Anteris (NASDAQ: AVR) boosts DurAVR trial spend and U.S. CMS-backed enrolment
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Anteris Technologies Global Corp. furnished its first-quarter 2026 results, highlighting heavy investment in its pivotal DurAVR heart valve trial. For the three months ended 31 March 2026, net operating cash outflows were $28.7 million, mainly tied to clinical, regulatory and manufacturing work on the Trial.
Research and development expenses were $17.5 million, driven by expanded manufacturing, quality processes, added headcount and clinical costs as more patients were enrolled. The company also reported related-party payments of $2.3 million for director fees and executive compensation during the quarter. The Trial is a ~1,000-patient randomized study comparing the DurAVR transcatheter valve to existing TAVR devices, supported in the U.S. by Medicare and Medicaid coverage under National Coverage Determination 20.32.
Positive
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Negative
- None.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Net operating cash outflows: $28.7 million
R&D expenses: $17.5 million
Related-party payments: US$2.3 million
+2 more
5 metrics
Net operating cash outflows
$28.7 million
Three months ended 31 March 2026, driven by Trial-related spending
R&D expenses
$17.5 million
Q1 2026, tied to manufacturing scale-up, quality and clinical costs
Related-party payments
US$2.3 million
Q1 2026, fees to non-executive directors and executive compensation
Planned Trial enrolment
Approximately 1,000 patients
All Comers Randomized Cohort in DurAVR pivotal Trial
ADAPT tissue clinical use
Over 55,000 patients
Cumulative worldwide clinical use of ADAPT tissue over 10+ years
Key Terms
Transcatheter Aortic Valve Replacement (TAVR), DurAVR Transcatheter Heart Valve (THV), National Coverage Determination 20.32, U.S. GAAP, +2 more
6 terms
Transcatheter Aortic Valve Replacement (TAVR) medical
"procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32"
DurAVR Transcatheter Heart Valve (THV) medical
"evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements"
National Coverage Determination 20.32 regulatory
"Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32"
U.S. GAAP financial
"financial statements which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)"
U.S. GAAP is a set of rules and standards that companies in the United States follow to prepare their financial reports. It helps ensure that financial information is consistent and clear, so investors and others can compare and understand a company's financial health easily.
ADAPT tissue medical
"DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology"
prospective randomized controlled trial medical
"The Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve"
Earnings Snapshot
Net operating cash outflows: $28.7 million
Q1 2026
Net operating cash outflows
$28.7 million
R&D expenses
$17.5 million
Related-party payments
US$2.3 million
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 12, 2026
(Exact name of registrant as specified in its charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrant’s telephone number, including area code: +61 7 3152 3200
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02. |
Results of Operations and Financial Condition.
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On May 12, 2026 USA ET (May 13, 2026 AEST), Anteris Technologies Global Corp. (the “Company”) (i) filed the Form 10-Q for the quarter
ended March 31, 2026 with a cover page (the “Results Announcement”) with the Australian Securities Exchange (“ASX”); and (ii) issued an ASX Announcement regarding the Company’s financial results for the quarter ended March 31, 2026, both of which
include unaudited and other historical financial information for the quarter ended March 31, 2026. The Results Announcement has been prepared for the purpose of complying with the reporting requirements of the ASX. Copies of the Results
Announcement and the ASX Announcement are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to
be filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, unless such subsequent filing specifically
references this Current Report on Form 8-K.
| Item 9.01. |
Financial Statements and Exhibits.
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Exhibits.
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The following exhibits are filed with this Current Report on Form 8-K:
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Exhibit
No.
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Description
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99.1
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Results Announcement, as filed with the ASX, for the quarter ended March 31, 2026
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99.2
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ASX Announcement regarding financial results for the quarter ended March 31, 2026
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
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Anteris Technologies Global Corp.
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Date: May 12, 2026
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By:
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/s/ Wayne Paterson
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Name:
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Wayne Paterson
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Title:
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Vice Chairman and Chief Executive Officer
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Exhibit 99.1
Anteris Announces Results for the First Quarter of 2026
MINNEAPOLIS, United States and BRISBANE, Australia 13 May 2026: 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 reported financial results for the quarter
ended 31 March 2026, and provided a corporate update.
Q1 2026 Highlights
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Completed aggregate capital raises totalling US$320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialisation of the DurAVR®
THV System
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Advanced PARADIGM Trial recruitment, supported by ongoing regulatory and operational work to activate additional countries and sites – post quarter-end, U.S. enrolment commenced
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Presented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026, supporting ongoing scientific
engagement and exchange with the clinical community
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“Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrolment ongoing in Europe and continued progress on key recruitment activities globally. With
the U.S. now on line and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
Business & Operations
Following initiation of our global pivotal trial in Q4 2025, we are seeing continued progress across Europe, and the United States where patient enrolment has recently
commenced.
Clinical centers are advancing through key start up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside
active patient screening and enrolment at activated sites.
In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment by supporting
reimbursement and facilitating site-level adoption. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32.
Collectively, these activities are supporting growing enrolment momentum as additional sites come on line and contribute to trial execution.
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860 Blue Gentian Road, Suite 340
Eagan, MN, 55121 United States
T: +1 651 493 0606
info.us@anteristech.com
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Anteris Technologies Global Corp.
