Anteris Technologies (AVR) 2024年年度報告「ASX」.pdf

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1、 1 Results Announcement Name of entity:Anteris Technologies Global Corp.ARBN:677 960 235 Reporting period:For the year ended December 31,2024 The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America(“US GAAP”

2、)and are denominated in U.S.dollars.The Companys results for announcement to the market are as follows:December 31,2024 US$000 December 31,2023 US$000 Change US$000 Change%Revenues from ordinary activities 2,703 2,735(32)(1%)Loss from ordinary activities after tax (75,967)(46,764)(29,203)62%Loss for

3、 the period attributable to members (76,291)(46,022)(30,269)66%Results of Operations Refer to the attached“Anteris Reports Full Year 2024 Financial Results and Provides Corporate Update.”Net Tangible Asset Backing:Net Tangible Assets is calculated as net assets(including Right-of-Use assets)less int

4、angible assets.The net tangible asset backing per share was$1.74 and$1.04 as of December 31,2024 and December 31,2023,respectively.Dividends:No dividends were proposed,declared,or issued during the year ended December 31,2024.Annual financial statements:The consolidated annual financial statements o

5、n which this report is based have been audited by KPMG.The Independent Auditors opinion is not modified but includes an Emphasis of Matter that the Company has suffered losses from operations that raise substantial doubt about its ability to continue as a going concern.Changes in control over entiti

6、es:Anteris Technologies Global Corp.(“ATGC”)was incorporated in Delaware on January 29,2024.ATGC was formed for the purpose of reorganizing the operations of Anteris Technologies Ltd(“ATL”),an Australian public company originally registered in Western Australia,Australia and listed on the ASX,into a

7、 structure whereby the ultimate parent company would be a Delaware corporation.On December 16,2024,ATGC received all the issued and outstanding shares of ATL pursuant to a scheme of arrangement under Australian law between ATL and its shareholders under Part 5.1 of the Corporations Act 2001(Cth).In

8、accordance with ASC 805 Business Combinations,when ATGC acquired ATL,the transaction was accounted for as a reverse recapitalization.The substance of the transaction was that the pre-transaction shareholders of ATL(the accounting acquirer)had effectively obtained control of ATGC.Under reverse recapi

9、talization accounting,the consolidated financial statements are issued under the name of the legal parent(being ATGC)but,with the exception of stockholders equity,the financial statements represent a continuation of ATLs financial information.Details of associates or joint ventures:On April 18,2023,

10、the Group acquired 30%of the shares of v2vmedtech,inc.Since acquisition date,the entity has been treated as a controlled entity for accounting purposes.There have been no changes in the holding percentage since acquisition date.Use of funds:On December 13,2024 ATGC released a prospectus for an initi

11、al public offering of 14,800,000 shares of Common Stock to be sold at an initial public offering price of$6.00 per share.The prospectus included detail of the intended use of the net proceeds being:approximately$74.4 million for the ongoing development of DurAVR THV and the preparation and enrolment

12、 of the pivotal trial of DurAVR THV for treating severe aortic stenosis;and 2 the remaining for working capital and other general corporate purposes determined from time to time,including the repayment of amounts owed under the Convertible Note Facility(refer to note 11 Debt Obligations of the annua

13、l financial report).There were no material variances in the use of funds during the fourth quarter of 2024.The convertible notes totalling$5.7 million were repaid on December 19,2024,and the facility was terminated in February 2025.Aggregate amount of payments to related parties and their associates

14、:During the fourth quarter of 2024,the aggregate amount of payments for director fees,ATL Company secretarial fees and CEO remuneration was$374 thousand.Details of audit disputes or audit qualification:None.Additional 4E disclosure requirements and commentary on these results are contained in the Fo

15、rm 10-K Annual Report for the year ended December 31,2024.UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549FORM 10-K(Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31,2024 OR TRANSITION REPORT PURSUANT

16、 TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42437 Anteris Technologies Global Corp.(Exact name of Registrant as specified in its Charter)Delaware 99-1407174(State or other jurisdiction of incorporation or organization)(I.

17、R.S.Employer Identification No.)Toowong Tower,Level 3,Suite 3029 Sherwood RoadToowong,QLDAustralia 4066(Address of principal executive offices)(Zip Code)Registrants telephone number,including area code:+61 7 3152 3200 Securities registered pursuant to Section 12(b)of the Act:Title of each class Trad

18、ing Symbol(s)Name of each exchange on which registered Common stock,par value$0.0001 per share AVR The Nasdaq Global MarketSecurities registered pursuant to Section 12(g)of the Act:None Indicate by check mark if the Registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities

19、Act.YES NO Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d)of 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 pre

20、ceding 12 months(or for such shorter period that the Registrant was required to file such reports),and(2)has been subject to such filing requirements for the past 90 days.YES NO Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be subm

21、itted pursuant to Rule 405 of Regulation S-T(232.405 of thischapter)during the preceding 12 months(or for such shorter period that the Registrant was required to submit such files).YES NO Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerate

22、d filer,smaller reporting company,or an emerging growth company.See thedefinitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filerNon-accelerated filerSmaller reporting

23、 companyEmerging growth company If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mar

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

25、eport.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 anerror to previously issued financial statements.Indicate by check mark whether any of those error correc

26、tions are restatements that required a recovery analysis of incentive-based compensation received by any of the registrantsexecutive officers 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-2 of the

27、Exchange Act).YES NO The registrant was not a public company as of the last business day of its most recently completed second fiscal quarter and,therefore,cannot calculate the aggregate market value ofits voting equity held by non-affiliates as of such date.The number of shares of Registrants Commo

28、n Stock outstanding as of March 12,2025 was 36,023,796.DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrants definitive proxy statement relating to the 2025 Annual Meeting of Stockholders,which will be filed with the Securities and Exchange Commission within 120days after the end of the Re

29、gistrants fiscal year ended December 31,2024,are incorporated by reference into Part III of this Annual Report on Form 10-K.TABLE OF CONTENTS Page PART I7 Item 1.Business.7 Item 1A.Risk Factors.38 Item 1B.Unresolved Staff Comments.71 Item 1C.Cybersecurity.71 Item 2.Properties.72 Item 3.Legal Proceed

30、ings.72 Item 4.Mine Safety Disclosures.72 PART II73 Item 5.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity Securities.73 Item 6.Reserved.74 Item 7.Managements Discussion and Analysis of Financial Condition and Results of Operations.74 Item 7A.Quantitat

31、ive and Qualitative Disclosures About Market Risk.84 Item 8.Financial Statements and Supplementary Data.85 Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.132 Item 9A.Controls and Procedures.132 Item 9B.Other Information.134 Item 9C.Disclosure Regarding Fo

32、reign Jurisdictions that Prevent Inspections.134 PART III135 Item 10.Directors,Executive Officers and Corporate Governance.135 Item 11.Executive Compensation.135 Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.135 Item 13.Certain Relationships a

33、nd Related Transactions,and Director Independence.141 Item 14.Principal Accountant Fees and Services.141 PART IV142 Item 15.Exhibits,Financial Statement Schedules.142 Item 16.Form 10-K Summary146iTable of ContentsINTRODUCTION Prior to the consummation of our initial public offering,we completed a se

34、ries of reorganization transactions(the“Reorganization”).Unless otherwise indicated or contextotherwise requires in this Annual Report on Form 10-K(this“Form 10-K”),all references in this Form 10-K to the“Company,”“Anteris,”“Anteris,”“we,”“us”and“our”refer toAnteris Technologies Ltd(“ATL”)prior to t

35、he Reorganization and Anteris Technologies Global Corp.(“ATGC”)after the Reorganization,and for purposes of this Form 10-K:“Acellularized”refers to when all cellular antigens(such as cells and cell remnants)known to initiate inflammation and interrelated calcification mechanisms have beenremoved.“AD

36、APT anti-calcification tissue”refers to the tissue produced by the ADAPT tissue engineering process,which transforms xenograft tissue(bovine heart tissue)intoa durable bioscaffold which Anteris uses in its DurAVR THV to mimic human tissue in aortic valve replacement.“Aldehydes”refers to organic comp

37、ounds.“Aortic stenosis”refers to the narrowing of the aortic valve restricting the flow of blood from the left ventricle(lower chamber of the heart)to the aorta(main artery).“Bioscaffold”refers to a durable structure engineered from biological material.“Biostability”refers to the ability of a materi

38、al to maintain its physical and chemical integrity after implantation into a living tissue and organs.“Coaptation”refers to the portion of the leaflets that touch when the aortic valve is in the closed position.“ComASUR delivery system”refers to the balloon expandable system which provides controlle

39、d deployment and accurate placement of the DurAVR THV,designed toachieve precise alignment with the hearts native commissures to achieve ideal valve positioning.“Commissure alignment”refers to the position of the transcatheter aortic valve replacement leaflets in line with the anatomical orientation

40、 of the recipients native valveleaflets.“Commissures”refers to where the valve leaflets are attached to the aortic wall inside the aortic sinus of Valsalva.1Table of Contents“Cytotoxicity”refers to toxicity to cells.“Doppler velocity index”and“DVI”refer to the index that expresses the EOA as a propo

41、rtion of valve area,with DVI representing the physical ratio of a patients aorticvalve area to the left ventricular outflow tract area.A higher DVI indicates improved blood flow through the aortic valve.DVI is independent of the flow state(like gradient)and diameter(like EOA).“DurAVR THV”refers to a

42、 transcatheter heart valve(“THV”)developed by Anteris.It is a novel,biomimetic(meaning human-like)valve made from a single-piece ofnative-shaped ADAPT tissue and is used for the treatment of aortic stenosis.The DurAVR THV(new aortic valve)is placed within the diseased aortic valve via aminimally inv

43、asive procedure.“Effective orifice area”and“EOA”refer to the smallest cross-sectional area of the aortic valve opening that is available for blood flow.A larger EOA reduces the work theleft ventricle(heart chamber)must do to pump blood through the valve.Patients with severe aortic stenosis typically

44、 have an EOA of 1 cm2.“Exercise capacity”refers to a measure of a patients exercise ability,measured in clinical trials by a six minute walk test(“6MWT”),which scores a person on the distancethey can cover in six minutes of walking.“Flow displacement”and“FD”refer to a marker of flow eccentricity in

45、the ascending aortic root.Flow in the ascending aortic root is mainly laminar with a flowdisplacement ranging from 615%only.A higher degree of FD reflects abnormal turbulent flow.“Flow reversal ratio”or“FRR”is calculated at peak systole in the ascending aorta.At this point there should be almost no

