AngioDynamics Inc. (ANGO) 2024年年度報告「NASDAQ」.pdf

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1、 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549FORM 10-KANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended May 31,2024 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the tra

2、nsition period from to Commission file number 0-50761AngioDynamics,Inc.(Exact name of registrant as specified in its charter)Delaware 11-3146460(State or other jurisdiction of incorporation or organization)(I.R.S.Employer Identification No.)14 Plaza Drive,Latham,New York 12110(Address of principal e

3、xecutive offices and zip code)(518)795-1400Registrants telephone number,including area code Securities registered pursuant to Section 12(b)of the Act:Title of each classTrading SymbolName of each exchange on which registeredCommon Stock,par value$.01 per shareANGONASDAQ Global Select Market Securiti

4、es registered pursuant to Section 12(g)of the Act:None(Title of Class)Indicate by check mark if the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d)o

5、f the Act.Yes No Indicate by check mark whether the registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(orfor such shorter period that the registrant was required to file such reports),and(2)has been subj

6、ect to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website,if any,every Interactive Data File required to be submitted and posted pursuantto Rule 405 of Regulation S-T during the preceding

7、 12 months(or for such shorter period that the registrant was required to submit and post such files).Yes No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein,and will not be contained,to the best of registrants knowledge,indefin

8、itive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reporting company,or an emerging growth c

9、ompany.Seedefinitions of“large accelerated filer”,“accelerated filer”,“smaller reporting company”and emerging growth company in Rule 12b-2 of the Exchange Act.(Check one):Large accelerated filer Accelerated filerNon-accelerated filer Smaller reporting companyEmerging growth companyIndicate by check

10、mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness of its internal control over financial reporting underSection 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered public accounting firm that prepared or issued its audi

11、t report.Yes No If securities are registered pursuant to Section 12(b)of the Act,indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an errorto previously issued financial statements.Indicate by check mark whether any of those er

12、ror corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrants executiveofficers during the relevant recovery period pursuant to 240.10D-1(b).Indicate by check mark whether the registrant is a shell company(as defined in Rule 12b

13、-2 of the Exchange Act).Yes No As of November 30,2023,the last business day of the registrants most recently completed second fiscal quarter,the aggregate market value of the registrants common stock held by non-affiliates was approximately$226,507,351 computed by reference to the last sale price of

14、 the common stock on that date as reported by The NASDAQ Global Select Market.As of July 24,2024 there were 40,276,582 shares of the registrants common stock outstanding.DOCUMENTS INCORPORATED BY REFERENCEThe information required for Part III of this Annual Report on Form 10-K is incorporated by ref

15、erence to the registrants Proxy Statement for its 2024 Annual Meeting of Stockholders to befiled within 120 days of the registrants fiscal year ended May 31,2024.AngioDynamics,Inc.and SubsidiariesINDEX PagePart I:Item 1.Business2Item 1A.Risk Factors14Item 1B.Unresolved Staff Comments29Item 1C.Cyber

16、Security29Item 2.Properties29Item 3.Legal Proceedings30Item 4.Mine Safety Disclosures30Part II:Item 5.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity31Item 6.Reserved32Item 7.Managements Discussion and Analysis of Financial Condition and Results of Ope

17、rations33Item 7A.Quantitative and Qualitative Disclosures About Market Risk44Item 8.Financial Statements and Supplementary Data44Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure44Item 9A.Controls and Procedures45Item 9B.Other Information47Item 9C.Foreign Ju

18、risdictions that Prevent Inspections47Part III:Item 10.Directors,Executive Officers and Corporate Governance48Item 11.Executive Compensation48Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters48Item 13.Certain Relationships and Related Transactions

19、,and Director Independence48Item 14.Principal Accounting Fees and Services48Part IV:Item 15.Exhibits,Financial Statement Schedules491 Part IUnless otherwise indicated in this report,AngioDynamics,the Company,we,our or us refers to AngioDynamics,Inc and our consolidatedsubsidiaries.Disclosure Regardi

20、ng Forward-Looking StatementsThis annual report on Form 10-K,including the sections entitled“Managements Discussion and Analysis of Financial Condition and Results ofOperations,”contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.All stateme

21、nts regardingAngioDynamics expected future financial position,results of operations,cash flows,business strategy,budgets,projected costs,capital expenditures,products,competitive positions,growth opportunities,plans and objectives of management for future operations,as well as statements that includ

22、e the wordssuch as expects,reaffirms,intends,anticipates,plans,believes,seeks,estimates,projects,optimistic,or variations of such words andsimilar expressions,are forward-looking statements.These forward-looking statements are not guarantees of future performance and are subject to risks anduncertai

23、nties.Investors are cautioned that actual events or results may differ materially from AngioDynamics expectations,expressed or implied.Factorsthat may affect the actual results achieved by AngioDynamics include,without limitation,the ability of AngioDynamics to develop its existing and newproducts,t

24、echnological advances and patents attained by competitors,infringement of AngioDynamics technology or assertions that AngioDynamicstechnology infringes the technology of third parties,the ability of AngioDynamics to effectively compete against competitors that have substantially greaterresources,fut

25、ure actions by the FDA or other regulatory agencies,domestic and foreign health care reforms and government regulations,results of pendingor future clinical trials,overall economic conditions(including inflation,labor shortages and supply chain challenges including the cost and availability ofraw ma

26、terials),the results of on-going litigation,challenges with respect to third-party distributors or joint venture partners or collaborators,the results ofsales efforts,the effects of product recalls and product liability claims,changes in key personnel,the ability of AngioDynamics to execute on strat

27、egicinitiatives,the effects of economic,credit and capital market conditions,general market conditions,market acceptance,foreign currency exchange ratefluctuations,the effects on pricing from group purchasing organizations and competition,the ability of AngioDynamics to obtain regulatory clearances

28、orapproval of its products,or to integrate acquired businesses.Other risks and uncertainties include,but are not limited to,the factors described from time totime in our reports filed with the Securities and Exchange Commission(the SEC).Although we believe that the assumptions underlying the forward

29、-looking statements contained herein are reasonable,any of the assumptions could beinaccurate and,therefore,there can be no assurance that the forward-looking statements included in this annual report on Form 10-K will prove to beaccurate.In light of the significant uncertainties inherent in the for

30、ward-looking statements included herein,the inclusion of such information should not beregarded as a representation by us or any other person that our objectives and plans will be achieved.Any forward-looking statements are made pursuant tothe Private Securities Litigation Reform Act of 1995 and,as

31、such,investors are cautioned not to place undue reliance on these forward-looking statementswhich speak only as of the date stated,or if no date is stated,as of the date of this report.AngioDynamics does not assume any obligation to publicly updateor revise any forward-looking statements for any rea

32、son.Disclosure Regarding TrademarksThis report includes trademarks,tradenames and service marks that are our property or the property of other third parties.Solely for convenience,suchtrademarks and tradenames sometimes appear without any“”or“”symbol.However,failure to include such symbols is not in

33、tended to suggest,in anyway,that we will not assert our rights or the rights of any applicable licensor,to these trademarks and tradenames.For a complete listing of all ourtrademarks,tradenames and service marks please visit 1.Business.OVERVIEWAngioDynamics is a leading and transformative medical te

34、chnology company focused on restoring healthy blood flow in the bodys vascular system,expanding cancer treatment options and improving quality of life for patients.HISTORYAngioDynamics was founded in Queensbury,N.Y.,U.S.,in 1988 and began manufacturing and shipping product in the early 1990s.The Com

35、pany isheadquartered in Latham,N.Y.,with manufacturing primarily out of the Queensbury facility.Initially dedicated to the research and development of productsused in interventional radiology,the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography

36、andthrombolytic delivery systems.The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007,Oncobionic inMay 2008,the assets of Diomed in June 2008,Vortex Medical,Inc.in October 2012,the assets of Microsulis Medical Limited in Ja

37、nuary 2013,and ClinicalDevices in August 2013.These acquisitions added product lines including ablation and NanoKnife systems,vascular access products,angiographic productsand accessories,dialysis products,2 drainage products,thrombolytic products,embolization products and venous products.In May 201

38、2,the Company acquired Navilyst Medicals FluidManagement 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,which the Company sold in June 2023 to M

39、eritMedical Systems,Inc.pursuant to an asset purchase agreement.In September 2018,the Company acquired RadiaDyne,which included endorectal andvaginal balloons.On October 2,2019,the Company acquired Eximo Medical,Ltd.,a pre-commercial stage medical device company and its proprietary355nm laser athere

40、ctomy technology(now called Auryon),which treats Peripheral Artery Disease.On December 17,2019,the Company acquired the C3Wave tip location asset from Medical Components Inc.,which the Company sold in February 2024 to Spectrum Vascular pursuant to an asset purchaseagreement.On July 27,2021,AngioDyna

41、mics acquired the Camaro Support Catheter asset from QX Medical,LLC and subsequently discontinued thisproduct in the third quarter of fiscal year 2024.AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.PRODUCTSOur product offerings fall within two segments,Med Tech a

42、nd Med Device.All products discussed below have been cleared for sale in the UnitedStates by the Food and Drug Administration.International regulatory clearances vary by product and jurisdiction.Med Tech AuryonThe Auryon Atherectomy System is one of our latest advancements inperipheral arterial dise

43、ase.The Auryon system is designed to deliver anoptimized wavelength,pulse width,and amplitude to remove lesions whilepreserving vessel wall endothelium.Additionally,the Auryon systemincludes aspiration which enhances the safety of the procedure.Regardlessof lesion type,the Auryon system provides saf

