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Item 1. Business

2021-07-27 compared with 2020-08-10 · 176 added, 160 removed, 298 unchanged (53% of the section changed)

AngioDynamics, Inc.

(together with its subsidiaries, "AngioDynamics," the "Company," "we," "our" or "us") 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.

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 was founded in Queensbury, N.Y., U.S., in 1988.

Queensbury was chosen due to its location in the heart of "Catheter Valley," an area in New York's Adirondack Region named for its long history of catheter and other medical device manufacturing.

Initially dedicated to the research and development of products used in interventional radiology, AngioDynamics began manufacturing and shipping product in the early 1990s.

The Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems.

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

The Company is headquartered in Latham, N.Y., with manufacturing primarily out of the Queensbury facility.

Initially dedicated to the research and development of products used in interventional radiology, the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems.

The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, Vortex Medical, Inc.

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 market-leading 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, AngioDynamics acquired Navilyst Medical, bringing market-leading Fluid Management systems into our portfolio.

The acquisition significantly expanded the Company's scale, doubling its share of the vascular access market while building critical mass in the peripheral vascular market.

These acquisitions added product lines including ablation and NanoKnife systems, vascular access products, angiographic products and accessories, dialysis products, drainage products, thrombolytic products, embolization products and venous products.

In May 2012, the Company acquired Navilyst Medical's Fluid Management business, which the Company sold in May 2019 to Medline Industries, Inc.

pursuant to an asset purchase agreement.

In August 2018, the Company acquired the BioSentry product line from Surgical Specialties, LLC.

In September 2018, the Company acquired RadiaDyne, which consisted of the OARtrac dose monitoring technology along with endorectal and vaginal balloons.

On May 31, 2019, the Company completed the sale of the Fluid Management business and all of the assets used primarily in connection with the Fluid Management business to Medline Industries, Inc.

pursuant to an asset purchase agreement dated April 17, 2019.

On October 2, 2019, the Company acquired Eximo Medical, Ltd., a pre-commercial stage medical device company and its proprietary 355nm laser atherectomy technology, which treats Peripheral Artery Disease.

This product has been renamed Auryon.

In September 2018, the Company acquired RadiaDyne, which included endorectal and vaginal balloons.

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.

This acquisition fills a gap in the Vascular Access portfolio.

Headquartered in Latham, N.Y., with manufacturing primarily out of the Queensbury facility, AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.

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

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

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

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

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.

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 NanoKnife System, an innovative alternative to thermal ablation.

The NanoKnife ® System is an alternative to traditional thermal ablation that has 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, 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 in the U.S.

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 minutes.

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

In addition to thermal ablation systems and NanoKnife, 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 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 IsoLoc 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, IsoLoc repositions and lifts the bowel in patients that have a low-lying bowel.

Alatus Vaginal Balloon Packing System

Alatus 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 Alatus, 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, Alatus 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 Interventions and Therapies Products

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

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, Pulse Spray and SpeedLyser infusion catheters.

AngioDynamics offers a range of options when treating thrombus and removing fresh, soft thrombi or emboli.

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AngioVac devices are for use with other manufacturers’ off-the-shelf pump, filter and reinfusion cannula, to facilitate venous drainage as part of an extracorporeal bypass procedure.

The AngioVac venous drainage cannula is a 22 French flat coil-reinforced cannula designed with a self-expanding nitinol reinforced funnel shaped distal tip.

The proprietary funnel shaped tip enhances venous drainage flow when the distal tip is exposed by retracting the sheath and prevents clogging of the cannula with commonly encountered undesirable intravascular material, and facilitates embolic removal of such extraneous material.

The Auryon Atherectomy system is the latest advancement in peripheral arterial disease.

Auryon System is designed to deliver an optimized wavelength, pulse width, and amplitude to remove lesions while preserving vessel wall endothelium.

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 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, Auryon has been shown to provide exceptional safety and efficacy.

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

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).

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 patented, 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.¹

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

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

Peripheral Products (Core)

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• 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.

This enables precise measurement for interventional devices (stents, filters, etc.)

This enables precise measurement for interventional devices such as stents.

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

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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 (fixed core and movable core) diagnostic guidewires.

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

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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 (endovenous laser treatment) system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins).

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.