46、backward flow,and any backward flow isconsidered abnormal.FRR represents the ratio of backward and forward flow at peak systole.“Hemodynamics”refers to how blood flows through the blood vessels.“Laminar flow”refers to a smooth,streamlined flow of blood.In a healthy heart,aortic flow is predominantly

47、 laminar during systole(when the left ventricle contracts andpumps blood into the aorta).Abnormal aortic flow is associated with turbulence,which can increase the risk of morbidity and increase the stress on the valve leafletsleading to increased wear and tear and subsequent structural valve deterio

48、ration.“Mean pressure gradient”and“MPG”refer to the average pressure across the aortic valve between the left ventricle and aorta.Patients with severe aortic stenosis haveMPG 40 mmHg.Post-TAVR MPG is expected to decrease,which indicates that the left ventricle is not working as hard to pump blood th

49、rough the aortic valve.“Transcatheter aortic valve replacement”or“TAVR”refer to a minimally invasive procedure for the treatment of aortic stenosis.A new aortic valve is placed inside thediseased valve,meaning the old,damaged valve is not removed.“ViV”refers to valve-in-valve.“Xenograft”refers to a

50、tissue that is derived from a species that is different from the recipient of the specimen,meaning tissue from animal species.2Table of ContentsSPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS All statements in this Form 10-K,other than statements of historical facts,including statements regarding

51、our future results of operations and financial position,businessstrategy,product development,and plans and objectives of management for future operations,are forward-looking statements.These forward-looking statements generally areidentified by the words“believe,”“project,”“expect,”“anticipate,”“est

52、imate,”“intend,”“budget,”“target,”“aim,”“strategy,”“plan,”“guidance,”“outlook,”“may,”“should,”“could,”“will,”“would,”“will be,”“will continue,”“will likely result”and similar expressions,although not all forward-looking statements contain these identifying words.Forward-lookingstatements,which are s

53、ubject to risks,include,but are not limited to,statements about:our current and future research and development(“R&D”)activities,including clinical testing and manufacturing and related costs and timing sufficiency of our capital resources our product development and business strategy,including the

54、potential size of the markets for our products and future development and/or expansion of our products inour markets our ability to commercialize products and generate product revenues our ability to raise additional funding when needed any statements concerning anticipated regulatory activities,inc

55、luding our ability to obtain regulatory clearances our R&D expenses and risks facing our operations and intellectual property.We have based the forward-looking statements contained in this Form 10-K largely on our current expectations,estimates,forecasts and projections about future events andfinanc

56、ial trends that we believe may affect our financial condition,results of operations,business strategy and financial needs.In light of the significant uncertainties in these forward-looking statements,you should not rely upon forward-looking statements as predictions of future events.Although we beli

57、eve that we have a reasonable basis for each forward-lookingstatement contained in this Form 10-K,we cannot guarantee that the future results,levels of activity,performance or events and circumstances reflected in the forward-lookingstatements will be achieved or occur at all.You should refer to the

58、 section titled“Risk Factors”for a discussion of important factors that may cause our actual results to differ materiallyfrom those expressed or implied by our forward-looking statements.Furthermore,if our forward-looking statements prove to be inaccurate,the inaccuracy may be material.The forward-l

59、ooking statements made in this Form 10-K relate only to events as of the date on which the statements are made.Except as required by law,we undertake noobligation to publicly update any forward-looking statements,whether as a result of new information,future events or otherwise.The Private Securitie

60、s Litigation Reform Act of 1995and Section 27A of the Securities Act do not protect any forward-looking statements that we make within this Form 10-K.You should read this Form 10-K and the documents that we reference in this Form 10-K completely and with the understanding that our actual future resu

61、lts may be materiallydifferent from what we expect.We qualify all of the forward-looking statements in this Form 10-K by these cautionary statements.3Table of ContentsThis Form 10-K contains certain data and information that we obtained from various publications,including industry data and informati

62、on from FMI.Statistical data in thesepublications also include projections based on a number of assumptions.The global,North American and European TAVR markets may not grow at the rate projected by market data orat all.Failure of the global,North American and European TAVR markets to grow at the pro

63、jected rate may have a material and adverse effect on our business and the market price of ourcommon stock,par value$0.0001 per share(“Common Stock”),and CHESS Depository Interests(“CDIs”).All references in this Form 10-K to Common Stock shall include the sharesrepresented by CDIs unless the context

64、 suggests otherwise.In addition,the nature of the medical technology industry results in significant uncertainties for any projections or estimatesrelating to the growth prospects or future condition of our industry.Furthermore,if any one or more of the assumptions underlying the market data are lat

65、er found to be incorrect,actualresults may differ from the projections based on these assumptions.You should not place undue reliance on these forward-looking statements.CAUTIONARY NOTE REGARDING INDUSTRY AND MARKET DATAThis Form 10-K includes information concerning the Companys industry and the mar

66、kets in which it operates that is based on information from various sources includingpublic filings,internal company sources,various third-party sources and management estimates.In addition,this Form 10-K contains information from a report prepared by FutureMarket Insights,Inc.(“FMI”),a market resea

67、rch firm that we commissioned to provide information on the global transcatheter heart valve replacement market.Management estimatesregarding the Companys position,share and industry size are derived from publicly available information and its internal research and are based on a number of key assum

68、ptions madeupon reviewing such data and the Companys knowledge of such industry and markets,which it believes to be reasonable.In some cases,we do not expressly refer to the sources fromwhich this information is derived.While the Company believes the industry,market and competitive position data inc

69、luded in this Form 10-K is reliable and is based on reasonableassumptions,such data is necessarily subject to a high degree of uncertainty and risk and is subject to change due to a variety of factors,including those described in“Cautionary NoteRegarding Forward-Looking Statements,”“Risk Factors”and

70、 elsewhere in this Form 10-K.These and other factors could cause results to differ materially from those expressed in theestimates included in this Form 10-K.The Company has not independently verified any data obtained from third-party sources and cannot assure you of the accuracy or completenessof

71、such data.RISK FACTOR SUMMARYInvesting in shares of our Common Stock involves a high degree of risk.You should carefully consider the following risks and uncertainties,together with all of the otherinformation contained in this Form 10-K,including the section titled“Managements Discussion and Analys

72、is of Financial Condition and Results of Operations”and our auditedconsolidated financial statements and related notes included elsewhere in this Form 10-K,together with our other publicly available filings with the Securities and Exchange Commission(the“SEC”),before making an investment decision.Th

73、e occurrence of any of the following risks,or of additional risks and uncertainties not presently known to us or that we currentlybelieve not to be material,could materially and adversely affect our business,financial condition,reputation or results of operations.Our business and any investment in o

74、ur securitiesinvolves risks.You should carefully consider the risks described in the section titled“Risk Factors”before making a decision to invest in our Common Stock.Set forth below is asummary of some,but not all,of the principal risks we face:We have a history of operating losses and may not ach

75、ieve or maintain profitability in the future.There is substantial doubt about our ability to continue as a going concern.We will require substantial additional future financing and may be unable to raise sufficient capital,which could have a material impact on our R&D programs orcommercialization of

76、 our products.Unsuccessful clinical trials or procedures relating to our products could have a material adverse effect on our prospects.If we are unable to successfully identify,develop,obtain and maintain regulatory clearance or approval and ultimately commercialize any of our current or future pro

77、ducts,orexperience significant delays in doing so,our business may be harmed.Even if a product receives regulatory clearance or approval,it may still face development and regulatory difficulties that could delay or impair future sales of products.4Table of ContentsSome of our products are in develop

78、ment and may not achieve market acceptance,which could limit our growth and adversely affect our business,financial condition,andresults of operations.We may find it difficult to enroll patients in our clinical trials,and patients could discontinue their participation in clinical trials,which could

79、delay or prevent clinical trials andmake those trials more expensive to undertake.We operate in a highly competitive and rapidly changing industry,and if we do not compete effectively,our business will be harmed.The success of many of our products may depend upon certain key physicians and heart val

80、ve centers.We rely on third parties to conduct our clinical trials and preclinical studies.If these third parties do not successfully carry out their contractual duties,comply withapplicable regulatory requirements or meet expected deadlines,our development programs and our ability to seek or obtain

81、 regulatory clearance and approval for orcommercialize our products may be delayed.We are subject to various risks relating to international activities that could affect our profitability,including risks associated with currency fluctuations and changes inforeign currency exchange rates.Any failure

82、to protect our information technology infrastructure and our products against cyber-based attacks,network security breaches,service interruptions or datacorruption could materially disrupt our operations and harm our business.Increased emphasis on environmental,social,and governance matters may have

83、 an adverse effect on our business,financial condition,results of operations and reputation.We could become exposed to product liability claims that could harm our business,and we may be unable to obtain insurance coverage at acceptable costs and adequatelevels.Use of our products in unapproved circ

84、umstances could expose us to liabilities.Our products and operations are subject to extensive government regulation,including environmental,health and safety regulations,which could result in substantial costs.Furthermore,any failure to comply with applicable requirements could harm our business.Hea

85、lthcare policy changes may have a material adverse effect on us.Even with regulatory clearance or approval to bring a product to market,our profitability may be impacted by ongoing coverage and reimbursement determinations bygovernment health care programs and other third-party payors for our produc

86、ts,or procedures and services that rely on our products.We could be exposed to significant liability claims if we are unable to obtain insurance at acceptable costs and adequate levels or otherwise protect ourselves againstpotential product liability claims.Tax laws,regulations,and enforcement pract

87、ices are evolving and may have a material adverse effect on our results of operations,cash flows and financial position.Our success depends on our ability to protect our intellectual property and our proprietary technology.Intellectual property rights of third parties could adversely affect our abil

88、ity to commercialize our products.Our reliance on third parties requires us to share our trade secrets,which increases the possibility that a competitor will discover them or that our trade secrets will bemisappropriated or disclosed.5Table of ContentsObtaining and maintaining our patent protection

89、depends on compliance with various procedural,document submission,fee payment and other requirements imposed bygovernmental patent agencies,and our patent protection could be reduced or eliminated for non-compliance with these requirements.Any difficulty with protecting our intellectual property cou

90、ld diminish the value of our intellectual property rights in the relevant jurisdiction.We have incurred significant costs associated with the Reorganization and will incur significant ongoing costs as a company whose Common Stock is publicly traded in theUnited States,and our management is required

