NASDAQ: AVR

Aortic valve stenosis is one of the most common and serious valvular heart diseases. It is fatal in approximately 50% of patients if left untreated after two years, and no pharmacotherapy is
available to treat this disease. Aortic stenosis causes a narrowing of the heart’s aortic valve, which reduces or blocks the amount of blood flowing from the heart to the body’s largest 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 approved in 2011 for high surgical risk patients, has emerged as an alternative to open-heart surgery. In 2019, the FDA also approved TAVR for use in
low-risk surgical patients. These low-risk surgical 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 diagnosed 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 solution for all patients, including both 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 flow of a healthy human aortic valve as compared to traditional
three-piece aortic valves. In our FIH study, we observed promising results in relation to hemodynamics, laminar flow and exercise 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 longer 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 improved hemodynamics as compared to traditional three-piece designs. These
designs and features cumulatively aim to provide a better quality of life as compared to the current standard of care associated with traditional three-piece designs. We intend to test these features in the randomized global pivotal study (the
“Pivotal Trial”) against commercially approved TAVR devices.

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 Pivotal Trial will be to
demonstrate non-inferiority of the DurAVR® THV system compared with commercially available TAVR systems for treatment of subjects with severe calcific aortic stenosis. We anticipate that the design of the Pivotal Trial will be a
prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either TAVR using the DurAVR® THV or TAVR using a commercially available and approved THV from competitors. We anticipate
that the subjects will include a broad array of risk profiles. We anticipate that subjects with a failed surgical bioprosthesis in need of a ViV TAVR will be enrolled in a separate parallel registry.

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In November 2022, we received conditional approval of our United States early feasibility study (“US EFS”) EFS investigational device exemption (“IDE”) application from the FDA to
evaluate the safety and feasibility of our DurAVR® THV system in the treatment of patients with symptomatic severe native aortic stenosis, enrolling 15 patients in four prominent 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 7.5 mmHg and Doppler velocity index (“DVI”) of 0.64. No paravalvular leaks were observed; however, there was one subject with
pre-existing significant conduction abnormalities who received a pacemaker. Furthermore, no mortality, disabling stroke, life-threatening bleeding, or reinterventions were reported at 30 days post-procedure. 12-month follow-up visits were completed
in December 2024. As of the date of this Form 10-K, some, but not all patient follow-up data, has been obtained, and the Company is not in a position to comment on such data 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 Montréal in Canada under a
compassionate 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 is unsuitable. In August 2023, a second Canadian patient was successfully
implanted with the DurAVR® THV system in a ViV procedure. As of January 2025, we have now treated seven ViV 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 clinical
trials at our facility in a suburb of Minneapolis, Minnesota. We are currently planning to submit an IDE for the DurAVR® THV system Pivotal Trial to the FDA by the end of quarter one of 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 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 could base a decision for pre-market approval that is required for commercialization of the DurAVR® THV system in the United States.

We are 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 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 opportunity for TAVR in relation to severe aortic stenosis and in relation to ViV procedures is 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 a company that is
primarily in the development phase, we currently generate small amounts of revenue and income which are insufficient to cover our investment in research, development and operational activities resulting in recurring net operating losses, incurred
since inception. We, like other development stage medical device companies, experience challenges in implementing our business strategy due to limited resources and a smaller capital base as we prioritize product development, minimize the period to
the commencement of commercial sales, ensure our focus on quality as well as scale our operations. The development and commercialization of new medical devices is highly competitive. Those competitors may have substantial market share, substantially
greater capital resources and established relationships with the structural heart community potentially creating barriers to adoption of our technology. Our success will partly be based on our ability to educate the market about the benefits of our
disruptive technology including current unmet clinical needs compared to commercially 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 products, and less invasive and novel technologies to address unmet patient needs. 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 evidence remains high.

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From time to 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 a development agreement
(the “Development Agreement”) with, v2vmedtech, inc. (“v2vmedtech”), which develops an innovative heart valve repair device for the minimally invasive treatment 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 the normal anatomy with a more “human like” valve design. Novel
molding 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 trials,
which we believe are delivering strong results and are bringing us closer to potentially achieving regulatory approvals for our DurAVR® THV system. We believe our FIH study at the Tbilisi Heart and Vascular Clinic in Tbilisi,
Georgia, and our EFS study represent key steps on our pathway to ultimately support an IDE to undertake the Pivotal Trial of our DurAVR® THV system.

•

Highly innovative physician-led R&D structure. Our DurAVR® THV and our ComASUR® balloon expandable delivery system have both been developed with
considerable input from leading interventional cardiologists and cardiac surgeons. We believe our emphasis on involving physicians in the R&D process allows us to better 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 our strong 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 patent applications through v2vmedtech.

•

Industry experienced executive team. Our management team and members of our Board of Directors (our “Board”) have extensive experience in the medical technology and health care
industries. We believe that our team’s diverse experiences and track record in the medical industry will assist our efforts to obtain regulatory approval of our products in the United States and other territories and continue to grow our
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 total global market opportunity
for TAVR in relation to severe aortic stenosis and in relation to ViV procedures is expected to reach $9.9 billion and $2.5 billion, respectively, in 2028. The key specific 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 indicated that the North American and European markets averaged 53% and 38% of the global market share, respectively, during the period 2016 to 2023. FMI forecasts
that the market opportunity in 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 relation to ViV procedures is forecast 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 published sources and key medical experts and applied a projected CAGR of 14.9% for the global
market, 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 and timesaving technologies; new product launches and approvals; rising demand for THV replacement; availability and cost of products; growing investment in healthcare expenditure; and increased regulatory focus on patient safety and
reimbursement policies. In addition, we expect the TAVR market to benefit from general trends, including an aging population, earlier diagnosis 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 active lifestyle.

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Since the inception of the TAVR procedure, the annual volume of TAVR procedures in the United States has 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. We believe that the rising geriatric population and the growing cardiovascular device market provides us with a clear business opportunity. The use of healthcare services is
significantly higher among older people.

DurAVR® THV’s single-piece native shaped biomimetic design replicates the performance of a healthy human aortic valve and is designed to restore normal blood flow as compared to
traditional three-piece transcatheter valves, either balloon expandable or self-expanding, which do not restore normal aortic flow. We believe this design, in combination with the ADAPT® tissue technology, has the potential to allow the
DurAVR® THV to last longer than traditional three-piece aortic valves, which have multiple leaflets sewn together that may lead 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 transcatheter aortic valve for the treatment of aortic stenosis that is shaped to mimic the performance of a healthy human aortic valve. Our DurAVR®
THV system has been designed with considerable input from some of the world’s leading interventional cardiologists and cardiac surgeons. DurAVR® THV’s single-piece design 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 to increase durability and last longer 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 improved hemodynamics as compared to traditional three-piece designs. These designs and features
cumulatively aim to restore a better quality of life compared to the current standard of care associated with traditional three-piece designs. We intend to test these features in the Pivotal Trial against commercially approved TAVR devices.

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The DurAVR® THV has the following attributes:

•

it is the first transcatheter aortic valve to use a patented construction of a molded single-piece of bioengineered tissue (our ADAPT® anti-calcification tissue with molded leaflets (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 to extend valve durability;

•

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 delivery system (see “ComASUR® Delivery System”) for controlled
deployment and accurate placement.

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ADAPT® Anti-Calcification Tissue

The ADAPT® tissue engineering process is an anti-calcification preparation that transforms xenograft tissue (bovine pericardium) into durable bioscaffolds that are used to mimic 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 and non-calcifying biomaterial.