44、ety and efficacy.The Auryonsystem is indicated for use in the treatment,including atherectomy,ofinfrainguinal stenoses and occlusions,including in-stent restenosis(ISR),and to aspirate thrombus adjacent to stenoses in native and stentedinfrainguinal arteries.ThrombectomyOur Thrombus Management portf

45、olio includes the AlphaVac Mechanical Thrombectomy System,AngioVac venous drainage cannula and circuit,aswell as catheter directed thrombolytic devices,including the Uni-Fuse system,the Uni-Fuse+system,the Pulse Spray system and SpeedLyser infusioncatheters.AngioDynamics offers a range of options wh

46、en treating thrombus and removing fresh,soft thrombi or emboli.AngioVacOur AngioVac venous drainage system includes a VenousDrainage Cannula and Extracorporeal Circuit.The cannula is indicatedfor use as a venous drainage cannula and for removal of fresh,softthrombi or emboli during extracorporeal by

47、pass.The AngioVac circuitis indicated for use in procedures requiring extracorporeal circulatorysupport for periods of up to six hours.AngioVac devices are for usewith other manufacturers off-the-shelf pump,filter and reinfusioncannula,to facilitate venous drainage as part of an extracorporealbypass

48、 procedure.The AngioVac venous drainage cannula is a 22 French flat coil-reinforced cannula designed with a proprietary self-expanding nitinol reinforced funnelshaped distal tip.The funnel shaped tip enhances venous drainage flow when the distal tip3 is exposed by retracting the sheath,helps prevent

49、 clogging of the cannula with commonly encountered undesirable intravascular material,and facilitatesembolic removal of such extraneous material.AlphaVacThe AlphaVac System is an emergent mechanical aspiration devicethat eliminates the need for perfusionist support.AlphaVac is offered inboth a 22 Fr

50、ench flat coil-reinforced cannula and an 18 French braidedreinforced cannula each designed with a proprietary self-expanding nitinolreinforced funnel shaped distal tip.AlphaVac is indicated for the non-surgical removal of thrombi or emboli from vasculature as well asaspiration of contrast media and

51、other fluids from the vasculature.Thecannula is intended for use in the venous system.The handle is indicated asa vacuum source for the AlphaVac MMA system.The AlphaVac F18system is indicated for the treatment of pulmonary embolism and allows forthe utilization in the non-surgical removal of thrombi

52、 or emboli from thevenous vasculature,reducing thrombus burden and improving rightventricular function in patients with PE.Thrombolytic CathetersThrombolytic catheters are used to deliver thrombolytic agents,which are drugs that dissolve blood clots in hemodialysis access grafts,arteries,veinsand su

53、rgical bypass grafts.AngioDynamics Uni-Fuse infusion catheter features pressure response outlets,a proprietary slit technology that provides aconsistent,even distribution of fluid volume along the entire length of the infusion pattern,designed to provide an advantage over standard side-holecatheters

54、.We also offer the Pulse-Spray infusion system for high pressure,pulsed delivery of lytic agents designed to shorten treatment time,and the SpeedLyserinfusion system built for dialysis grafts and fistulas.NanoKnifeThe NanoKnife IRE Ablation System is an alternative to traditionalthermal ablation tha

55、t received 510(k)clearance from the Food and DrugAdministration for the surgical ablation of soft tissue.The system utilizeslow energy direct current electrical pulses to permanently open pores intarget cell membranes.These permanent pores or nano-scale defects in thecell membranes result in cell de

56、ath.The treated tissue is then removed bythe bodys natural processes in a matter of weeks,mimicking natural celldeath.Unlike other ablation technologies,the NanoKnife System does notachieve tissue ablation using thermal energy.The NanoKnife System consists of two major components:a Low Energy Direct

57、 Current,or LEDC Generator and needle-like electrode probes.Up tosix(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 forvoltage,number of pulses,interval between pulses,and the pulse length into the gene

58、rator user interface.The generator then delivers a series of short electricpulses between each electrode probe.The energy delivery is hyperechoic and can be monitored under real-time ultrasound.4 Med DevicePeripheral Products(Interventional Devices)We offer a comprehensive portfolio of products for

59、use during minimally invasive procedures.Product categories include an extensive line ofangiographic catheters,guidewires,drainage catheters and micropuncture kits.Angiographic Catheters&GuidewiresOur extensive line of various angiographic catheter configurations are designed to allow physicians to

60、navigate and reach targeted anatomical locationswithin a patients vasculature that are in need of angiographic diagnosis.Typically run over a diagnostic guidewire,our angiographic catheters allowphysicians to deliver contrast media to the desired location to determine the diagnosis and subsequent th

61、erapeutic modalities,as needed for the patient.AngioDynamics offers three different angiographic catheter lines to meet physicians procedural needs.All of our catheters feature our soft,atraumatic,super-radiopaque tip that is uniquely welded to our co-extruded nylon shaft,which provides excellent vi

62、sibility under fluoroscopy and re-enforced tipstability.Soft-Vu Angiographic Catheters highlight the soft,atraumatic super-radiopaque and proprietary tip-to-shaft weld in a full offering of different tipshapes,lengths and french sized flush and selective catheters.Flush catheters are used in procedu

63、res where a large volume of contrast is required todeliver a concentrated bolus of contrast quickly for visualization or larger anatomical locations,such as the aorta or for run-offs into lowerextremities.Selective catheters are typically used to gain access to more specific vasculature within the b

64、ody to deliver smaller amounts of contrast.Mariner Hydrophilic Catheters also feature a hydrophilic coating on the distal 20cm of the catheter that reduces friction during catheteradvancement in the vasculature and allows for smooth navigation,as well as,optimum handling and control by the physician

65、.Accu-Vu Sizing Catheters are our line of flush catheters that also feature highly visible radiopaque marker bands,which are heat embedded,alongthe catheter shaft,providing a smooth transition across the catheter shaft to ensure the marker bands will not separate from the shaft.Theseradiopaque marke

66、r bands come in different patterns along the shaft and allow physicians,under fluoroscopy,to take measurements in differentanatomical locations for the placement of stents,IVC filters or other devices.The tight tolerances and consistent placement across the entire sizingpattern,within+/-1mm of accur

67、acy,provide a highly accurate measurement to the physician.AngioDynamics offers a line of diagnostic and interventional guidewires which are designed to aid in delivering diagnostic and/or therapeutic devicesto the desired location.The ADx Peripheral Vascular Guidewire line is AngioDynamics diagnost

68、ic line of guidewires that is available in a multitude of fixed core wireconfigurations,including J-Tip and Bentson,in various lengths and ODs.By utilizing a proprietary pre-coat process for the Polytetrafluoroethylene(PTFE)and upholding tight specifications,our ADx Guidewires offer high quality and

69、 performance for physicians.The NiT-Vu High Performance Micro Guidewires are our highly kink resistant nitinol shaft interventional wires that feature a highly visibleradiopaque tungsten tip and lubricious coating.The NiT-Vu wires are designed to reduce friction during wire advancement and also prov

70、ides torquecontrol,flexibility and kink resistance.Drainage ProductsTo aid physicians in percutaneous drainage procedures,AngioDynamics offers two different Drainage Catheter lines:Total Abscession DrainageCatheters and Exodus Drainage Catheters.Each line is available in a Multipurpose/General and B

71、iliary configuration,while Total Abscession also offers aNephrostomy option.Both lines offer options with a radiopaque marker band at the distal tip to aid in placement.The Total Abscession Drainage Catheter line offers a soft,kink resistant shaft that features the lubricious Blue Silk Finish for ea

72、sier insertion andpushability,while providing the optimal patient comfort.The unique Vault Locking Mechanism securely fixes the pigtail and prevents tampering oraccidental removal.The Exodus Drainage line features an integrated polymer blend extruded shaft with external catheter markings,and GLYCE H

73、ydrophilic Coatingon the distal 20cm of the catheter shaft.The unique Sure-Twist hub provides audible and tactile feedback when locked,without the need for aseparate tool.5 Micropuncture KitsAngioDynamics offers physicians two micropuncture kit lines that are designed to start each procedure with ea

74、se and efficiency:Mini Stick MAXCoaxial Microintroducer Kits and Micro-Introducer Kits.Each kit features a coaxial design with a 4F or 5F sheath introducer and stiff or standard dilator,along with a 21G needle and various 0.018”access wire configurations.Mini Stick MAX Coaxial Introducer kits contai

75、n a unique containment clip that keeps all the unique components of the kit together and organize.The kit options include our AngioDynamics proprietary coaxial introducer with smooth transition at the tip,translucent 21G needle with bevelindicator and 0.018”access wire available in three different w

76、ire material configurations.The Micro-Introducer Kits offer a variety of configurations that include aid in simplifying set up and gaining vascular access.PortsPorts are implantable devices utilized for the central venous administration of a variety of medical therapies and for blood sampling and di

77、agnosticpurposes.Central venous access facilitates a more systemic delivery of treatment agents,while mitigating certain harsh side effects of certain treatmentprotocols and eliminating the need for repeated access to peripheral veins.Depending upon needle gauge size and the port size,a port can be

78、utilized for upto approximately 2,000 accesses once implanted in the body.Our ports are used primarily in systemic or regional short-and long-term cancer treatmentprotocols that require frequent infusions of highly concentrated or toxic medications(such as chemotherapy agents,antibiotics or analgesi

79、cs)and frequentblood samplings.Our port products and accessories include:SmartPort,SmartPort+,SmartPort Plastic:The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access avein for both the delivery of medications or fluids and for administering power-inj

