What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-07-22 compared with 2021-07-27 · 148 added, 175 removed, 299 unchanged (52% of the section changed)

AngioDynamics, Inc.

designs, manufactures and sells a wide range of medical, surgical and diagnostic devices used by professional healthcare providers for the treatment of peripheral vascular disease, vascular access and for use in oncology and surgical settings.

Our devices are generally used in minimally invasive, image-guided procedures.

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 was founded in Queensbury, N.Y., U.S., in 1988 and began manufacturing and shipping product in the early 1990s.

3 unchanged sentences

in October 2012, Clinical Devices in August 2013, the assets of Diomed in June 2008 and the assets of Microsulis Medical Limited in January 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.

4 unchanged sentences

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.

AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.

Our product offerings fall within three Global Business Units (GBUs):

Endovascular Therapies (formerly, Vascular Interventions and Therapies ("VIT")), Oncology/Surgery ("OS") and Vascular Access ("VA").

Endovascular Therapies (“VIT”), Oncology/Surgery (“OS”) and Vascular Access (“VA).

As the Company has previously announced, the Company is focused on its ongoing transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company that delivers unique and innovative health care solutions.

As such, we believe the growth in the near to mid-term will be driven by our high technology products including Auryon, the Thrombectomy platform (which includes AngioVac, AlphaVac and thrombolytics) and NanoKnife.

We will refer to these high technology product lines as our Med Tech business and we will refer to the remainder of the portfolio as our Med Device business.

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.

Endovascular Therapies Products

AngioDynamics’ Endovascular Therapies product offerings support the medical areas of Thrombus Management, Atherectomy, Peripheral Products (Core) and Venous Insufficiency.

Thrombus Management

Our Thrombus Management portfolio includes the proprietary 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.

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 indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

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.

5 unchanged sentences

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 Auryon Atherectomy System is one of our latest advancement 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 exceptional safety and efficacy.

The Auryon system is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

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

AlphaVac is offered in both a 22 French flat coil-reinforced cannula and an 18 French braided reinforced cannula each designed with a proprietary self-expanding nitinol reinforced funnel shaped distal tip.

AlphaVac is indicated for the non-surgical removal of thrombi or emboli from vasculature as well as aspiration of contrast media and other fluids from the vasculature.

The cannula is intended for use in the venous system.

The handle is indicated as a vacuum source for the AlphaVac MMA system.

Thrombolytic Catheters

Thrombolytic catheters are used to deliver thrombolytic agents, which are drugs that dissolve blood clots in hemodialysis access grafts, arteries, veins and surgical bypass grafts.

AngioDynamics’ Uni-Fuse infusion catheter features pressure response outlets, a proprietary, time-tested slit technology that provides a consistent, even distribution of fluid volume along the entire length of the infusion pattern, resulting in a 12-fold advantage over standard side-hole catheters.

We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents to shorten treatment time, and the SpeedLyser infusion system built for dialysis grafts and fistulas.¹

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.

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.

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.

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.

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

Peripheral Products (Core)

1 unchanged sentence

Product categories include an extensive line of angiographic catheters and diagnostic and interventional guidewires, percutaneous drainage catheters and coaxial micro-introducer kits.

¹ Yusuf SW, et al.

Immediate and Early Follow-up Results of Pulse Spray Thrombolysis in Patients with Peripheral Ischaemia.

British Journal of Surgery 1995;

Angiographic Products and Accessories

7 unchanged sentences

Soft-Vu selective catheters are used to gain access to smaller or more distal vessels and advance the catheter or wire into the diseased section.

• Accu-Vu sizing catheters feature radiopaque marker bands at the distal (farthest away) portion of the catheter to provide a highly accurate measurement of the patient’s anatomy.

• Accu-Vu sizing catheters feature radiopaque marker bands at the distal portion of the catheter to provide a highly accurate measurement of the patient’s anatomy.

This enables precise measurement for interventional devices such as stents.

• AngiOptic catheters have total catheter radiopacity, ensuring tip-to-hub visibility.

This catheter is also constructed with a firm tip material that enhances stability during high-flow injections, providing excellent pushability.

• Mariner catheters have a hydrophilic coating that, when combined with water, reduces friction.

This makes insertion potentially easier and more comfortable for the patient, and can also be used for advancing through tortuous anatomy.