91、to devote substantial time to compliance initiatives and corporate governance practices,which could divert their attentionfrom the operation of our business.The market price and trading volume of our Common Stock may be volatile and may be affected by economic conditions beyond our control.An active

92、,liquid trading market for our Common Stock may not be maintained.We have identified material weaknesses in our internal control over financial reporting.If we fail to remediate these material weaknesses,or if we experience additionalmaterial weaknesses in the future or otherwise fail to maintain ef

93、fective internal control over financial reporting in the future,we may not be able to accurately or timely reportour financial condition or results of operations,which may adversely affect investor confidence in us and,as a result,the value of our Common Stock.Our Second Amended and Restated Certifi

94、cate of Incorporation(our“Second Amended and Restated Certificate of Incorporation”)and amended and restated bylaws(the“Amended and Restated Bylaws”)contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders may consider favorable.6Table of ContentsPART I Ite

95、m 1.Business.Overview Anteris is a structural heart company dedicated to revolutionizing cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients tohealthy function.Our lead product,the DurAVR THV,represents a unique product opportunity in a new THV class

96、 of single-piece heart valves,for the treatment of aortic stenosis.OurDurAVR THV consists of a single-piece,biomimetic valve made with our proprietary ADAPT tissue-enhancing technology and deployed with our ComASUR balloon-expandabledelivery system.ADAPT is our proprietary anti-calcification tissue

97、shaping technology that is designed to reengineer xenograft tissue into a pure,single-piece collagen bioscaffold.Our proprietary ADAPT tissue has been clinically demonstrated to be calcium free for up to 10 years post-procedure,according to Performance of the ADAPT-Treated CardioCelScaffold in Pedia

98、tric Patients With Congenital Cardiac Anomalies:Medium to Long-Term Outcomes,published by William Neethling et.al.,and has been distributed for use in over55,000 patients globally in other indications.Our ComASUR balloon-expandable delivery system,which was developed in consultation with physicians,

99、is designed to provide precisealignment with the hearts native commissures to achieve accurate placement of the DurAVR THV.We clinically developed our DurAVR THV system over several years with significant physician input with the goal of addressing hemodynamic limitations of the currentstandard-of-c

100、are products.As of January 2025,a total of 83 patients have been treated with the DurAVR THV across the United States,Canada and Europe.In November 2021,wecommenced our FIH study at the Tbilisi Heart and Vascular Clinic in Tbilisi,Georgia.Aortic valve stenosis is one of the most common and serious v

101、alvular heart diseases.It is fatal in approximately 50%of patients if left untreated after two years,and nopharmacotherapy is available to treat this disease.Aortic stenosis causes a narrowing of the hearts aortic valve,which reduces or blocks the amount of blood flowing from the heart tothe bodys l

102、argest artery,the aorta,and from there to the rest of the body.Minimally-invasive TAVR,which the United States Food and Drug Administration(“FDA”)initially approvedin 2011 for high surgical risk patients,has emerged as an alternative to open-heart surgery.In 2019,the FDA also approved TAVR for use i

103、n low-risk surgical patients.These low-risksurgical patients are often younger persons within the geriatric population that require heart valves with longer durability and pre-disease hemodynamics for an improved quality of life.More generally,patients with aortic valve stenosis are now being diagno

104、sed at a younger age.Yet,according to a publication in The Journal of American Medical Association,only 15-20%of severe aortic stenosis cases are treated today.While previous generations of TAVRs were designed for older,high risk,less-active patients,our DurAVR THV system is designed to be a solutio

105、n for all patients,includingboth older,less-active patients and younger patients.Our first in class DurAVR THV is a single-piece valve with a novel,biomimetic design that aims to replicate the normal blood flowof a healthy human aortic valve as compared to traditional three-piece aortic valves.In ou

106、r FIH study,we observed promising results in relation to hemodynamics,laminar flow andexercise capacity.When compared to a healthy aortic valve,our DurAVR THV showed no significant difference in aortic flow.In addition,our DurAVR THV has been developed with the aim to increase durability and last lo

107、nger than traditional three-piece designs through the use of our ADAPT anti-calcification tissue including a molded single-piece of tissue designed to mimic the performance of a pre-disease human aortic valve,which we believe can result in improvedhemodynamics as compared to traditional three-piece

108、designs.These designs and features cumulatively aim to provide a better quality of life as compared to the current standard of careassociated with traditional three-piece designs.We intend to test these features in the randomized global pivotal study(the“Pivotal Trial”)against commercially approved

109、TAVRdevices.The design and scope of the Pivotal Trial will be finalized following completion of our submission to the FDA and receipt of feedback from the FDA.The purpose of the PivotalTrial will be to demonstrate non-inferiority of the DurAVR THV system compared with commercially available TAVR sys

110、tems for treatment of subjects with severe calcific aorticstenosis.We anticipate that the design of the Pivotal Trial will be a prospective,randomized,controlled multicenter,international study wherein subjects will be randomized to receiveeither TAVR using the DurAVR THV or TAVR using a commerciall

111、y available and approved THV from competitors.We anticipate that the subjects will include a broad array of riskprofiles.We anticipate that subjects with a failed surgical bioprosthesis in need of a ViV TAVR will be enrolled in a separate parallel registry.7Table of ContentsIn November 2022,we recei

112、ved conditional approval of our United States early feasibility study(“US EFS”)EFS investigational device exemption(“IDE”)application from theFDA to evaluate the safety and feasibility of our DurAVR THV system in the treatment of patients with symptomatic severe native aortic stenosis,enrolling 15 p

113、atients in fourprominent heart valve centers across the United States.At 30 days post-procedure,patients had a mean effective orifice area(“EOA”)of 2.2 cm2,mean pressure gradient(“MPG”)of 7.5mmHg and Doppler velocity index(“DVI”)of 0.64.No paravalvular leaks were observed however,there was one subje

114、ct with pre-existing significant conduction abnormalities whoreceived a pacemaker.Furthermore,no mortality,disabling stroke,life-threatening bleeding,or reinterventions were reported at 30 days post-procedure.12-month follow-up visits werecompleted in December 2024.As of the date of this Form 10-K,s

115、ome,but not all patient follow-up data,has been obtained,and the Company is not in a position to comment on suchdata at this time.In July 2023,our DurAVR THV system was used for the first time in a ViV procedure,which was performed at the Institut de Cardiologie de Montral in Canada under acompassio

116、nate Special Access Program(“SAP”),which allows for the use of a non-commercial device for a specific patient where there is a clinical case that the approved device isunsuitable.In August 2023,a second Canadian patient was successfully implanted with the DurAVR THV system in a ViV procedure.As of J

117、anuary 2025,we have now treated sevenViV patients with our DurAVR THV.In addition,the FDA determined on March 24,2023 that approval of an IDE supplement is not required to manufacture the DurAVR valve for investigational use in clinicaltrials at our facility in a suburb of Minneapolis,Minnesota.We a

118、re currently planning to submit an IDE for the DurAVR THV system Pivotal Trial to the FDA by the end of quarter oneof 2025.If we obtain approval from the FDA,we intend to perform site activation and seek Institutional Review Board(“IRB”)approval for commencement of the study at each site.Subject to

119、the foregoing,we anticipate enrollment to begin in the third quarter of 2025.Such a trial would be designed to provide the primary clinical evidence on which the FDA couldbase a decision for pre-market approval that is required for commercialization of the DurAVR THV system in the United States.We a

120、re a development stage company and have incurred net losses in each year since operation,however,we believe that we have significant growth potential in a large,underpenetrated and growing market.Since the inception of the TAVR procedure,the annual volume of TAVR procedures in the United States has

121、increased significantly year-over-year,with an estimated 73,000 patients having undergone a TAVR procedure in the United States in 2019 according to the TVT Registry.According to FMI,the total global market opportunityfor TAVR in relation to severe aortic stenosis and in relation to ViV procedures i

122、s expected to reach$9.9 billion and$2.5 billion,respectively,in 2028.Our innovation-focused R&D practice is driven by rapid technological advancement and significant input from leading interventional cardiologists and cardiac surgeons.As acompany that is primarily in the development phase,we current

123、ly generate small amounts of revenue and income which are insufficient to cover our investment in research,developmentand operational activities resulting in recurring net operating losses,incurred since inception.We,like other development stage medical device companies,experience challenges inimple

124、menting our business strategy due to limited resources and a smaller capital base as we prioritize product development,minimize the period to the commencement of commercialsales,ensure our focus on quality as well as scale our operations.The development and commercialization of new medical devices i

125、s highly competitive.Those competitors may havesubstantial market share,substantially greater capital resources and established relationships with the structural heart community potentially creating barriers to adoption of ourtechnology.Our success will partly be based on our ability to educate the

126、market about the benefits of our disruptive technology including current unmet clinical needs compared tocommercially available devices as well as how we plan to capture market share post commercialization.We are dedicated to developing technological enhancements and new indications for existing pro

127、ducts,and less invasive and novel technologies to address unmet patientneeds.That dedication leads to our initiation and participation in clinical trials that seek to prove our pipeline is safe and effective as the demand for clinical and economic evidenceremains high.8Table of ContentsFrom time to

128、time,we enter into strategic agreements aimed at enhancing our business operations and profitability.For example,in April 2023,we invested in and entered into adevelopment agreement(the“Development Agreement”)with,v2vmedtech,inc.(“v2vmedtech”),which develops an innovative heart valve repair device f

129、or the minimally invasivetreatment of mitral and tricuspid valve regurgitation.Competitive Strengths We believe the continued growth of our company will be driven by the following competitive strengths:Novel,Biomimetic design.DurAVR is a novel,first in class,“biomimetic”THV.It is designed to mimic t

130、he normal anatomy with a more“human like”valve design.Novelmolding of the leaflets allows for a more even coaptation area delivering larger EOAs and lower MPGs.Significant clinical results to date in European and United States studies.Anteris has made significant progress in advancing clinical trial

131、s,which we believe aredelivering strong results and are bringing us closer to potentially achieving regulatory approvals for our DurAVR THV system.We believe our FIH study at the TbilisiHeart and Vascular Clinic in Tbilisi,Georgia,and our EFS study represent key steps on our pathway to ultimately su

132、pport an IDE to undertake the Pivotal Trial of ourDurAVR THV system.Highly innovative physician-led R&D structure.Our DurAVR THV and our ComASUR balloon expandable delivery system have both been developed withconsiderable input from leading interventional cardiologists and cardiac surgeons.We believ

