Anteris Technologies Global Corp

2/2/2023

Invention:	Biomimetic TAVR
Name:	DurAVR®
FDA Approval:	Pending
Pathway:	Class III PMA
Patents:	10+
NASDAQ:	AVR

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EXECUTIVE SUMMARY

DurAVR® is a transcatheter aortic valve replacement (TAVR) used to treat aortic stenosis. Unlike competing valves, the anti-calcification material from which it is made—called ADAPT®—exhibits zero calcification, the primary cause of valve deterioration. Furthermore, whereas existing TAVR valves comprise three seperate pieces of tissue sutured to a frame, ADAPT® tissue can be molded into three-dimensional shapes that retain their geometry. This enables DurAVR® to be made from a single piece of ADAPT® tissue that has been molded to the shape of a native aortic valve. This "biomimetic" design normalizes the valve's hemodynamics and flow.

Multiple patents protect ADAPT®, the biomimetic design of the DurAVR® valve, and the ComASUR® catheter system used for its delivery.

Following FDA approval of its Investigational Device Exemption (IDE) in Q4 2025, Anteris has commenced patient recruitment for the pivotal PARADIGM study. The trial will compare DurAVR® with the standard of care—SAPIEN by Edwards Lifesciences (~65% market share) and Evolut™ by Medtronic (~35% market share). PARADIGM’s primary endpoint is non-inferiority at 12 months. If results align with data from the First-in-Human (FIH) trial and Early Feasibility Study (EFS)—which have demonstrated measurable superiority—it is reasonable to expect that DurAVR® will capture a significant share of the USD 10 billion US TAVR market.

INTRODUCTION

Aortic stenosis is the narrowing of the aortic valve, which obstructs blood flow from the heart and causes elevated pressure within the left ventricle. The condition is most commonly driven by calcific degeneration—the progressive buildup of calcium on the valve leaflets that restricts their motion—though age-related wear and congenital abnormalities also contribute. There is no pharmacological therapy capable of reversing or halting calcification; once significant obstruction develops, valve replacement is the only effective treatment. This can be performed through open-heart surgery (SAVR) or a catheter-based procedure (TAVR). Since 2019, TAVR procedures have surpassed SAVR in the United States, marking a decisive shift toward minimally invasive treatment.

DurAVR® is designed for implantation using Anteris Technologies’ proprietary ComASUR® catheter system, which employs a balloon-expandable delivery mechanism. The valve is mounted on the catheter and inserted through the femoral artery, then guided along the aorta to the native valve site. Once correctly positioned, a balloon at the catheter’s tip is inflated to deploy the valve securely within the annulus. The balloon is then deflated and the catheter withdrawn, leaving the new DurAVR® valve functioning in place.

To date, DurAVR® has been successfully implanted in more than 100 patients, including 15 procedures performed in the United States under the FDA-approved Early Feasibility Study (EFS). Following approval of its Investigational Device Exemption (IDE), Anteris commenced recruitment for a pivotal, randomized clinical trial in Q4 2025. This study will compare DurAVR® with the standard of care—SAPIEN and Evolut™—and has a primary endpoint of non-inferiority in all-cause mortality, stroke, or hospitalization at 12 months.

A PRIMER ON HEMODYNAMICS

The aortic valve opens and closes with each heartbeat to regulate blood flow from the heart. The space available for blood to pass through when the valve is fully open is known as the effective orifice area (EOA). A healthy valve typically has an EOA of around 2 cm². When this opening becomes restricted due to calcification or age-related wear, the valve is described as stenotic. This narrowing increases the pressure required to push blood through the valve, raising the mean gradient above the normal range of 5–10 mmHg (millimetres of mercury). In simple terms, the smaller the EOA, the higher the mean gradient.

In the context of aortic valve replacement (AVR), hemodynamics refers to the relationship between EOA and mean gradient. A valve with “healthy” hemodynamics maintains an EOA near 2 cm² and a mean gradient between 5 and 10 mmHg, closely replicating normal physiological flow.