AngioDynamics guidewires include Nit-Vu (featuring a kink-resistant NiTi alloy core facilitating smooth navigation through tortuous vasculature and accurate wire control) and PTFE (Polytetrafluoroethylene) Coated diagnostic guidewires (fixed core and movable core).

AngioDynamics guidewires include Nit-Vu (featuring a kink-resistant NiTi alloy core facilitating smooth navigation through tortuous vasculature and accurate wire control) and Polytetrafluoroethylene (PTFE) Coated diagnostic guidewires (fixed core and movable core).

AngioDynamics catheters and guidewires are available in more than 500 tip configurations and lengths.

6 unchanged sentences

Micro Access Kits

Our Micro Access sets provide interventional physicians a smaller introducer system for minimally-invasive procedures.

Our Micro Access kits provide interventional physicians a smaller introducer system for minimally-invasive procedures.

Our Micro Access product line provides physicians with the means to choose from the wide selection of configurations, including guidewire, needle and introducer options.

1 unchanged sentence

Micro Introducer Kit and Ministick Max.

¹ Yusuf SW, et al.

Immediate and Early Follow-up Results of Pulse Spray Thrombolysis in Patients with Peripheral Ischaemia.

British Journal of Surgery 1995;

Venous Insufficiency

VenaCure EVLT laser system

Our VenaCure EVLT system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins).

Superficial venous disease is a malfunction of one or more valves in the leg veins whereby blood refluxes or does not return to the heart, thereby pooling in the legs and leading to symptoms such as pain, swelling and ulcerations.

The VenaCure EVLT system uses laser energy to stop the reflux by ablating (collapsing and destroying) the affected vein.

Blood is then re-routed to other healthy veins.

The procedure is minimally invasive and generally takes less than an hour, typically allowing the patient to quickly return to normal activities.

The VenaCure EVLT system is sold as a system that includes diode laser hardware and procedure kits which include disposable laser fiber components, an access sheath, access wires and needles.

Our VenaCure EVLT 1470 nanometer wavelength laser allows physicians to more efficiently heat the vein wall using lower power settings thereby reducing the risk of collateral damage.

The NeverTouch tip fiber eliminates laser tip contact with the vein wall, which in turn minimizes perforations of the vein wall that typically result in less pain and bruising as compared to traditional bare-tip fibers.

The NeverTouch tip also maximizes ultrasonic visibility, making it easier for physicians to use.

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.

Oncology/Surgery Products

AngioDynamics offers a range of comprehensive ablation technologies, including thermal tissue ablation systems (microwave energy and radiofrequency energy), surgical resection and the Irreversible Electroporation ("IRE") technology, the NanoKnife System, an innovative alternative to thermal ablation.

The NanoKnife 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 NanoKnife Ablation 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.

Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy.

The NanoKnife Ablation 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.

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.

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

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.

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.

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.

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

The Solero MTA System is not intended for cardiac use.

Radiofrequency Ablation

StarBurst Radiofrequency Ablation Devices

Radiofrequency Ablation (RFA) products use radiofrequency energy to provide a minimally invasive approach to ablating solid cancerous or benign tumors.

Our StarBurst Radiofrequency Ablation devices deliver radiofrequency energy to raise the temperature of cells above 45-50°C, causing cellular death.

The physician inserts the disposable needle electrode device into the targeted body tissue, typically under ultrasound, CT or Magnetic Resonance Imaging (MRI) guidance.

During the procedure, our system automatically adjusts the amount of energy delivered in order to maintain the temperature necessary to ablate the targeted tissue.

For a typical 5 cm ablation using our StarBurst Xli-enhanced disposable device, the ablation process takes approximately ten (10) minutes.

The RFA system consists of a radiofrequency generator and a family of disposable devices.

In addition to thermal ablation systems and the NanoKnife Ablation System, AngioDynamics also offers Habib 4X Surgical Resection devices that are used in minimally invasive laparoscopic surgery procedures in surgical specialties such as Hepato-Biliary, GI, Surgical Oncology, Transplant Surgery and Urology (Partial Nephrectomy Resections).

It is clinically indicated to assist in coagulation of tissue during intraoperative and laparoscopic procedures.

BioSentry Tract Sealant System

The BioSentry tract sealant system deploys a self-expanding hydrogel plug into the pleural space following a percutaneous lung biopsy, creating an airtight seal that closes the pleural puncture.