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Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia T: +61 1300 550 310 info.au@anteristech.com
ARBN: 677 960 235 |
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BRISBANE | MINNEAPOLIS | GENEVA | MALAGA
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anteristech.com
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Financial Results
The financial results for Anteris for the quarter ended 31 March 2026, are presented below. All amounts in $ refer to U.S. dollars.
The Company’s net operating cash outflows for the three months ended 31 March 2026, were $28.7 million, attributable to clinical, regulatory and manufacturing
requirements to support the PARADIGM Trial. This clinical focus is reflected in the Company’s operating expenditures, with R&D expenses of $17.5 million driven by the upscaling of manufacturing and quality capabilities, including process design
and validation activities and the expansion of headcount, and activities linked to the PARADIGM Trial, including clinical costs associated with the enrolment of additional patients and the scaling of our field-based clinical team. These were partly
offset by reduced DurAVR® THV product research costs.
Anteris refers to the detailed financial information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks.
ENDS
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 enrol approximately 1,000 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.
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Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage 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.
Authorisation and
Additional information
This
announcement was authorised for release on the ASX by the Board of Directors.
For more information:
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Global Investor Relations
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Investor Relations (US)
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investors@anteristech.com
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mchatterjee@bplifescience.com
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Debbie Ormsby
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Malini Chatterjee, Ph.D.
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Anteris Technologies Global Corp.
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Blueprint Life Science Group
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+61 1300 550 310 | +61 7 3152 3200
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+1 917 330 4269
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| Website | www.anteristech.com |
| X | @AnterisTech |
| https://www.linkedin.com/company/anteristech |
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Exhibit 99.2
Results for announcement to the market
Name of entity: Anteris Technologies Global Corp.
(“ATGC”)
ARBN: 677 960
235
Reporting period: For the quarter
ended 31 March 2026
The attached Form 10-Q Quarterly Report for the quarter ended 31 March 2026 has been filed
with the U.S. Securities and Exchange Commission (“SEC”). It includes the condensed consolidated financial statements which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
and are denominated in U.S. dollars.
The following supplementary information is provided in connection with the Form 10-Q for the purposes of complying with the waiver conditions relating to ASX Listing
Rule 4.7C in relation to quarterly activity reports. This information should be read in conjunction with the Form 10-Q and is provided to satisfy the Company’s ongoing disclosure obligations under the ASX Listing Rules.
Details of business activities during the quarter
Refer to the Form 10-Q and the “Anteris Announces Results for the First Quarter of 2026” announcement lodged with the ASX on 13 May 2026.
Aggregate amount of payments to related parties and their associates
During the first quarter of 2026, the aggregate amount of payments to related parties and their associates was US$2.3 million. The quarterly amount includes fees paid
to non-executive directors, as well as salary, annual incentive bonuses and discretionary bonuses linked to performance of the CEO, President and CFO. These payments were included in cash flows from operating activities.
There were no payments to related parties or their associates included in cash flows from investing activities.
ENDS
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® Transcatheter Heart Valve (“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.
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860 Blue Gentian Road, Suite 340
Eagan, MN, 55121 United States
T: +1 651 493 0606
info.us@anteristech.com
|
Anteris Technologies Global Corp.
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA
 anteristech.com
|
Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia T: +61 1300 550 310 info.au@anteristech.com
ARBN: 677 960 235 |
Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage 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.
Authorisation and Additional information
This announcement was authorised for release on the ASX by the Board of Directors.
For more information:
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Investor Relations
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Investor Relations (US)
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investors@anteristech.com
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mchatterjee@bplifescience.com
|
|
Debbie Ormsby
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Malini Chatterjee, Ph.D.
|
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Anteris Technologies Global Corp.
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Blueprint Life Science Group
|
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+61 1300 550 310 | +61 7 3152 3200
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+1 917 330 4269
|
| Website | www.anteristech.com |
| X | @AnterisTech |
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https://www.linkedin.com/company/anteristech
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2
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FAQ
What did Anteris Technologies Global Corp. (AVR) report for Q1 2026?
Anteris reported first-quarter 2026 results showing net operating cash outflows of $28.7 million, driven mainly by clinical, regulatory and manufacturing spending for its pivotal DurAVR heart valve Trial, and provided a business update on global patient enrolment progress.
How much did Anteris (AVR) spend on R&D in Q1 2026?
Anteris recorded $17.5 million in research and development expenses for Q1 2026. Spending reflected upscaling manufacturing and quality capabilities, adding staff, and clinical costs linked to enrolling more patients and expanding the field-based clinical team for the pivotal DurAVR Trial.
What were Anteris (AVR) operating cash outflows in Q1 2026?
Net operating cash outflows for the three months ended 31 March 2026 were $28.7 million. The company attributes this primarily to clinical, regulatory and manufacturing requirements supporting its global DurAVR transcatheter heart valve Trial across Europe, the United States and other activated study sites.
What is the design of Anteris’ DurAVR pivotal Trial?
The DurAVR pivotal Trial is a prospective randomized controlled study enrolling about 1,000 patients in an All Comers randomized cohort. Participants receive either DurAVR THV or a commercially available TAVR device, with a primary one-year composite endpoint of mortality, stroke and cardiovascular hospitalization.
How does CMS coverage affect Anteris’ U.S. DurAVR Trial?
Centers for Medicare and Medicaid Services coverage under TAVR National Coverage Determination 20.32 applies to eligible procedures at participating U.S. study sites. Anteris expects this reimbursement framework to support patient recruitment and site-level adoption, helping build operational momentum in its DurAVR Trial.