80、ected contrast to perform a CT scan.The ability to access a portfor power-injected contrast studies eliminates the need for additional needle sticks in the patients arm and wrist veins.Once implanted,repeatedaccess to the bloodstream can be accomplished with greater ease and less discomfort.Our Smar

81、tPort port line is available in standard,mini andlow-profile to accommodate more patient anatomies.The SmartPort+port line combines Vortex technology with BioFlo catheters.In addition to thethree titanium port body sizes,there is a plastic port body.BioFlo Port:Our BioFlo Port was the first port ava

82、ilable featuring a catheter with Endexo Technology.Advanced features of the BioFlo Portinclude multiple profile and catheter options,a large septum area for ease of access,PASV and non-PASV valve technology and the ability toadminister contrast through a CT injection for purposes of imaging.Xcela Pl

83、us:The Xcela Plus Port product family is Power-Injectable and part of a complete portfolio of vascular access products,and is fullycompatible with the LifeGuard Safety Infusion product family.It has easily identifiable critical information radiopaque“CT”lettering which helpsto confirm if port is pow

84、er-injectable or flipped.The Xcela Plus port family is available in single lumen standard size in either a non-valved orvalved configuration.Port TechnologiesBioFlo:AngioDynamics offers the BioFlo catheter,the only catheter on the market with Endexo Technology,a material more resistant to thrombusac

85、cumulation,in vitro(based on platelet count).Endexo Technology is a permanent and non-eluting polymer that is“blended”into thepolyurethane from which the catheter is made.It is present throughout the catheter,including the extraluminal,intraluminal and cut catheter surfaceof the tip.Endexo Technolog

86、y remains present for the life of the catheter.The BioFlo catheters long-term durability and efficacy is intended toprovide clinicians a high degree of safety and confidence in providing better patient care and improved patient outcomesVortex:Our Vortex port technology line of ports features a clear

87、-flow port technology that,we believe,revolutionized port design.With its roundedchamber,the Vortex port is designed to have no sludge-harboring corners or dead spaces.This product line consists of titanium,plastic and dual-lumen offerings.PASV Valve Technology:The PASV Valve Technology is designed

88、to automatically resist backflow and reduce blood reflux that could lead tocatheter-related complications.6 Venous InsufficiencyVenaCure EVLT laser systemOur VenaCure EVLT system products are used in endovascular laserprocedures to treat superficial venous disease(varicose veins).Superficialvenous d

89、isease is a malfunction of one or more valves in the leg veinswhereby blood refluxes or does not return to the heart,thereby pooling inthe 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 destr

90、oying)the affected vein.Blood is then re-routed toother 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 pr

91、ocedure 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 wallusing lower power settings thereby reducing the risk of collateral damage.The NeverTouch ti

92、p fiber eliminates laser tip contact with the vein wall,which inturn minimizes perforations of the vein wall that typically result in less pain and bruising as compared to traditional bare-tip fibers.The NeverTouch tip alsomaximizes ultrasonic visibility,making it easier for physicians to use.Proced

93、ure kits are available in a variety of lengths and configurations to accommodatevaried patient anatomies.The VenaCure EVLT system comes with a comprehensive physician training program and extensive marketing support.Microwave AblationSolero Microwave Tissue Ablation(MTA)SystemThe Solero MTA System f

94、eatures the Solero Microwave(MW)Generator and the specially designed Solero MW Applicators.The solidstate Solero MW Generator with a 2.45 GHz operating frequency canpower up to 140W for optimized power delivery and fast ablations.TheSolero MW Applicators optimized ceramic tip diffuses MW energy near

95、lyspherically,and its patented cooling channel with thermocouple providesreal-time monitoring to help protect non-targeted tissue during the ablation.In addition,the Solero MTA System offers physicians scalability with asingle applicator designed for multiple,predictable ablation volumes byvarying t

96、ime and wattage.Solero is a single applicator system able tocomplete 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 intendedfor cardiac use.IsoLoc Endorect

97、al BalloonThe IsoLoc Endorectal Balloons unique,customer-driven design is the result of collaborations with Radiation Oncologists,Therapists and Physicistswith 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 address

98、es patient comfort,but also simplifies three challenging clinical scenarios that many physicians facewhen using radiation therapy for and/or in relation to the prostate.First,its gas-release tip removes rectal gas and reduces prostate motion for gaseouspatients.Secondly,the structure of the ERB aids

99、 in defining the anatomy for difficult planning scenarios with post-radical patients.Lastly,the IsoLoc devicerepositions and lifts the bowel in patients that have a low-lying bowel.7 Alatus Vaginal Balloon Packing SystemThe Alatus device was developed with the patients comfort in mind and to assist

100、the physician to move healthy tissue away from the radiationtreatment field.Prior to the Alatus device,the clinician would push gauze into the vagina to move the bladder and bowel away from the radiation treatmentfield.Inserting gauze into the vagina can be uncomfortable before treatment and unpleas

101、ant at the end of treatment as it tends to dry out before removing.RESEARCH&DEVELOPMENTOur growth depends in large part on the continuous introduction of new and innovative products,together with ongoing enhancements to our existingproducts.This happens through internal product development,technolog

102、y licensing,strategic alliances and acquisitions.Our research and development(R&D)teams work closely with our marketing teams,sales force and regulatory and compliance teams to incorporate customer feedback into ourdevelopment and design process.We believe that we have a reputation among interventio

103、nal physicians as a strong partner for developing high qualityproducts because of our tradition of close physician collaboration,dedicated market focus,responsiveness and execution capabilities for productdevelopment and commercialization.We recognize the importance of,and intend to continue to make

104、 investments in R&D.COMPETITIONWe encounter significant competition across our product lines and in each market in which our products are sold.These markets are characterized byrapid change resulting from technological advances,scientific discoveries and changing customer needs and expectations.We f

105、ace competitors,rangingfrom large manufacturers with multiple business lines,to small manufacturers that offer a limited selection of products.Our primary device competitors include:Boston Scientific Corporation;Cook Medical;Medical Components,Inc.(MedComp);TeleFlex Medical;Becton Dickinson;Medtroni

106、c;Merit Medical;Terumo Medical Corporation;Johnson and Johnson;Philips Healthcare;Inari Medical;Varian MedicalSystems and Total Vein Systems.We believe our products compete primarily based on their quality,clinical outcomes,ease of use,reliability,physician familiarity and cost-effectiveness.In the

107、current environment of managed care,which is characterized by economically motivated buyers,consolidation among health careproviders,increased competition and declining reimbursement rates,we have been increasingly required to compete on the basis of price.We believe thatour continued competitive su

108、ccess 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 regulatoryand reimbursement appro

109、vals,manufacture and successfully market our products either directly or through third parties,and maintain sufficient inventory tomeet customer demand.SALES AND MARKETINGWe sell our broad line of quality devices in the United States primarily through a direct sales force and internationally through

110、 a combination of directsales and distributor relationships.We support our customers and sales organization with a marketing staff that includes product managers,customer servicerepresentatives and other marketing specialists.We focus our sales and marketing efforts on interventional radiologists,in

111、terventional cardiologists,vascularsurgeons,urologists,interventional and surgical oncologists and critical care nurses.MANUFACTURINGWe manufacture certain proprietary components and products and then assemble,inspect,test and package our finished products.By designing andmanufacturing many of our p

112、roducts from raw materials,and assembling and testing our subassemblies and products,we believe that we are able to maintainbetter quality control,ensure compliance with applicable regulatory standards and our internal specifications,and limit outside access to our proprietarytechnology.We have cust

113、om-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existingproduction machinery.We manufacture many of our products from two owned manufacturing properties,one in Queensbury,NY and one small facility in Glens Falls,NY,providing capabilities

114、 which include manufacturing,service,offices,engineering and research and we lease distribution warehouses.The manufacturingfacilities are registered with the FDA and have been certified to ISO 13485 standards.ISO 13485 is a quality system standard that satisfies European Unionregulatory requirement

115、s,thus allowing us to market and sell our products in European Union countries.AngioDynamics is certified under the MedicalDevice Single Audit Program(MDSAP)which allows a recognized auditing organization to conduct a single regulatory audit of a medical devicemanufacturer to satisfy the relevant re

116、quirements of the regulatory authorities participating in the program.International partners that are participating in theMDSAP include:Therapeutic Goods Administration of Australia8 Brazils Agncia Nacional de Vigilncia SanitriaHealth CanadaJapans Ministry of Health,Labour and Welfare,and the Japane

117、se Pharmaceuticals and Medical Devices AgencyU.S.Food and Drug AdministrationOur manufacturing facilities are subject to periodic inspections by regulatory authorities to ensure compliance with domestic and non-U.S.regulatoryrequirements.See“Government Regulation”section of this Item 1 for additiona

118、l information.See Part I,Item 2 Properties in this Annual Report on Form10-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 Ricacorporation,with its principal place

119、 of business in Alajuela,Costa Rica.Precision Concepts is manufacturing,storing,and handling certain products for theCompany and is registered with the FDA and certified to the ISO 13485 standard.The Company also relies on third party manufacturers for themanufacturing of certain products.During the

120、 third quarter of fiscal year 2024,AngioDynamics announced the restructuring of its manufacturing footprint and a plan to shift to a fullyoutsourced model by the third quarter of fiscal year 2026.BACKLOGWe have historically kept sufficient inventory on hand to ship product within 24-48 hours of orde