The ADAPT® tissue engineering process involves multiple steps to transform bovine pericardium into a durable bioprosthetic material. Bovine spongiform encephalopathy-free bovine
pericardium is decellularized to remove all cellular antigens that initiate an immune response. The material is then crosslinked to enable maintenance and stabilization of strength and elasticity to improve mechanical resistance. The cytotoxicity is
further reduced using detoxification and sterilization processes and anti-calcification methodology to remove and bind aldehydes and enable safe storage in a non-glutaraldehyde solution. Post-implantation, ADAPT® tissue provides a scaffold
for cell migration to create 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-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, published by William Neethling et. al.,
and it has been distributed for use in over 55,000 patients globally in other indications. Our ComASUR® balloon-expandable delivery system, which was developed in consultation with physicians, is designed to provide precise alignment with
the heart’s native commissures to achieve accurate placement of the DurAVR® THV.

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To meet the need for a durable TAVR, made from ADAPT® tissue scaffold, we have created DurAVR® THV, which is a first in class, biomimetic single-piece valve with optimal
hemodynamic and durability properties. Based on published clinical data in several peer-reviewed journals, including The Journal of Thoracic and Cardiovascular Surgery, the Expert Review of Medical Devices, and Interactive Cardiovascular and Thoracic
Surgery, ADAPT® has been observed to offer potentially significant improvements compared with other widely available commercial processes adopted by healthcare providers, including with respect to bio-compatibility, durability, strength,
pliability, functionality and controlled remodeling.

ComASUR® Delivery System

Our ComASUR® delivery system is a physician-developed balloon expandable delivery system that contains a reinforced steerable catheter for a precise deflection through the heart anatomy in
a controlled manner to avoid damage to the aorta. This delivery system provides controlled deployment and accurate placement of our DurAVR® THV. Our ComASUR® delivery system is designed to achieve precise alignment with the
heart’s 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, which is not achieved
consistently in competitive delivery systems. This feature positions the TAVR valve leaflets exactly in line with the anatomical orientation of the recipient’s native valve leaflets. We have a patent pending for this system.

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The ComASUR® delivery system provides even balloon expansion for the accurate placement of the DurAVR® THV as well as ease of use. Under fluoroscopic guidance the physician
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 and the DurAVR® THV is deployed.

Finally, the balloon is deflated and removed.

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Clinical 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 our ongoing FIH
study 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 obtained in 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 have benefited from the implantation of the DurAVR® THV 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 (our “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 secure approval from the FDA
to undertake 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 (including one compassionate
case, which was outside of the study) have benefited from the implantation of our DurAVR® THV system at this clinic across seven cohorts. Patient outcomes are formally measured at both 30 days and 12-months post-procedure.

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The scope of the study was to evaluate the safety and feasibility of the DurAVR® THV system in the treatment of subjects with symptomatic severe aortic stenosis. The study was 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 a single DurAVR® bioprosthetic heart valve into the proper anatomical
location and hemodynamic performance. The safety endpoints of the study assessed at 30 days and one year post procedure 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 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 demonstrate
functional capabilities. We believe that the sample size will allow investigators to make a qualitative assessment of the safety of DurAVR® THV in the population studied. Thus far, we have observed promising results in relation to patient
hemodynamics, laminar flow and exercise capacity. In addition, as noted by Dr. P. Garg (Norwich University Hospital, United Kingdom), the first five patients underwent Cardiac Magnetic Resonance, which incorporated two-dimensional phase contrast at
the level of the ascending aorta, at six months to investigate the aortic flow physiology post-DurAVR® THV implantation. Aortic flow characteristics were assessed through the measurement of aortic FD and aortic systolic FRR. The average 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® THV were compared with those of five age/height/weight-matched controls
with healthy native aortic valves. 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 valve placement. 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 complications. These patients were observed 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 of 0.5 cm² and average EOA at 30 days of 2.05 cm²) and by 294% at 12 months post-procedure
from baseline (average EOA at 12 months of 1.96 cm²). We also observed reduced average MPG 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 baseline (average DVI at baseline of 0.18 and average DVI at 30 days of 0.56), and then an increase of 202% from baseline to 12 months (average DVI of 0.54). Furthermore, no
mortality (from any cause), disabling stroke, life-threatening bleeding, myocardial infarction or device-related complications were reported 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 months post-procedure (average 6MWTD 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 this cohort we observed
increased average EOA by 164% at 30 days (average EOA at baseline of 0.75 cm² and average EOA at 30 days of 1.98 cm²) and by 165% at 12 months post-procedure from baseline (average EOA at 12 months of 1.99 cm²). We also observed reduced average MPG
across the valve by 79% at 30 days (average MPG at baseline of 46.84 mmHg and average MPG at 30 days of 9.94 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
stable hemodynamics 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 0.56). Furthermore, no valve-related mortality, disabling stroke, life-threatening
bleeding, myocardial infarction or valve-related complications were reported at 12 months post-procedure. Lastly, the 6MWTD measuring patient exercise capacity after aortic valve replacement improved by 20% from baseline (average 6MWTD at baseline of
234.88 meters and average 6MTWD at 30 days of 282.38 meters), with a 27% improvement from the baseline result and the 12 months post-procedure (average 6MWTD at 12 months of 297.43 meters).

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Cohort 3

We enrolled seven participants in our third cohort in April 2023, each of whom were implanted with our DurAVR® THV with no valve-related complications. In this cohort we observed 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 cm², average EOA at 30 days of 2.09 cm² and average EOA at 12 months 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 and average 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 with stable hemodynamics 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-related complications were reported at 12 months. Lastly, the 6MWTD 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 and average 6MWTD at 30 days of 222.71 meters) and with a 48% improvement from 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 cohort we observed
increased average EOA by 165% from baseline (average EOA at baseline of 0.9 cm² and average EOA at 30 days of 2.39 cm²), as observed at 30 days post-procedure. We also 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 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 30 days post-procedure. Lastly, the 6MWTD measuring patient exercise capacity 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 of 275.00 meters).

Cohort 5

Our fifth patient cohort consisted of 13 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), 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 30 days post-procedure of 180% (average DVI at baseline of 0.22 and average DVI at 30 days of 0.62). Furthermore, no mortality (from any cause),
life-threatening bleeding, myocardial infarction 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 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.

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 Form 10-K, the 30-day
clinical 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.

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United States Early Feasibility Study

In November 2022, we received approval with conditions of our EFS IDE application from the FDA to evaluate the safety and feasibility of our DurAVR® THV system in the treatment 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 the United States. Patient outcomes such as stroke, myocardial infarction, life-threatening
bleeds, and all-cause mortality are reported at 30 days and 1-year post implantation. Patients will be followed 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”) Category B device, which permits 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 hemodynamic
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 average EOA of 172% from
baseline (average EOA at baseline of 0.8 cm² and average EOA at 30 days of 2.2 cm²), reduction of MPG of 82% from baseline (average MPG at baseline of 41 mmHg and 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 leaks were observed; however, there was one subject with pre-existing significant conduction abnormalities who received a pacemaker. Furthermore, no mortality,
disabling stroke, life-threatening bleeding, or reinterventions were reported at 30 days post-procedure. 12-month follow up visits were completed in December, 2024, with analysis and reporting scheduled for the first quarter 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 Research Foundation (“CRF”) to conduct the EFS. IQVIA is a clinical research organization contracted to provide 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 are completed. CRF provides us with core lab services for the EFS and an independent clinical
events committee.