Depth markings provide accurate and consistent placement based on CT-guided measurements, while the depth adjustment wheel and locking mechanisms ensure proper plug deployment.

The hydrogel plug is made from a synthetic tissue-friendly polymer that fully reabsorbs into the body and the coaxial adapter mates with a coaxial needle to ensure a proper fit and delivery of the plug.

The BioSentry Tract Sealant System is indicated for sealing pleural punctures to significantly reduce the risk of pneumothoraxes (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy location for visualization during surgical resection.

IsoLoc Endorectal Balloon

The IsoLoc Endorectal Balloon's unique, customer-driven design is the result of collaborations with Radiation Oncologists, Therapists and Physicists with one goal in mind, to create a new standard for endorectal balloons (ERB) in the oncology space.

The design of the IsoLoc device not only addresses patient comfort, but also simplifies three challenging clinical scenarios that many physicians face when using radiation therapy for and/or in relation to the prostate.

First, it's gas-release tip removes rectal gas and reduces prostate motion for gaseous 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.

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.

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.

Studies have shown, relative to traditional gauze packing, the Alatus device offers a more comfortable procedure for the patient, reduces the need for post-procedural pain medication and moves healthy tissue away from the radiation field.

Vascular Access Products

Our portfolio of Vascular Access products includes a broad offering of peripherally inserted central catheters (PICCs), midline catheters, implantable ports, dialysis catheters and related accessories and supplies.

These products are used primarily to deliver short-term drug therapies, such as chemotherapeutic agents and antibiotics, into the central venous system.

Delivery to the circulatory system allows drugs to mix with a large volume of blood as compared to intravenous drug delivery into a superficial vessel.

Our Vascular Access product family also includes the proprietary BioFlo catheter and C3 Wave tip location.

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).

6 unchanged sentences

however, the midline catheter is advanced and placed so that the catheter tip is level or near the level of the axilla and distal to the shoulder.

Our Midline product offerings include:

• BioFlo Midline :

Our BioFlo Midline Catheter which incorporates Endexo Technology, is an effective solution to preserving a patient’s peripheral access.

Our Midline product is a BioFlo Midline Catheter which incorporates Endexo Technology and is an effective solution to preserving a patient’s peripheral access.

It provides a cost-effective alternative to multiple IV site rotations for patients who need short-term venous access.

11 unchanged sentences

C3 Wave PICC tip location system

The C3 Wave system is our innovative, wireless, app-based ECG system eliminates the need for a confirmatory chest x-ray of PICC tip placement, allowing greater patient access to the Company’s proprietary BioFlo PICCs.

The C3 Wave system is our innovative, wireless, app-based ECG system which eliminates the need for a confirmatory chest x-ray of PICC tip placement, allowing greater patient access to the Company’s proprietary BioFlo PICCs.

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

13 unchanged sentences

In addition to the three titanium port body sizes, there is a plastic port body.

Our Vortex port technology line of ports is a clear-flow port technology that, we believe, revolutionized port design.

Our Vortex port technology line of ports features a clear-flow port technology that, we believe, revolutionized port design.

With its rounded chamber, the Vortex port is designed to have no sludge-harboring corners or dead spaces.

12 unchanged sentences

The DuraMax catheter is a stepped-tip catheter designed to improve ease of use, dialysis efficiency and overall patient outcomes.

In addition, AngioDynamics also offers other renal therapies, including our DuraFlow Chronic Hemodialysis Catheter, Schon Chronic Hemodialysis Catheter, EVENMORE Chronic Hemodialysis Catheter, EMBOSAFE Valved Splitable Sheath Dilator and Perchik Button Suture Retention Device.

In addition, AngioDynamics also offers other renal therapies, including our DuraFlow Chronic Hemodialysis Catheter, Acute Dialysis Catheter, EVENMORE Chronic Hemodialysis Catheter, EMBOSAFE Valved Splitable Sheath Dilator and Perchik Button Suture Retention Device.

Venous Insufficiency

VenaCure EVLT laser system

Our VenaCure EVLT system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins).

The VenaCure EVLT system uses laser energy to stop the reflux by ablating (collapsing and destroying) the affected vein.

Blood is then re-routed to other healthy veins.

The procedure is minimally invasive and generally takes less than an hour, typically allowing the patient to quickly return to normal activities.

