Anteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial

Anteris Technologies (NASDAQ: AVR) secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services national coverage policy.

Rhea-AI Summary

Anteris Technologies (NASDAQ: AVR) secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services national coverage policy.

Eligible procedures at participating U.S. study sites are covered under the TAVR National Coverage Determination 20.32, using a Coverage with Evidence Development (CED) model to enable reimbursement while generating clinical evidence and support U.S. site activation.

Positive

• CMS national coverage for PARADIGM under TAVR NCD 20.32
• Medicare reimbursement eligibility supports U.S. site activation
• CED framework enables reimbursement while collecting clinical evidence
• Expected acceleration of operational momentum across participating centers

Negative

• Coverage applies only to eligible procedures at participating U.S. study sites
• Reimbursement is conditional on evidence generation under the CED model

Argus Apr 28 session

+0.35% close to close Open Argus

Details

News Market Reaction – AVR

In the Apr 28 session, AVR gained 0.35%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights CMS reimbursement eligibility under TAVR National Coverage Determinatio...

Analysis

This announcement highlights CMS reimbursement eligibility under TAVR National Coverage Determination 20.32 for PARADIGM Trial procedures at U.S. sites, which supports broader activation and evidence generation. In context of recent capital raises and Medtronic’s involvement, it represents another step toward executing the pivotal program. Investors may watch enrollment progress, future regulatory interactions, and any updates on trial scale or timelines as key milestones.

Key Figures

National Coverage Determination: 20.32

National Coverage Determination

20.32

CMS TAVR coverage policy applied to PARADIGM Trial procedures

Historical Context

5 past events · Latest: Feb 26

5 events

1. Feb 26

   Earnings & update

   24h Move

   +2.7%

   Reported weaker 2025 results and higher losses while updating DurAVR and PARADIGM.

2. Feb 23

   Conference appearances

   24h Move

   +8.4%

   Announced CEO presentations at TD Cowen and Barclays investor conferences.

3. Jan 22

   Strategic investment

   24h Move

   -1.7%

   Closed $90M Medtronic strategic investment as part of $320M funding package.

4. Jan 22

   Equity offering close

   24h Move

   -1.7%

   Closed $230M public offering and Medtronic private placement at $5.75 per share.

5. Jan 20

   Equity offering price

   24h Move

   +5.4%

   Priced $200M public offering and outlined Medtronic private placement terms.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

centers for medicare & medicaid services, cms, national coverage determination, coverage with evidence development, +2 more

6 terms

centers for medicare & medicaid services regulatory

"reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services"

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

cms regulatory

"Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy."

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that sets rules, payment rates and coverage decisions for major public health insurance programs; think of it as both a giant insurer and the rulebook maker for how many healthcare providers and drug makers get paid by government programs. Its policy changes and reimbursement decisions can materially affect revenue, profit forecasts and valuations for hospitals, insurers, device makers and drug companies, so investors watch CMS announcements closely.

national coverage determination regulatory

"are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32."

A national coverage determination is a federal decision that establishes whether a government health insurer will pay for a specific medical test, treatment, device, or service across the entire country. Think of it like a nationwide rule that tells doctors, hospitals and patients whether that category of care will be covered; for investors, such a decision can quickly expand or limit market access, reimbursement rates, and revenue potential for manufacturers and healthcare providers.

coverage with evidence development regulatory

"The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbur"

Coverage with evidence development is a conditional reimbursement policy where a payer agrees to pay for a medical test, device, or treatment only while additional data are collected to prove it works, is safe, or is cost-effective. For investors, this acts like provisional market access—sales can begin but long-term reimbursement and widespread adoption depend on the results of the required studies, so future revenue and valuation hinge on positive evidence.

transcatheter aortic valve replacement medical

"are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determin"

A minimally invasive procedure that replaces a damaged aortic heart valve by guiding a folded replacement valve to the heart through a thin tube (catheter) inserted in a blood vessel, avoiding the need for open‑chest surgery. It matters to investors because it shapes demand for medical devices, hospital services and reimbursements, impacts patient recovery times and complication rates, and can materially influence sales, margins and regulatory risk for device makers and healthcare providers — like swapping a worn door using a narrow hallway instead of tearing down a wall.

tavr medical

"under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32."

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that replaces a failing aortic heart valve by delivering a new valve through a blood vessel instead of opening the chest. It matters to investors because TAVR expands who can be treated, shortens hospital stays and recovery, and shapes revenue, regulatory risk and reimbursement for medical device makers, hospitals and insurers—similar to how a popular new product can reshape an industry’s market and costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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MINNEAPOLIS and BRISBANE, Australia, April 28, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced it has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32.

The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbursement with clinical evidence generation in the PARADIGM Trial. This milestone is expected to facilitate U.S. site activation, accelerating operational momentum across participating centers.

About the PARADIGM Trial

The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR^® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs).

This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR^® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

For further information, please refer to ClinicalTrials.gov NCT07194265.

About Anteris

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR^® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR^® THV is made using a single piece of molded ADAPT^® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT^® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR^® THV System is comprised of the DurAVR^® valve, the ADAPT^® tissue, and the balloon-expandable ComASUR^® Delivery System.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements regarding the expectation that achievement of the milestone will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

For more information:

Global Investor Relations	Investor Relations (US)
investors@anteristech.com	mchatterjee@bplifescience.com
Debbie Ormsby	Malini Chatterjee, Ph.D.
Anteris Technologies Global Corp.	Blueprint Life Science Group
+61 1300 550 310 | +61 7 3152 3200	+1 917 330 4269

Website	www.anteristech.com
X	@AnterisTech
LinkedIn	https://www.linkedin.com/company/anteristech

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does the CMS reimbursement mean for Anteris (AVR) and the PARADIGM Trial?

It means Medicare will cover eligible PARADIGM procedures at participating U.S. sites, enabling site activation. According to Anteris, coverage is provided under TAVR NCD 20.32 and uses a CED model to reimburse while clinical evidence is collected for the trial.

Which CMS policy covers PARADIGM procedures for Anteris (AVR)?

PARADIGM procedures are covered under the Transcatheter Aortic Valve Replacement National Coverage Determination 20.32. According to Anteris, this national coverage policy applies to eligible procedures performed at participating U.S. study sites.

Will CMS reimbursement speed up U.S. site activation for AVR's PARADIGM Trial?

Yes; reimbursement is expected to facilitate U.S. site activation and operational momentum. According to Anteris, the Medicare eligibility under the CED framework supports activation by covering eligible procedures while evidence is generated.

Does CMS coverage for PARADIGM allow unconditional Medicare payment for all procedures?

No; coverage applies only to eligible procedures at participating U.S. study sites under a CED model. According to Anteris, reimbursement is conditional on conducting the trial and generating clinical evidence per the policy.

How does the Coverage with Evidence Development (CED) model affect AVR's PARADIGM Trial?

CED enables reimbursement while requiring clinical evidence collection as part of the trial, linking payment to study participation. According to Anteris, this framework reimburses eligible procedures and supports data generation for regulatory and clinical assessment.