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Valve-in-Valve Procedures

In July 2023, DurAVR® THV was used for the first time in a ViV procedure as part of Health Canada’s SAP. A ViV procedure is required for patients with a life-threatening situation wherein
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. These patients are at high risk for another surgery and require a minimally
invasive treatment option. Canada’s SAP exists so that life-saving technology not currently available for commercial use 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 Health Canada for the importation 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 Karolinska Institute hospital.

EU Early Feasibility Study

Preparation of our EU EFS commenced in December 2024, with the activation of the first European Union (“EU”) investigational site. The first two subjects were implanted in January 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 aortic bioprosthetic valves 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 is anticipated to enroll up to 40 patients with data collected to be included in future regulatory applications.

Competition

We compete 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 small manufacturers offering a limited selection of products. In addition, we face competition from providers of other medical
therapies, such as pharmaceutical companies. Our primary competitors include Edwards Lifesciences Corporation and Medtronic plc. Currently, no competitor has a single-piece tissue TAVR commercially available or has publicly disclosed that a
single-piece tissue TAVR is in development.

Major shifts in industry market share have occurred in connection with product corrective actions, physician advisories, safety alerts, results of clinical trials to support superiority claims, and
publications about products, reflecting the importance of product quality, product efficacy and quality systems in the medical technology industry. In the current environment of managed care, economically motivated customers, consolidation among
healthcare providers, increased competition, declining reimbursement rates, and national and provincial tender pricing, competitively priced product offerings are essential to our business. In order to compete effectively, we must continue to create
or acquire advanced technology, incorporate this technology into proprietary products, obtain regulatory approvals in a timely manner, maintain high-quality manufacturing processes, and successfully market 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 property rights in the United 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 and the maintenance/renewal filings are made as required by the sixth year after registration,
by the tenth year after registration, and every 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.

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In the category of prosthetic heart valve devices, we are the sole owner of eight active United States patents, four pending United States patent applications, six active Australian patents, three
pending Australian patent applications, one pending Patent Cooperation Treaty (“PCT”) application, 17 active patents in other countries, and 29 pending applications in other countries. These patents and pending applications are directed to features
that are expected to provide competitive advantages such as: a novel process for production of calcification resistant cross-linked biomaterials for the prosthetic valve; three-dimensional molded heart valve leaflets made of cross-linked biomaterial
that mimic the performance of a native heart valve designed to provide enhanced performance characteristics such as low mean pressure gradient, low leaflet stress, large open area, high coaptation area and high duration in an open state, to name a
few; a prosthetic heart valve that has localized protective covering members that prevent direct contact between the valve and the stent 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 novel manner that reduces stresses on the biomaterial of the prosthetic 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 patent applications, one pending
Australian patent application, three pending PCT applications, and three pending applications in other countries. These patents and pending applications are directed to features that are expected to provide competitive advantages such as:
controllable and predictable commissural alignment; a balloon folding technique that mitigates valve rotations during expansion; a single-use valve crimping device; and a delivery catheter hard stop member made of a braided metal material that
provides improved trackability, effective expansion of the delivery sheath during advancement, and increased longitudinal compressive strength that serves to maintain the longitudinal position of the prosthetic heart valve on the balloon 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, seven active patents in
other countries, and one pending application in other countries. These patents and pending applications are directed to features that are expected to provide competitive 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 pending United States patent application, two active Australian patents, one pending PCT application, and
five active patents in other countries. These patents and pending applications are directed to features that are expected to provide competitive advantages such as a packaging design that includes integrated components and mechanisms for preparing
and mounting the valve on the delivery catheter system to make the clinician’s valve preparation process more efficient and user-friendly.

Anteris holds a 30% interest in v2vmedtech. v2vmedtech’s intellectual property is directed to implantable medical devices for mitigating heart valve regurgitation. Using a transcatheter deployment
technique, one or more clip devices are attached to the leaflets of a patient’s mitral or tricuspid heart valve to permanently join together edge portions of the leaflets. This is often referred to as an edge-to-edge repair procedure. As of
December 31, 2024, v2vmedtech had six pending patent applications and is the exclusive licensee of two pending 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”, and “GYNECEL”. Our filing 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 significant damage awards and injunctions that could prevent the manufacture 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 possible infringement of our patents. Protecting our intellectual 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 license agreements with various third parties pursuant to which we have obtained, for varying
terms, the exclusive or non-exclusive rights to certain patents held by such third parties in consideration for cross-licensing rights and/or royalty payments. We have also licensed certain patent rights to others.

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License Agreements

CardioCel™ and VascuCel™ Patch Business

We previously deployed our proprietary ADAPT® tissue in our CardioCel™ and VascuCel™ products. CardioCel™ is an advanced cardiovascular scaffold designed to repair and
treat a range of cardiovascular and vascular defects. CardioCel™ is used as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing. On October 11, 2019, we sold the distribution and manufacturing rights,
including the CardioCel™ and VascuCel™ trademarks, to LeMaitre Vascular Inc. (“LeMaitre”) for cash proceeds of $14.2 million, and a further $1.6 million was subsequently received. An additional $2.0 million (less the associated regulatory approval
costs incurred by LeMaitre, which were capped at EUR 0.6 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. The sale included an exclusive intellectual property license to use our propriety ADAPT® tissue limited to the cardiovascular patch field of use granted to LeMaitre.

Concurrent with such sale, we entered into a transition services agreement (the “Transition Services Agreement”) with LeMaitre pursuant to which we manufacture and sell CardioCel™ 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. This Transition Services Agreement expired in January 2025, whereupon LeMaitre commenced
manufacturing the product.

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, Philippines, Singapore, Thailand, Turkey, the United 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 for Canada and the FDA issued 510(k) clearance, is now held by LeMaitre, which sells its own version of CardioCel™ and VascuCel™. LeMaitre has also
received a European CE mark under the 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 CardioCel™ and VascuCel™ currently held in
LeMaitre’s facility in 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 the Transition Services Agreement.

License 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 to LeMaitre an exclusive, limited,
fully paid-up, royalty-free, worldwide, transferable, sublicensable, perpetual and irrevocable right and license under and to patents and technology in the fields of (i) patches for cardiac repair or replacement (excluding catheter-delivered repair
or catheter-delivered replacement devices), (ii) conduits formed from flat patches for cardiac repair or replacement; and (iii) vascular repair or replacement (the “Exclusive Fields”). In addition, pursuant to the License Agreement, we granted
LeMaitre a non-exclusive, limited, fully paid-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 leaflet repair 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 licensed patents and licensed technology in the Exclusive Fields solely 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) a non-exclusive, fully paid up, royalty-free, limited, worldwide perpetual license to use and reproduce any clinical data generated by LeMaitre and pertaining to the products developed under 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 licensed under 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 Agreement; however,
LeMaitre is permitted to terminate on 90 days’ notice.

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4C 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”), a medical technology company
that develops medical devices for the treatment of cardiovascular valve disease. Under the terms of the 4C Agreement, we supply and sell ADAPT® tissue to 4C, to be used in 4C’s production of medical devices related to mitral valves and
tricuspid human heart valves and granted a limited license to our related sterilization methods only in connection 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 purchase commitments under the 4C Agreement.

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 proceeds 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 with those supplied ADAPT® tissue-based products.

Pursuant to the 4C Agreement, we also granted to 4C a limited, revocable and royalty free license to use certain of our trademarks for marketing purposes for 4C’s medical devices that use ADAPT®
tissue. On October 14, 2019, in light of the transaction with LeMaitre, we revoked 4C’s license to the CardioCel™ trademark only. We retained our intellectual property 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 property rights relating to our tissue products developed either solely by us or jointly by us and 4C. The last-to-expire patent related to the intellectual
property covered by the 4C Agreement is scheduled 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 4C Agreement upon 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 purchased 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 with Columbia 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 tricuspid valve regurgitation, also known as leaky valve.

