What changed in this filing

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Item 1. Business

2026-07-14 compared with 2025-07-18 · 26 added, 29 removed, 392 unchanged (12% of the section changed)

22 unchanged sentences

International regulatory clearances vary by product and jurisdiction.

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

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.

The Auryon Atherectomy System represents one of our latest advancements in the treatment of peripheral arterial disease.

The device is engineered to deliver an optimized wavelength and short pulse width to remove a wide range of lesion types while minimizing damage to the vessel wall endothelium.

Incorporating integrated aspiration, the Auryon System enhances procedural safety by helping remove plaque from the vasculature.

The device delivers safe, effective and versatile treatment across a broad spectrum of lesion types and anatomical locations including above and below the knee.

Designed for flexibility, the device supports femoral, pedal or radial access allowing physicians to expand treatment options for their patients.

The Auryon system delivers a safe, efficient and comprehensive treatment option on one single platform.

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.

15 unchanged sentences

AngioDynamics’ Uni-Fuse infusion catheter features pressure response outlets, a proprietary slit technology that provides a consistent, even distribution of fluid volume along the entire length of the infusion pattern, designed to provide an advantage over standard side-hole catheters.

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.

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.

10 unchanged sentences

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.

In February 2026, the NanoKnife system received BSI approval for the product to bear the MDR CE mark supporting expanded indications for the ablation of pancreas, kidney, liver or prostate tumors, including intermediate risk prostate cancer.

Peripheral Products (Interventional Devices)

93 unchanged sentences

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.

The Solero MTA System and Accessories are indicated for the ablation of soft tissue during open procedures by the FDA in the USA and for open laparoscopic and percutaneous procedures under the European MDR regulations.

The Solero MTA System is not intended for cardiac use.

27 unchanged sentences

Johnson and Johnson;

Philips Healthcare;

Stryker Corporation;

Penumbra, Inc.;

Varian Medical Systems;

Abbott Laboratories and Total Vein Systems.

Siemens Healthineers;

Abbott Laboratories;

Profound Medical;

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.

6 unchanged sentences

MANUFACTURING

We manufacture certain proprietary components and products and then assemble, inspect, test and package our finished products.

By designing and manufacturing many of our products from raw materials, and assembling and testing our subassemblies and products, we believe that we are able to maintain better quality control, ensure compliance with applicable regulatory standards and our internal specifications, and limit outside access to our proprietary technology.

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.

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

We manufacture certain 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.

We also utilize third-party manufacturers for the manufacturing of certain products.

We have custom-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing production machinery that is utilized in our facilities and by our third-party manufacturers.

Our products are manufactured from raw materials and are assembled and tested to ensure compliance with applicable regulatory standards and our internal specifications.

The manufacturing facilities, both ours and third-party, are registered with the FDA and have been certified to ISO 13485 standards.

ISO 13485 is a quality system standard that satisfies European Union regulatory requirements, thus allowing us to market and sell our products in European Union countries.

10 unchanged sentences

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

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.

27 unchanged sentences

The 510(k) clearance procedure including questions and responses may take up to 12 months.

In some cases, supporting clinical data may be required.

The FDA may determine that a new or modified device is not substantially equivalent to a predicate device or may require that additional information, including clinical data, be submitted before a determination is made, either of which could significantly delay the introduction of a new or modified device.

10 unchanged sentences

FDA submissions require extensive validations and testing which requires a significant amount of time and financial resources.

Recent changes in both regulations and FDA perspectives have increased both time and testing requirements, which have caused and are expected to continue to cause significant delays and increased costs for clearances and approvals.

The increased focus by the FDA on such issues as chemical identification of all colorants, non-acceptance of certain colorants (certain forms of carbon black) and other concerns, continue to cause challenges and delays.

Changes in both regulations and FDA perspectives have increased time and testing requirements, which have caused

and are expected to continue to cause significant delays and increased costs for clearances and approvals.

In addition, changes to existing products call into question previously approved devices and result in additional costs for testing and material analysis.

The devices manufactured by us are also subject to the QSR, which imposes elaborate testing, control, documentation and other quality assurance procedures on our manufacturing facilities.

Every phase of production, including raw materials, components and subassembly, manufacturing, testing, quality control, labeling, tracing of customers after distribution and follow-up and reporting of complaint information is governed by the FDA’s QSR.

Device manufacturers are required to register their facilities and list their products with the FDA and certain state agencies.

The FDA periodically inspects manufacturing facilities and, if there are alleged violations, the operator of a facility must correct them or satisfactorily demonstrate the absence of the violations or face regulatory action.

Failure to maintain compliance with the QSR may result in the issuance of one or more Forms 483 or warning letters and could potentially result in a consent decree.

Failure to maintain the QSR appropriately could result in the issuance of further warning letters.

Failure to maintain compliance with the QMSR may result in the issuance of one or more Forms 483 or warning letters and could potentially result in a consent decree.

Failure to maintain the QMSR appropriately could result in the issuance of further warning letters.

In addition, non-compliance with applicable FDA requirements can result in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, failure of the FDA to grant marketing approvals, inability to obtain clearances or approvals for products, withdrawal of marketing approvals, a recommendation by the FDA to disallow us to enter into government contracts, and/or criminal prosecutions.

93 unchanged sentences

Clemmer is a graduate of the Massachusetts College of Liberal Arts, where he served as interim president from August 2015 until March 2016.

As previously disclosed, Mr.

Clemmer has announced his intention to retire on the earlier of November 30, 2026 and appointment of a successor CEO.

Trowbridge was appointed Executive Vice President and Chief Financial Officer (CFO) in February 2020, having served as Interim Chief Financial Officer since October 2019.

17 unchanged sentences

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.

34 unchanged sentences

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