133、e our emphasis on involving physicians in the R&D process allows us tobetter serve the needs of patients and physicians alike.Strong intellectual property position.Anteris relies on a combination of intellectual property assets to protect our innovative technology and our brand.This includes ourstro

134、ng patent portfolio,which includes 51 issued patents and 53 pending patent applications,in the United States and in other countries.We also have six pending patentapplications through v2vmedtech.Industry experienced executive team.Our management team and members of our Board of Directors(our“Board”)

135、have extensive experience in the medical technologyand health care industries.We believe that our teams diverse experiences and track record in the medical industry will assist our efforts to obtain regulatory approval of ourproducts in the United States and other territories and continue to grow ou

136、r business.Market Opportunity According to the World Bank,the total population over 65 in the United States and the European Union was approximately 165.0 million as of 2022.According to FMI,the totalglobal market opportunity for TAVR in relation to severe aortic stenosis and in relation to ViV proc

137、edures is expected to reach$9.9 billion and$2.5 billion,respectively,in 2028.The keyspecific markets that our Company is initially targeting are North America and Europe due to these markets accounting for the majority of the above global opportunity.FMI indicatedthat the North American and European

138、 markets averaged 53%and 38%of the global market share,respectively,during the period 2016 to 2023.FMI forecasts that the market opportunityin relation to severe aortic stenosis for North America and Europe will reach$5.5 billion and$3.7 billion,respectively,in 2028 and the market opportunity in rel

139、ation to ViV procedures isforecast to reach$1.5 billion and$0.8 billion,respectively,in 2028.To calculate these future market values,FMI has relied on actual data from 2023 collated from a variety of publishedsources and key medical experts and applied a projected CAGR of 14.9%for the global market,

140、16.2%for the North American market,and 14.0%for the European market.A non-exhaustive list of factors that may impact these forecast calculations include key players historic growth companies and manufacturers working together to develop new,affordable andtimesaving technologies new product launches

141、and approvals rising demand for THV replacement availability and cost of products growing investment in healthcare expenditure andincreased regulatory focus on patient safety and reimbursement policies.In addition,we expect the TAVR market to benefit from general trends,including an aging population

142、,earlierdiagnosis of aortic stenosis,increased incidence of obesity and diabetes(which contribute to heart disease),as well as the broader patient populations desire to pursue a more activelifestyle.9Table of ContentsSince the inception of the TAVR procedure,the annual volume of TAVR procedures in t

143、he United States has increased significantly year-over-year,with an estimated 73,000patients having undergone a TAVR procedure in the United States in 2019 according to the TVT Registry.We believe that the rising geriatric population and the growing cardiovasculardevice market provides us with a cle

144、ar business opportunity.The use of healthcare services is significantly higher among older people.DurAVR THVs single-piece native shaped biomimetic design replicates the performance of a healthy human aortic valve and is designed to restore normal blood flow ascompared to traditional three-piece tra

145、nscatheter valves,either balloon expandable or self-expanding,which do not restore normal aortic flow.We believe this design,in combination withthe ADAPT tissue technology,has the potential to allow the DurAVR THV to last longer than traditional three-piece aortic valves,which have multiple leaflets

146、 sewn together that maylead to compromised durability.Our Product Candidates DurAVR THV,which employs our ADAPT anti-calcification tissue and is deployed using our ComASUR delivery system,is currently in clinical development.DurAVR Transcatheter Heart Valve System Our DurAVR THV is a novel transcath

147、eter aortic valve for the treatment of aortic stenosis that is shaped to mimic the performance of a healthy human aortic valve.OurDurAVR THV system has been designed with considerable input from some of the worlds leading interventional cardiologists and cardiac surgeons.DurAVR THVs single-piecedesi

148、gn mimics the native anatomy of a human aortic valve,as compared to traditional three-piece aortic valves.In addition,our DurAVR THV has been developed with the aim toincrease durability and last longer than traditional three-piece designs through the use of our ADAPT anti-calcification tissue inclu

149、ding a molded single-piece of tissue designed tomimic the performance of a pre-disease human aortic valve,which we believe can result in improved hemodynamics as compared to traditional three-piece designs.These designs andfeatures cumulatively aim to restore a better quality of life compared to the

150、 current standard of care associated with traditional three-piece designs.We intend to test these features in thePivotal Trial against commercially approved TAVR devices.10Table of ContentsThe DurAVR THV has the following attributes:it is the first transcatheter aortic valve to use a patented constr

151、uction of a molded single-piece of bioengineered tissue(our ADAPT anti-calcification tissue with moldedleaflets(see“ADAPT Anti-Calcification Tissue”)it has fewer sutures and seams when compared with conventional valves,thereby preserving tissue integrity with the intent to reduce calcification risk

152、to extend valvedurability it is uniquely shaped to emulate the performance of a healthy human valve and produce long leaflet coaptation,laminar flows and near-normal hemodynamics it has large open cells in the stent frame to improve coronary access and it utilizes the ComASUR balloon expandable deli

153、very system(see“ComASUR Delivery System”)for controlled deployment and accurate placement.11Table of ContentsADAPT Anti-Calcification Tissue The ADAPT tissue engineering process is an anti-calcification preparation that transforms xenograft tissue(bovine pericardium)into durable bioscaffolds that ar

154、e used tomimic human tissue for surgical repair in multiple settings,including aortic valve replacement.The outcome of the ADAPT tissue engineering process is a novel,acellular,biostable andnon-calcifying biomaterial.The ADAPT tissue engineering process involves multiple steps to transform bovine pe

155、ricardium into a durable bioprosthetic material.Bovine spongiform encephalopathy-freebovine pericardium is decellularized to remove all cellular antigens that initiate an immune response.The material is then crosslinked to enable maintenance and stabilization of strengthand elasticity to improve mec

156、hanical resistance.The cytotoxicity is further reduced using detoxification and sterilization processes and anti-calcification methodology to remove andbind aldehydes and enable safe storage in a non-glutaraldehyde solution.Post-implantation,ADAPT tissue provides a scaffold for cell migration to cre

157、ate the optimal environment.Migrated cells can stimulate site-specific remodeling and repair and enable the formation of new blood vessels.Our proprietary ADAPT tissue has been clinically demonstrated to be calcium-free for up to 10 years post-procedure,according to Performance of the ADAPT-TreatedC

158、ardioCel Scaffold in Pediatric Patients With Congenital Cardiac Anomalies:Medium to Long-Term Outcomes,published by William Neethling et.al.,and it has been distributed foruse in over 55,000 patients globally in other indications.Our ComASUR balloon-expandable delivery system,which was developed in

159、consultation with physicians,is designed toprovide precise alignment with the hearts native commissures to achieve accurate placement of the DurAVR THV.12Table of ContentsTo meet the need for a durable TAVR,made from ADAPT tissue scaffold,we have created DurAVR THV,which is a first in class,biomimet

160、ic single-piece valve with optimalhemodynamic and durability properties.Based on published clinical data in several peer-reviewed journals,including The Journal of Thoracic and Cardiovascular Surgery,the ExpertReview of Medical Devices,and Interactive Cardiovascular and Thoracic Surgery,ADAPT has be

161、en observed to offer potentially significant improvements compared with other widelyavailable commercial processes adopted by healthcare providers,including with respect to bio-compatibility,durability,strength,pliability,functionality and controlled remodeling.ComASUR Delivery System Our ComASUR de

162、livery system is a physician-developed balloon expandable delivery system that contains a reinforced steerable catheter for a precise deflection through theheart anatomy in a controlled manner to avoid damage to the aorta.This delivery system provides controlled deployment and accurate placement of

163、our DurAVR THV.Our ComASURdelivery system is designed to achieve precise alignment with the hearts native commissures to achieve ideal valve positioning.Within the ComASUR delivery system,we have rotational control of the DurAVR valve with the native commissures.This allows for commissure alignment,

164、which is notachieved consistently in competitive delivery systems.This feature positions the TAVR valve leaflets exactly in line with the anatomical orientation of the recipients native valve leaflets.We have a patent pending for this system.13Table of Contents The ComASUR delivery system provides e

165、ven balloon expansion for the accurate placement of the DurAVR THV as well as ease of use.Under fluoroscopic guidance thephysician precisely aligns the DurAVR THV with the native annulus before deployment in the following manner:First,the balloon starts out as collapsed.The balloon is then expanded

166、and the DurAVR THV isdeployed.Finally,the balloon is deflated and removed.14Table of ContentsClinical Results and Trials We have made significant progress in advancing clinical trials of our DurAVR THV system.Thus far clinical development of our DurAVR THV system has consisted of ourongoing FIH stud

167、y carried out at the Tbilisi Heart and Vascular Clinic in Tbilisi,Georgia and the United States and the FDA-approved EFS,which builds upon the clinical data obtainedin the FIH study thus far and is critical to achieving pre-market approval in the United States.We have a total of 75 patients that hav

168、e benefited from the implantation of the DurAVRTHV in Georgia and the United States.In addition,the DurAVR THV has been implanted in eight compassionate ViV patients,including one Valve-in-Valve-in-Valve(“ViViV”)compassionate procedure.The preparation for our European Union early feasibility study(o

169、ur“EU EFS”)commenced in December 2024 and the first two subjects were implanted in January 2025.The following graphic shows the timelines and certain key anticipated dates for each of the FIH study,EFS and ViV procedures as well as ongoing activities as we aim to secureapproval from the FDA to under

170、take the Pivotal Trial:First-In-Human Study In November 2021,we commenced our FIH study at the Tbilisi Heart and Vascular Clinic in Tbilisi,Georgia.Since the inception of our FIH study,a total of 59 patients(includingone compassionate case,which was outside of the study)have benefited from the impla

171、ntation of our DurAVR THV system at this clinic across seven cohorts.Patient outcomes areformally measured at both 30 days and 12-months post-procedure.15Table of ContentsThe scope of the study was to evaluate the safety and feasibility of the DurAVR THV system in the treatment of subjects with symp

172、tomatic severe aortic stenosis.The studywas designed to be a prospective,non-randomized,single-arm,single-center study,with the performance endpoints immediately after the procedure including the correct positioning of asingle DurAVR bioprosthetic heart valve into the proper anatomical location and

173、hemodynamic performance.The safety endpoints of the study assessed at 30 days and one year postprocedure include all-cause mortality,myocardial infarction,stroke(disabling),and life-threatening bleeding.The study enrollment process was not restrictive to any age parameters,however the ages of study