Under the terms of the v2v Agreements, we agreed to provide certain development services to v2vmedtech in exchange for equity in v2vmedtech. Pursuant to the v2v Agreements, we provide engineering, clinical,
regulatory, marketing, and executive management resources, but excluding medical and chief medical officer services, in connection with v2vmedtech’s development of these valve 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 contributions are to be provided
over five stages linked to key development and regulatory requirements for the device for transcatheter edge-to-edge repair of the mitral valve (“TEER Product”).

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Stage 1 is the development of a preferred concept for the TEER Product, during which we will provide analytical, engineering and product development services for the TEER product, gather and document
preliminary or critical product requirements, create product specifications, design at least one concept to meet that product specification, and provide initial prototypes. During this stage, v2vmedtech will also 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 involved manufacturing and testing prototypes of the preferred concept to finalize the TEER Product design for concept lock. This stage included additional engineering and product development
services to modify the preferred concept of the TEER Product at our sole discretion. Before we make a decision to advance to Stage 3, a design review 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 established criteria in our quality system. The R&D contributions (excluding general and administration expenses) paid by us as set out in the Development Agreement under Stage 2 are
expected to be $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-Anteris members of v2vmedtech 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 the Development 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 TEER Product in animals to support regulatory submissions, which will be undertaken at our discretion. Before we make 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 v2vmedtech’s Board may be required before proceeding to Stage 5. The R&D contributions (excluding general
and administration expenses) paid by us as set out in the Development Agreement under Stage 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 patients anywhere in the world. During this stage, v2vmedtech will enter into agreements with 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-human study will be conducted by us and by appropriate non-Anteris members of v2vmedtech in
order to determine the success of the first-in-human study. The R&D contributions (excluding general 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 Stages 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 are generally permitted to use
our own employees, resources, lab facilities and other internal resources during the five development stages.

We have an option to terminate our activities for v2vmedtech, subject to certain break rights. These break rights allow us to discontinue additional development contributions subject 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 $1.0 million break fee in Stage 5. We will also pay all 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 of the completion of Stage 5 or the incurrence of $10.0 million of development 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 terms of the v2v
Agreements, v2vmedtech grants us a perpetual and exclusive license to the Developed Technology and Data for medical device applications other than leaky valve devices. As v2vmedtech is a development company, there is no revenue currently generated by
this entity.

The v2v Agreements will expire one year after completion of Stage 5. We may terminate the v2v Agreements upon exercise of our break rights under the Stock Purchase Agreement 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 of v2vmedtech’s 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 Stock Purchase Agreement. We and v2vmedtech may terminate the v2v Agreements upon an event of insolvency or a material breach by the other party.

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Development 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 contingent on successful
completion of further stages of R&D, including the design, prototyping and testing, preclinical testing and completion of regulatory submissions. The timing to complete these activities is influenced by the v2v Agreements, which state that the
development agreement can be terminated if certain expenditure amounts, development milestones or regulatory approvals are not incurred or achieved from March 31, 2027 and onwards. The total amount of eligible development contributions and
operational contributions paid by us under 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 agreement (the “ESIA Agreement”) with the Ear Science Institute Australia (“ESIA”), pursuant to which we have the right to use ESIA’s
silk-based material to create a proprietary silk-based technology for human cardiovascular applications and develop a synthetic heart valve substitute for clinical use (together, 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 or involves
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 to negotiate an exclusive license to use certain technology owned by the ESIA
to the extent necessary to further develop and commercialize the ESIA New Technology. Additionally, the ESIA 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 ESIA Agreement extended beyond the initial December 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 revenue from ESIA pursuant to the ESIA Agreement.

As of December 31, 2024, we paid an aggregate of $0.2 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 by Integer Holdings Corporation)
pursuant to which Aran supplies us with certain knitted materials from time to time pursuant to one or more purchase orders and in accordance with reasonable 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 written agreement 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 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 expires in May 2026, but may be extended by mutual agreement between 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 of the Harvey Supply Agreement upon our request. We may terminate the Harvey Supply Agreement without cause upon 90 days written notice, and Harvey may terminate the Harvey Supply 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.

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NPX Medical

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 NPX Medical, LLC (“NPX”), pursuant to
which NPX provides certain engineering and manufacturing services to us as requested by us in purchase orders from time to time. NPX also provides 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 renews automatically for successive one-year terms unless terminated. Either party to the NPX Services Agreement may terminate the agreement without cause upon 30 days written notice to the 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 quality requirements for the products manufactured 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 NPX Services Agreement is in effect.

Switchback Medical

We were party to a master services agreement (the “Switchback Master Services Agreement”), dated June 1, 2021 with Switchback Medical, LLC (“Switchback”), under which Switchback 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 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 purpose of manufacturing products during the term of the Switchback Master Services Agreement. We retained all rights, title and interest in the results of any
testing services, reports or data generated 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 new agreement with Switchback and expect
to finalize such agreement in the near 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”), under which Taurus provides us
with certain manufacturing services and supplies us with raw materials in accordance with specified quality requirements and other specifications. Taurus is not 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 materials covered by the Taurus Supplier Agreement. 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 supply agreement entered into under the Taurus Supplier Agreement, unless earlier terminated. Anteris may terminate the Taurus Supplier Agreement upon a change in control 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 a per project basis to perform
independent analyses and provide interpretations on various types of medical data and information, provide comprehensive data coordination and analysis center (“DCAC”) services, manage clinical events and data monitoring committees, and health
economics and outcomes research (“HEOR”). Data and other research and results generated or produced by CRF concerning core lab and HEOR activities pursuant to the CRF MSA is jointly owned by us and CRF. The data and other research and results
generated or produced 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 original term of the CRF 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 to the CRF MSA may provide notice of termination of the CRF MSA for the subsequent annual period or upon 60 days’ notice.

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QMED

We 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 accordance with individual service agreements
(the “Service Agreements”). Pursuant to the Service Agreements first entered into on July 8, 2024, QMED has agreed to provide us with clinical trial submission 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 and legal representation. Payment terms and term lengths for discrete tasks and services are set forth in individual Service Agreements. Under the General Terms
and Conditions, we may terminate 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 the Service Agreements upon default 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 provide services to us for individual studies
or projects pursuant to individual work orders. These services may include strategic planning, expert consultation, clinical trial services, statistical programming and analysis, data processing, data management, regulatory, project management,
pharmacovigilance, central laboratory services, clinical pharmacology services, electrocardiogram services, services utilizing certain of IQVIA’s technology, medical device services, and other services as may be mutually agreed to. The IQVIA-Anteris
MSA has an initial 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 30 days’ written 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 FDA under the Federal Food, Drug,
and Cosmetic Act (“FDCA”), as well as under other federal, state and local regulatory authorities in the United States, and under foreign regulatory authorities for medical devices. For devices intended for commercial distribution in the United
States, the FDA regulates product design and development, pre-clinical and clinical testing, manufacturing, packaging, labeling, storage, record keeping and reporting, clearance or approval, marketing, distribution, promotion, import and export, and
post-marketing surveillance to assure their safety and effectiveness for their intended uses.