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

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, allowing the patient to quickly return to normal activities with minimal post-operative pain.

VenaCure EVLT 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.

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 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.

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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.

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.

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

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 BioFlo, the only catheter on the market with Endexo Technology, a material more resistant to thrombus accumulation, in vitro (based on platelet count).

AngioDynamics offers the BioFlo catheter, the only catheter on the market with Endexo Technology, a material more resistant to thrombus accumulation, in vitro (based on platelet count).

Endexo Technology is a permanent and non-eluting polymer that is “blended” into the polyurethane from which the catheter is made.

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Endexo Technology remains present for the life of the catheter.

BioFlo’s long-term durability and efficacy is intended to provide clinicians a high degree of safety and confidence in providing better patient care and improved patient outcomes.

The BioFlo catheter’s long-term durability and efficacy is intended to provide clinicians a high degree of safety and confidence in providing better patient care and improved patient outcomes.

BioFlo catheters are available across the Vascular Access family of products, including PICCs, midlines, ports and dialysis catheters.

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• BioFlo PICC :

Our BioFlo line is the only power injectable PICC available that incorporates Endexo Technology into the manufacturing and design of the catheter.

Our BioFlo PICC line is the only power injectable PICC available that incorporates Endexo Technology into the manufacturing and design of the catheter.

Advanced features such as large lumen diameters allow the BioFlo PICC to deliver the power injection flow rates required for contrast-enhanced Computed Tomography (CT) scans compatible with up to 325 psi CT injections.

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C3 Wave PICC tip location system

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 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.

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• BioFlo Port :

Our BioFlo Port is the only port available that features a catheter with Endexo Technology.

Our BioFlo Port was the first port available featuring a catheter with Endexo Technology.

Advanced features of the BioFlo Port include multiple profile and catheter options, a large septum area for ease of access and the ability to administer contrast through a CT injection for purposes of imaging.

• SmartPort ® :

The Smart Port power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a (CT) scan.

• SmartPort, SmartPort+, SmartPort Plastic :

The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a CT scan.

The ability to access a port for power-injected contrast studies eliminates the need for additional needle sticks in the patient’s arm and wrist veins.

Once implanted, repeated access to the bloodstream can be accomplished with greater ease and less discomfort.

Our Smart Port is available in mini and low-profiles to accommodate more patient anatomies.

Our SmartPort port line is available in standard, mini and low-profiles to accommodate more patient anatomies.

The SmartPort+ port line combines Vortex technology with BioFlo catheters.

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.

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The PASV Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.

• LifeGuard ® :

The LifeGuard Safety Infusion Set and The LifeGuard Vision are used to infuse our ports and complement our port and vascular access catheters.

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Dialysis Products

We market a complete line of dialysis products that provide short and long-term vascular access for dialysis patients.

We market an extensive line of dialysis products that provide short and long-term vascular access for dialysis patients.

Dialysis, or cleaning of the blood, is necessary in conditions such as acute renal failure, chronic renal failure and end-stage renal disease (ESRD).

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• BioFlo DuraMax :

Our BioFlo DuraMax is the only dialysis catheter with Endexo Technology.

Our BioFlo DuraMax dialysis catheter is the only dialysis catheter with Endexo Technology.

Advanced features of the BioFlo DuraMax dialysis catheter include large inner diameter lumens designed for long term patency, a proprietary guidewire lumen to facilitate catheter exchanges and Curved Tip Technology that allows the catheter to self-center in the Superior Vena Cava (SVC).

• DuraMax ® :

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 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, Schon Chronic Hemodialysis Catheter, EVENMORE Chronic Hemodialysis Catheter, EMBOSAFE Valved Splitable Sheath Dilator and Perchik Button Suture Retention Device.

RESEARCH & DEVELOPMENT

Our growth depends in large part on the continuous introduction of new and innovative products, together with ongoing enhancements to our existing products.

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

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

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.

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

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TeleFlex Medical;

BD Medical Technology;

Becton Dickinson;

Smiths Medical, a subsidiary of Smiths Group plc;

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Johnson and Johnson;

Philips Healthcare;

Inari Medical;

Varian Medical Systems and Total Vein Systems.

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

We own two primary manufacturing properties providing capabilities which include manufacturing, service, engineering and research, distribution warehouses and offices.