The VenaCure EVLT system is sold as a system that includes diode laser hardware and procedure kits which include disposable laser fiber components, an access sheath, access wires and needles.

Our VenaCure EVLT 1470 nanometer wavelength laser allows physicians to more efficiently heat the vein wall using lower power settings thereby reducing the risk of collateral damage.

The NeverTouch tip also maximizes ultrasonic visibility, making it easier for physicians to use.

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.

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.

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.

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

The Solero MTA System is not intended for cardiac use.

Radiofrequency Ablation

StarBurst Radiofrequency Ablation Devices

Radiofrequency Ablation (RFA) products use radiofrequency energy to provide a minimally invasive approach to ablating solid cancerous or benign tumors.

Our StarBurst Radiofrequency Ablation devices deliver radiofrequency energy to raise the temperature of cells above 45-50°C, causing cellular death.

The physician inserts the disposable needle electrode device into the targeted body tissue, typically under ultrasound, CT or Magnetic Resonance Imaging (MRI) guidance.

During the procedure, our system automatically adjusts the amount of energy delivered in order to maintain the temperature necessary to ablate the targeted tissue.

For a typical 5 cm ablation using our StarBurst Xli-enhanced disposable device, the ablation process takes approximately ten (10) minutes.

The RFA system consists of a radiofrequency generator and a family of disposable devices.

It is clinically indicated to assist in coagulation of tissue during intraoperative and laparoscopic procedures.

BioSentry Tract Sealant System

The BioSentry Tract Sealant System deploys a self-expanding hydrogel plug into the pleural space following a percutaneous lung biopsy, creating an airtight seal that closes the pleural puncture.

Depth markings provide accurate and consistent placement based on CT-guided measurements, while the depth adjustment wheel and locking mechanisms ensure proper plug deployment.

IsoLoc Endorectal Balloon

First, its' gas-release tip removes rectal gas and reduces prostate motion for gaseous 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.

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.

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

1 unchanged sentence

This happens through internal product development, technology licensing, strategic alliances and acquisitions.

Our 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.

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.

We believe that we have a reputation among interventional physicians as a strong partner for developing high quality products because of our tradition of close physician collaboration, dedicated market focus, responsiveness and execution capabilities for product development and commercialization.

We recognize the importance of, and intend to continue to make investments in, research and development (R&D).

We recognize the importance of, and intend to continue to make investments in, R&D.

We encounter significant competition across our product lines and in each market in which our products are sold.

7 unchanged sentences

Becton Dickinson;

Smiths Medical, a subsidiary of Smiths Group plc;

Merit Medical;

6 unchanged sentences

In the current environment of managed care, which is characterized by economically motivated buyers, consolidation among health care providers, increased competition and declining reimbursement rates, we have been increasingly required to compete on the basis of price.

We believe that our continued competitive success will depend upon our ability to develop or acquire scientifically advanced technology, apply our technology cost-effectively across product lines and markets, attract and retain skilled personnel, obtain patent or other protection for our products, obtain required regulatory and reimbursement approvals, manufacture and successfully market our products either directly or through outside parties, and maintain sufficient inventory to meet customer demand.

We believe that our continued competitive success will depend upon our ability to develop or acquire scientifically advanced technology, apply our technology cost-effectively across product lines and markets, attract and retain skilled personnel, obtain patent or other protection for our products, obtain required regulatory and reimbursement approvals, manufacture and successfully market our products either directly or through third parties, and maintain sufficient inventory to meet customer demand.

SALES AND MARKETING

6 unchanged sentences

We have custom-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing production machinery.

We manufacture most 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.

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

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.

The manufacturing facilities 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.

9 unchanged sentences

See “Government Regulation” section of this Item 1 for additional information.

See Part I, Item 2 "Properties" of this report for details on each manufacturing location.

Historically, we ship the majority of products within 24-48 hours of receiving an order.

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.

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 2022, COVID-19 related issues including 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 $8.4 million at the end of the fourth quarter.

We continue to focus on meeting the demand for our product and working towards standard inventory and backlog levels in fiscal year 2023.

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

INTELLECTUAL PROPERTY

7 unchanged sentences

Some products contain trademarks of companies other than AngioDynamics.