Unless an exemption applies, each new medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting a Section 510(k)
clearance, de novo classification, or pre-market approval application (“PMA”). Additionally, each significant modification to a 510(k)-cleared or de novo classified device will 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 or supplement. The 510(k) clearance, de novo classification and pre-market approval processes can be resource intensive, expensive, and lengthy, and require
payment of significant user fees 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 of control 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 FDA’s general controls for medical devices, which include compliance with the applicable portions of FDA’s
current good manufacturing practices for devices, establishment registration and device listing, reporting of adverse events and malfunctions, reporting of corrections and removals, and appropriate, truthful and non-misleading labeling and
promotional materials. Some Class I devices, called Class I reserved devices, 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
notification requirements.

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Class II devices are those that are subject to the FDA’s general controls and any other special controls deemed necessary by the FDA to ensure the safety and effectiveness of the device. These
special controls can include performance standards, patient registries, product-specific FDA guidance documents, special labeling requirements and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the
FDA through the 510(k) premarket notification process, although some Class II devices are exempt 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 begin commercializing a product and 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, the device 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 different questions of safety or effectiveness. In some cases, the submission must include data from clinical studies in order to demonstrate substantial
equivalence to a predicate device. Commercialization may commence when the FDA issues a clearance letter finding such substantial equivalence.

Class III devices include devices deemed by the FDA to pose the greatest risk. Class III devices include those devices that (i) cannot be classified into Class I or Class II because insufficient
information exists to determine that general and special controls would provide a reasonable assurance of safety and effectiveness, and (ii) are intended for uses that are life-supporting, life-sustaining, of substantial importance in preventing
impairment in human health, or present a potential unreasonable risk of illness or injury.

Additionally, novel devices that lack a predicate device to which they can demonstrate substantial equivalence via the 510(k) premarket notification process are automatically classified into Class
III, unless the manufacturer can demonstrate that the device should be classified into Class I or II via the de novo classification process, discussed below. Devices placed in Class III require approval of a PMA, which contains valid scientific
evidence demonstrating a reasonable assurance of the safety and effectiveness of the device for its intended use. The pre-market approval process is generally more costly and time consuming than the 510(k) premarket notification process or the de
novo classification process. A PMA typically includes, but is not limited to, extensive technical information regarding device design and development, preclinical and clinical trial data, manufacturing information, labeling, and financial disclosure
information for the clinical investigators in device studies.

Under the FDCA, medical devices such as the DurAVR® THV system are regulated by the FDA Center for Devices and Radiological Health (“CDRH”). Accordingly, CDRH reviews 510(k)s, de novo
requests, and PMAs for clearance or approval.

CardioCel™, VascuCel™ and ADAPT® are pericardial tissue products and are Class II medical devices.

CardioCel™ was cleared for marketing by the FDA on January 30, 2014 as a Class II device. A modified version of CardioCel™ was cleared for marketing by the FDA on April 28, 2017. VascuCel™ (another
modified version of CardioCel™) was cleared for marketing by the FDA on October 14, 2016. ADAPT® tissue was cleared for marketing by the FDA on April 3, 2020.

Replacement heart valves, including the DurAVR® THV, are Class III medical devices. Additionally, because the ComASUR® delivery system is required for use of the DurAVR®
THV, the ComASUR® delivery system will be regulated as a component of the DurAVR® THV Class III device (as part of the overall system). Accordingly, the ComASUR® delivery system will be reviewed under any PMA
submitted for the DurAVR® THV system.

As noted above, if a novel device lacks a predicate device to which it can demonstrate substantial equivalence via that 510(k) process, it is automatically classified into Class III, which means it
requires a PMA. However, under the de novo classification process, a manufacturer that believes its novel device is actually low to moderate risk, can request the classification of the novel device into Class I or Class II. To obtain de novo
classification, the manufacturer must demonstrate that when general controls, or general controls and special controls, are applied, the probable benefits to health from using the device outweigh probable risks of such use, and that a significant
portion of the target population will have clinically significant results from use of the device. If a device is de novo classified into Class I or Class II, it becomes a legally marketed predicate device to which future devices can claim substantial
equivalence by submitting a 510(k). The de novo classification process is generally more costly and time consuming than the 510(k) premarket notification process but can be less costly and time consuming than the pre-market approval process. A de
novo classification request typically includes information similar to that required in a PMA, plus a recommendation for the proposed classification (Class I or Class II) and, if the device is proposed to be classified into Class II, any proposed
special controls.

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Obtaining FDA marketing clearance or approval for medical devices is expensive and uncertain, and may take several years, and generally requires significant scientific and clinical data. Our DurAVR®
THV system is classified as a Class III device for which we expect to submit a PMA upon completion of the currently contemplated pivotal clinical trial.

IDE Process

In the United States, absent certain limited exceptions, human clinical trials intended to support medical device clearance or approval require IDE approval. An IDE authorizes distribution of devices
that lack pre-market approval, de novo classification or 510(k) clearance for clinical evaluation purposes. Some types of studies deemed to present “non-significant risk” are deemed to have an approved IDE if certain requirements are satisfied,
including but not limited to obtaining IRB approval for the study, obtaining informed consent from study subjects, and complying with certain recordkeeping and reporting requirements. If the device presents a “significant risk” to human health, as
defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials. The IDE application must be supported by appropriate data, such as animal, biocompatibility and
laboratory testing results, showing that it is safe to test the device in humans and that the clinical test protocol is scientifically sound. The IDE application must be approved in advance by the FDA for a specified number of test subjects.
Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA, the study protocol and informed consent documents are approved by appropriate IRBs at the clinical trial sites, and informed consent
from study subjects has been obtained. There can be no assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number
of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and effectiveness, even if the trial meets its intended success criteria.

All non-exempt clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion of the investigational device, and
specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. Clinical trials must further comply with the FDA’s regulations for IRB approval and for informed consent and other human subject
protections. Required records and reports are subject to inspection by the FDA and other applicable authorities.

The results of clinical trials may be unfavorable, or, even if the intended safety and effectiveness success criteria are achieved, may not be considered sufficient for the FDA to grant marketing
approval or clearance of a product. The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA, for numerous reasons, including the following:

•

the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;

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patients do not enroll in clinical trials at the rate expected;

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patients do not comply with trial protocols;

•

patient follow-up is not at the rate expected;

•

patients die during a clinical trial, even though their death may not be related to the products that are part of the trial;

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device malfunctions occur in unexpected ways, with unexpected frequency, or with potential adverse consequences;

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side effects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of new or similar pre-market approvals or clearance of new or similar 510(k)s or de novo classification requests, or
result in the imposition of new requirements or testing;

•

IRBs and third-party clinical investigators may delay or reject the trial protocol;

•

third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, investigator agreement, investigational plan, good clinical
practices, the IDE regulations, or other FDA or IRB requirements;

•

we or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans, or otherwise fail to comply with
the IDE regulations governing responsibilities, records, and reports of sponsors of clinical investigations;

•

third-party clinical investigators have significant financial interests related to us or our study such that the FDA deems the study results unreliable, or we or investigators fail to disclose such interests;

•

regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials;

•

changes in government regulations or administrative actions;

•

the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness; or

•

the FDA concludes that our trial design is unreliable or inadequate to demonstrate safety and effectiveness.