COMPETITION FACTORS

Direct competitors

The TAVR market is currently dominated by two players: Edwards Lifesciences, which holds approximately 65% market share with its balloon-expandable SAPIEN valve, and Medtronic, which accounts for the remaining 35% with its self-expanding Evolut™ valve. Both DurAVR® and SAPIEN use a balloon-expandable transcatheter approach, while Evolut™ relies on a self-expanding design.

Substitutes

There are no pharmacological therapies capable of reversing or treating valve calcification, making valve replacement the only effective treatment option.

THE INVENTION

Existing TAVR valve leaflets are manufactured from animal tissue that has undergone proprietary anti-calcification treatment. Edwards Lifesciences’ SAPIEN 3 Ultra RESILIA valve—the current standard of care—uses RESILIA, a treated bovine pericardial tissue. In these designs, three separate leaflets are individually cut, shaped, and then sutured onto a supporting frame to form the functional valve.

Tissue science: ADAPT®

The DurAVR® valve leaflets are bovine pericardium tissue that has been treated with Anteris Technologies’ patented anti-calcification platform, ADAPT®. In this process, the xenograft is decellularized to remove the antigens that typically trigger an immune response. ADAPT® tissue has demonstrated an absence of calcification for up to ten years in clinical use (Neethling et al.), a durability attributed to the elimination of free aldehydes—chemically reactive groups implicated in calcification and long-term tissue degradation in conventional bioprosthetic valves. To date, ADAPT®-treated tissue has been used as a cardiac and vascular patch in more than 55,000 patients worldwide.

Valve design: Biomimetics

A unique feature of the ADAPT® process is that it enables the treated pericardium to be molded, allowing Anteris to shape the material into a replica of a native aortic valve. This "biomimetic" geometry normalizes leaflet motion, optimizes hemodynamics, and restores physiologic flow.

ADAPT® tissue molded to the shape of a native aortic valve

The DurAVR® valve is, in essence, this molded ADAPT® tissue structure sutured to a cobalt–chromium stent, creating a durable, anatomically accurate, and catheter-deliverable prosthetic valve.

This molding capability originates with ADAPT’s controlled cross-linking of the tissue’s collagen fibers. Cross-linking stabilizes the fiber network so the material behaves predictably under load, without the creep or deformation seen in conventionally fixed pericardium. In practical terms, it stabilizes the tissue’s Young’s modulus—the measure of how much a material deforms under stress—so the engineered shape holds its geometry once formed. This predictable mechanical behavior is what makes it possible for ADAPT® tissue to be molded into, and then reliably retain, the architecture of a native aortic valve.

Durability

Thanks to the superior anti-calcification properties of ADAPT® tissue, DurAVR® demonstrates greater long-term durability than existing TAVR valves. Its single-piece leaflet design also requires far fewer sutures to attach to the stent frame—around 100 compared with roughly 800 in conventional three-piece valves—resulting in higher structural integrity and fewer potential failure points. This increased durability extends the valve’s lifespan, making TAVR suitable for younger patients and expanding the overall addressable market, estimated to reach USD 10 billion by 2028.

Hemodynamics

In conventional three-piece valves, each leaflet is sutured to the frame individually, reducing the effective orifice area available for blood flow. DurAVR’s single-piece molded design eliminates these internal suture lines, allowing the leaflets to open more fully within the frame. This creates a larger effective orifice area and improves blood flow through the aorta, achieving hemodynamics that more closely match those of a native valve.

DurAVR®

SAPIEN 3UR

The restoration of near-normal, pre-disease hemodynamics means that DurAVR® functions as a curative valve replacement. Clinicians have described it as the first biomimetic valve—one whose geometry replicates the anatomy and motion of a native aortic valve—earning it a first-in-class designation. As shown below, DurAVR’s molded single-piece construction allows its leaflets to close in the same tri-leaflet configuration as a natural valve.

DurAVR®

SAPIEN 3

Here is how DurAVR® compares to SAPIEN 3 in head-to-head hydrodynamic bench tests (Janar Sathananthan, MD - presented at TCT 2022):

In Q4 2025, the company reported 1-year hemodynamic results for a total of 37 patients with a mean annual diameter of 22.4 mm:

In 65 symptomatic severe AS patients with small annuli (aortic annulus area 396 ± 37 mm²) across the EMBARK First in Human (FIH) and US Early Feasibility Study (EFS), the company reported an EOA of 2.1 ± 0.2 cm² and average MPG of 8.6 ± 2.6 mmHg at 12 months, with no valve related mortality and no moderate or severe paravalvular leak (PVL).