174、subjects enrolled to date have ranged between 59 and 88.Due to its nature as a FIH feasibility study,the primary endpoints of the study are not structured for statistical differences to historical controls,but rather to demonstratefunctional capabilities.We believe that the sample size will allow in

175、vestigators to make a qualitative assessment of the safety of DurAVR THV in the population studied.Thus far,wehave observed promising results in relation to patient hemodynamics,laminar flow and exercise capacity.In addition,as noted by Dr.P.Garg(Norwich University Hospital,UnitedKingdom),the first

176、five patients underwent Cardiac Magnetic Resonance,which incorporated two-dimensional phase contrast at the level of the ascending aorta,at six months toinvestigate the aortic flow physiology post-DurAVR THV implantation.Aortic flow characteristics were assessed through the measurement of aortic FD

177、and aortic systolic FRR.Theaverage FD of a healthy aortic valve was 10%while the average FRR of a healthy aortic valve was 1%.The six-month results of the first five patients who received the DurAVR THVwere compared with those of five age/height/weight-matched controls with healthy native aortic val

178、ves.DurAVR THV recipients had comparable flow displacement(14%versus 10%p=0.453)and flow reversal ratio(4%versus 1%p=0.328)as compared to the healthy controls.Furthermore,during the study,the ComASUR delivery system component of our DurAVR THV system has performed as expected,allowing for accurate v

179、alveplacement.The below cohort study results relate only to patients enrolled in the specific cohort and excludes the results of all compassionate cases.Cohort 1 Our initial patient cohort consisted of five patients,each of whom were implanted with our DurAVR THV system with no valve-related complic

180、ations.These patients wereobserved to have stable,improved valve function with strong safety results at 12-month follow-up.We observed increased average EOA by 311%at 30 days(average EOA at baseline of0.5 cm and average EOA at 30 days of 2.05 cm)and by 294%at 12 months post-procedure from baseline(a

181、verage EOA at 12 months of 1.96 cm).We also observed reduced averageMPG across the valve by 87%at 30 days(MPG at baseline of 58.8 mmHg and MPG at 30 days of 7.54 mmHg)and by 85%at 12 months from baseline(MPG at 12 months of 8.82 mmHg).We observed increased DVI of 212%with stable hemodynamics from ba

182、seline(average DVI at baseline of 0.18 and average DVI at 30 days of 0.56),and then an increase of 202%frombaseline to 12 months(average DVI of 0.54).Furthermore,no mortality(from any cause),disabling stroke,life-threatening bleeding,myocardial infarction or device-related complicationswere reported

183、 at 12 months.Lastly,the 6-minute walk test distance(“6MWTD”)measuring patient exercise capacity after aortic valve replacement improved by 21%from baseline(average 6MWTD at baseline of 224.60 meters and average 6MWTD at 30 days of 271.60 meters),with a 44%improvement from baseline to results at 12

184、months post-procedure(average6MWTD at 12 months of 323.50 meters).Cohort 2 Our second patient cohort consisted of eight patients,each of whom were implanted with our DurAVR THV system in May 2022 with no valve-related complications.In thiscohort we observed increased average EOA by 164%at 30 days(av

185、erage EOA at baseline of 0.75 cm and average EOA at 30 days of 1.98 cm)and by 165%at 12 months post-procedurefrom baseline(average EOA at 12 months of 1.99 cm).We also observed reduced average MPG across the valve by 79%at 30 days(average MPG at baseline of 46.84 mmHg and averageMPG at 30 days of 9.

186、94 mmHg)and by 80%at 12 months from baseline(average MPG at 12 months of 9.51 mmHg).We have observed a 146%increased DVI at 30 days with stablehemodynamics from baseline(average DVI at baseline of 0.21 and average DVI at 30 days of 0.51),and a 169%increased average DVI at 12 months(average DVI of 0.

187、56).Furthermore,novalve-related mortality,disabling stroke,life-threatening bleeding,myocardial infarction or valve-related complications were reported at 12 months post-procedure.Lastly,the 6MWTDmeasuring patient exercise capacity after aortic valve replacement improved by 20%from baseline(average

188、6MWTD at baseline of 234.88 meters and average 6MTWD at 30 days of282.38 meters),with a 27%improvement from the baseline result and the 12 months post-procedure(average 6MWTD at 12 months of 297.43 meters).16Table of ContentsCohort 3 We enrolled seven participants in our third cohort in April 2023,e

189、ach of whom were implanted with our DurAVR THV with no valve-related complications.In this cohort weobserved increased average EOA by 170%from baseline,as observed at 30 days and at 12 months post-procedure(average EOA at baseline of 0.77 cm,average EOA at 30 days of 2.09cm and average EOA at 12 mon

190、ths of 2.09 cm2).We also observed average reduced MPG across the valve by 87%at 30 days from baseline(average MPG at baseline of 57.14 mmHg andaverage MPG at 30 days of 7.53 mmHg)and by 85%at 12 months from baseline(average MPG at 12 months of 8.61 mmHg).We observed a 173%increased DVI at 30 days wi

191、th stablehemodynamics from baseline(average DVI at baseline of 0.22 and average DVI at 30 days of 0.59),and then an increase of 159%from baseline to 12 months(average DVI of 0.57).Furthermore,no mortality(from any cause),disabling stroke,life-threatening bleeding,myocardial infarction or valve-relat

192、ed complications were reported at 12 months.Lastly,the6MWTD measuring patient exercise capacity after aortic valve replacement improved by 28%from baseline at 30 days post-procedure(average 6MWTD at baseline of 174.57 meters andaverage 6MWTD at 30 days of 222.71 meters)and with a 48%improvement from

193、 the baseline results and the 12 months post-procedure(average 6MWTD at 12 months of 258.57 meters).Cohort 4 Our fourth patient cohort consists of eight patients,each of which were implanted with our DurAVR THV in December 2023 with no valve-related complications.In this cohortwe observed increased

194、average EOA by 165%from baseline(average EOA at baseline of 0.9 cm and average EOA at 30 days of 2.39 cm),as observed at 30 days post-procedure.Wealso observed reduced MPG across the valve by 85%from baseline(average MPG at baseline of 43.25 mmHg and average MPG at 30 days of 6.41 mmHg),as observed

195、at 30 days post-procedure.We observed an increase in DVI from baseline of 170%(average DVI at baseline of 0.23 and average DVI at 30 days of 0.62).Furthermore,no mortality(from any cause),disabling stroke,life-threatening bleeding,myocardial infarction or valve-related complications were reported at

196、 30 days post-procedure.Lastly,the 6MWTD measuring patient exercisecapacity after aortic valve replacement improved by 14%from baseline at 30 days post-procedure(average 6MWTD at baseline of 241.50 meters and average 6MWTD at 30 days of275.00 meters).Cohort 5 Our fifth patient cohort consisted of 13

197、 patients,each of which were successfully implanted with our DurAVR THV in April and May 2024 with no valve-related complications.In this cohort we observed at 30 days post-procedure increased average EOA by 208%from baseline(average EOA at baseline of 0.73 cm2 and average EOA at 30 days of 2.25 cm2

198、),reduced MPG across the valve by 84%from baseline(average MPG at baseline of 48.23 mmHg and average MPG at 30 days of 7.81 mmHg),and an increase in DVI from baseline at 30days post-procedure of 180%(average DVI at baseline of 0.22 and average DVI at 30 days of 0.62).Furthermore,no mortality(from an

199、y cause),life-threatening bleeding,myocardialinfarction or valve-related complications were reported at 30 days post-procedure.Cohort 6 Our sixth patient cohort consisted of nine patients,which were implanted with our DurAVR THV in September 2024.As of the date of this Form 10-K the 30-day clinical

200、datafor this cohort was not available for release,and the Company is not in a position to provide an update with respect to this data at this time.Cohort 7 Our seventh patient cohort consisted of eight patients,which were implanted with our DurAVR THV system in December 2024.As of the date of this F

201、orm 10-K,the 30-dayclinical data for this cohort was not available for release,and the Company is not in a position to provide an update with respect to this data at this time.17Table of ContentsUnited States Early Feasibility Study In November 2022,we received approval with conditions of our EFS ID

202、E application from the FDA to evaluate the safety and feasibility of our DurAVR THV system in thetreatment of patients with symptomatic severe native aortic stenosis.We commenced the EFS in August 2023,enrolling 15 patients at four prominent heart valve centers across theUnited States.Patient outcom

203、es such as stroke,myocardial infarction,life-threatening bleeds,and all-cause mortality are reported at 30 days and 1-year post implantation.Patients will befollowed up to 10 years post-implant.The FDA has categorized the DurAVR THV in this study as a Centers for Medicare and Medicaid Services(“CMS”

204、)Category B device,whichpermits Medicare coverage of the device when a Medicare beneficiary participates in the study.The primary and key secondary endpoints of this trial include safety and device feasibility assessments such as success of implantation at the anatomically accurate position,and hemo

205、dynamic performance assessments,including EOA,mean pressure gradient,aortic regurgitation and DVI.The EFS demonstrated a 100%precise placement and implant success of our DurAVR THV for all 15 patients.At 30 days post-procedure,patients had an increase in averageEOA of 172%from baseline(average EOA a

206、t baseline of 0.8 cm and average EOA at 30 days of 2.2 cm),reduction of MPG of 82%from baseline(average MPG at baseline of 41 mmHgand average MPG at 30 days of 7.5 mmHg)and an increase in DVI of 121%from baseline(average DVI at baseline of 0.28 and average DVI at 30 days of 0.64).No paravalvular lea

207、ks wereobserved however,there was one subject with pre-existing significant conduction abnormalities who received a pacemaker.Furthermore,no mortality,disabling stroke,life-threateningbleeding,or reinterventions were reported at 30 days post-procedure.12-month follow up visits were completed in Dece

208、mber,2024,with analysis and reporting scheduled for the firstquarter of 2025.As of the date of this Form 10-K,not all of the 12-month data,has been obtained,and the Company is not in a position to comment on such data at this time.We have partnered with IQVIA Inc(“IQVIA”)and the Cardiovascular Resea

209、rch Foundation(“CRF”)to conduct the EFS.IQVIA is a clinical research organization contracted toprovide clinical data monitoring,project and site management,data management,and safety reporting for the EFS.The term of the agreement is until the services for the EFS arecompleted.CRF provides us with c