The Pre-Market Approval Process

Following receipt of a PMA, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it is not, the agency will refuse
to file the PMA. If it is sufficiently complete, the FDA will accept the application for filing and begin the substantive review. The FDA, by statute and by regulation, has 180 days to review a filed PMA, although the review of an application more
often occurs over a significantly longer period of time. During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant,
requesting the applicant’s response to deficiencies within the submission communicated by the FDA. The issuance of a deficiency letter automatically stops the FDA 180-day review clock. The FDA considers a pre-market approval or pre-market approval
supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information (e.g. major deficiency letter) within a total of 360 days. Before approving or denying a PMA, the FDA may hold an advisory committee
meeting to obtain advice related to the safety and effectiveness of the medical devices and provide the FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve
it. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes for the device.
Overall, the FDA review of a PMA application generally takes between one and two years but may take significantly longer. The FDA can delay, limit or deny approval of a PMA for many reasons, including:

•

the device may not be shown to be safe or effective to the FDA’s satisfaction;

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the data from preclinical studies and/or clinical trials may be found unreliable or insufficient to support approval;

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the manufacturing process or facilities may not meet applicable requirements;

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the proposed labeling is found to be false or misleading;

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the device is not shown to conform to a required performance standard; or

•

changes in FDA approval policies or adoption of new regulations may require additional data.

If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter or an approvable letter, the latter of which usually contains a number of conditions that must be met in
order to secure final approval of the PMA. When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a pre-market approval letter authorizing commercial marketing of the device, subject to the conditions
of approval and the limitations established in the approval letter. If the FDA’s evaluation of a PMA or manufacturing facilities is not favorable, then the FDA will deny the PMA or issue a not approvable letter. The FDA also may determine that
additional tests or clinical trials are necessary, in which case the PMA may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data
are available. The pre-market approval process can be expensive, uncertain and lengthy, and a number of devices for which the FDA pre-market approval has been sought by other companies have never been approved by the FDA for marketing.

New PMAs or pre-market approval supplements generally are required for modifications to an approved device that could affect the safety or effectiveness of an approved device, including modifications
to the manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, ingredients, materials or design of the device that has been approved through the pre-market
approval process. Pre-market approval supplements often require submission of the same type of information as an initial PMA, except that the supplement is limited to information needed to support ay changes from the device covered by the approved
PMA and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.

In approving a PMA, as a condition of approval, the FDA may also require some form of post-approval study or post-market surveillance. The applicant conducts a follow-up study or follows certain
patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and effectiveness data for the device. The
FDA may also require post-market surveillance for certain devices cleared under a 510(k) notification or de novo classification, such as implants or life-supporting or life-sustaining devices used outside a device user facility. The FDA may also
approve a PMA with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale, distribution and use. Modifications to the manufacturing process,
labeling and design for a device which has received approval through the pre-market approval process generally require submission of a new PMA or pre-market approval supplement prior to marketing.

Ongoing Regulation by the FDA

Even after the FDA permits a device to be marketed, numerous regulatory requirements apply, including:

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establishment registration and device listing;

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the Device cGMP, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation,
and other quality assurance procedures during the manufacturing process;

•

labeling regulations, advertising and promotion requirements, restrictions on sale, distribution or use of a device, each including the FDA general prohibition against the promotion of products for any uses other than those cleared or
approved by the FDA, which are commonly known as “off label” uses;

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medical device reporting regulations requiring that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar device marketed by
the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

•

medical device corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA
that may present a risk to health;

•

recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death;

•

any order from FDA to repair, replace or refund a device;

•

product export requirements;

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device tracking requirements; and

•

post-market study and surveillance requirements.

If a device receives 510(k) clearance or de novo classification, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended
use, will require a new 510(k) clearance or possibly a pre-market approval. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the
FDA disagrees with the manufacturer’s determination not to seek a new 510(k) clearance, the FDA may retroactively require the manufacturer to seek 510(k) clearance or possibly a pre-market approval. The FDA could also require us to cease marketing
and distribution and/or to recall the modified device until 510(k) clearance or a pre-market approval is obtained. Also, in these circumstances, we may be subject to more significant actions, including regulatory fines and penalties.

Some changes to an approved pre-market approval device, including changes in indications, labeling, or manufacturing processes or facilities, among others, generally require submission and FDA
approval of a new PMA or pre-market approval supplement, as appropriate, before the change can be implemented. Supplements to a PMA often require the submission of the same type of information required for an original PMA, except that the supplement
is generally limited to that information needed to support the proposed change from the device covered by the original pre-market approval. The FDA generally uses the same procedures and actions in reviewing pre-market approval supplements as it does
in reviewing original PMA, although some pre-market approval supplements may be approved more quickly, such as supplements describing certain modifications in the manufacturing process that do not affect the specifications of the device.

FDA regulations require us to register as a medical device manufacturer with the FDA. These regulations require that we manufacture our products and maintain related documentation in a prescribed
manner with respect to manufacturing, testing and control activities. Furthermore, the FDA requires us to comply with various FDA regulations regarding labeling. Our facilities, records and manufacturing processes are subject to periodic unscheduled
inspections by the FDA or other regulatory authorities. When the FDA conducts an inspection, the investigators will identify any deficiencies they believe exist in the form of a notice of inspectional observations, or Form FDA 483. If we receive a
notice of inspectional observations or deficiencies from the FDA following an inspection, we would be required to respond in writing and would be required to undertake corrective and/or preventive or other actions in order to address the FDA’s or
other regulators’ concerns. Failure to address the FDA’s concerns may result in the issuance of a warning letter or other enforcement or administrative actions described below.

Additionally, some states have enacted laws and regulations governing the manufacture, sale, marketing or distribution of medical devices. These laws and regulations may also require medical device
manufacturers and/or distributors doing business within multiple states to register or apply for state licenses. These laws and regulations could also subject our facility to state inspection on a routine basis for compliance with any applicable
state requirements.

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Failure by us or by our suppliers to comply with applicable federal or state regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the
following sanctions:

•

warning or untitled letters, fines, injunctions, consent decrees and civil penalties;

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unanticipated expenditures, including for repairs, replacements, or refunds of devices;

•

customer notifications, voluntary or mandatory recall or seizure of our products;

•

operating restrictions, partial suspension or total shutdown of production;

•

delay in reviewing, or refusal to clear or approve, submissions or applications for new products or modifications to existing products;

•

FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries;

•

suspension or withdrawal of FDA approvals or clearances that have already been granted; and

•

criminal prosecution.

Newly discovered or developed safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications, and also may require the
implementation of other risk management measures. Also, new government requirements, including those resulting from new legislation or regulations, may be established, or the FDA’s policies may change, which could delay or prevent regulatory
clearance or approval of our products under development.

Our facilities, records and manufacturing processes are subject to periodic unscheduled inspections by the FDA or other regulatory authorities.

Regulation of Medical Devices Outside the United States

Outside of the United States, the regulation of medical devices is also complex. In Europe, for instance, products are subject to extensive regulatory requirements.
In 2021, a new regulatory scheme for medical devices, namely the EUMDR, became effective in EU Member States subject to a transition period during which some devices that were in conformity with the
previous rules could still be placed on the EU market for some time. The EUMDR requires that medical devices may only be placed on the market or put into service if they meet certain pre-established general safety and performance requirements when
properly installed, maintained, and used in accordance with their intended purpose. The EUMDR has significant requirements for many medical devices, including requirements for clinical evidence necessary to demonstrate the devices’ conformity (and
the related documentation), device identification and traceability, registration of devices and of economic operators throughout the distribution chain and post-market surveillance (dealing with the collection and review of the experience gained
from devices for the purpose of identifying any for any necessary corrective or preventive actions after they have been placed on the market or put into service). In some regions, the level of government regulation of medical devices is increasing,
which can lengthen time to market and increase registration and approval costs. In many countries, the national health or social security organizations require products to be qualified before they can be marketed and considered eligible for
reimbursement.