121、r receipt to meet customer demand.In fiscal year2024,the Companys ability to manufacture products,the reliability of our supply chain,labor shortages,backlog and inflation(including the cost andavailability of raw materials,direct labor and shipping)have impacted our business and resulted in a backl

122、og of$1.3 million at the end of the fourth quarterdown$1.4 million from the fourth quarter of fiscal year 2023.We continue to focus on meeting the demand for our product and working towards standardinventory and backlog levels in fiscal year 2025.See Part I,Item 1A Risk Factors in this Annual Report

123、 on Form 10-K.INTELLECTUAL PROPERTYPatents,trademarks and other proprietary rights are very important to our business.We also rely upon trade secrets,manufacturing know-how,technological innovations and licensing opportunities to maintain and improve our competitive position.We regularly monitor and

124、 review third-partyproprietary rights,including patents and patent applications,as available,to aid in the development of our intellectual property strategy,avoid infringementof third-party proprietary rights,and identify licensing opportunities.The Company owns an extensive portfolio of patents and

125、 patent applications in theUnited States and in certain foreign countries.The portfolio also includes exclusive licenses to third party patents and applications.Most of our products aresold under the AngioDynamics trade name or trademark.Additionally,products are sold under product trademarks and/or

126、 registered product trademarksowned by AngioDynamics,Inc.,or an affiliate or subsidiary.Some products contain trademarks of companies other than AngioDynamics.See Part I,Item 3 Legal Proceedings and Note 17 to the consolidated financial statements in this Annual Report on Form 10-K for additional de

127、tailson litigation regarding proprietary technology.LITIGATIONWe operate in an industry characterized by extensive patent litigation.Patent litigation can result in significant damage awards and injunctions thatcould prevent the manufacture and sale of affected products,or result in significant roya

128、lty payments in order to continue selling those products.The medicaldevice industry is also susceptible to significant product liability claims.These claims may be brought by individuals seeking relief on their own behalf orpurporting to represent a class.In addition,product liability claims may be

129、asserted against us in the future based on events we are not aware of at thepresent time.At any given time,we are involved in a number of product liability actions.For additional information,see both Part I,Item 3 LegalProceedings and Note 17 to the consolidated financial statements in this Annual R

130、eport on Form 10-K.GOVERNMENT REGULATIONThe 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 Regulatio

131、nBefore a new medical device can be introduced into the market,a manufacturer generally must obtain marketing clearance or approval from the FDAthrough either a 510(k)submission(a premarket notification)or a premarket approval application(PMA).The 510(k)clearance procedure is available only if a man

132、ufacturer can establish that its device is“substantially equivalent”in intended use and insafety and effectiveness to a“predicate device,”which is(i)a device that has been cleared9 through the 510(k)clearance process;(ii)a device that was legally marketed prior to May 28,1976(preamendment device);or

133、(iii)a device that wasoriginally on the U.S.market as a Class III device(Premarket approval)and later downclassified to Class II or I.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 in

134、tended use,requires a new 510(k)clearance.The 510(k)clearance procedure including questions and responses may take up to 12 months.In some cases,supporting clinical data may berequired.The FDA may determine that a new or modified device is not substantially equivalent to a predicate device or may re

135、quire that additionalinformation,including clinical data,be submitted before a determination is made,either of which could significantly delay the introduction of a new ormodified device.If a device cannot demonstrate substantial equivalence,it may be subject to either a De Novo 510(k)submission or

136、a PMA.The PMA application procedure is more comprehensive than the 510(k)procedure and typically takes more time to complete.The PMA applicationmust be supported by scientific evidence providing pre-clinical and clinical data relating to the safety and efficacy of the device and must include otherin

137、formation about the device and its components,design,manufacturing,and labeling.The FDA will approve a PMA application only if reasonableassurance that the device is safe and effective for its intended use can be provided.As part of the PMA application review,the FDA will inspect themanufacturers fa

138、cilities for compliance with its Quality System Regulation,or QSR.As part of the PMA approval the FDA may place restrictions on thedevice,such as requiring additional patient follow-up for an indefinite period of time.If the FDAs evaluation of the PMA application or the manufacturingfacility is not

139、favorable,the FDA may deny approval of the PMA application or issue a“not approvable”letter.The FDA may also require additional clinicaltrials,which can delay the PMA approval process by several years.After the PMA is approved,if significant changes are made to a device,itsmanufacturing or labeling,

140、a PMA supplement containing additional information must be filed for prior FDA approval.Historically,our products have been introduced into the market using the 510(k)procedure.FDA submissions require extensive validations and testing which requires a significant amount of time and financial resourc

141、es.Recent changes in bothregulations and FDA perspectives have increased both time and testing requirements,which have caused and are expected to continue to cause significantdelays and increased costs for clearances and approvals.The increased focus by the FDA on such issues as chemical identificat

142、ion 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 existingproducts call into question previously approved devices and result in additional costs for testing and material analysis.Th

143、e devices manufactured by us are also subject to the QSR,which imposes elaborate testing,control,documentation and other quality assuranceprocedures on our manufacturing facilities.Every phase of production,including raw materials,components and subassembly,manufacturing,testing,quality control,labe

144、ling,tracing of customers after distribution and follow-up and reporting of complaint information is governed by the FDAs QSR.Devicemanufacturers are required to register their facilities and list their products with the FDA and certain state agencies.The FDA periodically inspectsmanufacturing facil

145、ities and,if there are alleged violations,the operator of a facility must correct them or satisfactorily demonstrate the absence of theviolations or face regulatory action.Failure to maintain compliance with the QSR may result in the issuance of one or more Forms 483 or warning lettersand could pote

146、ntially 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 orpa

147、rtial suspension of production,failure of the FDA to grant marketing approvals,inability to obtain clearances or approvals for products,withdrawal ofmarketing approvals,a recommendation by the FDA to disallow us to enter into government contracts,and/or criminal prosecutions.The FDA also has theauth

148、ority to request repair,replacement or refund of the cost of any device manufactured or distributed by us.Other U.S.Regulatory BodiesWe 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 andour products are a

149、lso 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.In addition,we are subject to various federaland state laws

150、governing our relationships with the physicians and others who purchase or make referrals for our products.For instance,federal lawprohibits payments of any form that are intended to induce a referral for any item payable under Medicare,Medicaid or any other federal healthcareprogram.Many states hav

151、e similar laws.There can be no assurance that we will not be required to incur significant costs to comply with such laws andregulations now or in the future,or that such laws or regulations will not have a material adverse effect upon our ability to do business.10 International RegulationInternatio

152、nally,all of our current products are considered medical devices under applicable regulatory regimes,and we anticipate that this will be truefor all of our future products.Sales of medical devices are subject to regulatory requirements in many countries.The regulatory review process may varygreatly

153、from country to country.In order to distribute and sell products into the European Union as well as a number of other countries including many Central European Free TradeAgreement participants,Scandinavian,and Middle Eastern countries,a CE Mark is required.New products must be compliant with the Med

154、ical DeviceRegulation(MDR)as of May 2021 and previously CE Marked products must become compliant when their certification expires,with a transition periodending December 2027 for higher classification devices,or December 2028 for lower classification devices.Products with an expiring certification m

155、ust bein distribution before certification expiration dates to continue to be sold.Clinical evaluations of products under MDR requires more information thanpreviously required.All devices must have current clinical literature that specifically addresses data-driven safety and performance criteria,an

156、d legacydevices often require additional biocompatibility,bench testing and redesign to address changes in standards over time.Additionally,there can be extendedtime frames under MDR for product certifications that can be 12-18 months or longer.During that time period,significant design modification

157、s cannot bemade.Similar regulations are in place for Canada,Japan,China,Brazil and most other countries.In some cases,we rely on our international distributors toobtain regulatory approvals,complete product registrations,comply with clinical trial requirements and complete those steps that are custo

158、marily taken inthe applicable jurisdictions.International sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United States,or arebanned or deviate from lawful performance standards,are subject to FDA export requirements.Before export

159、ing such products to a foreign country,we mustfirst comply with the FDAs regulatory procedures for exporting unapproved devices.The process of obtaining approval to distribute medical products is costly and time-consuming in virtually all the major markets where we sell medicaldevices.We cannot assu

160、re 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 preventsale of our c

161、urrent or future products.THIRD-PARTY REIMBURSEMENT AND ANTI-FRAUD AND CORRUPT PRACTICES REGULATIONUnited StatesThe delivery of our devices is subject to regulation by the Department of Health and Human Services(HHS)and comparable state and non-U.S.agencies responsible for reimbursement and regulati

162、on of health care items and services.U.S.laws and regulations are imposed primarily in conjunctionwith the Medicare and Medicaid programs,as well as the governments interest in regulating the quality and cost of health care.Foreign governments alsoimpose regulations in conjunction with their health

163、care reimbursement programs and the delivery of health care items and services.U.S.federal health care laws apply when we or customers submit claims for items or services that are reimbursed under Medicare,Medicaid,or otherfederally-funded health care programs.The principal U.S.federal laws include:

164、(1)the Anti-kickback Statute which prohibits offers to pay or receiveremuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable by a federal health care program,subject tocertain safe harbor exceptions;(2)the False Claims Act which prohibits the sub

165、mission 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;(3)the Stark law which prohibits physicians fromreferring Medicare or Medicaid patients to a provider that bills these programs

166、 for the provision of certain designated health services if the physician(or amember of the physicians immediate family)has a financial relationship with that provider;and(4)health care fraud statutes that prohibit false statementsand improper claims to any third-party payer.There are often similar