210、ore lab services for the EFS and an independent clinical events committee.18Table of ContentsValve-in-Valve Procedures In July 2023,DurAVR THV was used for the first time in a ViV procedure as part of Health Canadas SAP.A ViV procedure is required for patients with a life-threateningsituation wherei

211、n their current bioprosthetic aortic valve is failing due to calcification or structural deterioration,and a new heart valve must be implanted inside the failing valve.Thesepatients are at high risk for another surgery and require a minimally invasive treatment option.Canadas SAP exists so that life

212、-saving technology not currently available for commercialuse in Canada can be provided when no other commercially available alternatives are suitable.Our participation in the Canadian SAP program is voluntary.There is no formal agreement with Health Canada,other than letters of authorization by Heal

213、th Canada for theimportation and or sale of special access devices.In addition,DurAVR THV was used for the first time in Sweden as a complex valve-in-valve-in-valve procedure at the KarolinskaInstitute hospital.EU Early Feasibility Study Preparation of our EU EFS commenced in December 2024,with the

214、activation of the first European Union(“EU”)investigational site.The first two subjects were implanted inJanuary 2025.The EU EFS plans to evaluate the safety and feasibility of the DurAVR THV system in the treatment of symptomatic,severe aortic stenosis or failed surgical aorticbioprosthetic valves

215、and is expected to provide ViV data in a controlled setting as well as generate further feasibility and safety data in patients with severe aortic stenosis.The study isanticipated to enroll up to 40 patients with data collected to be included in future regulatory applications.Competition We compete

216、in the cardiovascular device market,and in particular the TAVR market.These markets are characterized by rapid change resulting from technological advances,innovations and scientific discoveries.Our products face a mix of competitors ranging from large manufacturers with multiple business lines to s

217、mall manufacturers offering a limitedselection of products.In addition,we face competition from providers of other medical therapies,such as pharmaceutical companies.Our primary competitors include EdwardsLifesciences Corporation and Medtronic plc.Currently,no competitor has a single-piece tissue TA

218、VR commercially available or has publicly disclosed that a single-piece tissue TAVR isin development.Major shifts in industry market share have occurred in connection with product corrective actions,physician advisories,safety alerts,results of clinical trials to supportsuperiority claims,and public

219、ations about products,reflecting the importance of product quality,product efficacy and quality systems in the medical technology industry.In the currentenvironment of managed care,economically motivated customers,consolidation among healthcare providers,increased competition,declining reimbursement

220、 rates,and national andprovincial tender pricing,competitively priced product offerings are essential to our business.In order to compete effectively,we must continue to create or acquire advancedtechnology,incorporate this technology into proprietary products,obtain regulatory approvals in a timely

221、 manner,maintain high-quality manufacturing processes,and successfullymarket these products.Intellectual Property We rely on a combination of patent,copyright,trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual propertyrights in the Uni

222、ted States and other markets.United States federal registrations for trademarks can remain in force in perpetuity,provided the mark is still being used in commerce andthe maintenance/renewal filings are made as required by the sixth year after registration,by the tenth year after registration,and ev

223、ery ten years thereafter.As of December 31,2024,Anteris owned a total of 51 active patents expiring between 2025 and 2042,and 53 pending patent applications,as further detailed below.19Table of ContentsIn the category of prosthetic heart valve devices,we are the sole owner of eight active United Sta

224、tes patents,four pending United States patent applications,six activeAustralian patents,three pending Australian patent applications,one pending Patent Cooperation Treaty(“PCT”)application,17 active patents in other countries,and 29 pendingapplications in other countries.These patents and pending ap

225、plications are directed to features that are expected to provide competitive advantages such as:a novel process forproduction of calcification resistant cross-linked biomaterials for the prosthetic valve three-dimensional molded heart valve leaflets made of cross-linked biomaterial that mimic theper

226、formance of a native heart valve designed to provide enhanced performance characteristics such as low mean pressure gradient,low leaflet stress,large open area,high coaptationarea and high duration in an open state,to name a few a prosthetic heart valve that has localized protective covering members

227、 that prevent direct contact between the valve and thestent frame to enhance the durability and longevity of the prosthetic valve when the valve is in an open state and attachment of the biomaterial valve to the stent frame in a novelmanner that reduces stresses on the biomaterial of the prosthetic

228、valve.In the category of delivery systems for the prosthetic heart valve devices,we are the sole owner of one active United States patent,six pending United States patentapplications,one pending Australian patent application,three pending PCT applications,and three pending applications in other coun

229、tries.These patents and pending applications aredirected to features that are expected to provide competitive advantages such as:controllable and predictable commissural alignment a balloon folding technique that mitigates valverotations during expansion a single-use valve crimping device and a deli

230、very catheter hard stop member made of a braided metal material that provides improved trackability,effectiveexpansion of the delivery sheath during advancement,and increased longitudinal compressive strength that serves to maintain the longitudinal position of the prosthetic heart valve onthe ballo

231、on member.In the category of sterilization and storage of the prosthetic heart valve devices,we are the sole owner of two active United States patents,one active Australian patent,sevenactive patents in other countries,and one pending application in other countries.These patents and pending applicat

232、ions are directed to features that are expected to providecompetitive advantages such as a novel process for sterilizing the valve made of collagen-containing implantable biomaterials and storage thereafter.In the category of packaging,we are the sole owners of two active United States patents,one p

233、ending United States patent application,two active Australian patents,onepending PCT application,and five active patents in other countries.These patents and pending applications are directed to features that are expected to provide competitive advantagessuch as a packaging design that includes inte

234、grated components and mechanisms for preparing and mounting the valve on the delivery catheter system to make the clinicians valvepreparation process more efficient and user-friendly.Anteris holds a 30%interest in v2vmedtech.v2vmedtechs intellectual property is directed to implantable medical device

235、s for mitigating heart valve regurgitation.Using atranscatheter deployment technique,one or more clip devices are attached to the leaflets of a patients mitral or tricuspid heart valve to permanently join together edge portions of theleaflets.This is often referred to as an edge-to-edge repair proce

236、dure.As of December 31,2024,v2vmedtech had six pending patent applications and is the exclusive licensee of twopending patent applications owned by Columbia University.We have trademark registrations for several of our most material marks,including“ADAPT,”“ADAPT FOR LIFE”,“ANTERIS”,“ComASUR”,“DurAVR

237、”,and“GYNECEL”.Ourfiling for the“ANTERIS”trademark in India is pending.Our trademarks were obtained between 2006 and 2024.Nearly all of our United States trademarks are federal trademarks.We operate in an industry characterized by extensive patent litigation.Patent litigation may result in significa

238、nt damage awards and injunctions that could prevent themanufacture and sale of affected products or result in significant royalty payments in order to continue selling the products.We undertake reasonable measures to protect our patent rights,including monitoring the products of our competitors for

239、possible infringement of our patents.Protecting ourintellectual property rights is important to us,and we plan to continue to maintain and defend our rights regarding our intellectual property.Additionally,we are a party to licenseagreements with various third parties pursuant to which we have obtai

240、ned,for varying terms,the exclusive or non-exclusive rights to certain patents held by such third parties inconsideration for cross-licensing rights and/or royalty payments.We have also licensed certain patent rights to others.20Table of ContentsLicense Agreements CardioCel and VascuCel Patch Busine

241、ss We previously deployed our proprietary ADAPT tissue in our CardioCel and VascuCel products.CardioCel is an advanced cardiovascular scaffold designed to repairand treat a range of cardiovascular and vascular defects.CardioCel is used as a patch in great vessel repair,peripheral vascular reconstruc

242、tion and suture line buttressing.On October11,2019,we sold the distribution and manufacturing rights,including the CardioCel and VascuCel trademarks,to LeMaitre Vascular Inc.(“LeMaitre”)for cash proceeds of$14.2million,and a further$1.6 million was subsequently received.An additional$2.0 million(les

243、s the associated regulatory approval costs incurred by LeMaitre,which were capped at EUR0.6 million)has been recognized as a receivable as of December 31,2024 with LeMaitre confirming receipt of the European Union Medical Device Regulation(Regulation(EU)2017/745)(“EUMDR”)approvals in January 2025.Th

244、e sale included an exclusive intellectual property license to use our propriety ADAPT tissue limited to the cardiovascular patch field of usegranted to LeMaitre.Concurrent with such sale,we entered into a transition services agreement(the“Transition Services Agreement”)with LeMaitre pursuant to whic

245、h we manufacture and sellCardioCel and VascuCel products to LeMaitre in exchange for a price per product currently ranging between Australian dollar(“AUD$”)$200 and AUD$1,400 per product.ThisTransition Services Agreement expired in January 2025,whereupon LeMaitre commenced manufacturing the product.

246、Until January 2025,we remained the legal manufacturer for CardioCel and VascuCel products sold by LeMaitre in the Asia Pacific region,North Africa,Middle East region,including Bahrain Kuwait,Lebanon,Israel,Qatar,Saudi Arabia,the United Arab Emirates,Hong Kong,Indonesia,South Korea,Malaysia,Philippin

247、es,Singapore,Thailand,Turkey,theUnited Kingdom,and Vietnam.LeMaitre is in the process of transitioning to become a legal manufacturer for these regions.The CardioCel and VascuCel medical device license forCanada and the FDA issued 510(k)clearance,is now held by LeMaitre,which sells its own version o

248、f CardioCel and VascuCel.LeMaitre has also received a European CE mark underthe EUMDR transition period for its version of CardioCel and VascuCel.Under the EUMDR,LeMaitre is able to continue to distribute its remaining inventory of Anteris CardioCeland VascuCel currently held in LeMaitres facility i

249、n Europe.For further information,refer to the section titled“United States FDA Regulation of Medical Devices.”We have received cash proceeds of$13.4 million through December 31,2024 from manufacturing the CardioCel and VascuCel products for LeMaitre,pursuant to theTransition Services Agreement.Licen

250、se Agreement We are party to that certain License Agreement,dated as of October 11,2019,by and between us and LeMaitre(the“License Agreement”),pursuant to which we granted toLeMaitre an exclusive,limited,fully paid-up,royalty-free,worldwide,transferable,sublicensable,perpetual and irrevocable right

251、and license under and to patents and technology in thefields of(i)patches for cardiac repair or replacement(excluding catheter-delivered repair or catheter-delivered replacement devices),(ii)conduits formed from flat patches for cardiacrepair or replacement and(iii)vascular repair or replacement(the