In many instances, global regulatory agencies have come together in an attempt to harmonize medical device regulatory requirements. In 2011, the regulatory agencies of Australia, Brazil, Canada, China,
European Union, Japan and the United States, as well as the World Health Organization came together and established the International Medical Device Regulators Forum (the “IMDRF”). The IMDRF continues to grow and now has a management committee of
regulatory agency representatives from 10 countries as well as the European Union and affiliate members and observers from many other countries. One example of the IMDRF harmonizing medical device regulatory requirements is the Medical Device
Single Audit Program, whereby a medical device manufacturer can have a single Quality Management System audit of their facility which covers the regulatory requirements of Australia, Brazil, Canada, Japan and the United States. Instead of having
separate periodic quality inspections from regulators of each of these countries, a single comprehensive inspection is performed.

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Other regional groups working to harmonize regulatory requirements are the Asia-Pacific Economic Cooperation group, Global Harmonization Working Party and African Medical Devices Forum. While
regulatory requirements are constantly evolving, regulatory agencies recognize the impact and are attempting to harmonize their efforts.

While the list of regulated countries continues to grow, many of the regulated countries leverage device approvals from the US or Europe, meaning that the testing and clinical studies required to
satisfy device safety and efficacy requirements of the US and Europe, often carry over to other geographies.

Other United States Regulatory Matters

Medical device companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct
their business. Manufacturing, sales, promotion, third-party payor reimbursement and other activities following product clearance or approval are subject to regulation by numerous regulatory authorities in the United States in addition to the FDA,
including the CMS, other divisions of the Department of Health and Human Services (“DHHS”), the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the
Environmental Protection Agency, and state and local governments. For example, in the United States, sales, marketing, participation in government health care programs or contracts with third-party payors, and scientific and educational programs also
must comply with state and federal fraud and abuse, anti-kickback, false claims, transparency, government price reporting, anti-corruption, and health information privacy and security laws and regulations. Internationally, other governments also
impose regulations in connection with their healthcare reimbursement programs and the delivery of healthcare items and services. These laws include the following:

•

United States federal healthcare fraud and abuse laws generally apply to our activities because our products are covered under federal healthcare programs such as Medicare and Medicaid. The federal Anti-Kickback Statute (the “Anti-Kickback
Statute”) is particularly relevant because of its broad applicability. The Anti-Kickback Statute makes it illegal for any person, including a prescription medical device manufacturer (or a party acting on its behalf), to knowingly and
willfully solicit, receive, offer or pay any remuneration that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular medical device, for which payment may be made under a
federal healthcare program, such as Medicare or Medicaid. Almost any financial arrangement with a healthcare provider, patient or customer could implicate the Anti-Kickback Statute. Statutory exceptions and regulatory safe harbors protect
certain arrangements if specific requirements are met. Individual states have corollaries to the federal Anti-Kickback Statute that may also apply and may be more expansive or impose additional requirements.

•

Another fraud and abuse law that may be implicated by ownership and compensation arrangements with health care professionals or their families is the Physician Self-Referral Law, commonly referred to as the “Stark Law”. The Stark Law
prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception
applies. While the Stark Law generally only provides to those entities that provide “designated health services” and submit claims for such services, it may nonetheless be implicated by certain ownership or compensation arrangements with
health care professionals or family members. Individual states have corollaries to the federal Stark law that may also apply and may be more expansive or impose additional requirements.

•

Another development affecting the medical technology industry is the increased use of the federal Civil False Claims Act (the “False Claims Act”) and, in particular, actions brought pursuant to the False Claims
Act’s “whistleblower” or “qui tam” provisions. In recent years, the number of suits brought against healthcare companies by private individuals has increased dramatically. The federal civil and criminal false claims acts prohibit individuals
or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal
government. Individual states have false claims acts with respect to Medicaid spending that may also apply and may be more expansive or impose additional requirements. Additionally, some states have insurance fraud provisions that apply to
commercial payors or all payors under insurance laws that have similar whistleblower or relator provisions (e.g., Insurance Fraud Prevention Act for California).

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•

The Civil Monetary Penalty Act of 1981 (“CMP”) allows the DHHS Office of Inspector General to seek civil monetary penalties and sometimes exclusion from participation in the government health care programs for a wide variety of conduct.
For example, the CMP and implementing regulations impose penalties against any person or entity that is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for
an item or service that was not provided as claimed or is false or fraudulent. Other conduct that may result in violation of the CMP is offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should
know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier.

•

The Health Insurance Portability and Accountability Act (“HIPAA”) prohibits executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. HIPAA, as amended
by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and
transmission of individually identifiable health information. While HIPAA applies only to covered entities, which generally does not include device manufacturers, HIPAA and HITECH impose those same obligations to business associates under
contractual terms. HIPAA may also still apply directly to the manufacturer depending on the scope and nature of data sharing arrangement or other contracting arrangements. In addition to HIPAA and its accompanying regulations, device
manufacturers may be subject to additional state consumer and privacy laws which may be more expansive or restrictive on the use and protection of patient and consumer data.

•

The FDCA prohibits the adulteration or misbranding of medical devices. Medical device manufacturers may also be subject to state corollaries to the FDCA.

•

The federal Physician Payment Sunshine Act and its implementing regulations, which require applicable manufacturers of covered drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the
Children’s Health Insurance Program (with certain exceptions) to report annually to CMS and DHHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists
and chiropractors), non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate
family members.

•

The Foreign Corrupt Practices Act (“FCPA”) prohibits any United States individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party
or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the
United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, if any, and to devise and maintain an
adequate system of internal accounting controls for international operations. On February 10, 2025, Executive Order “Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security” was signed, which
directs the U.S. attorney general to review and update guidelines and policies related to FCPA enforcement and to cease new FCPA investigations and enforcement actions until a new enforcement policy is implemented.

•

Analogous state and foreign laws and regulations, such as state anti-kickback, anti-referral, and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by
non-governmental third-party payors, including private insurers; state laws that require certain medical device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the
federal government and may require applicable manufacturers to disclose or report certain information related to payments and other transfers of value to health care professionals and entities or sales, marketing, pricing, clinical trials,
marketing expenditures and activities, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA,
thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.

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United States Health Care Reform

Changes in healthcare policy in the United States subject us to additional regulatory requirements that may interrupt the development and the commercialization of our current and
future products. Current and future legislative proposals may limit coverage for the procedures associated with the use of our products. Changes in healthcare policy may further reform state and federal legislation and regulations related to
reimbursement and coverage for our current and future products.

We believe that there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to disclose and/or reduce health care costs while expanding
individual healthcare benefits. Certain of these changes could impose additional limitations on the rates we will be able to charge for our current and future products or the amounts of reimbursement available for our current and future products from
governmental agencies or third-party payors. Federal and state regulators are also prioritizing costs and charge transparency initiatives, including rebate programs, that may impact our ability to charge and collect payment for our products or
charging and collection activities for services that use our products. Other initiatives currently on the healthcare reform agenda include value-based care initiatives, which will impact medical device sales and contracting models, and therefore,
product pricing. However, such health policy priorities are consistently evolving and subject to change under shifting political conditions and leadership. As such, depending on policy priorities, current and future health care reform legislation and
policies could have a material adverse effect on our business and financial condition given the potential impact to the availability and demand for our products. Notably, we will be impacted by the reimbursement coverage eligibility and rate
schedules set by CMS for both our products and for services and procedures involving our products. For example, on June 21, 2019, CMS issued a National Coverage Determination for Transcatheter Aortic Valve Replacement which informed Medicare
Administrative Contractors of coverage requirements for the procedure. Current coverage and reimbursement levels are subject to ongoing analysis and could change, thus having an adverse effect on market demand and our pricing flexibility.