Item 3 "Legal Proceedings" and Note 17 to the consolidated financial statements in this Annual Report on Form 10-K for additional details on litigation regarding proprietary technology.

See Part I, Item 3 "Legal Proceedings" and Note 16 to the consolidated financial statements in this Annual Report on Form 10-K for additional details on litigation regarding proprietary technology.

We operate in an industry characterized by extensive patent litigation.

4 unchanged sentences

At any given time, we are involved in a number of product liability actions.

For additional information, see both Part I.

Item 3 "Legal Proceedings" and Note 17 to the consolidated financial statements in this Annual Report on Form 10-K.

For additional information, see both Part I, Item 3 "Legal Proceedings" and Note 16 to the consolidated financial statements in this Annual Report on Form 10-K.

GOVERNMENT REGULATION

2 unchanged sentences

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) procedure is available only in particular circumstances.

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 a legally marketed device with 510(k) clearance in class I or II or pre-amendment status based upon products commercially distributed on or before May 28, 1976.

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 (preamendments device);

(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;

(iv) or a 510(k) exempt device.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance.

1 unchanged sentence

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 new or modified device products.

If a device cannot demonstrate substantial equivalence, it may be subject to either a de novo submission or a PMA.

If a device cannot demonstrate substantial equivalence, it may be subject to either a De Novo 510(K) submission or a PMA.

The PMA application procedure is more comprehensive than the 510(k) procedure and typically takes more time to complete.

2 unchanged sentences

As part of the PMA application review, the FDA will inspect the manufacturer’s facilities for compliance with its Quality System Regulation, or QSR.

As part of the PMA approval the FDA may place restrictions on the device, such as requiring additional patient follow-up for an indefinite period of time.

As part of the PMA approval the FDA may place

restrictions on the device, such as requiring additional patient follow-up for an indefinite period of time.

If the FDA’s evaluation of the PMA application or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter.

2 unchanged sentences

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

The process of FDA submissions requires 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.

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.

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.

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

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.

5 unchanged sentences

Regulatory Bodies

We and our products are subject to a variety of state and local laws in those jurisdictions where our products are, or will be, marketed.

We and our products are subject to a variety of federal, state and local laws in those jurisdictions where our products are, or will be, marketed.

We and our products are also subject to a variety of federal, state and local laws relating to matters such as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances.

7 unchanged sentences

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

For example, the European Union has a dedicated set of regulations regarding medical devices, specifically regulating their design, manufacturing, clinical trials, labeling and adverse event reporting.

Devices that comply with those requirements are entitled to bear a Conformité Européenne, or CE Mark, indicating that the device conforms to the essential requirements of the applicable directives and can be commercially distributed in countries that are members of the European Union.

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.

New products must be compliant with the Medical Device Regulation ("MDR") as of May 2021 and previously CE Marked products must become compliant when their certification expires, with a transition period ending May 2025.

Products with an expiring certification must be in distribution before certification expiration dates to continue to be sold.

Clinical evaluations of products under MDR requires more information than previously required.

All devices must have current clinical literature that specifically addresses data-driven safety and performance criteria, and legacy devices often require additional biocompatibility, bench testing and redesign to address changes in standards over time.

Additionally, there can be extended time frames under MDR for product certifications that can be 12-18 months or longer.

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

3 unchanged sentences

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 approved in a timely or cost-effective manner or approved 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.

8 unchanged sentences

federal laws include:

(1) the Anti-kickback Statute which prohibits offers to pay or receive remuneration of any kind for the purpose of including or rewarding referrals of items or services reimbursable by a federal health care program, subject to certain safe harbor exceptions;

(1) the Anti-kickback Statute which prohibits offers to pay or receive remuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable by a federal health care program, subject to certain safe harbor exceptions;

(2) the False Claims Act which prohibits the submission of false or otherwise improper claims for payment to a federally-funded health care program, including claims resulting from a violation of the Anti-kickback Statute;

7 unchanged sentences

International

Our success in international markets will depend largely upon the availability of reimbursement from the third-party payors through which healthcare providers are paid in those markets.

The delivery of our devices in any market is subject to evolving regulation by the EU Medical Device Regulations, notified bodies and comparable nation-specific bodies responsible for reimbursement and regulation of health care items and services.

Our success in international markets will depend largely upon the availability of reimbursement from the national public health payers as well as private, third party payors, through which healthcare providers are paid in those markets.