These facilities are registered with the FDA and have been certified to ISO 13485 standards, as well as the CMD/CAS Canadian Medical Device Regulations.

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.

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.

AngioDynamics is certified under the Medical Device Single Audit Program ("MDSAP") which allows a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

• Therapeutic Goods Administration of Australia

• Brazil’s Agência Nacional de Vigilância Sanitária

• Health Canada

• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

Food and Drug Administration

Our manufacturing facilities are subject to periodic inspections by regulatory authorities to ensure compliance with domestic and non-U.S.

regulatory requirements.

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

See Item 2 "Properties" for details on each manufacturing location.

On May 31, 2019, the Company completed the sale of the Fluid Management business which included one of the two Glens Falls, NY manufacturing facilities.

As of June 1, 2019, the Company manufactures most of its product from the Queensbury, NY facility and one small facility in Glens Falls, NY.

Historically, we ship the majority of products within 24-48 hours of receiving an order, and accordingly our backlog is not significant.

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.

INTELLECTUAL PROPERTY

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Some products contain trademarks of companies other than AngioDynamics.

Item 3 of this report for additional details on litigation regarding proprietary technology.

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.

We operate in an industry characterized by extensive patent litigation.

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For additional information, see both Part I.

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

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

GOVERNMENT REGULATION

The products we manufacture and market are subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, or FDCA, and international regulations to our specific target markets.

The products we manufacture and market are subject to regulation by the United States Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, or FDCA, and international regulations in our specific target markets.

United States FDA Regulation

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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 preamendment 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 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.

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.

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

The process of FDA submissions requires extensive and expensive validations and testing.

The financial outlay for this is large and requires a significant amount of time.

Recent changes in both regulations and FDA perspectives have increased both time and testing requirements, which have caused significant delays and increased costs for approvals.

The parameters for increased testing have and will continue to cause severe delays.

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 problems and delays.

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.

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

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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.

Penalties for failure to maintain compliance to the QSR include warning letters and potentially consent decrees.

Failure to maintain the QSR appropriately could result in the development 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, withdrawal of marketing approvals, a recommendation by the FDA to disallow us to enter into government contracts, and criminal prosecutions.

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.

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.

The FDA also has the authority to request repair, replacement or refund of the cost of any device manufactured or distributed by us.

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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;

(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;

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In addition, the U.S.

Foreign Corrupt Practices Act (FCPA) can be used to prosecute companies in

Foreign Corrupt Practices Act (FCPA) can be used to prosecute companies in the U.S.

for arrangements with physicians or other parties outside the U.S.

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There can be no assurance that reimbursement approvals will be received.

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

Our product liability insurance coverage is limited to a maximum of $10 million per product liability claim and an annual aggregate policy limit of $10 million, subject to a self-insured retention of $500,000 per occurrence and $2 million in the aggregate.

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A successful product liability claim or other claim, with respect to uninsured or underinsured liabilities, could have a material adverse effect on our business.

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

ENVIRONMENTAL, HEALTH AND SAFETY

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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.

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.

The engagement of our workforce is crucial to delivering on our competitive strategy, and we place high importance on informed and engaged employees.

We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, town hall meetings and our company intranet.

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.

Executive Officers of the Company

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Trowbridge 47 Executive Vice President and Chief Financial Officer

Boucher 53 Senior Vice President and General Manager, Oncology/Surgery

Marna Bronfen-Moore 54 Senior Vice President, Human Resources

Campbell 50 Senior Vice President and General Manager, Vascular Access

Scott Centea 42 Senior Vice President and General Manager, VIT

Scott Centea 43 Senior Vice President and General Manager, Endovascular Therapies

Davis 56 Senior Vice President, Business Development

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Nighan 52 Senior Vice President, Quality and Regulatory Affairs

Seabury 53 Senior Vice President, Information Technology

Laura Piccinini 51 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.

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where he directed the strategic and day-to-day operations for global business divisions that collectively manufactured 23 different product categories.

In addition, he managed global manufacturing, research and development, operational excellence, business development and all

other functions associated with the medical supplies business.

In addition, he managed global manufacturing, research and development, operational excellence, business development and all other functions associated with the medical supplies business.

Prior to his role at Covidien, Mr.

Clemmer served as Group President at Kendall Healthcare, where he managed the U.S.