252、“Exclusive Fields”).In addition,pursuant to the License Agreement,we granted LeMaitre a non-exclusive,limited,fullypaid-up,royalty-free,worldwide,transferable,sublicensable,perpetual and irrevocable right and license under and to patents and technology in the fields of patches for surgical leafletre

253、pair or replacement(excluding catheter delivered repair or catheter delivered replacement).Pursuant to the License Agreement,LeMaitre also granted us:(i)a non-exclusive,fully paid-up,royalty-free,limited,revocable,terminable,non-transferable,non-sublicensable right and license under and to the licen

254、sed patents and licensed technology in the Exclusive Fieldssolely for the purpose of manufacturing products for and on behalf of LeMaitre under the Transition Services Agreement during the term of the Transition Services Agreement,and(ii)anon-exclusive,fully paid up,royalty-free,limited,worldwide pe

255、rpetual license to use and reproduce any clinical data generated by LeMaitre and pertaining to the products developedunder the License Agreement.Consideration under the License Agreement consisted of a one-time upfront payment of$8.0 million from LeMaitre to us.All intellectual property licensedunde

256、r the License Agreement will be owned by us,but improvements by each party shall be owned by the party that conceived,invented and reduced to practice such improvements.The License Agreement has an indefinite term unless terminated by LeMaitre.We do not have the right to terminate the License Agreem

257、ent however,LeMaitre is permitted to terminateon 90 days notice.21Table of Contents4C Medical Technologies On August 30,2017,and as further amended,we entered into a supply and license agreement(as amended,the“4C Agreement”)with 4C Medical Technologies,Inc.(“4C”),amedical technology company that dev

258、elops medical devices for the treatment of cardiovascular valve disease.Under the terms of the 4C Agreement,we supply and sell ADAPT tissueto 4C,to be used in 4Cs production of medical devices related to mitral valves and tricuspid human heart valves and granted a limited license to our related ster

259、ilization methods only inconnection with use of ADAPT tissue by 4C in its production of medical devices.Sales under the 4C Agreement are made pursuant to individual purchase orders at a price per unit based on anticipated annual volume.There are no minimum purchasecommitments under the 4C Agreement.

260、During the term of the 4C Agreement,our supply of ADAPT tissue to 4C is exclusive,meaning that we agree not to develop,manufacture,or sell certain ADAPT tissue-based products in the mitral valve or tricuspid valve field other than for 4C without prior written approval.We received$8.4 million in proc

261、eeds through December 31,2024(life to date)under the 4C Agreement relating to the sale and supply of ADAPT tissue-based products to 4C and granting 4C a worldwide license to use our sterilization method in connection withthose supplied ADAPT tissue-based products.Pursuant to the 4C Agreement,we also

262、 granted to 4C a limited,revocable and royalty free license to use certain of our trademarks for marketing purposes for 4Cs medicaldevices that use ADAPT tissue.On October 14,2019,in light of the transaction with LeMaitre,we revoked 4Cs license to the CardioCel trademark only.We retained our intelle

263、ctualproperty rights existing at the time of the 4C Agreement(except for limited licenses granted to 4C in effect during the term of the 4C Agreement),including new intellectual propertyrights relating to our tissue products developed either solely by us or jointly by us and 4C.The last-to-expire pa

264、tent related to the intellectual property covered by the 4C Agreement isscheduled to expire between July 2032 and August 2032.The current term of the 4C Agreement expires on June 1,2026,at which time it automatically renew for successive one-year terms.Either we or 4C may terminate the 4CAgreement u

265、pon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent,files a petition for bankruptcy or upon the occurrence of similar events.Collaborations v2vmedtech On April 18,2023,we purcha

266、sed 30%of the equity capital stock of v2vmedtech,pursuant to a contribution and stock purchase agreement(the“Stock Purchase Agreement”),and concurrently contributed$0.2 million and entered into a series of agreements(collectively,the“v2v Agreements”)with v2vmedtech.v2vmedtech has a license agreement

267、 withColumbia University to develop an innovative heart valve repair device utilizing a transcatheter edge-to-edge repair method for a minimally invasive treatment of mitral and tricuspidvalve regurgitation,also known as leaky valve.Under the terms of the v2v Agreements,we agreed to provide certain

268、development services to v2vmedtech in exchange for equity in v2vmedtech.Pursuant to the v2vAgreements,we provide engineering,clinical,regulatory,marketing,and executive management resources,but excluding medical and chief medical officer services,in connection withv2vmedtechs development of these va

269、lve repair devices.We are responsible for developing products and preparing regulatory filings and all costs and expenses incurred by us directly,related to the development of devices constitute development contributions under the v2v Agreements,for which we are solely responsible.These contribution

270、s are to be provided overfive stages linked to key development and regulatory requirements for the device for transcatheter edge-to-edge repair of the mitral valve(“TEER Product”).22Table of ContentsStage 1 is the development of a preferred concept for the TEER Product,during which we will provide a

271、nalytical,engineering and product development services for the TEERproduct,gather and document preliminary or critical product requirements,create product specifications,design at least one concept to meet that product specification,and provideinitial prototypes.During this stage,v2vmedtech will als

272、o establish a separate medical advisory board(the“v2v Advisory Board”).Stage 1 concluded with a design review with non-Anteris members of v2vmedtech,prior to proceeding to Stage 2.The R&D contributions(excluding general and administration expenses)paid by us under Stage 1 were$2.2 million.Stage 2 in

273、volved manufacturing and testing prototypes of the preferred concept to finalize the TEER Product design for concept lock.This stage included additionalengineering and product development services to modify the preferred concept of the TEER Product at our sole discretion.Before we make a decision to

274、 advance to Stage 3,a designreview with non-Anteris members of v2vmedtech will be conducted and their feedback will be considered.In addition,to advance to Stage 3,the TEER Product must meet all establishedcriteria in our quality system.The R&D contributions(excluding general and administration expe

275、nses)paid by us as set out in the Development Agreement under Stage 2 are expected tobe$0.4 million to$0.8 million.Stage 3 involves non-clinical bench lab testing of the TEER Product,at our discretion.Before we make a decision to advance to Stage 4,a design review with non-Anterismembers of v2vmedte

276、ch will be conducted and their feedback will be considered.The R&D contributions(excluding general and administration expenses)paid by us as set out in theDevelopment Agreement under Stage 3 are expected to be$0.8 million to$1.8 million.Stage 4 involves pre-clinical acute and chronic studies of the

277、TEER Product in animals to support regulatory submissions,which will be undertaken at our discretion.Before wemake a decision to advance to Stage 5,a design review with non-Anteris members of v2vmedtech will be conducted and their feedback will be considered.Approval from v2vmedtechsBoard may be req

278、uired before proceeding to Stage 5.The R&D contributions(excluding general and administration expenses)paid by us as set out in the Development Agreement underStage 4 are expected to be$0.7 million to$1.6 million.Stage 5 is the first use of the TEER Product in a first-in-human study in one cohort of

279、 patients anywhere in the world.During this stage,v2vmedtech will enter into agreementswith the sites and practitioners performing the first-in-human study services and must maintain appropriate insurance.A review of endpoints and resulting data from the first-in-humanstudy will be conducted by us a

280、nd by appropriate non-Anteris members of v2vmedtech in order to determine the success of the first-in-human study.The R&D contributions(excludinggeneral and administration expenses)paid by us under Stage 5 as set out in the Development Agreement are expected to be$1.0 million to$2.2 million.During S

281、tages 2 through 5,we may solicit input from the v2v Advisory Board and will coordinate,facilitate and participate in meetings of the v2v Advisory Board.We aregenerally permitted to use our own employees,resources,lab facilities and other internal resources during the five development stages.We have

282、an option to terminate our activities for v2vmedtech,subject to certain break rights.These break rights allow us to discontinue additional development contributionssubject to a fee of$0.2 million during Stage 1 and incrementally increasing by$0.2 million for each stage of development to a maximum$1.

283、0 million break fee in Stage 5.We will also payall customary corporate,operational,and legal costs(“operational contributions”)of v2vmedtech up to an amount determined by the Board of v2vmedtech each year.After the earlier ofthe completion of Stage 5 or the incurrence of$10.0 million of development

284、contributions and operational contributions,our ownership stake in v2vmedtech will be increased from 30%to between 58%and 60%.v2vmedtech owns all intellectual property rights to the technology and data developed(the“Developed Technology and Data”)pursuant to the v2v Agreements.However,under the term

285、s of the v2v Agreements,v2vmedtech grants us a perpetual and exclusive license to the Developed Technology and Data for medical device applications other than leakyvalve devices.As v2vmedtech is a development company,there is no revenue currently generated by this entity.The v2v Agreements will expi

286、re one year after completion of Stage 5.We may terminate the v2v Agreements upon exercise of our break rights under the Stock PurchaseAgreement and payment of the applicable break fee or upon a material breach by v2vmedtech.v2vmedtech may terminate the v2v Agreements once we no longer own any shares

287、 ofv2vmedtechs issued and outstanding capital stock or upon its exercise of its break rights under the Stock Purchase Agreement or the exercise of certain rights it holds under the StockPurchase Agreement.We and v2vmedtech may terminate the v2v Agreements upon an event of insolvency or a material br

288、each by the other party.23Table of ContentsDevelopment is currently in Stage 2 and has reached concept lock on the clips and coupler.Timing for a FIH trial cannot be reasonably determined at this time as it is contingenton successful completion of further stages of R&D,including the design,prototypi

289、ng and testing,preclinical testing and completion of regulatory submissions.The timing to completethese activities is influenced by the v2v Agreements,which state that the development agreement can be terminated if certain expenditure amounts,development milestones orregulatory approvals are not inc

290、urred or achieved from March 31,2027 and onwards.The total amount of eligible development contributions and operational contributions paid by usunder the v2v Agreements as of December 31,2024 was$3.6 million.Ear Science Institute Australia On December 5,2022,we entered into a material development ag

291、reement(the“ESIA Agreement”)with the Ear Science Institute Australia(“ESIA”),pursuant to which we havethe right to use ESIAs silk-based material to create a proprietary silk-based technology for human cardiovascular applications and develop a synthetic heart valve substitute for clinicaluse(together

292、,the“ESIA New Technology”).Pursuant to the ESIA Agreement,we investigated applying the ESIA New Technology to our DurAVR THV design.Under the terms of the ESIA Agreement,we own all intellectual property rights in the ESIA New Technology to the extent it relies on our own intellectual property rights