Reimbursement and healthcare payment systems vary significantly by country.

1 unchanged sentence

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

Outside the U.S., we generally rely on our distributors to obtain reimbursement approval in the countries in which they will sell our products.

Outside the U.S., we maintain a healthcare economics team that works 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.

7 unchanged sentences

ENVIRONMENTAL, HEALTH AND SAFETY

We are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain hazardous and potentially hazardous substances used in connection with our operations.

in connection with our operations.

Our operations are also subject to laws and regulations related to occupational health and safety.

3 unchanged sentences

None of our employees are represented by a labor union and we have never experienced a work stoppage.

In the highly competitive medical device industry, we consider attracting, developing, and retaining talented people in technical, operational, marketing, sales, research, management and other positions to be critical to our long-term growth strategy.

Our ability to recruit and retain such talent depends on several factors, including compensation and benefits, talent development, career opportunities and work environment.

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.

Our ability to recruit and retain such talent depends on several factors, including culture, compensation and benefits, talent development, career opportunities, recognition and work environment.

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

3 unchanged sentences

As a result of the COVID-19 pandemic, we also further strengthened our communication platforms.

Our employee communications

during the pandemic have kept our employees informed on critical priorities, important actions being taken by management in response to the pandemic and continued efforts to protect employee health, safety and well-being.

Our employee communications during the pandemic have kept our employees informed on critical priorities, important actions being taken by management in response to the pandemic and continued efforts to protect employee health, safety and well-being.

Executive Officers of the Company

3 unchanged sentences

Trowbridge 47 Executive Vice President and Chief Financial Officer

Marna Bronfen-Moore 54 Senior Vice President, Human Resources

Campbell 50 Senior Vice President and General Manager, Vascular Access

Campbell 51 Senior Vice President and General Manager, Vascular Access and Oncology

Scott Centea 44 Senior Vice President and General Manager, Endovascular Therapies

Davis 56 Senior Vice President, Business Development

Helsel 57 Senior Vice President, Global Operations

Nighan 52 Senior Vice President, Quality and Regulatory Affairs

Helsel 58 Senior Vice President, Global Operations and Research and Development

Laura Piccinini 52 Senior Vice President and General Manager, International

Richard Rosenzweig 54 Senior Vice President, General Counsel and Secretary

Clemmer became our President and Chief Executive Officer in April 2016.

Rosenzweig 55 Senior Vice President, General Counsel and Secretary

Clemmer became our President and Chief Executive Officer (CEO) in April 2016.

Prior to joining AngioDynamics, Mr.

8 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.

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

Prior to his appointment as Chief Financial Officer, he served as the Company’s Senior Vice President and General Counsel.

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

Prior to his appointment as CFO, he served as the Company’s Senior Vice President and General Counsel.

He joined AngioDynamics in June 2008 as Corporate Counsel.

5 unchanged sentences

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.

Bronfen-Moore joined AngioDynamics as the Senior Vice President of Human Resources in September 2019 bringing with her over 20 years of experience in the medical device industry.

Prior to joining AngioDynamics, Ms.

Bronfen-Moore spent almost three years at Hologic as the Vice President, Global Human Resources, for both the Corporate Functions and Asia Pacific.

Before Hologic, Ms.

Bronfen-Moore served as Vice President, Human Resources for Global Operations, Quality, and Regulatory at Haemonetics, Director, Human Resources for Boston Scientific, and in various leadership roles of increasing responsibility at C.

Bronfen-Moore began her professional career as the Head of Human Resources for Burrows Paper Corporation.

Bronfen-Moore holds a Bachelor of Arts degree from Purdue University in Psychology, Master of Science in Industrial/Organizational Psychology from Rensselaer Polytechnic Institute, and completed all of the coursework requirements for a PhD in Management from Rensselaer Polytechnic Institute.

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

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

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.

5 unchanged sentences

Scott Centea joined AngioDynamics in 2005 as a sales representative serving the Carolinas.

During his tenure, he has served in a variety of positions with increased responsibility including VP of Corporate Accounts where he was in charge of

leading a team of individuals to execute Health System Purchasing Contracts.

During his tenure, he has served in a variety of positions with increased responsibility including Vice President of Corporate Accounts where he was in charge of leading a team of individuals to execute Health System Purchasing Contracts.

From there Mr.