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

Clemmer served as Group President at Kendall Healthcare (which was acquired by Tyco International in 1994), where he managed the U.S.

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

Clemmer began his career at Sage Products, Inc.

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In addition to serving as the Company’s CFO and managing the finance functions, Mr.

Trowbridge also manages the Legal function on an interim basis.

Trowbridge also oversees the Company’s clinical affairs, medical affairs and healthcare economics departments.

Trowbridge also managed the Legal function on an interim basis until January 30, 2021.

Prior to AngioDynamics, Mr.

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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.

Boucher is our Senior Vice President and General Manager of our Oncology business.

Prior to joining AngioDynamics in November 2017, Mr.

Boucher served as Executive in Residence for PDI's Infection Prevention business.

Prior to that, he spent 20 years at Covidien where he served as General Manager for several global businesses, including Lung Solutions, Surgical Solutions and Respiratory Care.

Boucher is a graduate of North Dakota State University.

Boucher left the Company effective July 10, 2020.

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 3 years at Hologic as the Vice President, Global Human Resources, for both the Corporate Functions and Asia Pacific.

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 CR.

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

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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 VP 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 VP of Marketing for Vascular Interventions and Therapies, before being promoted into his most recent and current role as Sr.

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

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

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Prior to joining AngioDynamics, Mr.

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

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.R.

Before joining C.

Bard, Inc., Mr.

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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 services 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 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.

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Helsel worked at Haemonetics for three years where he served as Executive Vice President for Global Manufacturing and also spent almost nineteen years in various positions with increasing responsibility at Covidien, including Vice President of Operations for the Surgical Solutions Division and Medical Supplies Division.

in Lean and Six Sigma, Mr.

An expert in Lean and Six Sigma, Mr.

Helsel also served as Global Director of Operational Excellence, supporting sixty-three manufacturing facilities.

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

Seabury is our Senior Vice President, Information Technology and joined the Company in September 2011.

Prior to joining AngioDynamics, Mrs.

Seabury served as Vice President of Emerging Technologies and Product Development for Pitney Bowes Software, managing global software development teams for both core products and emerging SaaS solutions.

Prior to her role at Pitney Bowes, Mrs.

Seabury held several key leadership positions at MapInfo Corporation, including Global Managing Director of IT, IT Business Applications Director and Director of Web Operations.

Seabury is certified in PSI, Operational Excellence, ITIL and is a Six-Sigma Green Belt.

In addition, Mrs.

Seabury has extensive experience in project management and has participated in a variety of leadership development programs.

Seabury holds a Bachelor of Science degree in Applied Arts and Science from Rochester Institute of Technology.

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

From June 2020 to June 2021, she served as CEO and a member of the Board of Directors for Respiratory Motion, Inc.

Prior to that, from 2017 to 2020, she served as Global Head of Commercial Operations for the Implants business unit at Nobel Biocare Systems, then a Danaher subsidiary now part of Envista Holdings.

From 2015 to 2017, Ms.

Piccinini served as President of EMEA at Covidien and prior to that at Stryker.

Piccinini is a graduate of the Parma University of Medicine, where she received a nursing degree with specializations in ICU, Anesthesia, and First Aid as a Helicopter Flight Coordinator.

Rosenzwei g joined AngioDynamics as Senior Vice President General Counsel and Secretary in February 2021.

Rosenzweig brings to his role more than 20 years of experience in executive leadership providing legal guidance, governance and compliance oversight, and strategic business direction to global medical device and health care companies, including C.

Bard for more than ten years where he most recently served as Vice President, Law, and Assistant Secretary, Phibro Animal Health Corporation and Impath, Inc.

as Senior Vice President, General Counsel and Secretary, and Johnson & Johnson as Director, Licensing and Acquisitions.

Prior to AngioDynamics, Mr.

Rosenzweig advised companies in the medical device industry as an independent consultant on corporate development initiatives.

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.

AVAILABLE INFORMATION

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Our website is www.angiodynamics.com .

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 Securities and Exchange Commission, or 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.

Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our investor relations department:

AngioDynamics, 14 Plaza Drive, Latham, N.Y.

12110, Attention:

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.

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

We use these channels as well as social media and blogs to communicate with the public about our company, our services and other issues.

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.

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

Saleem Cheeks.

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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