Leaflet kinematics and coaptation

Leaflet kinematics describes the motion of valve leaflets during opening and closing. DurAVR’s biomimetic design produces more native-like leaflet motion, where the leaflets bulge slightly as they begin to open and then “snap” into a fully expanded position that remains stable throughout systole. This behavior closely replicates that of a natural aortic valve and contrasts with existing TAVR valves, whose leaflets typically swing open like hinged doors and exhibit a flapping motion when fully deployed.

DurAVR® also features an extended coaptation zone—greater than 8 mm—which represents the length of leaflet contact in the closed position. This increased coaptation reduces leaflet twisting, or pinwheeling, and contributes to smoother valve closure. Together, these properties minimize turbulence across the valve, reducing mechanical stress and enhancing long-term durability.

Aortic flow

The most novel outcome of these native-like leaflet dynamics is the normalization of aortic flow—the pattern and direction of blood as it exits the valve. While conventional TAVR valves often create turbulent, disordered flow, DurAVR’s biomimetic architecture restores a laminar, or smooth, flow profile that mirrors the pre-disease physiology of a healthy heart.

The greater the turbulence in blood flow, the more energy the heart must expend to circulate blood throughout the body. By restoring laminar, or smooth, aortic flow, DurAVR’s biomimetic design improves the heart’s overall energy efficiency.

Aortic flow quality is typically assessed using two parameters: Flow Displacement (FD) and Flow Reversal Rate (FRR). In a healthy native valve, FD is around 12% and FRR is close to 0%, indicating efficient, forward-directed flow. The chart below shows how DurAVR® performs relative to existing valves on these measures, based on bench test results (presented at the Anteris Technologies Annual General Meeting 2022)

Commissural alignment

The ComASUR® delivery system incorporates a patented mechanism that allows the valve to be uncoupled and rotated for precise commissural alignment with the patient’s native anatomy. In addition, the biomimetic leaflet geometry of DurAVR® naturally promotes better alignment with the native commissures. This reduces backward pressure on the left ventricle and enhances washout of the aortic sinuses—both of which contribute to improved aortic flow dynamics.

Coronary access

The valve’s native-like design also permits a shorter frame height without compromising hemodynamic performance. This lower profile facilitates easier coronary access for potential future valve-in-valve procedures, an increasingly important consideration as TAVR extends to younger patient populations.

Summary: removing performance trade-offs

The TAVR market has long been defined by a trade-off between hemodynamic performance and ease of use. Edwards Lifesciences’ SAPIEN valve, which is balloon-expandable, is favored for its procedural simplicity and precise placement but delivers only moderate hemodynamics due to its non-anatomic design. Medtronic’s Evolut™, a self-expanding valve, achieves superior hemodynamics through a more conformable frame and supra-annular leaflet position but sacrifices deployment control and ease of use. Anteris Technologies’ DurAVR® eliminates this trade-off: its biomimetic, balloon-expandable valve replicates the natural shape and motion of a native aortic valve, delivering both Evolut™-level hemodynamics and SAPIEN-level usability.

COST ADVANTAGES

The tissue leaflets of TAVR valves are manually sutured to the stent frame. The DurAVR® valve utilizes fewer sutures in its design, which may offer an advantage in terms of manufacturing efficiency and production cost.

PRICING

TAVR devices command a premium price point of approximately USD $35,000—significantly higher than surgical aortic valve replacement (SAVR) alternatives at around USD $8,000, and substantially above unit production costs. Several structural factors support this pricing:

A stable market duopoly led by Edwards Lifesciences and Medtronic
Limited purchasing power among hospitals due to market fragmentation
Reduced hospital length of stay compared to SAVR procedures

INTELLECTUAL PROPERTY

Anteris holds a portfolio of around 60 patents covering the ADAPT® tissue technology, the single-piece molded leaflet and structural design of the DurAVR® valve, and the ComASUR® delivery system. The biomimetic valve design itself is protected under U.S. patent US11648107.