167、state false claims,anti-kickback,and anti-self-referral and insurance laws that apply tostate-funded Medicaid and other health care programs and private third-party payers.In addition,the U.S.Foreign Corrupt Practices Act(FCPA)can be usedto prosecute companies in the U.S.for arrangements with physic

168、ians or other parties outside the U.S.if the physician or party is a government official ofanother country and the arrangement violates the law of that country.InternationalThe delivery of our devices in any EU member country is subject to evolving regulation by the EU Medical Device Regulations,not

169、ified bodies andcomparable nation-specific bodies whether part of the EU or not,responsible for reimbursement and regulation of health care items and services.Oursuccess in international markets will depend largely upon the availability of reimbursement from the national public health payers as well

170、 as private,thirdparty payors,through which healthcare providers are paid in those markets.Reimbursement and healthcare payment systems vary significantly by country.The main types of healthcare payment systems are government sponsored healthcare and private insurance.Reimbursement11 approval must b

171、e obtained individually in each country in which our products are marketed.Members of our healthcare economics team work directly withproviders,our distributors and health systems to obtain reimbursement approval in the countries in which they will use or sell our products.There can be noassurance t

172、hat reimbursement approvals will be received.See Part I.Item 1A Risk Factors in this Annual Report on Form 10-K.INSURANCEOur product liability insurance coverage is limited to a maximum of$10 million per product liability claim and an annual aggregate policy limit of$10million,subject to a self-insu

173、red retention of$500,000 per occurrence and$2 million in the aggregate.The policy covers,subject to policy conditions andexclusions,claims of bodily injury and property damage from any product sold or manufactured by us.There is no assurance that this level of coverage is adequate.We may not be able

174、 to sustain or maintain this level of coverage and cannot assure youthat adequate insurance coverage will continue to be available on commercially reasonable terms,or at all.A successful product liability claim or otherclaim,with respect to uninsured or underinsured liabilities,could have a material

175、 adverse effect on our business.See Part I.Item 1A Risk Factors in thisAnnual Report on Form 10-K.ENVIRONMENTAL,HEALTH AND SAFETYWe are subject to federal,state and local laws,rules,regulations and policies governing the use,generation,manufacture,storage,air emission,effluentdischarge,handling and

176、disposal of certain hazardous and potentially hazardous substances used in connection with our operations.Our operations are alsosubject to laws and regulations related to occupational health and safety.We maintain safety,training and maintenance programs as part of our ongoingefforts to ensure comp

177、liance with applicable laws and regulations.Although we believe that we have complied with environmental,health and safety lawsand regulations in all material respects and,to date,have not been required to take any action to correct any noncompliance,there can be no assurance thatwe will not be requ

178、ired to incur significant costs to comply with environmental regulations in the future.EMPLOYEESAs of May 31,2024,we had approximately 748 full time employees.None of our employees are represented by a labor union and we have neverexperienced a work stoppage.In the highly competitive medical technol

179、ogy industry,we consider attracting,developing,engaging and retaining highperforming talent in positions critical to our long-term growth strategy including but not limited to technical,operational,marketing,sales,research anddevelopment,and management.Our ability to recruit and retain such talent d

180、epends on several factors,including culture,compensation and benefits,talentdevelopment,career opportunities,recognition and work environment.Our goal is to create a diverse and inclusive culture that encourages an environmentwhere employees feel welcomed,respected and valued.We are an equal opportu

181、nity/affirmative action employer committed to making employmentdecisions without regard to race,religion,ethnicity or national origin,gender,sexual orientation,gender identity or expression,age,disability,protectedveteran status or any other characteristics protected by law.The engagement of our wor

182、kforce is crucial to delivering on our competitive strategy,and we place high importance on informed and engagedemployees.We communicate frequently and transparently with our employees through a variety of communication methods,including video and writtencommunications,town hall meetings and our com

183、pany intranet.Executive Officers of the CompanyThe following table sets forth certain information with respect to our executive officers.NameAgePositionJames C.Clemmer60President and Chief Executive OfficerStephen A.Trowbridge50Executive Vice President and Chief Financial OfficerChad T.Campbell53Sen

184、ior Vice President and General Manager,Global Oncology and Vascular AccessLaura Piccinini54Senior Vice President and General Manager,Endovascular Therapies and InternationalWarren G.Nighan55Senior Vice President,Global Supply Chain,Quality and Regulatory AffairsJames C.Clemmer became our President a

185、nd Chief Executive Officer(CEO)in April 2016.Prior to joining AngioDynamics,Mr.Clemmer served asPresident of the$1.8 billion medical supplies segment at Covidien plc.where he directed the strategic and day-to-day operations for global businessdivisions that collectively manufactured 23 different pro

186、duct categories.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(which was ac

187、quired by Tyco International in 1994),where he managed the U.S.business acrossfive divisions and built the strategic plan for the medical supplies segment before Covidien was spun off12 from Tyco.Mr.Clemmer began his career at Sage Products,Inc.Mr.Clemmer currently serves on the Board of Directors f

188、or AngioDynamics and previouslyserved on the Board of Directors for Lantheus Medical Imaging.Mr.Clemmer is a graduate of the Massachusetts College of Liberal Arts,where he served asinterim president from August 2015 until March 2016.Stephen A.Trowbridge was appointed Executive Vice President and Chi

189、ef Financial Officer(CFO)in February 2020,having served as Interim ChiefFinancial Officer since October 2019.Prior to his appointment as CFO,he served as the Companys Senior Vice President and General Counsel.He joinedAngioDynamics in June 2008 as Corporate Counsel.In addition to serving as the Comp

190、anys CFO and managing the finance functions,Mr.Trowbridge alsomanages the Legal function.Prior to AngioDynamics,Mr.Trowbridge served as Corporate Counsel at Philips Healthcare and Intermagnetics GeneralCorporation.Mr.Trowbridge began his career with Cadwalader,Wickersham&Taft LLP in the firms Merger

191、s and Acquisitions and Securities Group.Mr.Trowbridge received a Bachelor of Science in Science and Technology Studies from Rensselaer Polytechnic Institute,a Juris Doctor from the University ofPennsylvania Law School,and a Master of Business Administration from Duke Universitys Fuqua School of Busi

192、ness.Chad T.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.Campbell

193、 oversees global commercialization of the Global Business Units portfolio.Mr.Campbell joined AngioDynamics from Medtronic where he servedas the Vice President of Marketing for the Patient Care and Safety business after serving as the Vice President of Marketing for the SharpSafety business atCovidie

194、n(Medtronic).During his tenure at Covidien,Mr.Campbell also held roles including Director of Marketing,Area Vice President of Sales,RegionManager,Product Manager and Account Manager.Mr.Campbell received a Bachelor of Arts from the University of Kentucky.Laura Piccinini was appointed Senior Vice Pres

195、ident and Global Manager for Endovascular Therapies and International in January 2024,after servingas Senior Vice President and General Manager for International since joining AngioDynamics in June 2021.Ms.Piccinini brings more than 25 years ofexperience in leadership roles in the medical device ind

196、ustry,with an extensive background in the field of respiratory and surgical care.From June 2020 toJune 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 GlobalHead of Commercial Operations for the Implants business

197、unit at Nobel Biocare Systems,then a Danaher subsidiary now part of Envista Holdings.From2015 to 2017,Ms.Piccinini served as President of EMEA at Covidien and prior to that at Stryker.Ms.Piccinini is a graduate of the Parma University ofMedicine,where she received a nursing degree with specializatio

198、ns in ICU,Anesthesia,and First Aid as a Helicopter Flight Coordinator.Warren G.Nighan was appointed Senior Vice President,Global Supply Chain,Quality and Regulatory Affairs in March 2024,after serving as SeniorVice President of Quality and Regulatory Affairs since joining AngioDynamics in April 2017

199、.Before joining AngioDynamics,Mr.Nighan was a quality andregulatory 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 Affa

200、irs and Regulatory Affairs at Haemonetics Corporation,VicePresident of Quality/Regulatory/Clinical/Technical Services at St.Jude Medicals Atrial Fibrillation Division,and Corporate Vice President ofQuality/Compliance at Tyco Healthcare/Covidien(Medtronic).Mr.Nighan earned a Bachelor and Master of Sc

201、ience in Nursing from NortheasternUniversitys Bouv College of Health Sciences.AVAILABLE INFORMATIONOur corporate headquarters is located at 14 Plaza Drive,Latham,New York 12110.Our phone number is(518)795-1400.Our website .We make available,free-of-charge through our website,our Annual Reports on Fo

202、rm 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 reasonablypracticable after we electronically file or furnish such materials to the SEC.In addit

203、ion,our website includes,among other things,charters of the variouscommittees of our Board of Directors and our code of conduct and ethics applicable to all employees,officers and directors.Within the time period requiredby the SEC,we will post on our website any amendment to the code of conduct and

204、 ethics and any waiver applicable to any executive officer,director orsenior financial officer.We use our website as a means of disclosing material non-public information and for complying with our disclosure obligationsunder Regulation FD.Accordingly,investors should monitor our website,in addition

205、 to following our press releases,SEC filings and public conference callsand 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.Itis possible that the information we post on social media and blogs could be de

206、emed to be material information.Therefore,we encourage investors,themedia,and others interested in our Company to review the information we post on the social media channels and blogs listed on our website.Anystockholder also may obtain copies of these documents,free of charge,by sending a request i

207、n writing to our Corporate headquarters,Attention:SaleemCheeks.Information on our website or connected to our website is not incorporated by reference into this Annual Report on Form 10-K.13 Item 1A.Risk Factors.In addition to the other information contained in this Annual Report on Form 10-K and in

