must obtain marketing clearance or approval from the FDA through either a 510(k) submission (a premarket notification) or a premarket approval application (PMA).

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);

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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.

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.

Historically, our products have been introduced into the market using the 510(k) procedure.

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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.

Sales of medical devices are subject to regulatory requirements in many countries.

The regulatory review process may vary greatly from country to country.

Sales of medical devices are subject to regulatory requirements in most countries.

The regulatory review process varies 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.

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During that time period, significant design modifications cannot be made.

All legacy devices have achieved the MDR CE Mark.

Similar regulations are in place for Canada, Japan, China, Brazil and most other countries.

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The process of obtaining approval to distribute medical products is costly and time-consuming in virtually all the major markets where we sell medical devices.

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.

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.

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The main types of healthcare payment systems are government sponsored healthcare and private insurance.

Reimbursement

approval must be obtained individually in each country in which our products are marketed.

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.

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Our goal is to create a diverse and inclusive culture that encourages an environment where employees feel welcomed, respected and valued.

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.

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Trowbridge 50 Executive Vice President and Chief Financial Officer

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

Weiss 56 Senior Vice President, Chief Legal Officer & Corporate Secretary

Campbell 54 Senior Vice President and General Manager, Oncology and Interventional Devices

Laura Piccinini 55 Senior Vice President and General Manager, Cardiovascular and International

Nighan 56 Senior Vice President, Global Supply Chain, Quality and Regulatory Affairs

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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

business across five divisions and built the strategic plan for the medical supplies segment before Covidien was spun off from Tyco.

Clemmer began his career at Sage Products, Inc.

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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.

Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for Vascular Access.

Weiss was appointed Senior Vice President, Chief Legal Officer and Corporate Secretary in December 2024.

Prior to joining AngioDynamics, Mr.

Weiss served as Executive Vice President and Chief Legal Officer of Butterfly Network, Inc., overseeing legal, compliance, quality and regulatory functions.

Prior roles include Chief Legal Officer of Emulate, Inc., and Senior Vice President, General Counsel, and Corporate Secretary for Analog Devices, Inc.

Weiss' career includes leadership positions at Medtronic, Covidien, and Tyco Healthcare, where he managed international legal matters, mergers and acquisitions, intellectual property litigation, and global compliance initiatives.

He began his career in the Corporate department of Goodwin Procter & Hoar in Boston.

Weiss holds a Juris Doctor from Boston University and a Bachelor’s degree from Tulane University.

He serves on the Boards of Directors for Greater Boston Legal Services and the Northeast Chapter of the Association for Corporate Counsel.

Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for Vascular Access (now Interventional Devices).

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.

Campbell assumed responsibility of the Oncology Global

Business Unit in addition to his role of General Manager for Vascular Access.

In his role, Mr.

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Campbell received a Bachelor of Arts from the University of Kentucky.

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.

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.

Piccinini brings more than 25 years of experience in leadership roles in the medical device industry, with an extensive background in the field of respiratory and surgical care.

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

What changed 10-K

Item 1. Business