Centea assumed the role of VP of Marketing for Endovascular Therapies, before being promoted into his most recent and current role as Sr.

Vice President/General Manager of Endovascular Therapies and Peripheral Artery Disease.

Centea assumed the role of Vice President of Marketing for Endovascular Therapies, before being promoted into his most recent and current role as Senior Vice President/General Manager of Endovascular Therapies and Peripheral Artery Disease.

Centea currently holds board positions with the American Venous Forum (AVF) and the Capital District American Heart Association.

Centea holds a Bachelor of Arts in Communications from Newberry College.

Davis joined AngioDynamics as Senior Vice President of Business Development in March 2015.

Prior to joining AngioDynamics, Mr.

Davis most recently was the Vice President of Business Integration at C.

where he also served as the Divisional Head of Business Development from 2004-2013.

Before joining C.

Bard, Inc., Mr.

Davis held the position of Chief Financial Officer and Treasurer at Axya Medical Inc.

He holds a Bachelor of Science in Business Administration from Bryant College and Master in Business Administration in Finance from Bentley University Graduate School of Business.

Helsel currently serves as Senior Vice President of Global Operations and has been with AngioDynamics since December 2017.

Helsel currently serves as Senior Vice President of Global Operations and Research and Development and has been with AngioDynamics since December 2017.

Prior to joining AngioDynamics he was Senior Vice President, Global Supply Chain, at Hill-Rom Holdings for almost three years.

4 unchanged sentences

Helsel holds a Bachelor of Science in Mechanical Engineering from LeTourneau University.

Nighan joined AngioDynamics as the Senior Vice President of Quality and Regulatory Affairs in April 2017.

Before joining AngioDynamics, Mr.

Nighan was a quality and regulatory consultant to clients in FDA-regulated industries, specializing in execution and management of quality systems implementation and remediation.

Previously, Mr.

Nighan served as the Executive Vice President of Global Clinical, Quality Affairs and Regulatory Affairs at Haemonetics Corporation, Vice President of Quality/Regulatory/Clinical/Technical Services at St.

Jude Medical’s Atrial Fibrillation Division, and Corporate Vice President of Quality/Compliance at Tyco Healthcare/Covidien (Medtronic).

Nighan earned a Bachelor and Master of Science in Nursing from Northeastern University’s Bouvé College of Health Sciences.

Laura Piccinini joined AngioDynamics as Senior Vice President and General Manager for International in June 2021.

12 unchanged sentences

Rosenzweig received his Bachelor of Arts in Psychology from Brandeis University and his Juris Doctor from Boston University School of Law.

He is an advisor to TEAMFund, an impact investment fund, serves as Vice Chair and Chair-Elect of the Director’s Leadership Council of the Rutgers Cancer Institute of New Jersey, and is a member of the Director’s Leadership Council for Rutgers Biomedical and Health Sciences, an academic medical center.

He serves as Vice Chair and Chair-Elect of the Director’s Leadership Council of the Rutgers Cancer Institute of New Jersey, and is a member of the Director’s Leadership Council for Rutgers Biomedical and Health Sciences, an academic medical center.

AVAILABLE INFORMATION

3 unchanged sentences

We make available, free-of-charge through our website, our Annual Reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file or furnish such materials to the SEC.

In addition, our website includes, among other things, charters of the various committees of our Board of Directors and our code of business conduct and ethics applicable to all employees, officers and directors.

Within the time period required by the SEC, we will post on our website any amendment to the code of business conduct and ethics and any waiver applicable to any executive officer, director or senior financial officer.

We use our website as a means of disclosing material non-public

information and for complying with our disclosure obligations under Regulation FD.

In addition, our website includes, among other things, charters of the various committees of our Board of Directors and our code of conduct and ethics applicable to all employees, officers and directors.

Within the time period required by the SEC, we will post on our website any amendment to the code of conduct and ethics and any waiver applicable to any executive officer, director or senior financial officer.

We use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts.

1 unchanged sentence

It is possible that the information we post on social media and blogs could be deemed to be material information.

Therefore, we encourage investors, the media, and others interested in our Company to review the information we post on the social media channels and blogs listed on our website.

Therefore, we encourage

investors, the media, and others interested in our Company to review the information we post on the social media channels and blogs listed on our website.

Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our Corporate headquarters, Attention:

2 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