208、 our other filings with the Securities and ExchangeCommission,the following risk factors should be considered carefully by investors in evaluating our business.Our financial and operating results are subjectto a number of risks and uncertainties,including those set forth below,many of which are not

209、within our control.Our business,financial condition,results ofoperations and/or liquidity could be materially and adversely affected by any of these risks or by additional risks not presently known to us or that wecurrently deem immaterial.RISKS RELATED TO OUR BUSINESS AND INDUSTRYWe face intense co

210、mpetition in the medical device industry which continues to experience consolidation.We may be unable to compete effectively withrespect to technological innovation and price which may have a material adverse effect on our revenues,financial condition,results of operations and/orliquidity.The market

211、s for our products are highly competitive and we expect competition to continue to intensify.The medical device industry is characterizedby rapid technological change,frequent product introductions and evolving customer requirements.Our customers consider many factors when choosingproducts,including

212、 technology,features and benefits,quality,reliability,ease of use,clinical or economic outcomes,availability,price and customer service.We face competition globally from a wide range of companies,many of whom have substantially greater financial,marketing and other resources than us.We may not be ab

213、le to compete effectively,and we may lose market share to our competitors.Our primary device competitors include:Boston ScientificCorporation;Cook Medical;Medical Components,Inc.(MedComp);TeleFlex Medical;Becton Dickinson;Medtronic;Merit Medical;Terumo MedicalCorporation;Johnson and Johnson;Philips

214、Healthcare;Inari Medical;Varian Medical Systems and Total Vein Systems.Our competitors may succeed in adapting faster than us to changing customer needs or requirements,in developing and introducing technologies andproducts earlier,in obtaining patent protection(which could create barriers to market

215、 entry for us)or regulatory clearance earlier,or in commercializing newproducts or technologies more rapidly than us.Our competitors may also develop products and technologies that are superior to ours or that otherwise couldrender our products obsolete or noncompetitive.The trend of increased conso

216、lidation in the medical technology industry has resulted in companies withgreater scale and market power,intensifying competition and increasing pricing pressure.We may also face competition from providers of other medicaltherapies,such as pharmaceutical companies,that may offer non-surgical therapi

217、es for conditions that are currently,or in the future may be,treated using ourproducts.If we are not able to compete effectively,our market share and revenue may decline.In addition,the increasing purchasing power of health systems,group purchasing organizations(“GPOs”)and integrated health delivery

218、 networks(“IDNs”),together with increased competition and declining reimbursement rates,has resulted increasingly with the Company competing on the basis ofprice.Due to the highly competitive nature of the GPO and IDN contracting processes,we may not be able to obtain market prices for our products

219、or obtainor maintain contract positions with major GPOs and IDNs,which could adversely impact our profitability.Also,sales through a GPO or IDN can besignificant to our business and our inability to retain contracts with our customers,or acquire additional contracts,could have a material adverse eff

220、ect onour business,financial condition,results of operations and/or liquidity.Our inability to continue to effectively develop,acquire and/or market new products and technologies could have a material adverse effect on ourbusiness,financial condition and/or results of operations.The market for our d

221、evices is characterized by rapid technological change,new product introductions,technological improvements,changes inphysician requirements and evolving industry standards.Product life cycles are relatively short because medical device manufacturers continually developmore effective and less expensi

222、ve versions of existing devices in response to physician demand.We engage in product development and improvementprograms to maintain and improve our competitive position.Our products are technologically complex and these programs involve significant planning,market studies,investment in research and

223、 development,clinical trials and regulatory clearances or approvals and may require more time and expense thananticipated to bring such products to market.We may not,however,be successful in enhancing existing products,or developing new products ortechnologies that will achieve regulatory approval,b

224、e developed or manufactured in a cost-effective manner,obtain appropriate intellectual propertyprotection or receive market acceptance.We also may be unable to recover all or a meaningful part of our investment in these products or technologies.Additionally,there can be no assurance that the size of

225、 the markets in which we compete will increase above existing levels or not decline,that we will beable to maintain,gain or regain market share or that we can compete effectively on the basis of price or that the number of procedures in which our productsare used will increase above existing levels

226、or not decline.14 In particular,the future prospects of many of our high growth products,such as the NanoKnife system,the AngioVac system,the AlphaVac system andthe Auryon system,rely on continued market development and continued generation of clinical data pursuant to clinical trials conducted by u

227、s,ourcompetitors or other third parties.If the results of these trials are not what we expect or fail to generate meaningful clinical data,it may adversely impact ourability to obtain product approvals.If any of these products fail to achieve clinical acceptance or are perceived unfavorably by the m

228、arket,it could severelylimit our ability to drive revenue growth,which could have a material adverse effect on our business,financial condition,results of operations and/orliquidity.See Risk Factor titled“Our business and prospects rely heavily upon our ability to successfully complete clinical tria

229、ls,including,but not limitedto,our NanoKnife DIRECT clinical study,our NanoKnife PRESERVE clinical study and clinical studies for AngioVac.We may choose to,or may be requiredto,suspend,repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements,the re

230、sults are negative orinconclusive or the trials are not well designed.”As part of our business strategy,we expect to continue to engage in business development activities which includes selectively evaluating and pursuingthe acquisition of complementary businesses,technologies and products.These act

231、ivities may result in substantial investment of our time and financialresources and competition for targets may be significant.We may not be able to identify appropriate acquisition candidates,consummate transactions,obtainagreements with favorable terms or obtain any necessary financing or regulato

232、ry approvals.Further,once a business is acquired,any inability to successfullyintegrate the business or achieve anticipated cost savings or operating synergies,decreases in customer loyalty or product orders,failure to retain anddevelop its workforce,failure to establish and maintain appropriate con

233、trols,higher or unanticipated expenses,or unknown or contingent liabilities couldadversely affect our ability to realize the anticipated benefits of any acquisition.The evaluation and integration of an acquired business,whether or notsuccessful,requires significant efforts which may result in additi

234、onal expenses and divert the attention of our management and technical personnel fromother projects.If we proceed with one or more significant acquisitions in which the consideration consists of cash,a substantial portion of our available cash could beused to consummate the acquisitions.If we consum

235、mate one or more acquisitions in which the consideration consists of capital stock,our stockholders couldsuffer significant dilution of their interest in us.In addition,we could incur or assume significant amounts of indebtedness in connection with acquisitions.These transactions are inherently risk

236、y and may not enhance our financial position or results of operations or create value for our shareholders as they arebased on projections and assumptions which are uncertain and subject to change and there can be no assurance that any past or future transaction will besuccessful.If we fail to devel

237、op and successfully manufacture and launch new products,generate satisfactory clinical results,provide sufficient economic value,enhance existing products,or identify,acquire and integrate complementary businesses,technologies and products or if we experience a decrease in marketsize or market share

238、 or declines in average selling price or procedural volumes,or otherwise fail to compete effectively,we may not achieve our growthgoals,which could have a material adverse effect on our business,financial condition and/or results of operations.If we do not maintain our reputation with interventional

239、 physicians,interventional and surgical oncologists,and critical care nurses,our growth will belimited and our business could be harmed.Physicians typically influence the medical device purchasing decisions of the hospitals and other healthcare institutions in which they practice.Consequently,our re

240、putation with interventional physicians,interventional and surgical oncologists,and critical care nurses is crucial to our continuedgrowth.We believe that we have built a positive reputation based on the quality of our products,our physician-driven product development efforts,ourmarketing and traini

241、ng efforts and our presence at medical society meetings.Any actual or perceived diminution in the quality of our products,or our failureor inability to maintain these other efforts,could damage our reputation with interventional physicians,interventional and surgical oncologists,and criticalcare nur

242、ses,and cause our growth to be limited and our business to be harmed,which could have a material adverse effect on our business,financialcondition,results of operations and/or liquidity.Our business and prospects rely heavily upon our ability to successfully complete clinical trials,including,but no

243、t limited to,our NanoKnife DIRECTclinical study,our NanoKnife PRESERVE clinical study and clinical studies for AngioVac.We may choose to,or may be required to,suspend,repeat orterminate our clinical trials if they are not conducted in accordance with regulatory requirements,the results are negative

244、or inconclusive or the trialsare not well designed.Clinical trials must be conducted in accordance with the applicable laws and regulations in the jurisdictions in which the clinical trials are conducted,including FDAs current Good Clinical Practices.The clinical trials are subject to oversight by t

245、he FDA,regulatory agencies in other jurisdictions,ethicscommittees and institutional review boards at the medical institutions where the clinical trials are conducted.Clinical trial protocols may require a largenumber of patients to be enrolled in the trials.Patient enrollment is a function of many

246、factors,including the size of the patient population for the targetindication,the proximity of patients to clinical sites,the eligibility criteria for the trial,the existence of competing clinical trials and the15 availability of alternative or new treatments.Clinical trials may be suspended by the

247、FDA or by a regulatory agency in another jurisdiction at any time if theFDA or the regulatory agency finds deficiencies in the conduct of these trials or it is believed that these trials expose patients to unacceptable health risks.We,the FDA or regulatory agencies in other jurisdictions might delay

248、 or terminate our clinical trials for various reasons,including insufficient patientenrollment,fatalities,unforeseen adverse side effects by enrolled patients or the development of new therapies that require us to revise or amend our clinicaltrial protocols.Patients may be discouraged from enrolling

249、 in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assesssafety and effectiveness,if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomfortsor if they participate in contemporaneo

