[8-K] Anteris Technologies Global Corp. Reports Material Event

Anteris Technologies Global Corp. furnished a Regulation FD update via Form 8‑K announcing that the U.S. FDA approved its DurAVR® Transcatheter Heart Valve Global Pivotal Trial, known as the PARADIGM Trial.

Rhea-AI Filing Summary

Anteris Technologies Global Corp. furnished a Regulation FD update via Form 8‑K announcing that the U.S. FDA approved its DurAVR® Transcatheter Heart Valve Global Pivotal Trial, known as the PARADIGM Trial. The company attached the related press release as Exhibit 99.1, and the information was furnished, not filed, under the Exchange Act.

Insights

Medtech regulatory analyst

FDA cleared Anteris to run a pivotal trial for DurAVR THV.

The company reports FDA approval for its DurAVR THV Global Pivotal Trial (PARADIGM). A pivotal trial is typically designed to support a marketing submission if successful, but this announcement pertains to trial approval rather than product approval.

The disclosure was furnished under Item 7.01, indicating informational purposes. Concrete impacts will depend on trial execution and outcomes; these details were not included in the excerpt.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

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

What did Anteris Technologies Global Corp. (AVR) announce?

The company announced U.S. FDA approval for its DurAVRae THV Global Pivotal Trial, the PARADIGM Trial, via a Regulation FD 8-K.

Which regulatory filing did AVR use for this announcement?

Anteris used a Form 8-K under Item 7.01 (Regulation FD Disclosure).

What exhibit accompanies the AVR 8-K?

Exhibit 99.1 is a press release titled: "FDA Approves Anteriss DurAVR ae THV Global Pivotal Trial (the PARADIGM Trial)."

Does the 8-K indicate the information is filed or furnished?

The information is furnished, not filed, under the Exchange Act.

What is the product involved in AVR's update?

DurAVRae Transcatheter Heart Valve (THV).

On which market does AVR trade?

AVR trades on The Nasdaq Global Market.

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

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 11/03/2025 - 07:45 AM Learn about SEC filing dates

false000201151400020115142025-11-032025-11-03

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): November 3, 2025

Anteris Technologies Global Corp.

(Exact name of registrant as specified in its charter)

Delaware	001-42437	99-1407174
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, Queensland Australia	4066
(Address of Principal Executive Offices)	(Zip Code)

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:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		AVR		The Nasdaq Global Market

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 7.01.          Regulation FD Disclosure

On November 3, 2025, Anteris Technologies Global Corp. (the “Company”) lodged a press release, regarding the Company obtaining approval from the U.S. Food and Drug Administration (“FDA”) for the Company’s DurAVR^® Transcatheter Heart Valve (“THV”) Global Pivotal Trial (the “PARADIGM Trial”). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Current Report on Form 8-K, including the exhibit 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.

(d) Exhibits.

The following exhibits are filed with this Current Report on Form 8-K:

Exhibit No.		Description
99.1		Press Release: FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	Anteris Technologies Global Corp.
Date: November 3, 2025
	By:	/s/ Wayne Paterson
	Name:	Wayne Paterson
	Title:	Vice Chairman and Chief Executive Officer