Anteris (AVR) secures EU go‑ahead to start DurAVR clinical trial

Rhea-AI Filing Summary

Anteris Technologies Global Corp. announced it obtained its first European regulatory clearance to commence the DurAVR Transcatheter Heart Valve Global Trial. The company furnished a press release as Exhibit 99.1.

This clearance permits initiation of the DurAVR clinical program in Europe. The information was furnished, not filed, under the Exchange Act and is not incorporated into other securities filings unless specifically referenced.

Insights

Regulatory and Clinical Strategy Analyst

Regulatory clearance in Europe enables DurAVR trial start; milestone advances clinical path but adds execution risk.

Anteris Technologies Global Corp. disclosed its first European regulatory clearance to commence the DurAVR Transcatheter Heart Valve Global Trial on October 15, 2025. This authorization permits trial initiation activities and represents a concrete step in advancing DurAVR’s clinical development.

The milestone is strategically meaningful because trial commencement is a prerequisite for generating clinical data required for later approvals. The disclosure is furnished with a press release (Exhibit 99.1), indicating a communications update rather than a change to previously filed financial statements. It signals progress but not product approval, commercial rights, or safety/efficacy outcomes.

Key watch items: trial site activation and first patient enrollment timing in Europe; additional clearances that may be needed for other geographies referenced by the term “Global Trial”; and any protocol details or interim data shared in future reports. Monitor subsequent company updates for concrete operational markers, including specific country authorizations and trial milestones over the next few quarters.

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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): October 15, 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, QLD 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 October 15, 2025, Anteris Technologies Global Corp. (the “Company”) issued a press release regarding the Company obtaining its first European regulatory clearance to commence the DurAVR^® Transcatheter Heart Valve Global Trial.

The information 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 (the “Securities Act”) 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 dated October 15, 2025.
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: October 15, 2025
	By:	/s/ Wayne Paterson
	Name:	Wayne Paterson
	Title:	Vice Chairman and Chief Executive Officer

FAQ

What did Anteris (AVR) announce?

The company obtained its first European regulatory clearance to commence the DurAVR Transcatheter Heart Valve Global Trial and furnished a press release.

What is DurAVR in the Anteris (AVR) update?

DurAVR is the company’s transcatheter heart valve platform that will be studied in a global clinical trial.

Is this a marketing approval for Anteris (AVR)?

No. The disclosure states a regulatory clearance to commence a clinical trial in Europe, not a marketing authorization.

Where can I find the detailed announcement from Anteris (AVR)?

See Exhibit 99.1, the press release dated October 15, 2025.

On which exchange does Anteris (AVR) trade?

Common stock trades on The Nasdaq Global Market under the ticker AVR.

Was the Anteris (AVR) announcement filed or furnished?

It was furnished and is not deemed filed under the Exchange Act unless specifically incorporated by reference.