250、us clinical trials of competing products.In addition,we rely on contract research organizations,or CROs,with respect to conducting our clinical trials.We may experience significant costoverruns associated with,and we may encounter difficulties managing,these CROs.Termination of our clinical trials o

251、r significant delays in completing ourclinical trials could have a material adverse effect on our business,financial condition,results of operations and/or liquidity.If we are unable to convince customers that our products can improve the cost structure of their business,our revenue growth and profi

252、tability may bematerially and adversely impacted.Worldwide initiatives to contain healthcare costs have led governments and the private sector to enact cost containment efforts as a means of managingthe growth of health care utilization.Common techniques include policies on price regulation,competit

253、ive pricing,bidding and tender mechanics,coverageand payment,comparative effectiveness of therapies,technology assessments,and managed-care arrangements.These changes are causing the marketplaceto put increased emphasis on the delivery of more cost-effective medical devices and therapies.Government

254、programs,including Medicare and Medicaid,private health care insurance,and managed-care plans have attempted to control costs by limiting the amount of reimbursement they will pay for particularprocedures or treatments,tying reimbursement to outcomes,shifting to population health management,and othe

255、r mechanisms designed to constrainutilization and contain costs.Simultaneously,hospitals are redefining their role in health care delivery as many assume much more risk and control of thetotal cost of patient care.To successfully make this transformation,health systems are consolidating,purchasing o

256、r partnering with physicians and post-acutecare providers,while also narrowing networks thus allowing greater control over outcomes.This has created an increasing level of price sensitivity amongcustomers for our products and could have a material adverse effect on our business,financial condition,r

257、esults of operations and/or liquidity.We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions.We currently purchase significant amounts of several key products,raw materials and product components from

258、single and limited source suppliers andanticipate that we will do so for future products as well.Any delays in delivery of or shortages in those or other products and components(like weexperienced during our 2022 and 2023 fiscal year)could interrupt and delay manufacturing of our products,lead to ba

259、cklogs and result in the cancellation oforders for our products.Any or all of these suppliers could discontinue the manufacture or supply of these products,raw materials and/or components at anytime.Due to FDA and other business considerations,we may not be able to identify and integrate alternative

260、 sources of supply in a timely fashion or at all.Any transition to alternate suppliers may result in production delays and increased costs and may limit our ability to deliver products to our customers.Furthermore,if we are unable to identify alternative sources of supply,we would have to modify our

261、 products to use substitute components,which maycause delays in shipments,backlogs,increased prices for our products or increased design and manufacturing costs.In addition,we historically have purchased and may purchase in the future certain products as a distributor for the manufacturer of those p

262、roducts.Anyconstraint or interruption in the supply of raw materials,other product components or finished products that we distribute could materially impact our abilityto sell products,and have a material adverse effect on our business,financial condition,results of operations and/or liquidity.We r

263、ely on third-party manufacturers to manufacture some of our products today,and we have announced a plan to move to a fully outsourced modelfor manufacturing in various parts of the world,which exposes us to additional risks,including reduced control over manufacturing,delivery timing,product quality

264、 issues,potential price fluctuations,regulatory,environmental,labor or other operational disruptions,which would result in a loss ofrevenue or reduced profitability.We currently rely on third-party manufacturers for a portion of our products and due to the resource and cost limitations of manufactur

265、ing in upstate NewYork,on January 5,2024,we announced a restructuring of our manufacturing footprint and a shift to an outsourced model(the“Plan”).This Plan is intendedto transfer all product manufacturing processes to third-party16 manufacturers located in various parts of the world,including,but n

266、ot limited to the United States,Costa Rica,Latvia,Italy,Israel and China.Therestructuring activities associated with the Plan are expected to be completed in the third quarter of fiscal year 2026.If we are unable to effectively executeon this Plan within the announced timeline it could have a materi

267、al adverse effect on our business,financial condition and/or results of operations.Our manufacturing strategy may present certain risks and uncertainties that could have a material adverse effect on our business,financial condition and/orresults of operations,many of which we cannot predict,includin

268、g,but not limited to:the ability to effectively negotiate and enter into contracts with third party manufacturers;if market demand for our products is less than our purchase obligations to our manufacturers,we may incur substantial penalties and substantialinventory write-offs;manufacturers of our p

269、roducts are subject to ongoing periodic inspections by the FDA and other regulatory authorities for compliance with strictlyenforced good manufacturing practices regulations and similar foreign standards,and we do not have control over our third-party manufacturerscompliance with these regulations a

270、nd standards;we may have to share intellectual property rights,including any improvements in the manufacturing processes or new manufacturing processes forour products;our product costs may increase if our manufacturers pass their increasing costs onto us;if our agreement with a third-party manufact

271、urer expires,we may not be able to renegotiate a new agreement with that manufacturer on favorableterms,if at all.If we cannot successfully complete such renegotiation,we may not be able to locate any necessary acceptable replacementmanufacturers or enter into favorable agreements with such replacem

272、ent manufacturers in a timely manner,if at all;andmanufacturing could be curtailed or partially or completely shut down as the result of a number of circumstances,most of which are outside of ourcontrol,such as unscheduled maintenance,an earthquake,hurricane,flood,tsunami or other natural disaster,s

273、ignificant labor strikes or workstoppages,government implementation of export limitations or freezes,political unrest or pandemics.In addition,our business practices in international markets are subject to the requirements of the U.S.Foreign Corrupt Practices Act of 1977,asamended,any violation of w

274、hich could subject us to significant fines,criminal sanctions and other penalties.We expect all of our contracted manufacturingfacilities,to comply with all applicable laws,including labor,safety and environmental laws,and to otherwise meet our standards of conduct.Our ability tofind manufacturing f

275、acilities that uphold these standards is a challenge,especially with respect to facilities located outside the United States.We also aresubject to the risk that one or more of these manufacturing facilities will engage in business practices in violation of our standards or applicable laws,whichcould

276、 damage our reputation,hurt our relationship with our customers and result in negative publicity,damage to our brand and a material and adverse effecton our business,financial condition,results of operations and/or liquidity.A portion of the manufacturing activities is conducted in China.As a result

277、,our business,financial condition,results of operations could be affectedsignificantly by economic,political and legal developments in China as well as trade disputes between China and the United States and the potentialimposition of bilateral tariffs.The imposition of tariffs or export restrictions

278、 on products imported by us from China could require us to(i)increase prices toour members or(ii)locate suitable alternative manufacturing capacity or relocate our operations from China to other countries.In the event we are unable toincrease our prices or find alternative manufacturing capacity or

279、relocate to an alternative base of operation outside of China on favorable terms,we wouldlikely experience higher manufacturing costs and lower gross margins,which could have an adverse effect on our business and results of operations.TheChinese economy differs from the economies of most developed c

280、ountries in many respects,including the degree of government involvement,the level ofdevelopment,the growth rate,the control of foreign exchange,access to financing and the allocation of resources.We are heavily dependent on third-party distributors to generate a substantial portion of our internati

281、onal revenues and are at the risk of thesedistributors also selling for our competitors,failing to be financially viable and failing to effectively distribute our products in compliance withapplicable laws.Outside of North America we rely heavily on third party distributors,either on a country-by-co

282、untry basis or on a multi-country,regional basis,tomarket,sell and distribute our products where we do not have a direct sales and marketing presence(including,among others,China,Japan,Brazil,theMiddle East and many European countries).As such,our revenue,if any,depends on the terms of such arrangem

283、ents and the distributors efforts.Theseefforts may turn out not to be sufficient and our third-party distributors may not effectively sell our products.International distributors accounted forapproximately 77%of international revenues for the fiscal year ended May 31,2024.International sales decreas

284、ed 6%in fiscal year 2024 partially due to thesale of the PICCs,Midline,dialysis and BioSentry businesses,along with the discontinuation of the RadioFrequency Ablation product line.If we are unableto maintain our relationships or establish direct sales capabilities on acceptable terms or at all,we ma

285、y lose significant revenue or be unable to achieve ourgrowth aspirations.In certain circumstances,distributors may also sell competing products,or products for competing diagnostic modalities,and may haveincentives to shift sales17 towards those competing products.As a result,we cannot assure you th

286、at our international distributors will increase or maintain our current levels of unitsales or increase or maintain our current unit pricing,which,in turn,could have a material adverse effect on our business,financial condition,results ofoperations and/or liquidity.In addition,there is a risk that o

287、ur distributors will not be financially viable due to current economic and/or regulatory events intheir respective countries or remit payments to us in a timely manner.If our distributors fail to comply with applicable laws or fail to effectively market andsell our products,our financial condition a

288、nd results of operations could be materially and adversely impacted.Failure to secure adequate reimbursement for our products could materially impair our ability to grow revenue and drive profitability.Our products are used in medical procedures and purchased principally by hospitals or physicians w

289、hich typically bill various third-party payors,suchas governmental programs(e.g.,Medicare,Medicaid and comparable foreign programs),private insurance plans and managed care plans,for the healthcareservices provided to their patients.The ability of our customers to obtain appropriate reimbursement fo

290、r products and services from third-party payors iscritical to the success of medical device companies because it affects which products customers purchase and the prices they are willing to pay.In general,athird-party payor only covers a medical product or procedure when the plan administrator is sa

291、tisfied that the product or procedure improves healthoutcomes,including quality of life or functional ability,in a safe and cost-effective manner.Even if a device has received clearance or approval formarketing by the FDA,there is no assurance that third-party payors,including Medicare and managed c

292、are companies,will cover the cost of the device andrelated procedures.Even if coverage is available,third-party payors may place restrictions on the circumstances where they provide coverage or may offerreimbursement that is not sufficient to cover the cost of our products.Third-party payors who cov