The proprietary characteristics of ADAPT® tissue are central to Anteris’s intellectual property advantage. Its unique biochemical composition and processing method make it the only material that can be molded into a true single-piece, three-dimensional valve structure resembling a native aortic valve. Competing anti-calcification materials—such as the RESILIA tissue used in newer iterations of SAPIEN—are not easily moldable into such geometries. Moreover, because ADAPT® is a biochemical material produced through a complex, multi-step process, it is inherently difficult to reverse engineer. Even if competitors manage to replicate the molding capability, Anteris’s patents on the biomimetic valve geometry would still restrict their ability to commercialize similar designs.

KEY OPINION LEADERS

TAVR specialists on the DurAVR® THV:

"The hemodynamics of this valve are absolutely stunning."
- Dr. Michael Reardon, MD (TCT discussion, 2022)

"Think about how our patients are benefiting from this...The ability now to think that we could treat younger people with bioprosthetic valves with the hope that it might be the only valve they ever need, with hemodynamics that simulate a normal valve. It's pretty mind-boggling."
- Dr. Martin Leon, MD (TCT discussion, 2022)

"It's pretty much a slam dunk for older patients."
- Dr. Rebecca Hahn, MD (AVR AGM interview, 2022)

"For other clinicians who have never seen the data, you've just got to be there to look at the valve, look at the leaflet and the numbers. It's quite astounding."
- Dr. Carl Poon, MD (AVR AGM interview, 2022)

"I think there is always a trend in research, people try to follow each other. You need sometimes for someone to come and say that we need to look at things differently. This is why DurAVR is a new concept, which I am sure will have major implications for the future of this therapy."
- Dr. Thomas Modine, MD (TCT discussion, 2022)

"What we are seeing is single digit mean gradients and EOAs above 2 for intra-annual technology in small annuli. And I have not seen that with any technology thus far."
- Dr. Azeem Latib, MD (PCR discussion, 2023)

[Re. valve-in-valve] "I was searching for a valve that would be a short frame valve, but I wanted to give the patient a good hemodynamic result. And I had concerns in a smaller surgical valve that I wasn't going to get that with the commercially available balloon-expandable short-frame...One of the attractive features of the DurAVR is the short frame, the windows are large, the coronary access is preserved...but it's really the superior hemodynamics - the single-leaflet construction, no suture lines, and really being able to put an intra-annular prosthesis in place in a short frame but then giving a good hemodynamic result and being able to get back in the coronaries...Initially on the table post valve deployment we had a mean gradient of 7. The following day on trans-thoracic echo we had a mean gradient of 13. So in a small Trifecta with a balloon expandable intra-annular valve, that's spectacular...It's certainly as good as the results we've seen with the supra-annular valves that we've used. Actually even better I would say."
- Dr. Anita Asgar, MD (PCR interview with Vinayak Bapat, MD, 2023)

“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical. The latest results we are seeing with the balloon-expandable DurAVR valve are impressive, showing restoration of laminar flow, favorable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population.”
- Dr. Rishi Puri, MD, PhD, Coronary and Structural Interventional Cardiologist at the Cleveland Clinic, (AVR ASX Announcement, 29 October 2025)

"The DurAVR® THV demonstrated high rates of technical and device success with encouraging 30-day hemodynamic outcomes, including very low PPM in small annuli patients. These results reflect a unique balance of balloon-expandable benefits characterised by high device success and low pacemaker rates, combined with a hemodynamic profile typically associated with self-expanding platforms.”
- Dr. De Backer, MD, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

MARKET SIZE AND CONCENTRATION

The TAVR market is expected to reach $9.9bn in 2028. It is an under-penetrated market, with only 15-20% of severe aortic stenosis patients treated today (Gahl, et al).

The U.S. TAVR procedure volume is heavily concentrated in a relatively small group of high-volume centres. Data from the STS/ACC TVT Registry indicate that in 2023 the U.S. recorded 100,501 commercial TAVR procedures across 838 sites, with major specialist hospitals performing “many hundreds” of cases annually—for example, Cleveland Clinic reports roughly 700 TAVRs per year. Similarly, 2019 registry data show 72,991 procedures across 715 sites, with an average of only 84 TAVRs per site, and more than 160 hospitals performing fewer than 50 cases. Together, these data demonstrate a long-tailed distribution: while many hospitals offer TAVR, a minority of specialist centres perform disproportionately large volumes.