293、 orinvolves heart valves but shared the development costs with ESIA.Furthermore,it contained an option for a period of 12 months,upon expiration of the ESIA Agreement,for Anteris tonegotiate an exclusive license to use certain technology owned by the ESIA to the extent necessary to further develop a

294、nd commercialize the ESIA New Technology.Additionally,theESIA New Technology cannot be used either for commercial purposes or on humans during the term of the ESIA Agreement.It was determined that the ESIA material was not commercially viable for Anteris purposes.The development project under the ES

295、IA Agreement extended beyond the initialDecember 31,2024 term of the ESIA Agreement,however the development project,and therefore the agreement,was terminated on February 11,2025.We did not receive any revenuefrom ESIA pursuant to the ESIA Agreement.As of December 31,2024,we paid an aggregate of$0.2

296、 million to ESIA under the ESIA Agreement.Single Source Suppliers Aran Biomedical We are party to a supply and quality agreement(the“Aran Supply Agreement”),dated November 16,2021,with Aran Biomedical Teoranta(“Aran”)(subsequently acquired byInteger Holdings Corporation)pursuant to which Aran suppli

297、es us with certain knitted materials from time to time pursuant to one or more purchase orders and in accordance withreasonable quality requirements provided by us.The Aran Supply Agreement has an initial term of five years and renews thereafter for successive one-year terms upon mutual writtenagree

298、ment of the parties.Either us or Aran may terminate the Aran Supply Agreement upon an uncured material breach.Harvey Industries Group We have entered into a supply and quality agreement(the“Harvey Supply Agreement”)with Harvey Industries Group Pty Ltd(“Harvey”),a supplier of animal derived materials

299、for therapeutic applications.Under the Harvey Supply Agreement,Harvey supplies us with bovine pericardia used in the manufacturing of our products pursuant to orders placed by us.We have the ability to reject any product that does not meet the applicable specifications.The Harvey Supply Agreement ex

300、pires in May 2026,but may be extended by mutual agreementbetween us and Harvey.If the Harvey Supply Agreement is not extended,Harvey will continue to supply us with bovine pericardia for an additional four months after the expiration ofthe Harvey Supply Agreement upon our request.We may terminate th

301、e Harvey Supply Agreement without cause upon 90 days written notice,and Harvey may terminate the HarveySupply Agreement with 12 months written notice.Either us or Harvey may terminate the Harvey Supply Agreement for cause upon an uncured breach or a non-remediable breach.24Table of ContentsNPX Medic

302、al We are party to a services agreement(the“NPX Services Agreement”),dated March 25,2020,and subsequently amended on February 21,2021 and March 24,2024,with NPXMedical,LLC(“NPX”),pursuant to which NPX provides certain engineering and manufacturing services to us as requested by us in purchase orders

303、 from time to time.NPX alsoprovides certain product development services to us under the NPX Services Agreement.The NPX Services Agreement had an original expiration date of March 25,2021 and renewsautomatically for successive one-year terms unless terminated.Either party to the NPX Services Agreeme

304、nt may terminate the agreement without cause upon 30 days written notice tothe other party or for cause upon an uncured material breach of the NPX Services Agreement.We are also party to a quality agreement with NPX(the“NPX Quality Agreement”),dated February 11,2021,which provides for certain qualit

305、y requirements for the productsmanufactured for us by NPX,as specified by us in purchase orders made under the NPX Services Agreement.The NPX Quality Agreement will remain in effect as long as the NPXServices Agreement is in effect.Switchback Medical We were party to a master services agreement(the“

306、Switchback Master Services Agreement”),dated June 1,2021 with Switchback Medical,LLC(“Switchback”),under whichSwitchback provided us with various development and manufacturing services,including engineering and testing services,pursuant to purchase orders made by us from time to time.We also granted

307、 Switchback a limited,exclusive,revocable,non-sublicensable,fully paid-up,royalty-free license to certain of our intellectual property to be used solely for the purposeof manufacturing products during the term of the Switchback Master Services Agreement.We retained all rights,title and interest in t

308、he results of any testing services,reports or datagenerated or provided by Switchback and to any developed intellectual property.The Switchback Master Services Agreement expired on June 1,2024,however,we are negotiating a newagreement with Switchback and expect to finalize such agreement in the near

309、 term.Taurus Engineering and Manufacturing We are party to a supplier quality agreement(the“Taurus Supplier Agreement”),dated February 15,2024,with Taurus Engineering and Manufacturing,Inc.(“Taurus”),underwhich Taurus provides us with certain manufacturing services and supplies us with raw materials

310、 in accordance with specified quality requirements and other specifications.Taurus isnot an exclusive supplier to us for the materials that it supplies,but under the terms of the Taurus Supplier Agreement,Taurus may not supply anyone other than us with the materialscovered by the Taurus Supplier Agr

311、eement.The Taurus Supplier Agreement has a two-year term and is scheduled to expire on the later of February 15,2026 or the term of any supplyagreement entered into under the Taurus Supplier Agreement,unless earlier terminated.Anteris may terminate the Taurus Supplier Agreement upon a change in cont

312、rol of Taurus.Other Agreements CRF We are party to a Combined Bioinformatics Master Services Agreement,dated September 1,2021,with CRF(the“CRF MSA”).Pursuant to the CRF MSA,CRF is engaged on aper project basis to perform independent analyses and provide interpretations on various types of medical da

313、ta and information,provide comprehensive data coordination and analysiscenter(“DCAC”)services,manage clinical events and data monitoring committees,and health economics and outcomes research(“HEOR”).Data and other research and resultsgenerated or produced by CRF concerning core lab and HEOR activiti

314、es pursuant to the CRF MSA is jointly owned by us and CRF.The data and other research and results generated orproduced by CRF concerning DCAC activities pursuant to the CRF MSA is owned by us.Payment terms under the CRF MSA are set forth in work orders for discrete tasks.The originalterm of the CRF

315、MSA was through December 31,2022,and has automatically renewed for subsequent annual terms,with the current term expiring on December 31,2025.Either party tothe CRF MSA may provide notice of termination of the CRF MSA for the subsequent annual period or upon 60 days notice.25Table of ContentsQMED We

316、 have agreed to be bound by General Terms and Conditions with QMED Consulting A/S(“QMED”),pursuant to which QMED provides certain services to us in accordancewith individual service agreements(the“Service Agreements”).Pursuant to the Service Agreements first entered into on July 8,2024,QMED has agre

317、ed to provide us with clinical trialsubmission support for the EU,including the provision of life science services in the areas of regulatory affairs,training,quality assurance and control,clinical trial consultancy andlegal representation.Payment terms and term lengths for discrete tasks and servic

318、es are set forth in individual Service Agreements.Under the General Terms and Conditions,we mayterminate the Service Agreements at our discretion by providing 30 days notice,or upon ten days notice and payment of a 15%termination fee.Either we or QMED may terminate theService Agreements upon default

319、 or an uncured material breach.IQVIA We are party to a Master Services Agreement,dated October 5,2021(the“IQVIA-Anteris MSA”).Pursuant to the IQVIA-Anteris MSA,IQVIA and its affiliates provideservices to us for individual studies or projects pursuant to individual work orders.These services may incl

320、ude strategic planning,expert consultation,clinical trial services,statisticalprogramming and analysis,data processing,data management,regulatory,project management,pharmacovigilance,central laboratory services,clinical pharmacology services,electrocardiogram services,services utilizing certain of I

321、QVIAs technology,medical device services,and other services as may be mutually agreed to.The IQVIA-Anteris MSA has aninitial term of five years.We may terminate the IQVIA-Anteris MSA without cause upon 60 days written notice.Either party may terminate the IQVIA-Anteris MSA for cause with 30days writ

322、ten notice upon an uncured material breach.Government Regulation United States FDA Regulation of Medical Devices Our products are regulated as medical devices in the United States.Accordingly,our products and operations are subject to extensive and ongoing regulation by the FDAunder the Federal Food

323、,Drug,and Cosmetic Act(“FDCA”),as well as under other federal,state and local regulatory authorities in the United States,and under foreign regulatoryauthorities for medical devices.For devices intended for commercial distribution in the United States,the FDA regulates product design and development

324、,pre-clinical and clinicaltesting,manufacturing,packaging,labeling,storage,record keeping and reporting,clearance or approval,marketing,distribution,promotion,import and export,and post-marketingsurveillance to assure their safety and effectiveness for their intended uses.Unless an exemption applies

325、,each new medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting aSection 510(k)clearance,de novo classification,or pre-market approval application(“PMA”).Additionally,each significant modification to a 510(k)-cleared

326、 or de novo classified devicewill require a new submission prior to marketing,and each modification that affects the safety and effectiveness of a device with an approved PMA will require a new PMA orsupplement.The 510(k)clearance,de novo classification and pre-market approval processes can be resou

327、rce intensive,expensive,and lengthy,and require payment of significant userfees unless a waiver or exemption is available.FDA classifies medical devices into one of three classes-Class I,Class II or Class III-depending on the degree of risk associated with each medical device and the extent ofcontro

328、l needed to provide reasonable assurances with respect to safety and effectiveness.Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to the FDAs general controls for medical devices,which includecompliance with the applicable portions of FDAs current

329、 good manufacturing practices for devices,establishment registration and device listing,reporting of adverse events andmalfunctions,reporting of corrections and removals,and appropriate,truthful and non-misleading labeling and promotional materials.Some Class I devices,called Class I reserveddevices

330、,also require premarket clearance by the FDA through the 510(k)premarket notification process described below.Most Class I devices are exempt from the premarket notificationrequirements.26Table of ContentsClass II devices are those that are subject to the FDAs general controls and any other special

331、controls deemed necessary by the FDA to ensure the safety and effectiveness ofthe device.These special controls can include performance standards,patient registries,product-specific FDA guidance documents,special labeling requirements and post-marketsurveillance.Most Class II devices are subject to

332、premarket review and clearance by the FDA through the 510(k)premarket notification process,although some Class II devices areexempt from such requirement.Under the 510(k)premarket notification process,a medical device manufacturer provides the FDA with a premarket notification that it intends to beg

333、in commercializing a productand demonstrates to the FDA that the product is substantially equivalent to another legally marketed predicate device.To be found substantially equivalent to a predicate device,thedevice must be for the same intended use and have either the same technological characteristics as the predicate or different technological characteristics that do not raise differentquestions