293、er the cost of medical products or equipment,in addition to allowing a general charge for the procedure,often maintain listsof exclusive suppliers or approved lists of products deemed to be cost-effective.If our products are not on approved lists of third-party payors,healthcareproviders must determ

294、ine if the additional cost and effort required in obtaining prior authorization,and the uncertainty of actually obtaining coverage,isjustified by any perceived clinical benefits from using our products.Finally,the advent of contracted fixed rates per procedure has made it difficult to receive reimbu

295、rsement for disposable products,even if the use ofthese products improves clinical outcomes.In addition,many third-party payors are moving to managed care systems in which providers contract to providecomprehensive healthcare for a fixed cost per person.Managed care providers often attempt to contro

296、l the cost of healthcare by authorizing fewer electivesurgical procedures.Under current prospective payment systems,such as the diagnosis related group system and the hospital out-patient prospectivepayment system,both of which are used by Medicare and in many managed care systems used by private th

297、ird-party payors,the cost of our products will beincorporated into the overall cost of a procedure and not be separately reimbursed.If hospitals and physicians cannot obtain adequate reimbursement for our products or the procedures in which they are used,this could have a materialadverse effect on o

298、ur business,financial condition,results of operations and/or liquidity.Reimbursement varies by country and can significantly impact the acceptance of new technology.Implementation of healthcare reforms in the UnitedStates and in other countries may limit,reduce or eliminate reimbursement for our pro

299、ducts and adversely affect both our pricing flexibility and the demandfor our products.Even when we develop a promising new product,we may find limited demand for the product unless reimbursement approval is obtainedfrom private and governmental third-party payors.Changes in healthcare systems in th

300、e United States or elsewhere in a manner that significantly reducesreimbursement for procedures using our medical devices or denies coverage for these procedures,or adverse decisions relating to our products byadministrators of these systems in coverage or reimbursement issues,would have an adverse

301、impact on the acceptance of our products and the prices whichour customers are willing to pay for them.If a product liability claim is brought against us or our product liability insurance coverage is inadequate,our business could be harmed.The design,manufacture and marketing of the types of medica

302、l devices we sell entail an inherent risk of product liability.Our products are used byphysicians to treat seriously ill patients.We are periodically subject to product liability claims,and patients or customers may in the future bring claimsagainst us in a number of circumstances and for a number o

303、f reasons,including if our products were misused,if a component of our product fails,if ourmanufacture or design was flawed,if the product produced unsatisfactory results or if the instructions for use and operating manuals and disclosure ofproduct related risks for our products were found to be ina

304、dequate.In addition,individuals or groups seeking to represent a class may file suit against us.The outcome of litigation,particularly class action lawsuits,is difficult to assess or quantify.Plaintiffs in these types of lawsuits often seek recovery of verylarge or indeterminate amounts,including no

305、t only actual damages,but also punitive damages.The magnitude of the potential losses relating to theselawsuits may remain unknown for substantial periods of time.18 We carry a product liability policy with a limit of$10.0 million per product liability claim and an aggregate policy limit of$10.0 mil

306、lion,subject to aself-insured retention of$0.5 million per occurrence and$2.0 million in the aggregate.We believe,based on claims made against us in the past,our existingproduct liability insurance coverage is reasonably adequate to protect us from any liabilities we might incur.However,there is no

307、assurance that thiscoverage will be sufficient to satisfy any claim made against us.In addition,we may not be able to continue to maintain adequate coverage at a reasonablecost and on reasonable terms,if at all.Any product liability claim brought against us,with or without merit,could increase our p

308、roduct liability insurancerates or prevent us from securing any coverage in the future.Additionally,if one or more product liability claims is brought against us for uninsuredliabilities or is in excess of our insurance coverage,our financial condition,results of operations and/or liquidity could be

309、 negatively impacted.Further,suchclaims may require us to recall some of our products,which could result in significant costs to us.We may be exposed to risks associated with product line divestitures as we may never realize the expected benefits and could cause operationaldisruptions with personnel

310、,systems and infrastructure changes.On February 15,2024,the Company entered into an asset purchase agreement(the Asset Purchase Agreement)with Spectrum Vascular pursuant towhich Spectrum acquired the Companys PICC and Midline businesses for$34.5 million in cash and resulted in a pre-tax book income

311、of$6.7 million.Included in the agreement is a$5.5 million earn-out related to the sales of divested products over a two-year period and a milestone payment of$5.0 millionpaid upon final transfer of the manufacturing to a third-party.The Company and Spectrum entered into various agreements to facilit

312、ate the transition toSpectrum,including a Transactions Services Agreement and Contract Manufacturing Agreement.On June 8,2023,the Company entered into an asset purchase agreement(the Asset Purchase Agreement)with Merit Medical Systems,Inc.pursuantto which Merit acquired the dialysis product portfoli

313、o and BioSentry tract sealant system biopsy businesses for$100.0 million in cash.The Company andMerit entered into various agreements to facilitate the transition to Merit,including a Transactions Services Agreement and Contract ManufacturingAgreement.These divestitures along with potential future d

314、ivestitures of certain product lines will allow us to transform ourselves into a high growth,highly profitable,medical technology company.If we are unable to achieve our growth and profitability objectives due to competition,lack of acceptance of our products,failure to generate favorable clinical d

315、ata or gain regulatory approvals,or other risks as described in this section,or due to other events,we will not besuccessful in transforming our business and may not see the appropriate market valuation.The divestiture of product lines will impact revenue,earnings andcash flows,which over time we ex

316、pect to replace by investing in higher margin revenue streams.There is a risk that we will be unable to replace therevenue,earnings and cash flow that these product lines generated,or that the cost of such will be higher than expected.If we are unable to achieve ourprofit and growth objectives,such

317、failure will be exacerbated by the loss of revenue,earnings and cash flow generated by our divested product lines andcould materially impact our financial position and results of operations,resulting in a decline in our stock price.The sale of product lines could require us to restructure significan

318、t personnel,systems and infrastructure.In some instances,we may enter into short termtransition service arrangements,under which the parties perform certain services for each other pending establishment of new processes and systems.Although these transitions are thoroughly planned,it is not unlikely

319、 in a transaction of this complexity that disruptions could occur.If disruptions to ourfinancial controls,IT,administrative support,manufacturing or regulatory processes occur,and if such disruptions prove to be more severe than our planninganticipated,this could have a material adverse effect on ou

320、r business.International and national economic and industry conditions constantly change,and could materially and adversely affect our business,financialcondition and results of operations.Our business,financial condition and results of operation are affected by many changing economic,industry and o

321、ther conditions beyond our control.Actual or potential changes in international,national,regional and local economic,business and financial conditions,including recession,high inflation andtrade protection measures,creditworthiness of our customers,may negatively affect consumer preferences,percepti

322、ons,spending patterns or demographictrends,any of which could adversely affect our business,financial condition,results of operations and/or liquidity.We are subject to macro-economic fluctuations in the U.S.and worldwide economy.Concerns about consumer and investor confidence,volatilecorporate prof

323、its and reduced capital spending,international conflicts,terrorist and military activity,civil unrest and pandemic illness could reduce customerorders or cause customer order cancellations.In addition,political and social turmoil may put further pressure on economic conditions in the United Statesan

324、d abroad.The global economy has been periodically impacted by the effects of global economic downturns.There can be no assurance that there will notbe further such events or deterioration in the global economy.These economic conditions make it more difficult for us to accurately forecast and plan ou

325、rfuture business activities.19 Volatility in the cost of raw materials,components,freight and energy increases the costs of producing and distributing our products.New laws orregulations adopted in response to climate change could also increase energy and transportation costs,as well as the costs of

326、 certain raw materials andcomponents.Increases in oil prices may increase our packaging and transportation costs.Recently,the costs of labor,raw materials,transportation,construction,services,and energy necessary for the production and distribution of our products have increased significantly.While

327、we have implementedcost containment measures,selective price increases and taken other actions to offset these inflationary pressures in our supply chain,we may not be able tocompletely offset all the increases in our operational costs,any of which could adversely affect our business,financial condi

328、tion,results of operations and/orliquidity.Sales outside the U.S.accounted for approximately 17%of our net sales during our fiscal year ended May 31,2024.We anticipate that sales frominternational operations will continue to represent a significant portion of our total sales,and we intend to continu

329、e our expansion into emerging and/orfaster-growing markets outside the U.S.Our sales and profitability from our international operations are subject to risks and uncertainties that could have amaterial adverse effect on our business,financial condition and/or results of operations,many of which we c

330、annot predict,including:fluctuations in currency exchange rates which may,in some instances affect spending behavior and reduce cash flows and revenue outside the U.S.;healthcare reform legislation;multiple non-U.S.regulatory requirements that are subject to change and could restrict our ability to

331、manufacture and sell our products;local product preferences and product requirements;longer-term receivables than are typical in the U.S.and/or the ability to obtain payment;trade protection measures and import or export licensing requirements;less intellectual property protection in some countries

332、outside the U.S.than exists in the U.S.;different labor regulations and workforce instability;the potential payment of U.S.income taxes on earnings of certain foreign subsidiaries subject to U.S.taxation upon repatriation;the expiration and non-renewal of foreign tax rulings;potential negative conse

333、quences from changes in or interpretation of tax laws,including changes in our effective tax rate or the applicable tax ratein one or more jurisdictions;andeconomic instability and inflation,recession or interest rate fluctuations.Geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets,supplychains or operatio