This concentration is even clearer in state-level analyses. A multi-state study covering eight U.S. states found that by 2017, low-volume TAVR sites (<50 cases/year) accounted for 39% of hospitals but performed only 14% of all TAVR procedures, meaning roughly 60% of centres performed about 86% of the total volume. High-volume programs, often defined as ≥300 cases per year, represent only a small fraction of total sites, yet collectively handle a large share of procedures. This structural concentration has important commercial implications: Anteris does not need to deploy large, nationwide salesforces to access most of the U.S. TAVR opportunity. Focusing on the leading high-volume centres captures the majority of procedural demand.

Importantly, Anteris has already established relationships with key figures at these high-volume centres — for example, Dr. Michael Reardon, a cardiac surgeon and internationally recognised leader in TAVR, serves as co-chair of the company’s pivotal PARADIGM study, while Dr. Martin Leon, one of the most influential figures in structural heart intervention, sits on Anteris’s Global Medical Advisory Board. These affiliations provide both clinical credibility and strategic access to the limited number of sites that dominate U.S. TAVR procedure volume.

FDA PIVOTAL TRIAL (PMA): PARADIGM

The PARADIGM trial is a prospective, randomized, controlled, multicenter, international study evaluating the safety and effectiveness of the DurAVR® THV. Up to 1,054 patients with severe calcific aortic stenosis will be enrolled in the All Comers Randomized Cohort. Participants will be randomized 1:1 to receive either the DurAVR® or a commercially available device from the SAPIEN or Evolut™ series, with outcomes tracked over a 10-year follow-up period.

APPENDIX: CLINICAL DATA

SOURCES

Cavalcante J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression: update from First-in-Human (FIH) Study with novel DurAVR Transcatheter Heart Valve. Oral Presentation at: New York Valves; June 2024; New York, New York, USA.

Gahl B, Celik M, Head S, et al. Natural History of Asymptomatic Severe Aortic Stenosis and the Association of Early Intervention With OutcomesA Systematic Review and Meta-analysis. JAMA Cardiol. https://jamanetwork.com/journals/jamacardiology/fullarticle/2768167

Garg P, Markl M, Sathananthan J, Sellers S, Meduri C, Cavalcante J. Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention. Nature Reviews Cardiology. https://www.nature.com/articles/s41569-023-00943-6

Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010 Oct 21

Neethling W, Rea A, Forster G, Bhirangi K. Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, Front Pediatr, 2020;8:198

Puri, R. DurAVR: A Novel First-in-Class Biomimetic Transcatheter Aortic Valve 1-Year Performance. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.

Vemulapalli, S., et al. “Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.” The New England Journal of Medicine, 2019. DOI:10.1056/NEJMsa1901109

Waggoner T. DurAVR Biomimetic Transcatheter Heart Valve: Early Feasibility Study (EFS) Update. Oral Presentation at: CRT Conference; March 2024; Washington, USA.

Anteris DurAVR® THV Demonstrates Favorable Hemodynamics in Small Annuli Patients with no Valve Related Mortality at One Year, 29 October 2025, Anteris ASX Announcement

How and Why Volumes Matter in Aortic Valve Replacement. Consult QD, 22 Jan 2025, Cleveland Clinic. https://consultqd.clevelandclinic.org/how-and-why-volumes-matter-in-aortic-valve-replacement

Report Finds TAVR is Dominant Form of Aortic Valve Replacement; Outcomes Steadily Improving in the U.S. ACC press release, 16 Nov 2020, American College of Cardiology. https://www.acc.org/about-acc/press-releases/2020/11/16/18/53/report-finds-tavr-is-dominant-form-of-aortic-valve-replacement-outcomes-steadily-improving-in-the-us

Transcatheter Heart Valve Replacement Market Size and Share Forecast Outlook 2025 to 2035. https://www.futuremarketinsights.com/reports/transcatheter-heart-valve-replacement-tavi-market

Image credits: Anteris Technologies, Edwards Lifesciences

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