Data Privacy and Security

Numerous state, federal and foreign laws govern health privacy, consumer protection, and other use of individually identifiable information. This includes the collection, dissemination, use, access
to, confidentiality and security of personal information and health-related information. In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws,
including HIPAA, and federal and state consumer protection laws and regulations, that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our
partners. Notably, the Office for Civil Rights at DHHS has expanded the application of HIPAA to regulated entities’ use of tracking technologies that collect and analyze information about how users interact with regulated entities’ websites or mobile
applications. In addition, certain state and non-United States laws and regulations, such as the California Consumer Privacy Act, the California Privacy Rights Act and the EU General Data Protection Regulation, govern the privacy and security of
personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating
compliance efforts. Failure to comply with these laws or regulations, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations
are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

Corporate Information

The Company was incorporated in the State of Delaware on January 29, 2024. The Company is a global company with its principal executive offices located at Toowong Tower, Level 3, Suite 302, 9
Sherwood Road, Toowong, QLD 4066, Australia, and other key locations located at 860 Blue Gentian Road, Suite 340, Eagan, Minnesota 55121 as well as two other sites in Minnesota and sites in Western Australia, Australia and Geneva, Switzerland. The
Company’s telephone number is +61 7 3152 3200. Additional information can be found on our website address: www.anteristech.com. Information contained on, or that is accessible through, the website shall not
be deemed incorporated into and is not a part of this Form 10-K.

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Initial Public Offering and Reorganization

On December 12, 2024, our registration statement on Form S-1 (File No. 333-283414) (the “Registration Statement”) relating to our initial public offering became effective pursuant to which we issued
and sold 14,878,481 shares of Common Stock at a public offering price of $6.00 per share. We received net proceeds of $80.1 million, after deducting the underwriting discounts, commissions and offering expenses and giving effect to the exercise
of the underwriters’ option to purchase additional shares. None of the expenses associated with the initial public offering were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates.

Prior to the consummation of the initial public offering, we completed the Reorganization pursuant to which we received all of the issued and outstanding shares of ATL, which was formerly an Australian
public company originally registered in Western Australia, Australia and listed on the ASX, pursuant to a scheme of arrangement under Australian law between ATL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act
2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATL also cancelled all existing options it had on issue in exchange for our company issuing replacement options to acquire Common Stock pursuant to a scheme
of arrangement between ATL and its optionholders (the “Option Scheme”) under Part 5.1 of the Corporations Act. The Scheme was approved by ATL’s shareholders at a general meeting of shareholders, which was held on December 3, 2024. The Option Scheme
was approved by ATL’s optionholders at a general meeting of optionholders held on the same day. ATL obtained approval of the Scheme and the Option Scheme by the Supreme Court of Queensland on December 4, 2024. As a result of the Reorganization, ATL
became a wholly owned subsidiary of our company and the shareholders of ATL immediately prior to the consummation of the initial public company became holders of the either one share of Common Stock for every ordinary share of ATL or one CDI for
every one ordinary share of ATL for each share held as of the record date.

In connection with the Reorganization, on December 16, 2024, we issued (i) 21,139,816 shares of Common Stock to shareholders of ATL, 20,360,496 of which are represented by CDIs, pursuant to the
Scheme and (ii) 6,118,807 options to purchase shares of Common Stock pursuant to the Option Scheme. The foregoing issuances were made pursuant to an exemption from registration under Section 3(a)(10) of the Securities Act. Each option is exercisable
into one share of Common Stock, including as represented by a CDI, upon the payment of the relevant exercise price.

Human Capital

Overview

As of December 31, 2024, we had approximately 136 full time equivalent employees. We have never experienced a work stoppage or interruption due to labor disputes. We believe our relations with our
employees are good.

Employee Talent and Retention

Our business and future operating results depend in significant part upon the continued contributions of our key personnel, including qualified personnel with medical device and tissue processing
experience, and senior management with experience in the medical device or tissue processing space, many of whom would be difficult to replace. Our business and future operating results depend in significant part on our ability to attract and retain
qualified management, operations, processing, marketing, sales, and support personnel for our operations.

We have programs and processes in place to help ensure that our compensation, benefits programs, and work environment attract and retain such personnel, and we strive to enhance those programs and
processes to respond to the increasingly competitive market for talent. We also strive to offer competitive equitable pay, comprehensive benefits, and services that retain and meet the varying needs of our employees. The principal purposes of our
equity and cash incentive plans and non-officer incentive plans are to attract, retain, motivate, and reward our employees.

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Culture

Fostering and maintaining a strong and collaborative culture is a key strategic focus. We also have ethics and compliance policies that are designed to instill a commitment to ethical behavior and
legal compliance across our company. Employees are encouraged to approach their supervisors if they believe violations of policies have occurred. Employees are also able to confidentially and anonymously report any such violations through ethics
and compliance hotlines and an online form. Furthermore, the company has a whistleblower policy whereby employees are able to submit an anonymous disclosure either by email, web form or our ethics and compliance hotlines.

We aim to hire based on our AORTIC (Accountability, Objectivity, Respect, Teamwork, Integrity, Courage) values and continuously build our culture around those values. Employees are encouraged to
present culture building activities that promote collaboration and inclusivity.

Training and Development

We are committed to the learning and development of all global team members by offering training programs. The goals of the training programs are to highlight and boost our company culture, empower
employees to add knowledge and skills, increase their job satisfaction and increase team productivity with behaviors that help us succeed on our mission together. Such programs include educational workshops, department-led knowledge-based training
(i.e., quality systems, safety, simulation demonstrations), leadership development cohorts, AORTIC values skill building, and new hire onboarding.

Health and Safety

We are committed to providing a safe working environment compliant with all relevant and applicable laws. We maintain our commitment to a safe working environment by routinely conducting assessments
of the workplace in order to detect, assess and respond to identified hazards or risks; giving preference to removing any hazards or risks in order to prevent injury, illness or incidents from occurring; and striving to reduce the likelihood of the
risk or hazard occurring and its severity, where we are unable to eliminate the risk entirely. We have processes to report all work-related injuries, illness and near-misses to management.

Responsibilities of employees and managers are to create and maintain a safe working environment by reporting any unsafe conditions or potential hazards immediately for assessment and remediation;
following all safe work method statements, safe travel practices, procedures, instructions, rules legislation and laws relating to workplace health and safety; treating all breaches of workplace health and safety standards seriously and taking
appropriate action; and providing adequate information, instruction, training and supervision to enable our employees to perform their roles effectively and safely.

Employee Engagement

We solicit anonymous employee feedback to assess employee satisfaction and engagement and to identify opportunities for development through a third-party provider. Employee feedback is also gathered
through surveys, the employee review process, pulse surveys, and exit interviews.

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Available Information

Prior to the Reorganization, regulatory information on the Company was filed with the ASX. Following the Reorganization, the Company files information with both the ASX and the SEC.

We file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements, and related amendments, exhibits and other information with the SEC. You may access
and read our filings without charge through the SEC’s website at www.sec.gov, the ASX’s website at www.asx.com.au or through our website at https://anteristech.com/investors/financials.html, as soon as reasonably practicable after such materials
are electronically filed with or furnished to the SEC pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (the “Exchange Act”) and the ASX Listing Rules. Information contained on, or accessible through, our website shall not
be deemed incorporated into and is not a part of this Form 10-K.